EAS Instructs at FDLI Educational Events

EAS Senior Director for Food Consulting Services, Allen Sayler will present a lunch-time seminar for FDLI’s Law Over Lunch program on September 17 at DLA Piper in Washington D.C.. Allen’s topic, Recent FDA and CDC Human Illness Investigations, Recalls & Enforcement Actions – Trends and Lessons Learned is open to FDLI members only.

Additionally, two of our experts in food and dietary supplement labeling are speaking at FDLI’s Intro to Food Law and Regulation on September 24-25, 2019 at Crowell Moring in Washington, D.C.. Gisela Leon will present an Introduction to Food Law and Regulation and Andrea Yablunosky will instruct Food Labeling, Nutrient Content and Other Claims. EAS is pleased to be a frequent contributor to numerous FDLI educational programs on a variety of product areas.

Finally, James Hoadley, Ph.D., will teach a session on FDA Food Labeling for an FDLI seminar presented at CFSAN, on September 12, 2019.

EAS to Present Webinar on Prior Notice of Imported Foods for NCBFAA

EAS Independent Consultant Angel Suarez will present a webinar on October 8, 2019 for the National Customs Brokers and Forwarders Association of America (NCBFAA). Discussing the Roles of Import Divisions Review and Compliance, Angel will share insights from his many years of experience as a Supervisor Consumer Safety Officer with FDA where he had responsibility of import enforcement in areas of seafood and Low-Acid Canned Food (LACF) as well as foreign inspections, warning letters, detentions, import alerts, import bulletins, and sample collections. Registrations are being taken by NCBFAA directly. Please visit their website to learn more.

Crane to Instruct CHPA OTC Academy Courses

Independent Advisor for OTC Drugs and Labeling, Susan Crane, will be an instructor at the October 28-29, 2019 Consumer Healthcare Products Association (CHPA) OTC 101 Seminar followed by an October 30 Monograph Workshop in Wilmington, DE. EAS has been a proud participant in OTC Academy educational events for a number of years. Registrations are being taken directly through CHPA.

Register for Upcoming EAS Webinars on Food Defense, Effective Expert Witness Techniques and QMS

Register now for the EAS complimentary webinar Food Defense – Untangling Challenges and Strengthening Opportunities, presented by Independent Advisor for FSMA, Charles Breen and Independent Consultant, Kathy Knutson, Ph.D. which will be held September 12, 2019, at 1 pm eastern. Food Defense is increasingly a worry for firms as our global business climate opens opportunities for intentional harm both domestically and overseas. Charles and Kathy will help food manufacturers understand how to identify and mitigate the impact of intentional attacks that compromise food safety.

On September 25 George Yanulis D.Eng. will present a webinar focusing on the medical device Quality Management System transition from CFR 820 to the ISO 13485:2016. Dr. Yanulis will discuss reasons behind the change as well as some of the more technically challenging areas of ISO compliance. Join George by registering here.

Ronald Levine, EAS Independent Consultant and General Counsel with Herrick Feinstein LLP will present a webinar on considerations for becoming an expert witness on November 6, 2019, at 1 pm​. Ron’s has decades of experience preparing expert witnesses in a variety of legal cases focusing on compliance with FDA regulations. Ron’s complimentary webinar will help those interested in exploring a career as an expert witness understand the expectations and those already acting in an expert witness capacity to strengthen their skills. Register here.

Expert Witness Training Set for November 6 in Alexandria, VA

EAS Independent Consultant and General Counsel with Herrick Feinstein LLP, Ronald J. Levine, will present a one-day intensive seminar on understanding the requirements and expectations of becoming a strong expert witness and will be joined by EAS Independent Advisor for Label and Claims, Betty Campbell. With more and more matters finding their way to the courts, in many cases the expert witness reports and testimony can provide the key pieces of information to make or break a case. Ron will share his expertise and help participants hone their skills on developing reports and testimony as well as how to build their resume. Join Ron and Betty in Alexandria, VA on November 6 (register early as seating is limited) or attend the training remotely. More information can be found here.

EAS Webinar on Food Defense – Untangling the Challenges and Strengthening Opportunities

EAS Independent Advisor for FSMA, Charles Breen and Consultant Kathy Knutson, Ph.D. will co-present a webinar on Food Defense on September 12, 2019 at 1pm eastern. Food Defense is increasingly a worry for firms as our global business climate opens opportunities for intentional harm both domestically and overseas. The ability of food manufacturers to identify and mitigate the impact of intentional attacks that compromise food safety is not only required as part of the Food Safety Modernization Act (FSMA) it makes good business sense to protect consumer health and brand reputation. Join Charles and Kathy for this complimentary webinar by registering here.

GRAS Submissions of Food Safety Webinar Announced

EAS Independent Consultants and Toxicologists, Robin Guy and Robert Kapp will present a discussion on the challenges and pitfalls of successful GRAS submissions. GRAS, or Generally Recognized as Safe, is a designation granted by FDA for food ingredients. It can take years of safety studies and thorough documentation before a GRAS designation is warranted so understanding the requirements is essential for streamlining the process.

Join Robin and Bob on August 22 at 1 pm eastern for an informative discussion on GRAS and how you can increase your chances for a successful submission the first time. Register today!

Risks to OLDs Discussed in Natural Products Insider

Natural Products Insider

Independent Consultant Bruce Elsner discussed considerations of Own Label Distributors for the assurance of GMP compliance and certificates of analysis in Natural Products Insider. Dietary supplement companies that contract out some or all their operations often fail to consider how little they know about the operations of those providing the contracted services and thus may be taking significant risks, he says.

Warehousing Compliance and FSMA Reviewed in Food Safety Strategies

Food Safety Strategies

The requirement to comply with FSMA is well understood for food manufacturers, and there are no exceptions for warehousing facilities. FDA inspections of facilities that receive, store and distribute human or animal food can occur at any time and firms must be prepared for such an inspection 24 hours a day. Jerry Heaps discusses ways warehousing facilities can and should stay on top of FSMA requirements in Food Safety Strategies.

Register for EAS Webinar on FDA Inspections in India

Independent Consultant, Sophia Lily, is expert of pharmaceuticals who is based in India will present a webinar on how to prepare for FDA facility inspections, including a look at recent FDA observations and trends. Understanding how gaps may be addressed before FDA knocks on your door will lead to a safer consumer product as well as a smoother inspection process. Join Sophia Lily on July 24 at — eastern and — Indian Standard Time. This webinar is conveniently timed for our overseas audiences. Register today!

EAS Offers Dairy 101 at Process Expo

Process Expo

EAS will bring its popular Dairy Processing 101 seminar to the Process Expo in Chicago, October 8-11, 2019. This full day event covering an overview of the US dairy industry will include the impact of dairy farm practices on the quality and composition of raw milk; how raw milk and dairy product prices are established; an appreciation of government requirements for dairy plants including FSMA’S PCHF regulation; exposure to milk chemistry and microbiology (including dairy cultures); an in-depth overview of dairy processing technologies related to milk beverages, cheese, yogurt, ice cream, as well as hands-on practical knowledge of dairy laboratory testing systems and capabilities. Registrations are being taken by Process Expo.

EAS to Offer Training on Expert Witness Preparations

As highly regulated industries are subject to more claims and litigations, and with growing agency challenges to ingredients, processes and branding, the target company’s regulatory compliance is often a key issue in presenting a successful defense. An expert witness’ opinion, report and testimony will play an essential role in mounting the response. Join EAS Consulting Group’s Independent Consultant and General Counsel at Herrick Feinstein LLP, Ronald J. Levine, for a one-day seminar on the role, expectations and skills for being an effective expert witness. Serving as an expert can be a part-time or full-time career. Whether you are just starting as an expert, or are looking to improve your skills, this seminar is meant to help to arm you for the important role you will be playing. We will also be discussing how to craft your resume and promote yourself with an aim of increasing opportunities to serve as an expert. [Add hyperlink when ready]

Next Dietary Supplement GMP Refresher Training in Andover, MA

EAS’ next Dietary Supplement GMP Refresher Training takes place August 13, 2019 in Andover, MA. Taught by Independent Consultant Tamika Cathey, this one-day intensive training is designed and priced so that firms can outsource their GMP training requirements to EAS. Conveniently located around the country, following the August training in Massachusetts, the fall GMP Refresher training will take place in Long Island November 12, 2019. Visit the EAS website for more information on the August 13 GMP Refresher training in Andover and the November 12 GMP Refresher training in Long Island.

EAS Presents cGMP Workshop at AHPA Hemp-CBD Supplement Congress

AHPA Logo

EAS Senior Director for Dietary Supplements and Tobacco Services, Tara Lin Couch, Ph.D. will present a workshop on cGMPs for dietary supplements along with attorney Marc Ullman of Rivken Radler, LLP at the upcoming American Herbal Products Association Hemp-CBD Supplement Congress in Denver, August 14-15, 2019. This event, focused on the challenges and opportunities of marketing hemp and CBD in dietary supplement products, will provide critical information for companies navigating the rapidly evolving legal, regulatory and financial landscapes to manufacture and market dietary supplement products with hemp or hemp-derived ingredients like CBD. For more information and to register visit the AHPA webpage.

Join EAS for Complimentary Webinars

EAS will host two complimentary webinars in June. First, on the 18th, EAS Independent Consultant Mehrdad Tajkarimi, Ph.D. teams up with Leann Chuboff from SQFI for a webinar on understanding the food fraud puzzle. This webinar is co-sponsored by Food Safety News magazine and will be held at 1pm eastern. Register here.

On June 20, also at 1pm eastern, Senior Director for Pharmaceuticals and Devices, Bryan J. Coleman, will present on GMPs for OTCs with suggestions for how to improve compliance as FDA ramps up enforcement and inspections. With more than 80 therapeutic categories, OTC drug products play an ever-increasing role in health care and manufacturers must recognize that the FDA applies the same, stringent 21 CFR 210 and 211 drug GMP standards to OTC products. Register for the GMPs for OTCs webinar here.

Couch to Speak at the ACI – CRN Legal, Regulatory and Compliance Forum

Tara Couch will also speak at the ACI – CRN Dietary Supplement Legal, Regulatory and Compliance Forum taking place June 18-20, 2019 in New York City. Tara will present as part of a panel called Coattails, Master Files, and NDIs which will be held on June 18 and will be analyzing the latest statements and activities from FDA with regard to NDI systems and guidance that would help protect the manufacturers’ significant investment in developing new dietary ingredients; comparing similarities with FDA’s proposals for NDIs to similar proprietary systems enforced by FDA; and exploring mechanisms for FDA enforcement.

EAS Exhibiting at Future Food Tech

EAS Senior Director for Food Consulting Services, Allen Sayler and Independent Consultant, Ron Levine, will represent EAS at Future Food Tech – NYC taking place June 18-19, 2019 in New York City. Stop by the EAS booth to learn more about our services for food innovators such as product development and labeling, food additive submissions for new ingredients, claims substantiation and more.

Fairman Authors Supply Chain Transparency and Quality Assurance Articles for Natural Products Insider

EAS Independent Consultant Heather Fairman authored two recent articles for Natural Products Insider. First, Supply Chain Transparency on the demand by consumers and regulators for supply chain transparency from farm to fork. Next, Quality Assurance for manufacturers of nutrition bars. In addition to consulting for EAS, Heather is a technical advisor for the Small Island Developing States (SIDS) DOCK Island Women Open Network (IWON, sidsdock.org), an intergovernmental organization.

Cathey on Creating Dietary Supplement Specifications

Tamika Cathey was a guest columnist for Ask the Expert in Tablets and Capsules Solid Dose Digest where she responded to the question of creating a dietary supplement specification program that meets FDA expectations. In June 2007, the FDA published 21 CFR Part 111, which established cGMP requirements for dietary supplements. Since then, manufacturers have struggled to understand and comply with these requirements regarding specifications development.

EAS Blogs on Proposed Efficiencies in Pharma Manufacturing

EAS regulatory intern Neha Mookuparambil authored a blog for ISPE iSpeak on FDA’s Proposed Approach to Improve Efficiencies for the Advancement of Pharma Manufacturing through Continuous Manufacturing. The FDA has been pushing for advanced manufacturing processes in the pharmaceutical industry. The efficiency, consistency, reliability and ease with adoption of CM could provide for cost benefits and timely supply of drugs.

Couch to Present at World Tea Expo

Tara Lin Couch, Ph.D., Senior Director of Dietary Supplement and Tobacco Services will present a session on “Dietary Supplements or Food – What is Tea?” at the World Tea Expo which is being held June 10-13, 2019 in Las Vegas. With the enforcement of provisions under FSMA and FDA’s dedicated review of ingredients it considers to be DSHEA, understanding how to market teas, powders and botanicals has never been more critical. Join Tara on June 12, 2019 for her presentation.

EAS to Exhibit at IFT Annual Meeting

Join EAS Chairman and CEO, Ed Steele, President and COO, Dean Cirotta and Director of Labeling and Cosmetics, Cathryn Sacra at the EAS booth #424 on June 3-5, 2019 at the IFT Annual Meeting in New Orleans. Discuss regulatory needs pertaining to foods and dietary supplements and learn how EAS can assist your firm. Interested in registering for our fall food and dietary supplement compliance seminars? Stop by the EAS booth to pick up our special IFT registration discount code.

Sayler Interviewed for Food Processing Magazine Article on Trump’s Effect on Food Industry

EAS Senior Director for Food Consulting Services, Allen Sayler, was interviewed for an article published in Food Processing Magazine on the regulatory state of the food industry under the Trump administration. Published during Scott Gottlieb’s tenure as FDA commissioner, Sayler discussed how Gottleib appeared to have the full confidence of the Trump administration. EAS continues to monitor Agency updates under the acting commissioner, Norman Sharpless.

Coleman to Present at CHPA Regulatory and Scientific Affairs Committee Meeting

Senior Director for Pharmaceutical and Device Consulting Services, Bryan Coleman, will speak on recent inspection trends for cosmetic to OTC crossover products at the upcoming CHPA Regulatory and Scientific Affairs Committee Meeting on May 20 in Bethesda, MD. In addition, EAS is a proud sponsor of the Regulatory and Scientific Quality conference which takes place May 21-22, also in Bethesda.

EAS to Sponsor, Exhibit and Participate on Panel at Upcoming FDLI Annual Meeting

EAS is a proud sponsor of the FDLI Annual Conference, taking place in Washington, D.C. May 2-3. In addition, Senior Director Tara Couch will be participating in a breakout session on day one covering a status update on Modified Risk Tobacco Applications. Also in attendance at the conference, Allen Sayler, Senior Director for Food Consulting Services and Cathryn Sacra, Director of Labeling and Cosmetics Cosmetic Consulting Services. Stop by the EAS table to learn more about our services.

510(k) Guidance and Substantial Equivalence Discussed in MedTech Intelligence

Independent Consultant, Jay Mansour, discussed the movement away from substantial equivalence in favor of performance testing for the 510(k) application process in a recent MedTech Intelligence. “Expanding on the Abbreviated 510(k) Program for demonstrating substantial equivalence for 510(k) premarket submissions, FDA is identifying certain “well understood” medical devices that may be cleared based on performance criteria,” he says.

Insider Podcast on 25 Years of DSHEA Features Senior Director, Tara Lin Couch, Ph.D.

Tara Lin Couch was interviewed for a Natural Products Insider podcast on her reflections of 25 years of DSHEA. Recorded at SupplySide East, she discusses how the dietary supplement industry, pre-DSHEA, was the “wild, wild west” and that 21 CFR 111, Current Good Manufacturing Practices, completely changed the way the dietary supplement industry operates, with “current” processes adapting as technology advances.

New EAS Complimentary On-Demand Webinars Available

EAS recently presented three complimentary webinars that are now available for on-demand viewing. The first, on the challenges of preparing infant formula notifications presented by EAS Independent Advisor Robert Martin, Ph.D., Independent Consultants Timothy Morck and Robbie Burns and Senior Director for Food Consulting Services Allen Sayler, covered an overview of filing and safety study requirements. It can now be viewed on-demand on the EAS website.

Next, The FSMA Foreign Supplier Verification Program requires a Qualified Individual, who has the pertinent education and on the job experience enabling him or her to perform their duties, overseeing FSVP. EAS Independent Advisors, Charles Breen and Domenic Veneziano presented an overview of the program as well as addressed common questions asked by the exporters of food products into the U.S. marketplace. Find this on-demand webinar here.

Finally, in late March, Susan Crane, EAS Independent Advisor for OTC Drugs and Labeling discussed cosmetics labeling and claims requirements. Those wishing for a deeper dive into Cosmetics Claims regulations are invited to join Norma Skolnik on May 7 for a look at how words do matter when it comes to marketing a product.

The Future of Homeopathy Discussed in ISPE iSpeak blog

ISPE Logo

EAS Independent Advisor for OTC Drugs and Labeling, Susan Crane, published a blog discussing the future of Homeopathy on the International Society of Pharmaceutical Engineering (ISPE) blog page iSpeak. FDA and FTC are taking a more proactive approach to homeopathic drugs indicating that they will be held to the same standard as other products with regard to claims.

Jeffrey Roberts to Discuss 21 CFR Part 11 Compliance with Electronic Signatures

Regardless of the type of industry, if you are regulated by the FDA you are bound by the rules around electronic data integrity. Whether preparing to release a finished batch of material, making decisions on data and information that was created and generated electronically or preparing to file a technical dossier with the FDA; your electronic recordkeeping and other electronic data forms require more than just being available for review and inspection. The FDA requires these sources of evidence to be generated, processed and maintained in a manner that provides complete traceability, prevents unauthorized alteration and requires a verified electronic signature that ensures identity and authenticity. Learn the specifics of Part 11 requirements for electronic signatures with Jeffrey Roberts on May 14, 2019. This complimentary webinar will discuss how record keeping is inclusive of a larger focus on GMPs for electronic records that are created, modified, maintained, archived, retrieved, or transmitted as well the specifics of content that must be included in these records for verification and validation.

Peyton Discusses Continued Confusion Over Hemp Products in Cannabis Industry Journal

Cannabis Industry Journal Logo

Charlotte Peyton, a noted expert in cannabis, has published an article in a recent Cannabis Industry Journal. She discusses FDA’s stance with Hemp, CBD versus Isolates, and good manufacturing practice considerations. You may also wish to view the recent 2018 Farm Bill and the Cannabis Industry webinar presented by Attorney Marc Ullman, Of Counsel with Rivkin Radler and Tara Lin Couch, PhD, Senior Director of Dietary Supplement and Tobacco Services. This webinar is available on-demand on the EAS website.

Join EAS at SupplySide East Booth F152

SupplySideEast logo 2018


Tara Lin Couch, Ph.D. and Independent Consultant Heather Fairman will represent EAS at the upcoming SupplySide East in Secaucus, NJ April 9-10, 2019. This is a great opportunity to meet the EAS team to discuss your questions regarding dietary supplement regulations and how to prepare for cannabis GMPs. If you would like to schedule a meeting at SupplySide East please contact us.

Armstrong Publishes Article on the Delaney Clause in FDLI Update

FDLI Logo

Steve Armstrong, EAS Independent Advisor for Food Law and Regulation, is co-author of an article published in the March 2019 Food Drug Law Institute Update Magazine covering FDA’s recent decision to delist six synthetic ingredients as required by the Delaney Clause, a 60-year-old provision of the Food, Drug, and Cosmetic Act (FDCA) which states, in plain language that FDA may not approve any food additive—even one that is safe—if it is “found to induce cancer” in laboratory animals. Steve hypothesizes as to whether it is time to repeal the Delaney Clause.

Norma Skolnik Presents Webinar on Cosmetic Claims

In the competitive cosmetics world, discerning consumers are carefully considering product purchases to determine which offer the results they are hoping to achieve. In response, the pressure on marketing and labeling teams may entice to push the envelope with regards to product claims. However, words do matter, particularly in the eyes of FDA. Learn how the words used on a cosmetic label can alter the intended meaning of a claim and FDA views on them. Ensure your cosmetic products are labeled and marketed in a compliant manner, offering consumers an accurate understanding of what they can expect and protecting your products from FDA concerns. Join Norma Skolnik on May 7, 2019 for a complimentary webinar and ensure your cosmetic product labeling and claims are compliant with FDA regulations.

EAS Sponsors CHPA Regulatory Scientific and Quality Conference, Coleman to Present

CHPA May 21-21, 2019

EAS is a proud event sponsor for the upcoming CHPA Regulatory Scientific and Quality Conference taking place in Bethesda, MD May 21-22, 2019. In addition, Bryan J. Coleman, Senior Director for Pharmaceuticals and Medical Devices will be speaking on Recent FDA inspection trends in Cosmetic to OTC cross-over products at a special Regulatory & Scientific Affairs Committee meeting which is being held May 20, before the kick-off of RSQ.

EAS to Present on Pharma Data Integrity at CPhI North America

CPHI North America 2018 logo

EAS Independent Consultant, Brian Nadel, is an invited speaker on the subject of Pharma Data Integrity at the upcoming CPhI North America which will be held in Chicago April 30-May 2, 2019. Join Brian for a discussion on the reasons why once FDA considers some of a company’s data to be inaccurate it considers all of their data to be inaccurate. Brian will also discuss methods for ensuring data integrity both now and in the future.

Steve Armstrong to Present at Two Upcoming FDLI Events

Join EAS Independent Advisor for Food Law and Regulation, Steve Armstrong, at the upcoming FDLI Intro to Food Law and Regulation taking place in Washington, D.C., March 19-20, 2019. Steve will be part of an esteemed group of presenters and will discuss Food Safety and Unintended Components and Contaminants of Food. Click here to hear more. In addition, Steve will be speaking again at the FDLI Food Enforcement conference on March 21, 2019. He will be part of a panel discussion on FDA’s FSMA enforcement.

EAS Webinar: Dietary Supplements and FSMA, Fallacy or Fact?

Since the passage of the Food Safety Modernization Act (FSMA) in 2011, dietary supplements are now subject to many aspects of the seven major regulations that were issued by FDA to support enforcement of FSMA. One of the most important of these regulations being 21 CFR 117, Current Good Manufacturing Practice (cGMP) and Hazard Analysis and Risk-Based Preventative Controls for Human Food (PCHF). Which aspects of FSMA’s Preventive Controls for Human Foods, 21 CFR 117, apply to dietary supplements? What about other FSMA responsibilities like FSVP? How does the dietary supplement industry including raw material manufacturers and suppliers, dietary supplement manufacturers, and dietary supplement brand owners avoid enforcement actions?

Join EAS Consulting Group’s FSMA and Dietary Supplement experts Heather Fairman and Maury Bandurraga for an overview of the FSMA regulation and a deeper dive into those aspects which specifically apply to dietary supplements. Register now for our April 16, 2019 webinar at 1:00 pm Eastern.

EAS Webinar – Qualified Individuals – FDA’s Final Link in the Chain of Food Safety and Food Imports

EAS Independent Advisor for Import Operations, Domenic Veneziano and EAS Independent Advisor for FSMA, Charles Breen are collaborating for a complimentary EAS webinar discussing the requirements of a Qualified Individual per FDA requirements. Join us on April 3, 2019, at 1 pm Eastern to learn about this important provision for food importers under the Foreign Supplier Verification Program (FSVP) Final Rule. Part 1 Subpart L, Section §1.503 requires that importers of human and animal food enlist a QI who has responsibility for developing a program and performing each activity to ensure the products they are importing are not adulterated or misbranded and have been produced in accordance with the preventive control regulations for human or animal food or the Produce Safety Rule. FDA has specific expectations of the QI. Does your company meet the mark? Join us for our webinar and learn more about FSVP and EAS services as a QI through this explainer video.

EAS Offers Hygienic “Best” Sanitation Practices for Delivering Safe Snack Foods at SNAXPO

EAS Independent Consultants David Blomquist and Jenifer Kane will present a one-day seminar at the upcoming SNAC International Annual Conference, SNAXPO, March 31-April 2, 2019 in Orlando, FL. The training which takes place on March 31 will provide practical information, “real-world” examples and tips on how to enhance daily operational practices related to improving existing food safety and quality programs for the snack food industry. Focusing on criteria for selecting, installing and maintaining processing equipment and utensils, how to effectively clean processing equipment and more. Participants will gain an appreciation of compliance requirements of the applicable FSMA regulations.

EAS Offers Webinar on Developing New Infant Formula Notification

The submission stage of a New Infant Formula Notification may seem like the beginning of the end of a years-long process of research and strategic development. But, without all the right documentation in place, this last step prior to product launch can be unnecessarily delayed for those companies not well-prepared for the rigors of FDA review and assessment.

Learn the steps to NIFNs as well as the pitfalls and challenges companies face in leading up to the assembling of an Infant Formula dossier. EAS Consulting Group’s experts will walk you through challenges and pitfalls which delay or prevent final FDA approval of this most important nutrient for growing infants. Join Robert Martin, Ph.D., Robert Burns, Ph.D., and Timothy Morck, Ph.D. on April 2, 2019, at 1 pm Eastern for a technical overview of one of FDA’s most challenging applications. Register today and learn more about EAS services in infant formulas in this explainer video.

New EAS Webinar Announced – What Does the Farm Bill Mean for the Cannabis Industry?

The 2018 Farm Bill answered many questions for the cannabis industry, but its message has also been largely misunderstood. Misinterpretations as to the legality of including cannabis as an ingredient in foods, herbal products, and dietary supplements have erroneously lead firms to begin planning and production of illegal products, and, in the case of those which legally include (by state) CBD ingredients there is often little regard or understanding of how to manage the quality, including product specifications for the production of a consistent and safe product.

Join EAS Senior Tara Lin Couch, Ph.D., and special guest, Marc Ullman with Rivkin Radler, LLP on March 13, 2019, at 1 pm Eastern for a dynamic discussion on what the Farm Bill really means for the cannabis industry. What is FDA’s position on cannabis and how are the states managing the patchwork of federal regulations that make this burgeoning industry so confusing? In those cases where companies are legally producing cannabis products, what steps should be taken to implement and improve upon sound quality systems? Register here and learn more about EAS quality systems services for the cannabis industry here. You may also wish to view our CBD and Hemp Regulatory Fact Sheet here.

Last Chance to Register – EAS Food and Dietary Supplement Labeling Seminars

EAS is offering our popular Food and Dietary Supplement Labeling Seminars in Philadelphia March 12-13 and March 14-15, 2019 respectively. Join independent consultants and labeling experts Gisela Leon and Jim Hoadley, Ph.D. for an in-depth look at the various requirements surrounding the development of Nutrition and Supplement Facts Panels, including FDA’s latest requirements. Join EAS for either the Food Labeling Seminar or Dietary Supplement Labeling Seminar, or both! Group discounts for two or more employees are available.

OTC Drug Safety, Innovation, and Reform Act Discussed in Solid Dose Digest

EAS Independent Consultant, Norma Skolnik and Advisor for OTC Drugs and Labeling, Susan Crane, has​ co-written an article on the OTC Drug Safety, Innovation, and Reform Act. Recently published in Solid Dose Digest, the article includes a proposed review and overhaul of the OTC Monograph process, eliminating inefficiencies and allows for better response times to safety concerns. Learn more in Solid Dose Digest and join Susan in Part 2 of her Five-part webinar series on OTC Monographs. Part 1 – an Overview of the OTC Monograph system, is available On-Demand now. Part 2 on OTC Labeling and Listing Requirements takes place on February 27, 2019.

EAS Webinar on Regulatory Challenges of Submitting New Infant Formula Notifications

The submission stage of a New Infant Formula Notification may seem like the beginning of the end of a years-long process of research and strategic development. But, without all the right documentation in place, this last step prior to product launch can be unnecessarily delayed for those companies not well-prepared for the rigors of FDA review and assessment. Learn the steps to NIFNs as well as the pitfalls and challenges companies face in leading up to the assembling of an Infant Formula dossier. EAS Consulting Group’s experts, scientists, and leaders in their fields at FDA and industry will walk you through challenges and pitfalls which delay or prevent final FDA approval of this most important nutrient for growing infants. Join Robert Martin, Ph.D., Robert Burns, Ph.D. and Timothy Morck, Ph.D. for an informative and technical overview of one of FDA’s most challenging applications on April 2, 2019, at 1:00 pm eastern. Reserve your seat today!

Developing VMS Products for Commercial and Compliance Success

EAS independent consultant, Steve Cammarn, is presenting a webinar on considerations for Developing Vitamin, Mineral and Supplement Products for Commercial and Compliance Success. Join EAS February 7, 2019, at 1 pm Eastern where Dr. Cammarn will share principles and techniques for a phased-approach of the development of vitamin, mineral, and supplements products incorporating product design, process development, supply chain establishment, and qualification. Dr. Cammarn weaves together the scientific principles as well as the overarching regulatory requirements that must be met for commercial and compliance success. Join us!

EAS Announces Next GMP Compliance for Laboratories Seminar in Denver

EAS Senior Director for Dietary Supplement Consulting Services, Tara Lin Couch, Ph.D. will instruct the next EAS seminar on Good Manufacturing Practices for Dietary Supplement Laboratories April 23, 2019 in Denver, CO. This one-day intensive program will discuss FDA’s current GMP requirements for Research and Development and Quality Control of Laboratories including physical, analytical, and microbiological laboratories. Topics include analyst training and qualification; the labs’ physical facility and environment; instrument qualification, calibration and maintenance programs and more.

Own Label Distributor Responsibilities Discussed in Natural Products Insider

Senior Director for Dietary Supplement and Tobacco Services, Tara Lin Couch, Ph.D. was interviewed for an article in Natural Products Insider on Own Label Distributors and challenges of industry to establish product specifications. According to FDA data, in fiscal year 2018, about 24 percent of the FDA Form 483 inspection reports cited firms for failing to establish specifications of finished dietary supplements. This issue is clearly a challenge for the industry and one in which OLDs should be well-versed and ensure compliance.

Food Safety Magazine Part II of Series on FSMA Training

Independent Consultant Mehrdad Tajkarimi has published part two of his three-part series in Food Safety Magazine on designing food safety training programs to meet FSMA compliance expectations. Food safety training is critical, not only in meeting FDA requirements, but in protecting consumers and the safety of our food supply. Whether training is designed and hosted in-house or delivered through expert training sources such as EAS, it is important that the content and delivery meet the audience where they are and deliver the information in an easily digestible format.

GMPs Refresher Training – New Dates Announced

EAS has announced a new date for our Riverside, CA GMP One-Day Refresher Training. This California training, now hosted on May 14, 2019, and its sister one-day Refresher trainings in Texas, Massachusetts and New York, are designed to meet the annual requirements many companies have that enable employees to stay current in GMP requirements. EAS is hosting four GMP Refresher trainings around the country in 2019. Please join us and consider outsourcing your company’s Refresher compliance trainings to EAS!

Pharmaceutical GMPs for Safer Products and Swifter Approvals

EAS published a blog on the International Society of Pharmaceutical Engineers’ iSpeak blog on how GMPs and data integrity align for safer products and swifter approvals. FDA has noted that in recent years, findings from pharma facility inspections show increasing challenges with meeting data integrity requirements, which has led to regulatory actions including warning letters, import alerts, and consent decrees.

Steps to Develop Compliant SOPs Discussed in AHPA Report

The December American Herbal Products Association (AHPA) Report (subscription required) included an EAS authored article on steps to develop fully compliant Standard Operating Procedures. Though the development and detail of each SOP is at the discretion of individual companies, they should provide a thorough manual that enables each employee to understand their roles and responsibilities and how to perform and document them with regard to the cGMPs. As current practices evolve, so too should SOPs as they are designed to be living documents, representing best practices and required procedures.

FDA Encourages Innovation and Safety as Part of Medical Device Regulatory Overhaul

EAS authored an article in MedTech Intelligence on FDA’s efforts at encouraging innovation while keeping a close eye on safety as part of a medical device regulatory overhaul. FDA is working to retire outdated predicates for 510(k) submissions as well as improve their post-market surveillance system through a multi-collaborative effort called National Evaluation System for Health Technology (NEST).

Couch Shares Thoughts on Contract Laboratory Best Practices as Part of Insider Q&A

Senior Director for Dietary Supplement and Tobacco Services, Tara Lin Couch, Ph.D. participated in a discussion with other industry leaders on best practices for contract laboratories in a recent Natural Products Insider. Contract labs are often enlisted to certify that products are fully and validly tested, and the relationship with these labs can sometimes be complicated by a lack of provided material and product matrix information to ensure that appropriate, scientifically valid test methodologies are used. Couch and her industry colleagues share thoughts on how to convey expectations and develop agreements.

Join EAS for Complimentary Webinar Series on OTC Monograph Reforms

Join EAS Independent Advisor for OTC Drugs and Labeling, Susan Crane, as she explores the history of OTC Monographs and how OTC drug companies can expect updates to the Monograph system to impact their labels in a webinar series starting January 16, 2019. Part one will discuss the history of OTC monographs and why reforms are necessary. Part two is February 27, 2019 and will discuss understanding the FDA and FTC Labeling and Claim Requirements for Cosmetic and Homeopathic products in the OTC market. The final sessions, with dates to be announced will discuss what makes a drug an OTC and the Monographs Compliance System; and GMP obligations – understanding how the GMPs are Applied and how to prepare for FDA Inspection. Reserve your seat today!

Overcoming Seafood Fraud – a Free EAS Webinar Presented by Tim Hansen

Seafood is largely accepted based on how it is labeled or listed on a menu. This is true for seafood wholesalers, distributors as well as retailers. The financial incentive for unethical practices is huge but measures can be adopted to protect product identity and integrity. Join EAS Independent Consultant and former Director of the Seafood Inspection Program at NOAA, Tim Hansen, for a discussion on various types of fraudulent activity in the seafood industry including where and why fraud can occur in the supply chain. He’ll discuss how seafood operators, buyers, and consumers can protect themselves as well as regulatory issues and possibly short, medium and long-term solutions.

Join Tim on December 18, 2018, at 1:00 pm Eastern for his discussion on Overcoming Seafood Fraud in a complimentary webinar hosted by EAS. Reserve your seat today!

Essential Quality Systems for Own Label Distributors Discussed in Natural Products Insider

Senior Director for Dietary Supplement and Tobacco Services, Tara Lin Couch, Ph.D., has written an article for Natural Products Insider on the intersection of OLD and Quality Systems. “The development and implementation of essential own label distributor quality systems and programs will go a long way to ensure GMP compliance in a contract manufacturer partnership,” she says.

In addition, for those who missed or would like to review the very informative webinar presented by Bruce Elsner, also on OLD responsibilities, it is now available on-demand on the EAS website along with many other complimentary webinars covering a wide range of regulatory topics.

Appendix T Storm is Hitting the Grade A Dairy Industry

Senior Director for Food Consulting Services, Allen Sayler, published an article in Dairy Foods Magazine on FDA’s PMO (Produce Milk Ordinance) new Appendix T, which mirrors FSMA in many ways in that it requires preventive controls for those hazards not already covered in the PMO. This new requirement may well be the dairy industry’s most significant new regulatory challenge for 2019. “One of the major challenges many firms face is the establishment of acceptable written food safety programs and maintenance of required records that demonstrate compliance with Appendix T. The failure of a Grade “A” dairy plant to meet any of these requirements will result in either loss of its Grade “A” designation or a request for the state to remove its Grade “A” designation.”

EAS Schedules Five Part Webinar Series on OTC Monograph Regulations

EAS Independent Advisor for OTC Drugs and Labeling, Susan Crane, will explore the history of OTC Monographs, why reforms are necessary and being undertaken now, and how OTC drug companies can expect those changes to impact their labels in a five-part complimentary webinar series.

Part 1 (January 16, 2019) will cover OTC Drug Monographs, Past, Present and Future and will discuss what a Monograph is, how it is used and how to interpret the different sections of the monograph.

Part 2 (February 27, 2019) will cover OTC Labeling requirements and Drug listings responsibilities.

Last Chance to Register for the EAS and FDA Presentation on New Dietary Fiber Regulations for IFT

We are just days away from the webinar that EAS is co-presenting with FDA for IFT. Declaring Dietary Fiber in Nutrition Information will be presented by Independent Consultant and labeling expert, James Hoadley, Ph.D., Douglas Balentine, Ph.D., Director at FDA’s CFSAN Office of Nutrition and Food Labeling, and Sarah Gebauer, Ph.D., Nutritionist at CFAN. The webinar will take place December 6, 2018, at 9:00 am EST. Registrations are accepted by the IFT. FDA and EAS will join forces to discuss the policy on labeling dietary fiber and unravel challenges facing the food industry as it considers the path forward.

EAS to Exhibit, Present at SupplySide West in Las Vegas

EAS Senior Director for Dietary Supplement and Tobacco Services, Tara Lin Couch, Ph.D., Independent Consultant Heather Fairman and President and COO, Dean Cirotta will represent EAS at the upcoming Supplyside West show November 6-10, 2018 in Las Vegas. You may find EAS at booth #5641. EAS is also well represented in the SupplySide West technical sessions as Tara will discuss Effectively Partnering with a Contract Laboratory as part of a panel on Wednesday, November 7 from 1:30–4:30 pm; and Tara and Heather together will present on Contract Manufacturing scheduled for Saturday, November 10 from 8:30 am–11:30 am. In addition, President and COO, Dean Cirotta will moderate a panel as part of the 7thannual AHPA Botanical Congress in Cooperation with ABC on how 21 CFR 111 applies to the Dietary Supplement industry.

EAS to Present Two Sessions at Food Safety Consortium

EAS will be presenting two sessions at the upcoming Food Safety Tech’s Food Safety Consortium taking place November 13-15, 2018 in Schaumburg, IL. Independent Consultant Andrea Yablunoksy will present on Recall Readiness: Understanding Requirements, Similarities & Differences in a USDA and FDA Program and Kathy Knutson, Ph.D. will discuss Lessons Learned in Food Safety and Applied to Cannabis-infused Edibles as part of the Cannabis Quality track. Both presentations take place on November 15th.

Overcoming Seafood Fraud – a Free EAS Webinar Presented by Tim Hansen

Seafood is largely accepted based on how it is labeled or listed on a menu. This is true for seafood wholesalers, distributors as well as retailers. The financial incentive for unethical practices is huge but measures can be adopted by processors, wholesalers, and retailers to protect product identity and integrity. Join EAS Independent Consultant, and former head of NOAA Fisheries, Tim Hansen, for a discussion on various types of fraudulent activity in the seafood industry including where and why fraud can occur in the supply chain. He’ll discuss how seafood operators, buyers, and consumers can protect themselves as well as regulatory issues and possibly short, medium and long-term solutions.

Join Tim on December 5, 2018, at 1:00 pm Eastern for his discussion. Reserve your seat today!

EAS to Offer Five Part Webinar Series Looking at OTC Monograph Regulations

Join EAS Independent Advisor for OTC Drugs and Labeling, Susan Crane, as she explores the history of OTC Monographs, why reforms are necessary and being undertaken now, and how OTC drug companies can expect those changes to impact their labels in the future in a five-part series starting January 16, 2019.

Part 1 of the series, OTC Drug Monographs, Past, Present, and Future will discuss what a Monograph is and how it is used. She’ll dive into reading and interpreting the different sections of the monograph and discuss what the future might hold as Congress considers changes to the system. Join Susan on January 16, 2019, at 1:00 pm Eastern for part 1.

Later sessions will include topics such as what makes a drug an OTC and the Monographs Compliance System; OTC Labeling requirements and Drug listings responsibilities; Understanding the FDA and FTC Labeling and Claim Requirements for Cosmetic products, Homeopathic products in the OTC market; as well as OTC Drugs and Your GMP Obligations – Understanding how the GMPs are Applied and Preparation for FDA Inspection.

EAS Consultants Present FSVP Webinar for NCBFAA

EAS Independent Advisor for FSMA, Charles Breen and EAS Independent Consultant, Bryan Armentrout are presenting a webinar focusing on FSVP requirements for the National Customs Brokers and Forwarders Association, NCBFAA.  Titled “Foreign Supplier Verification and How to Protect Your Business”the webinar is open to members and non-members of NCBFAA and will take place November 8, 2018, from 12-1 pm Eastern.

FDA’s recently increased inspections of importers to evaluate their compliance with FSVP requirements is a reflection of FDA’s commitment to making FSVP work. FDA inspections are also revealing that a significant number of importers do not understand what is needed to comply nor how. Customs brokers and freight forwarders, if not importers themselves, can help clients know what FDA is looking for, and who can assist them. Learn actionable steps and protect not just your food, but your business as well.  The cost of registration is $50.00 for members of NCBFAA and for non-members, $75.00.  For more information or to register, visit the NCBFAA registration page.

Crozier-Dodson Article on Pathogen Control in Poultry Processing Published in Meating Place

Beth Crozier-Dodson published an article in Meating Place discussing top tips for proactive pathogen control in poultry processing. “One of the most significant aspects of any poultry food safety plan is the implementation of pathogen control measures at each critical control point identified in the processing plant. Those who do this in a proactive manner will be able to reduce the risk of microbial contamination that could prompt a costly recall.”

EAS and FDA Present Webinar on New Dietary Fiber Regulations for IFT

EAS Independent Consultant and labeling expert, James Hoadley, Ph.D. will present a webinar focusing on Declaring Dietary Fiber in Nutrition Information along with Douglas Balentine, Ph.D., Director, Office of Nutrition and Food Labeling, and Sarah Gebauer, Ph.D., Nutritionist at the Center for Food Safety and Applied Nutrition, FDA. The webinar will take place on December 6, 2018, at 9:00 AM – 10:00 AM CT and will be hosted by the Institute for Food Technologists (IFT).

FDA’s release of two Guidance documents in 2018 on labeling of dietary fiber, as well as the prior publication of a scientific review of non-digestible carbohydrates being evaluated for the physiological benefit, have created a need for clarification of these guidance documents to solve industry confusion. Most of the fiber ingredients currently used by industry and declared on labels as fiber have been acknowledged as fiber either by regulation or by enforcement discretion, but what next?  FDA, EAS, and IFT will join forces to discuss the policy on labeling dietary fiber and unravel challenges facing the food industry as it considers the path forward. The webinar is free for IFT members, non-members may register for $20. Join us!

Photos of Old Town Alexandria Put Final Touch on EAS Office Expansion

EAS Headquarters has just undergone a renovation to add additional space to its headquarter offices in the heart of Old Town Alexandria. Included in the buildout is more office space to accommodate expanding staff and the inclusions of a larger conference and training room equipped with state of art audio visual equipment. EAS now has the facility to hold in-house training course and to conduct video training programs and conferences with clients throughout the world. The office is conveniently located across from the King Street Metro Station within minutes of Reagan Airport and downtown Washington.

The corridors are lined with photographs taken of historic Old Town Alexandria by a local award-winning photographer, Carol Jean Stalun. Ms. Stalun was recently invited to the office to view her work and to thank her for her contribution to the appearance of our new headquarters. Her photographs can be viewed at https://www.caroljeanstalun.com/.

We welcome all of you to visit us whenever you are in the area. We would be happy to show off our updated space and to meet you in person.

 

Being a Third-Eye in a Plant with a Problem – Discussions on Listeria and Salmonella Protection in Food Safety Magazine

Carl Custer wrote about the challenges of Listeria, Salmonella, extraneous materials and worse in an article published in Food Safety Magazine. Carl also shared some of his experiences at problem-solving both while at FSIS and working with clients as a consultant, observing plant practices as “third-eye” in order to solve food safety problems.

Food and Dietary Supplement Labeling and Dietary Supplement GMP Compliance Seminars Coming to Philly

We have just scheduled our spring compliance seminars for Philadelphia, PA. Join us March 12-13 for the Food Labeling Compliance Seminar; March 14-15 for the Dietary Supplement Labeling Compliance Seminar and April 2-3 for the Dietary Supplement GMP Compliance Seminar. These are great opportunities to learn the new details of FDA labeling requirements as well as how to comply with GMP provisions for dietary supplements. Early-bird discounts apply as do multiple employees from the same company. Visit our registration pages to learn more.

Medical Device Regulatory Landscape Discussed in Post AdvaMed MedTech Wrap Up

Senior Director for Pharmaceuticals and Medical Devices, Bryan J. Coleman discussed innovations and the regulatory landscape in an AdvaMed MedTech blog. Bryan shared his thoughts as FDA continues to harmonize and leverage existing regulatory approaches in increasingly more creative ways that allow the industry to grow and flex along with innovation. Still based in sound science and documented evidence, FDA expects sponsor and contract manufacturers to tighten controls over raw materials and component quality equal to internal design and production. Now more than ever companies must plan and prepare for meeting quality requirements and ensure quality measures are weaving design, supporting technologies, supply chain and feedback mechanisms into one cohesive program.

Fairman Discusses Tips to Ensure Compliance with Audits in Natural Products Insider

EAS Independent Consultant Heather Fairman discussed Own Label Distributor audits of contract manufacturers as well as steps for ensuring their compliance in the Natural Products Insider. “Own label distributors performing contract supplier and/or contract manufacturer audits often have critical blind spots that may result in products not meeting specifications or their quality and safety expectations,” she says.

Couch Shares Dietary Supplement OLD Responsibilities in AgroFOOD Industry HI Tech

Senior Director Tara Lin Couch, Ph.D. shared Own Label Distributor (OLD) responsibilities in a recent article published in Technoscienze – AgroFOOD Industry HI Tech. Regardless of whether an OLD is domestic or international, the FDA is clear that the OLD is responsible for compliance with the regulatory requirements in 21 CFR 111, she says. “The development of critical OLD processes should include procedures such as qualification of OLD contractors; demonstration that the quality unit is fulfilling obligations of finished product specifications; a complaint system for evaluating all reported consumer concerns for the identification and reporting of Serious Adverse Events (SAEs) to FDA; and change control processes to ensure revisions are tracked and monitored.”

Skolnik Discusses AERs in Natural Products Insider

Norma Skolnik discussed Adverse Events Reporting (AER) requirements for the dietary supplement industry in Natural Products Insider. The requirements as well as the Guidance for Industry: Questions & Answers Regarding Adverse Event Reporting and Recordkeeping for Dietary Supplements as required by the Dietary Supplement & Nonprescription Drug Consumer Protection Act,” published in 2007 cover SAE reporting for manufacturers and OLDs as well as FDA notification to companies when FDA receives an SAE involving one of their products.

EAS to Exhibit, Present at SupplySide West in Las Vegas

EAS Senior Director for Dietary Supplement and Tobacco Services, Tara Lin Couch, Ph.D., Independent Consultant Heather Fairman, and President and COO Dean Cirotta will represent EAS at the upcoming SupplySide West show November 6-10, 2018 in Las Vegas. You may find EAS at booth #5641. EAS is also well represented in the SupplySide West technical sessions as Tara will discuss Effectively Partnering with a Contract Laboratory as part of a panel on Wednesday, November 7 from 1:30-4:30 pm; and Tara and Heather will present on Contract Manufacturing scheduled for Saturday, November 10 from 8:30am-11:30 am. In addition, President and COO, Dean Cirotta will moderate a panel as part of the 7thannual AHPA Botanical Congress in Cooperation with ABC on how 21 CFR 111 applies to the Dietary Supplement industry.

Cirotta to Moderate Panel at FDLI Conference Focusing on Tobacco and Nicotine Products

Dean Cirotta will moderate a panel at the upcoming FDLI Tobacco and Nicotine Products Regulation and Policy Conference concerning “The Latest on Product Standards and Other Potential Regulatory Action”. The conference, which takes place October 25-26, 2018 in Washington, D.C., will address issues of effectively regulating the broad spectrum of tobacco and nicotine products both in the U.S. and globally.

EAS Webinar Series Continues with Topics Ranging from Tobacco TPMPs, Own Label Distributors and Pharmaceutical Data Integrity

EAS is offering a number of complementary regulatory webinars this fall. Please join us for these live sessions or view one of our On-Demand webinars found under the Resources tab of our website.

Preparing for Tobacco TPMPs – October 9, 2018, at 1:00 pm Eastern

Join EAS President and COO, Dean Cirotta and Senior Director for Dietary Supplement and Tobacco Services, Tara Lin Couch, Ph.D. for a discussion of expectations for FDA’s in-development Tobacco TPMP Rule and how you can assess your current quality systems in preparation. This webinar is hosted in Cooperation with the Tobacco Merchants Association.

Own Label Distributor Responsibilities – October 11, 2018, at 1:00 pm Eastern

As more and more OTC drug and dietary supplement companies are contracting out manufacturing, packaging, laboratory testing, and distribution services, it is imperative that those in responsible positions for OLDs gain a full understanding of FDA’s requirements for knowing what and how these contracted activities are performed. Learn more about your “OLD” responsibilities and how to document that you are meeting them with EAS Independent Consultant, Bruce Elsner.

Problems with Pharma Data Integrity – October 18, 2018, at 1:00 pm Eastern

FDA takes data Integrity very seriously and their many Warning Letters and Import Alerts to dosage form and Active Pharmaceutical Ingredient (API) manufacturers in the past several years indicate that validation is a consistent problem. Join EAS Independent Consultant Brian Nadel to better understand the Agency’s expectations for data integrity as well as how your company can assess your compliance. Learn critical strategies and processes that each firm should undertake to limit data integrity risk and demonstrate reliable data every time.

Breen Co-Authors Article in Food Quality and Safety Magazine on Responding to Food Safety Emergencies

Independent Advisor for FSMA, Charles Breen has co-authored an article with Stacey Stevens, Senior Vice President of FoodMinds, a food PR firm with which EAS has a collaborative partnership on responding to a food safety emergency. The article, published in Food Quality and Safety magazine discusses the many issues of responding to an emergency and how to focus messaging on that response.

EAS Presents Webinar on Preparing for Tobacco TPMPs in Cooperation with TMA

TMAEAS President and COO, Dean Cirotta and Senior Director for Dietary Supplements and Tobacco Services, Tara Lin Couch, Ph.D. will present a free webinar on October 9, 2018, at 1:00 PM Eastern on Preparing for the Tobacco Product Manufacturing Practices Rule (TPMPs). This webinar is hosted in cooperation with the Tobacco Merchants Association. Since CTP Director, Mitch Zeller’s announcement at the 2018 TMA Annual Meeting that the Agency is prioritizing a TPMPs, the industry has been speculating regarding what these rules may encompass. Join us October 9th for this informative webinar, which will provide an overview of expectations for the TPMP rule and how you can begin assessing your current quality systems.

Couch Discusses Contract Manufacturing Partnerships in Natural Products Insider Podcast

Senior Director for Dietary Supplements, Dr. Tara Lin Couch was interviewed for a Natural Products Insider podcast on contract manufacturing partnerships. Dr. Couch is one of two EAS presenters for the upcoming SupplySide West trade show taking place in Las Vegas. Stay tuned for more information on EAS presentations by Dr. Couch and EAS Independent Consultant Heather Fairman.

EAS Offers Training Solutions for GMPs, Food, and Dietary Supplement Labeling Issues

Companies looking to ensure employees understand of the most up to date FDA requirements may look to EAS for their training solutions. With three upcoming seminars

Our expert trainers will provide a detailed approach to complicated and often confusing challenges enabling take-aways that can be readily applied to improve compliance. Training seminars can also be offered in-house and customized to specific needs.

EAS to Exhibit, Speak at CPhI North America in Philadelphia

EAS Consulting Group is proud to be an invited speaker at the upcoming CPhI North America, April 24-26, 2018 in Philadelphia. You can find EAS at exhibit booth 856 where Senior Director for Pharmaceuticals and Medical Devices, Bryan J. Coleman and Regulatory Specialist, Victoria Pankovich will be available to discuss questions and concerns surrounding your business. We also invite you to attend Bryan’s session as part of the CPhI technical program on Regulatory Considerations, Strategy and Best Practices for Choosing a CMO which will be Tuesday, April 24th at 3:30 pm.

EAS Consultants to Present at Two Upcoming FDLI Events

Andrea Yablunosky will be speaking on Food Labeling: Nutrient Content, Health, and Other Claims on September 24, 2018 at the upcoming FDLI Introduction to Food Law and Regulation which will be held in Washington, D.C. She’ll discuss a variety of claims including Natural, Organic and Fresh as well as the effects of state law litigation on use of Health Claims.

Priya Jambhekar will be presenting the session on Regulations of Biologics Manufacturing on October 4, 2018, at the FDLI Introduction to Biologics and Biosimilars, taking place in Washington, D.C. She’ll discuss standards of inspections, the scope of pre-approval inspections as well as responding to FDA 483 forms and warning letters.

Tajkarimi and Sayler Discuss RTEs in Natural Products Insider

Independent Consultant Mehrdad Tajkarimi and Senior Director Allen Sayler co-wrote an article for Natural Products Insider discussing Cause, Effect and Impact of RTE Operations on complying with FDA’s draft Listeria guidance. Food manufacturers are expected to operate within an entirely new scheme of “design out” of potential entry and harborage of Listeria, develop “hygienic zoning”, enhance monitoring and record keeping for cleaning and sanitizing a food processing facility and more. As FDA inspectors use draft FDA guidance for Control of Listeria Monocytogenes in Ready to Eat Foods during routine and targeted investigations, these new criteria, as well as others found in the guidance, will become the new benchmark of safety against Listeria in RTE operations.

EAS Authors AHPA Report Article on Botanical Submissions – NDI Versus GRAS in a Post-DSHEA World

EAS authored an article discussing options for dietary supplement ingredient submissions – New Dietary Ingredient (NDIs) and Generally Recognized as Safe (GRAS) on August 8, 2018, of the AHPA Report (AHPA membership required to view). Botanical chemicals may be isolated and also sold as dietary supplements, and in some cases, FDA’s interpretation of botanical and plant parts would qualify them for an NDI submission. In some cases, GRAS is a more appropriate submission for this unique category of botanicals. EAS can discuss your particular situation and help you to determine the right path for your product.

EAS Webinar – Don’t Wait for FDA, Conduct Your Own Swab-a-Thon!

EAS Independent Consultant, Kathy Knutson, Ph.D. will host a complimentary webinar on the importance of Environmental Monitoring on September 17, 2018, at 11:00 PM Eastern. Given the hot-button issue of pathogen contamination, even with the best of safety controls, it is imperative that companies have a robust environmental monitoring program that includes vigilant and regular testing. Join Dr. Knutson for this complimentary webinar!

Latest EAS On-Demand Webinars Posted to EAS Website

We had an overwhelming response to our recent webinar “Quality Systems for the Cannabis Industry” presented by Tara Lin Couch, Ph.D., Senior Director for Dietary Supplement and Tobacco Services. Independent Consultant, Peter Saxon, presented a webinar for foreign firms to understand how to manage FDA inspections. Also, April Kates presented a webinar on Temporary Marketing Permits Opportunity and pitfalls of the Specialized FDA Application. All recordings are available on the EAS website under the On-Demand Webinars tab and are available for viewing.

Sayler Discusses Fast Tracking FDA FURLS in Food Safety Tech

Senior Director for Food Consulting Services, Allen Sayler, has written an article for Food Safety Tech on FDA Fast-Track Unified and Listing Systems (FURLS) program and whether it is expediting or impeding access to overseas markets. “The FDA recently released a notification that their FURLS system has been updated to include an Export Listing Module (ELM),” he says. This allows U.S. food manufacturers to electronically submit, and for FDA to receive and process requests for inclusion on the export lists for FDA-regulated food products and present these lists to countries that require them, whether a company is participating in this program or is looking for new markets outside the U.S.

Tajkarimi Writes of Food Safety Training as a Solution for FSMA Challenges

Mehrdad Tajkarimi discusses the importance of food safety training as a solution to FSMA challenges in Part One of a three-part series for Food Safety Magazine. “There are several challenges ahead for proper food safety training at all levels,” he says. “These challenges include, but are not limited to, numbers of training hours, type, content, and facilitation procedures.” The types and applications of training have dramatic impacts on food safety management systems, improvements in FSMA compliance, and employee productivity.

Lavieri Highlights the Impact of the Human Element in Food Safety Programs in Food Safety News

Robert Lavieri authored a guest column in Food Safety News on the important and often overlooked “human element” to food safety planning and programs. Companies spend much time and effort designing and cross-checking procedures to protect against food safety issues, but the human element or employee training and assurance of appropriate training to the job function is equally important. Make sure you “test, verify and regularly evaluate and hold accountable the human elements as you do your equipment i.e. Process Control, Automatic Sampling, CIP, Calibrations, etc,” he says.

EAS Co-Authors Article for FDLI Update on the Benefits of Consultants as Part of a Legal Team

EAS joined forces with Ronald J. Levine, co-chair on Herrick, Feinstein LLP’s Litigation Department to author an article published in the Food Drug Law Institute Update Magazine on how the use of consultants can benefit a legal team. Consultants provide unique insights, given their detailed expertise in a particular subject matter, offering context and in-depth understanding of FDA regulations and intent of guidance documents. Consultants are frequently engaged, particularly during the discovery and trial stages for the planning and execution of a legal strategy. While the benefits they provide cannot be underestimated, the same due diligence for choosing the right consultant for the particular project must also not be taken lightly. Read more here.

EAS Consultants Invited Speakers at Two FDLI Conferences

EAS is pleased to be invited speakers at two upcoming Food Drug Law Institute (FDLI) Events. Andrea Yablunosky will speak at an in-house event held at FDA CFSAN on Food Labeling: Nutrient Content, Health, and Other Claims on August 7th. Bruce Silverglade will speak on the same subject as part of the Intro to Food Law conference which will be held in Washington, D.C. September 24-25, 2018. For more information on the Intro to Food Law event, click here.

Yablunosky and Knutson to Speak at Upcoming Food Safety Consortium

EAS Independent Consultants, Andrea Yablunosky and Kathy Knutson are invited speakers at the upcoming Food Safety Consortium. Yablunosky will speak on food recalls, discussing the USDA/FSIS recall committee, as well as roles district offices play in a recall. She’ll then move on to the steps in a recall and important to-dos such as the drafting of a recall press release. Yablunosky is a former Director of Government Affairs at ConAgra Foods where she advised the company business units on implications of FDA and USDA policy objectives. With a background in food science and nutrition she is well-versed in policy development, product reformulations and promotions, recall preparedness and effective recall management.

Kathy Knutson, Ph.D. will speak on Lessons Learned in Food Safety and Applied to Cannabis-infused Edibles. She will discuss GMPs as the foundation of food safety and how HACCP builds on GMPs. Dr. Knutson is a microbiologist and certified lead instructor for Preventive Controls for Qualified Individuals through the Food Safety Preventive Controls Alliance. She consults with companies in meeting FSMA requirements, including manufacturers in the cannabis industry and she educates on issues surrounding cannabis-infused food products for sale in states with medical and recreational use legislation.

Food Safety Consortium will take place November 13-15, 2018 in Schaumburg, IL.

Crane Returns as a Presenter at CHPA’s OTC Academy

Susan Crane, Independent Advisor for OTC Drugs and Labeling will be presenting a session at the upcoming Consumer Healthcare Products Association OTC Academy on OTC drug labeling requirements, to include Drug Facts format and content, translating an OTC monograph into a compliant label, as well as covering other regulations that impact OTC drugs, such as child-resistant packaging requirements and Made in USA claims. This year’s OTC Academy will take place in Wilmington, DE October 9-10, 2018.

EAS Offers Complimentary Webinars on Cannabis, Foreign FDA Inspections, Temporary Marketing Permits and More

Quality Systems for the Cannabis Industry – Preparing for State GMPs
August 6, 2018, 1:00pm Eastern

Tara Lin Couch Ph.D., Senior Director for Dietary Supplements and Tobacco Services, will help cannabis firms prepare for cannabis Good Manufacturing Practices (GMPs). While regulations vary from state to state the quality systems under which cannabis products are grown and manufactured have similarities that can begin to pave the way for putting practices and procedures in place to meet compliance expectations, including those of testing and quality control of in-process materials, finished batches and packaged/labeled products. The time is right for the cannabis industry to begin assessing manufacturing processes and implementing sound and effective quality systems in order to begin preparing for GMP regulations. Reserve your seat by clicking here.

Preparing for Foreign FDA Inspections
August 14, 2018, 1:00pm Eastern

Have you ever wondered why your foreign suppliers: API, intermediates, food ingredients, etc. are suddenly in trouble with regulatory authorities? Did they just go astray or is your auditing program not performing as designed? Actually, there are several things at play. EAS Independent Consultant, Peter Saxon, will shed some light on reasons FDA inspections can “go south” as well as provide insight on how disappointing results can be managed. His insights will provide an opportunity for companies to consider improvements to their internal audit structure to help minimize regulatory risks. Join us for this webinar by clicking here.

Temporary Marketing Permits – Opportunity and Pitfalls of the Specialized FDA Application
August 21, 2018, 1:00pm Eastern

Food Standards are an important component of FDA’s oversight, ensuring honesty and fairness to the consumer through requirements that provide for the basic nature of a standardized food to be uniform in terms of its characteristics as well as the ingredients that it must or may contain. But what happens when a newly developed food or production method warrants consideration of a product category outside of the standard? Petitioning to amend a food standard or to create a new one, is a lengthy and complicated process; however, a temporary solution may be available through a specialized category called a Temporary Marketing Permit (TMP’s). Learn more when EAS Independent Consultant, April Kates, discusses this unique marketing option in a webinar on the opportunities and Pitfalls of Temporary Marketing Permits and learn best practices for a successful TMP application. Reserve your seat by clicking here.

New Webinar on Environmental Monitoring Added to EAS’ Summer Compliance Line-Up

Are Industry-Initiated Environmental Swab-a-Thons a Benefit?
September 17, 2018, 1:00pm Eastern

The emphasis on proactive management of issues that could cause a food safety hazard, per FDA’s Food Safety Modernization Act, requires firms to improve controls for a variety of issues at all levels. One hot-button concern that continues to wreak havoc in the industry is that of pathogen contamination. It is generally understood that contamination in the processing environment will eventually make its way into the product. Even with the best of safety controls, it is imperative that companies have a robust environmental monitoring program that includes vigilant and regular testing. After all, finished product testing gives limited data and is a small snapshot of the entire lot manufactured. FDA can take hundreds of swabs during inspections, does your environmental monitoring meet that level of testing?

EAS Independent Consultant, Kathy Knutson, Ph.D. will host a complimentary webinar on the importance of Environmental Monitoring. Don’t wait for FDA, conduct your own swab-a-thon! Join us September 17, 2018, at 1:00 pm Eastern to learn important ways your company can stay ahead of the curve. Register by clicking here.

EAS Offers Official FSPCA Preventive Controls for Human Foods and FSVP Seminars

EAS Independent Consultant and FSPCA recognized lead instructor, Jenifer Kane, will co-instruct two FSPCA courses with Independent Consultant and trainer Susan Moyers, Ph.D. on the intricacies of Preventive Controls for Human Food as well as the Foreign Supplier Verification Program. Both courses will take place in early October in Alexandria, VA.

The Current Good Manufacturing Practice, Hazard Analysis, and Risk-based Preventive Controls for Human Food regulation (referred to as the Preventive Controls for Human Food Regulation) is intended to ensure safe manufacturing/processing, packing and holding of food products for human consumption in the U.S. and requires that certain activities must be completed by a “preventive controls qualified individual” who has “successfully completed training in the development and application of risk-based preventive controls”. This course meets FDA’s requirement. Join EAS October 1-3, 2018 in Alexandria for this 2.5 intensive training. Earlybird discounts are available through August 14, 2018.

Next, the “Foreign Supplier Verification Program (FSVP)” requires importers to verify that their foreign suppliers of food, food ingredients and food additives imported into the US market are compliant with all parts of the FSMA and its “Preventive Controls for Human Foods (PCHF) and “Preventive Controls for Animal Feeds (PCAF”) regulations. EAS’ two-day intensive FSVP Compliance Seminar will explain in detail FSVP rules, risk exposure by importers as well as US-based food processors using foreign sources of foods, food ingredients and food additives. Join us October 3-4, 2018 for this 1.5-day training. Earlybird rates are in effect through August 14, 2018.

Dietary Supplement GMP Seminar to Take Place in Dallas, TX

EAS Consulting Group will offer its two-day intensive Dietary Supplement GMP seminar September 26-27, 2018 in Dallas. Instructed by EAS Senior Director for Dietary Supplements and Tobacco Services, Tara Lin Couch, Ph.D., EAS Independent Advisor for Quality and Compliance, Robert Fish and back by popular demand, Marc Ullman, Of Counsel at Rivkin Radler, LLP, this next GMP course will include a new section on how quality and compliance applies to the emerging cannabis industry. Early-bird registration rates are in effect through August 5, 2018. In addition, we are pleased to offer members of the American Herbal Products Association (AHPA) an extended early-bird rate of $1,000.00. For more information or to reserve your seat, click here.

EAS Consultants to Present in Two Technical Sessions at the IFT 2018 Annual Meeting

EAS Independent Advisor Charles Breen is the panel moderator for two technical sessions at IFT – one on the Preventive Controls for Human Foods and another on the Foreign Supplier Verification Program. Esteemed panelists include for PCHF, Joann Givens, Director of the Office of Human and Animal Food Operations-West, Office of Regulatory Affairs at FDA, Robert Brackett, Director of Illinois Institute for Technology and Vice President of Institute for Food Safety and Health, Jeffrey Acker, Vice President of Food Safety and Compliance, Dairy Farmers of America and Susan Moyers, EAS Independent Consultant. Panelists for the FSVP include Susan Moyers, Robert Brackett and Erika Daniel with Almater, an Italian food technology and consulting firm with which EAS partners to assist European companies wishing to export food products to the U.S.

If you are attending IFT we invite you to stop by the EAS booth, S322 and attend these two sessions. PCHF – Successes and Challenges for FDA and the Food Industry will take place on Monday, July 16, 2018 at 10:30 am – 12:00 pm; and Food Importing: Green Light Strategies for Compliance with Game-Changing FSVP Requirements will take place Tuesday, July 17, 2018, at 10:30 am – 12:00 pm. Both will be held in room S502AB at the McCormick Place, the 2018 Annual Conference venue.

Please contact Allen Sayler at asayler@easconsultinggroup.com to set up an appointment to speak with EAS at the trade show.

EAS Short Videos Describe Services to the Food Industry

EAS offers a wealth of regulatory consulting capabilities in all FDA commodity areas, as well as USDA and some state regulatory services as they pertain to food and dietary supplement products. EAS is creating short clips that discuss our capabilities and is posting them on our website. We invite you to learn more about our Product Development and Labeling services, FSMA, food and dietary supplement labeling as well as food additive services through these videos. We’ll be adding additional so stay tuned.

Dixon Helps Tobacco Firms Prepare for FDA Inspections in the Tobacco Reporte

Karen Dixon discusses critical points for helping tobacco firms prepare for FDA Inspections in this month’s issue of the Tobacco Reporter, including FDA’s inspection authority and how companies should prepare internally, including a having a detailed inspection plan in place. It is important to note that FDA inspections are not always preannounced, so companies in all industries are encouraged to have written and detailed SOPs as well as ready access to critical information that would be pertinent and requested as part of FDA’s inspection.

Probiotics Here to Stay Says DeMuri in Natural Products Insider

EAS Independent Consultant Steve DeMuri authored an article in Natural Products Insider on Probiotic health benefits of natural foods and supplements. With many reported health benefits currently being studied, “Probiotics are here to stay and now is the time for companies to conduct new product development to incorporate probiotics into the “tinkering process” that is part of all food technology and product development efforts,” he says.

Elizabeth Campbell and April Kates Discuss Clean Labels in Natural Products Insider

EAS Independent Advisor Elizabeth “Betty” Campbell and Independent Consultant, April Kates have co-written an article on how to keep “clean label” claims legal for Natural Products Insider. “Marketing a clean label can be a great way to for brands to connect to consumers,” they say, “but they need to ensure their statements don’t run afoul of a legal claim.”

EAS Presents Summer Webinar Series on Regulatory Topics Pertaining to Cannabis, Foreign FDA Inspections and Temporary Marketing Permits

Quality Systems for the Cannabis Industry – Preparing for State GMPs

Tara Lin Couch Ph.D., Senior Director for Dietary Supplements and Tobacco Services, will present a webinar on August 6, 2018, at 1:00 pm Eastern to help cannabis firms prepare for cannabis Good Manufacturing Practices (GMPs). Titled “Quality Systems for the Cannabis Industry, Preparing for State GMPs”, she will discuss how GMPs applications to this unique industry cannot be understated. While regulations vary from state to state the quality systems under which cannabis products are grown and manufactured have similarities that can begin to pave the way for putting practices and procedures in place to meet compliance expectations, including those of testing and quality control of in-process materials, finished batches and packaged/labeled products. The time is right for the cannabis industry to begin assessing manufacturing processes and implementing sound and effective quality systems in order to begin preparing for GMP regulations. Stay ahead of the curve, standardize your product quality and be a leader in your industry. Join Tara on August 6, 2018, at 1:00 pm Eastern for this free webinar by clicking here.

Preparing for Foreign FDA Inspections

Have you ever wondered why your foreign suppliers: API, intermediates, food ingredients, etc. are suddenly in trouble with regulatory authorities? Did they just go astray or is your auditing program not performing as designed? Actually, there are several things at play. EAS Independent Consultant, Peter Saxon, will shed some light on reasons FDA inspections can “go south” as well as provide insight on how disappointing results can be managed. Saxon has personally attended 90 FDA inspections of foreign facilities and another 15 inspections by other regulatory agencies (TGA, WHO, EDQM). His insights will provide an opportunity for companies to consider improvements to their internal audit structure to help minimize regulatory risks. Join us August 14, 2018, at 1:00 pm Eastern for a free webinar on Preparing for FDA Inspections where you will learn where most regulatory problems are found by the FDA, how OAI (Other Action Indicated) results are categorized by the FDA and what you can do to avoid these disappointing results.

Temporary Marketing Permits – Opportunity and Pitfalls of the Specialized FDA Application

Food Standards are an important component of FDA’s oversight, ensuring honesty and fairness to the consumer through requirements that provide for the basic nature of a standardized food to be uniform in terms of its characteristics as well as the ingredients that it must or may contain. But what happens when a newly developed food or production method warrants consideration of a product category outside of the standard? Petitioning to amend a food standard or to create a new one, is a lengthy and complicated process; however, a temporary solution may be available through a specialized category called a Temporary Marketing Permit (TMP’s). With TMP’s companies with novel standardized food innovations may apply to market test a food product that deviates from the standard of identity for that particular food, providing FDA with data needed to consider a future petition to amend the standard. Join Independent Consultant April Kates, on August 21, 2018, at 1:00 pm for this informative webinar on Opportunities and Pitfalls of Temporary Marketing Permits where you’ll learn best practices for submitting a successful TMP application.

Fairman Discusses the Potential Effects of Brexit on US-UK Food and Dietary Supplement Trade

The U.K.’s departure from the EU sparks uncertainty in future trade agreements with the United States, which may not be finalized until after Brexit occurs, says Heather Fairman in a recent article for Natural Products Insider. “For U.S. supplement companies that currently are actively exporting/importing products to the U.K., a watchful eye should be kept on the Brexit transition.”

Couch Authors Tablets and Capsules Feature on the Importance of Quality Agreements

Senior Director for Dietary Supplements and Tobacco Services, Tara Lin Couch, Ph.D. has published an article in Tablets and Capsules magazine on the importance of quality agreements for dietary supplement manufacturers. “The dietary supplement industry, like the pharmaceutical and food industries, relies heavily on contractors and subcontractors. However, no matter who does what along the supply chain, the product owner is ultimately responsible for GMP compliance,” she says.

Schebella Offers Tips for Designing Cannabis Food Edibles in the State of California in Cannabis Industry Journal

Independent Consultant Celia Schebella discusses tips for designing a cannabis edible in the state of California that meets customer expectations and regulatory requirements in Cannabis Industry Journal. Designing a cannabis food product with GMPs, local regulations, ingredient sourcing and scalability in mind can help companies succeed, she says.

Rapid Testing Methods for the Dairy Industry to be Discussed at IAFP

Independent Consultant David Blomquist will discuss rapid testing methods for safety and spoilage in the dairy industry at the upcoming International Association of Food Protection’s annual meeting which will take place July 8-10, 2018 in Salt Lake City. IAFP provides an opportunity for professionals to discuss current and emerging food safety issues, the latest science and innovative solutions to new and recurring problems.

Murphy to Present on Raw Milk and Processed Dairy Products at ADSA

Independent Consultant Steven Murphy will speak at the upcoming June 24-27, 2018 American Dairy Safety Association Annual Meeting in a session called “Time for Change; Indicators of Public Health Concern for Raw Milk and Processed Dairy Products”. Mr. Murphy’s presentation will take place on June 26 at 22:45 pm. Says Murphy, “Regulatory standards used as indicators of conditions considered public health risks for Grade “A” milk and milk products fall under FDA’s Grade “A” Pasteurized Milk Ordinance (PMO). These standards have not changed in decades and this overview will present a perspective based on current science on where changes are warranted.”

Blomquist to Present on Rapid Testing Methods at the IAFP

Independent Consultant, David Blomquist, will speak on “Rapid Testing Methods for Safety and Spoilage in the Dairy Industry – What Is Needed, What Works and What Does Not” on July 9, 2018, at the International Association of Food Protection Conference. Says Blomquist, “The dairy industry has been a leader in sanitation and hygiene for over a century. As food safety becomes more critical for all industries, methods to determine the quality of dairy products rapidly becomes more critical.” This session will focus on different technologies that have the potential to determine low levels of spoilage organisms in a variety of dairy products and will discuss the strengths and weakness of each. If you are attending the IAFP, we hope you will join us for this session.

EAS has much expertise in regulatory assistance to the dairy industry. For more information on our capabilities view our Dairy Industry Services Sheet.

Couch to Present at the CRN Conference on Implementing Compliance Controls

Tara Lin Couch Ph.D.Senior Director for Dietary Supplement and Tobacco Services, Tara Lin Couch, Ph.D., will be speaking at the upcoming Council for Responsible Nutrition Conference on Implementing Compliance Controls to Meet New Sophisticated cGMP Standards. This conference is taking place June 18-20, 2018 in New York City at the InterContinental New York Times Square and Dr. Couch, speaking as part of a panel, will present on June 19 at 4:45 pm. The panel will discuss items such as:

  • Understanding the FDA’s more sophisticated approach to dietary supplement cGMPs
  • Petitioning the FDA for an exemption to the 100% identity requirement for ingredient testing
  • Assessing the impact of program alignment under Dr. Gottlieb
  • Reassessing cGMPs in the context of cleanliness, safety, and testing for raw materials as based on this new approach
  • Identifying the right test for the right ingredient within the context of cGMP standards
  • Comprehending how this potential enforcement ramp-up may lead to an uptick in 483 observations

We hope you’ll join Dr. Couch at this informative event!

Armstrong Authors Article on Mergers and Acquisitions for Natural Products Insider

Steve ArmstrongIndependent Advisor for Food Law and Regulation, Steve Armstrong, has authored an article for Natural Products Insider on buying a 21st-century food company and mergers and acquisitions. “A health and nutrition startup should resolve any potential issues with its quality control, labeling and advertising practices before it is acquired,” he says.

EAS offers a number of services to attorneys working in the area of due diligence and mergers and acquisitions. For more information on these services please review our Food and Drug Attorney Services Sheet.

OTC Monograph Webinar Postponed Due to Pending Legislation

As you may be aware, Congress is currently working on legislation to update the Over-the-Counter (OTC) monograph system. This legislation, the Over-the-Counter Drug Safety, Innovation, and Reform Act, has bipartisan support in Congress as well as the backing of the FDA, industry and other public health organizations. As such, it is expected to pass and be signed into law by the President before the mid-term elections in November.

Due to the significant changes ahead, EAS has decided to postpone the webinar “The OTC Monograph System – Past, Present, and Future originally scheduled for July, and will instead monitor this legislation and present the webinar after the passage of the bill. This will enable us to provide you with better information on how to market your OTC products going forward.

Dietary Supplement GMP Online Short Course Available for Purchase

EAS Senior Director for Dietary Supplement and Tobacco Services, Tara Lin Couch, Ph.D., along with attorney Marc Ullman from Rivkin Radler, and EAS Independent Advisor for Quality and Compliance, Robert Fish, held a Dietary Supplement Short Course, consisting of four hours of regulatory content, recently. It is now available to view as an on-demand webinar on the EAS website. This video is $99 to view for non-EAS clients and free to view for EAS clients.

The GMP short course is a great tool for those seeking a broader overview of GMPs, as it covers the basics of working in a GMP environment including personal hygiene, sanitation, the use of Standard Operating Procedures (SOPs), and Good Documentation Practices (GDPs) and addresses the top 5 observations cited in FDA Warning Letters since 2010. To access the short course, click here. EAS clients may use discount code [clientwebinar], non-EAS clients will be billed upon viewing.

EAS to Moderate Two Panels at IFT Annual Meeting, Exhibits at booth #S322

IFTEAS will be well represented at the upcoming IFT Annual Meeting taking place in Chicago, July 15-18, 2018. EAS Chairman and CEO, Ed Steele, President and COO, Dean Cirotta and Senior Director for Food Consulting Services, Allen Sayler, will be manning the EAS booth (#S322) and taking questions from conference attendees about the latest compliance requirements of FSMA as well as new services such as our Strategic Product Development and Labeling and our collaboration with FoodMinds on challenging marketing initiatives.

Charles BreenIn addition, Charles Breen, EAS Independent Advisor for FSMA will moderate two session panels as part of the IFT technical program, one on the Foreign Supplier Verification Program and another on Preventive Controls for Human Food. EAS Independent Consultant Susan Moyers, Ph.D. will be a panelist on both. Both sessions will be held in McCormick Place – S502AB.

The first session, Preventive Controls for Human Foods: Successes and Challenges for FDA and the Food Industry, will take place Monday, July 16 at 10:30-12:00 pm. In addition to Dr. Moyers, panelists will include Jeffrey Acker, Vice President of Food Safety and Compliance, Dairy Farmers of America; Joanne Givens, Director of the Office of Human and Animal Food Operations-West, Office of Regulatory Affairs, Food and Drug Administration and Robert Brackett, Ph.D., Illinois Institute of Technology Vice President and Director of IIT Institute of Food Safety and Health.

The next session, Food Importing – Green Light Strategies for Compliance with Game-Changing FSVP Requirements will take place Tuesday, July 17 at 10:30 am – 12:00 pm. In addition to Dr. Moyers panelists will include Robert Brackett and Gabriel Pascual, Founding Director & Managing Officer, Agency for Development of Export Markets (ADEM).

We look forward to seeing you at IFT and invite you to contact us in advance at asayler@easconsultinggroup.comto set up an appointment at the show to discuss your particular regulatory challenges.

EAS Authors Article in MedTech Intelligence on the New De Novo Pathway

EAS authored an article for MedTech Intelligence on FDA’s new approach to the regulatory pathway for De Novo medical device classification which simplifies the approval process for the class I or class II devices for which there is no one-to-one precedent or predicate. De Novo applications are appropriate in cases where it appears that the device meets the statutory standards for classification into Class I or Class II under section 513(a)(1) of the Food Drug & Cosmetic Act, and when the sponsor has determined that the device does not fall within any existing classification regulation.

EAS offers a number of services to the medical device industry. For more information, click here.

Preventive Controls for Human Food and Foreign Supplier Verification Program FSPCA Courses Offered

EAS Independent Consultant and FSPCA recognized lead instructor, Jenifer Kane, will co-instruct two FSPCA courses with Independent Consultant and trainer Susan Moyers, Ph.D. on the intricacies of Preventive Controls for Human Food as well as the Foreign Supplier Verification Program. Both courses will take place in early October in Alexandria, VA.

The Current Good Manufacturing Practice, Hazard Analysis, and Risk-based Preventive Controls for Human Food regulation (referred to as the Preventive Controls for Human Food Regulation) is intended to ensure safe manufacturing/processing, packing and holding of food products for human consumption in the U.S. and requires that certain activities must be completed by a “preventive controls qualified individual” who has “successfully completed training in the development and application of risk-based preventive controls”. This course meets FDA’s requirement. Join EAS October 1-3, 2018 in Alexandria for this 2.5 intensive training. Earlybird discounts are available through August 14, 2018.

Next, the “Foreign Supplier Verification Program (FSVP)” requires importers to verify that their foreign suppliers of food, food ingredients and food additives imported into the US market are compliant with all parts of the FSMA and its “Preventive Controls for Human Foods (PCHF) and “Preventive Controls for Animal Feeds (PCAF”) regulations. EAS’ two-day intensive FSVP Compliance Seminar will explain in detail FSVP rules, risk exposure by importers as well as US-based food processors using foreign sources of foods, food ingredients, and food additives. Join us October 3-4, 2018 for this 1.5-day training. Earlybird rates are in effect through August 14, 2018.

Gustavo Gonzalez Presents First FSVP Webinar Targeted to Spanish Speaking Audiences

Gustavo Gonzalez, Ph.D., will present EAS’s first Spanish language webinar titled Foreign Supplier Verification Program – What Does it Mean for You? targeted towards foreign firms exporting foods into the U.S. This complimentary webinar will cover FDA requirements and documentation necessary to comply with the increased requirements of the Food Safety Modernization Act. Join us on June 6, 2018, at 1:00 pm Eastern. For more information on this free webinar and to register, click here.

EAS to Exhibit at Food Defense Conference

EAS will be exhibiting at the upcoming fourth annual Food Defense Conference to be held May 22-24, 2018 in Minneapolis. Senior Director for Food Consulting Services Allen Sayler will be in attendance along with experts from around the world to discuss and learn from each other about the current state of food defense.

Tara Lin Couch, Ph.D. to Discuss Preparing for Cannabis GMPs

Tara Lin Couch Ph.D., Senior Director for Dietary Supplements and Tobacco Services, will present a webinar on August 6, 2018, at 1:00 pm Eastern to help cannabis firms prepare for cannabis Good Manufacturing Practices (GMPs). As states begin to regulate legalized cannabis, the concern of how GMPs apply to this unique industry cannot be understated. While regulations vary from state to state the quality systems under which cannabis products are grown and manufactured have similarities that can begin to pave the way for putting practices and procedures in place to meet compliance expectations, including those of testing and quality control of in-process materials, finished batches and packaged/labeled products. The time is right for the cannabis industry to begin assessing manufacturing processes and implementing sound and effective quality systems in order to begin preparing for GMP regulations. Stay ahead of the curve, standardize your product quality and be a leader in your industry. Join Tara on August 6, 2018, at 1:00 pm Eastern for this free webinar by clicking here.

Gabe Miller Discusses Necessity of Food Safety Programs for the Cannabis industry

Gabe Miller, an expert in Food Safety Programs has written an article for the Cannabis Industry Journal on how solid food safety programs can help make cannabis products safer and save businesses a lot of time and money.

Gabe spoke at the upcoming University of Madison Cleaning and Sanitation Short Course on sanitary equipment design on May 1. Gabe is a specialist in troubleshooting food safety and quality problems and has extensive experience in evaluating electrical, mechanical and equipment systems. He is a 3-A Sanitary Standards Inc. Certified Conformance Evaluator (CCE) who works with food processing equipment design and engineering companies to advance hygienic design.

Fairman Authors Articles on Workplace Safety and Golden Rules for Co-Packers

Independent Consultant, Heather Fairman has published two articles recently. One in Food Processing Magazine focuses on the positive impact of workplace safety programs on corporate culture. Next, she wrote about five “golden rules” for co-packers to stay competitive and profitable for Natural Products Insider. In addition to being a gifted writer and expert consultant on quality control and quality assurance issues, Heather serves as a Technical Advisor for the SIDS DOCK Island Women Open Network (IWON), an intergovernmental organization of Small Island Developing States (SIDS), which has all the rights and privileges of a United Nations organization comprised of 32 countries and who are embarking on developing a raw material market for the herbal supply-chain.

Veneziano, Cirotta Speak at FDLI Annual Meeting

Domenic VenezianoEAS is pleased to be invited speakers at two sessions as part of the FDLI Annual Conference. Independent Advisor for Import Operations, Domenic Veneziano, spoke Friday, May 4, 2018, at a session on International Harmonization Efforts. Mr. Veneziano is a former director of the FDA’s Division of Import Operations, where he spent ten years overseeing FDA’s import operations program and providing leadership, guidance, and direction to approximately 1,000 field investigators in more than 320 U.S. ports of entry.

Please join Domenic on June 26, 2018, EAS Webinar on VQIP which will delve more deeply into this option for expedited entry of products to the U.S. market.

Dean CirottaDean Cirotta, President, and COO moderated a May 3, 2018, panel session called FDA Center Directors: Center for Tobacco Products (CTP). The discussion included priorities and goals for the Center as well as feedback on issues facing the industry. As noted in the What’s Happening at FDA section of this EAS-e-News, FDA is actively working on Good Manufacturing Practice equivalents for the tobacco industry, which is called Tobacco Product Manufacturing Practices. EAS has been actively following this development and is able to provide guidance on expected compliance requirements.

Steve Murphy to Present on Raw Materials at ADSA in Knoxville

Steve Murphy will present a session called “Time for Change; Indicators of Public Health Concern for Raw Milk and Processed Dairy Products” at the upcoming American Dairy Science Association Annual Meeting taking place June 24-27, 2018 in Knoxville. Says Murphy, “Regulatory standards used as indicators of conditions considered public health risks for Grade “A” milk and milk products fall under FDA’s Grade “A” Pasteurized Milk Ordinance (PMO). These standards have not changed in decades. This overview will present a perspective based on current science on where changes are warranted.”

EAS Independent Experts Offer Summer Webinar Compliance Series

EAS Consulting Group is offering a full line-up of educational opportunities through our informative webinar series. These 45-minute webinars are an opportunity to get up to the minute regulatory information on the latest topics pertaining to FDA regulated industries, with time for questions after the presentation. Reserve your seat today!

Susan Crane to Host Webinar on the OTC Monograph System – Past, Present and Future

Independent Advisor for OTC Drugs and Labeling, Susan Crane, will host a webinar July 31, 2018, at 1:00 pm Eastern on OTC monographs. Join her for a better understanding of how to read and interpret the different sections of the monograph and translate the required elements into a Drug Facts panel. She’ll also discuss what the future might hold for OTC drugs as Congress considers changes to the monograph system. This webinar is complimentary and you may register by clicking here.

Couch to Speak at Council for Responsible Nutrition Conference on Compliance Controls for GMP Standards

Tara Lin Couch Ph.D.Senior Director for Dietary Supplement and Tobacco Services, Tara Lin Couch, Ph.D., will speak on Implementing Compliance Controls to Meet New Sophisticated cGMP Standards at the June 18-20, 2018 ACI-CRN’s Annual Legal, Regulatory and Compliance Forum on Dietary Supplementsconference which will be held in New York City. Tara will be covering various topics including:

  • Understanding the FDA’s more sophisticated approach to dietary supplement cGMPs
  • Comprehending how this potential enforcement ramp-up may lead to an uptick in 483 observations
  • Reassessing cGMPs in the context of cleanliness, safety, and testing for raw materials as based on this new approach
  • Identifying the right test for the right ingredient within the context of cGMP standards

Domenic Veneziano to Discuss VQIP Regulations

Independent Advisor for Import Operations and former FDA Director of Import Operations, Domenic Veneziano, will host a webinar focusing on the specific requirements and applications of the Voluntary Qualified Importer Program (VQIP) on June 26, 2018, at 1:00 pm Eastern. VQIP is a fee-based, voluntary application whereby firms who meet certain food safety and import history requirements may receive expedited review and entry of their products into the US market. VQIP will take effect in October 2018 so it is now time to determine eligibility and apply to be included in the program. Join Domenic on June 26th by clicking here. There is a $99 registration fee associated with this webinar.

Nutrition Facts and Supplement Facts Labels Compliance Dates Extended

The U.S. Food and Drug Administration has issued a final rule to extend the compliance dates for updating Nutrition Facts and Supplement Facts labels, from July 26, 2018, to January 1, 2020, for manufacturers with $10 million or more in annual food sales. Manufacturers with less than $10 million in annual food sales will receive an extra year to comply – until January 1, 2021. The agency published a proposed rule to extend the compliance date in September 2017, and this rule finalizes that extension. This approximately 18-month extension will provide sufficient time to transition to the new version of the Nutrition Facts label.

Inflation Adjusted Values for Six FSMA Regulations

The FDA released inflation-adjusted values for six FSMA regulations covering 2016-2017. These values are particularly noteworthy for smaller businesses that may not be covered, may receive an exemption, or have later compliance dates based on their sales being less than the indicated value. In addition, certain businesses subject to the Preventive Controls for Human Food, Preventive Controls for Animal Food, Produce Safety, Foreign Supplier Verification Programs, Sanitary Transportation and Intentional Adulteration Regulations should also refer to the updated values to determine whether they meet the cut-off value for the applicable regulation. Contact Allen Sayler, Senior Director for Food Consulting Services for assistance with FSMA questions at 571-447-5509 or asayler@easconsultinggroup.com

Independent Advisor for Food Law and Regulation, Steve Armstrong, Wins Service to FDLI Award

Steve Armstrong is the winner of the 2018 Service to FDLI award, presented at this year’s FDLI Annual Conference held in Washington, D.C. Steve is the former chief law counsel at Campbell Soup Company and has been consulting with EAS, providing expert opinion and strategy in the areas of product development and labeling since 2016. Steve is a sought-after speaker and writer, particularly on the subject of GMOs and other claims. His contributions to FDLI and the industry through his own efforts and as a representative of EAS facilitate greater industry understanding and promotion of ethical and sound practices.

You may read Steve’s most recent article on due diligence, mergers and acquisitions, and considerations when purchasing a 21st Century Food Company in a recent Natural Products Insider.

Sayler Presents on 21 CFR 117 at the AHPA Dietary Supplement Regulatory Summit

Senior Director for Food Consulting Services, Allen Sayler, will speak on how FSMA impacts the dietary supplement industry during the Dietary Supplement Regulatory Summit, taking place May 16, 2018, in Washington, DC. The Dietary Supplements Regulatory Summit is the collaboration between AHPA, CHPA, CRN, NPA, and UNPA — the trade associations representing the dietary supplements industry and will feature updates and insights from FDA and industry regulatory experts, and will focus on the key regulatory compliance issues facing the dietary supplements industry.

Insights into FDA’s Interpretation and Enforcement of Medical Foods

Independent Advisor for Labeling and Claims, Betty Campbell and Senior Director for Food Consulting Services, Allen Sayer have co-written an article on how FDA interprets and enforces regulations of Medical Foods in Food Safety Magazine. This narrow product category sees a lot of confusion within the industry as to what constitutes a medical food, how it can be labeled and its ingredient requirements.

EAS Offers Final Webinar as Part of CHPA OTC Academy Series

The final webinar as part of the EAS presented series for CHPA’s OTC Academy will take place on April 17, 2018, at 2 pm when Independent Advisor for Quality and Compliance Robert Fish, will discuss Responding to 483s and Warning Letters. Fish says that it is extremely important to promptly respond to any correspondence from FDA, particularly the FDA-483 or a Warning Letter. If a foreign firm receives a Warning Letter from FDA the company will most likely be placed on an Automatic Detention list which means that none of their products will be permitted entry into the U.S. until the issues are corrected and FDA has verified the corrections. This webinar will explain the FDA processes and provide guidance on how to manage these issues.

Armstrong Discusses FSMA One Year Later in FDLI Update

Independent Advisor for Food Law and Regulation, Steve Armstrong discussed how FSMA implementation has impacted food safety systems during its first year of enforcement in the prestigious FDLI Update. Mr. Armstrong is the former Chief Law Counsel for Campbell Soup Company and works with EAS client on product development issues.

Quality Assurance and Net Profits Discussed in EAS-Authored Article in Dairy Foods Magazine

EAS Independent Consultant, Rudy Westervelt, discussed fulfilling quality assurance potential and generating a net profit in a recent article published in Dairy Foods Magazine. Quality assurance could — and should — drive revenue by providing information that allows plant leadership to control costs, improve operational efficiencies and maximize finished product output, he says. Westervelt specializes in problem-solving related to dairy food quality, loss reduction, employee safety results, throughput and cost control.

EAS Releases Videos on FSMA and Product Development Services

EAS Independent Advisor for FSMA, Charles Breen, hosts a new informational video on EAS services in the complex area of the Food Safety Modernization Act, including FSVP, VQIP and more. FSMA is the largest overhaul to FDA’s food regulations in the last 70+ years and EAS is proud that our assembled team of independent regulatory consultants has such vast expertise in the many areas under the FSMA umbrella.

EAS Independent Advisor for Food Law and Regulation, Steve Armstrong produced a similar video recently on our services in the area of product development and labeling, a challenging area as companies work to build strategic development and marketing strategies in a very competitive international marketplace.

A great number of EAS webinars are available on YouTube channel. Please join us for any of our on-demand webinars on a variety of topics, from SQF to dietary supplement laboratory compliance to drug establishment and registration listing information. As always EAS and our team of over 150 regulatory consultants are here to assist.

Armstrong to Present at Food Law Innovative Conference

Independent Advisor for Food Law and Regulation, Steve Armstrong, will discuss Innovative Claims, as part of a USDA Review at the April 19-20, 2018 third annual CLE Food Law Conference in Denver. His co-presenter is Jeffrey Canavan, Deputy Director, Labeling & Program Delivery with the Food Safety Inspection Services, USDA. Up to 12 Hours of MCLE Credit are available for attending this conference, including one hour of Ethics.

EAS to Exhibit at Upcoming SupplySide EAST in Secaucus, NJ

EAS Senior Director for Dietary Supplement and Tobacco Services, Tara Lin Couch, Ph.D. and Independent Advisor for Dietary Supplements, Timothy Stewart, Ph.D. will attend SupplySide East in Secaucus, NJ April 10-11, 2018. Please come by the EAS exhibit booth, F152, to discuss regulatory challenges impacting your business and opportunities for solutions provided by EAS’ extensive network of over 150 independent consultants.

EAS is Marquee Sponsor of TMA’s 103rd Annual Meeting and Conference

TMAEAS President and COO, Dean Cirotta and Independent Consultant Karen Dixon will attend the Tobacco Manufacturers Association’s Annual Meeting and Conference taking place April 9-11, 2018 in Leesburg, VA. EAS is also a Marquee Sponsor of the event. The meeting will discuss FDA’s new policy direction for the tobacco industry, including a Nicotine Product Standard, the Cigar Exemption, FDA Premarket Submissions, and Harm Reduction.

Dietary Supplement Labeling Compliance Seminar to Take Place in Kansas City, MO

Those with oversight of labeling compliance of dietary supplements may wish to register for our next Dietary Supplement Labeling Compliance Seminar which will take place September 26-27, 2018 in Kansas City, MO. Immediately following the food labeling compliance seminar, this intensive two-day session will cover the latest FDA requirements and be taught by our expert trainers James Hoadley, Ph.D. a former FDA Senior Regulatory Scientist in the Office of Nutritional Products, Labeling and Dietary Supplements who participated in the development of NLEA-implementing nutrition labeling and health claim regulations, and Gisela Leon, an internationally recognized expert who has reviewed hundreds of labels for US compliance and helps international products to come into compliance with US regulations.

Food NFP and New Labeling Requirements Regulatory Update Seminar

Due to much industry confusion regarding FDA’s changes to Nutrition Facts Panel, EAS will conduct one-day regulatory update seminar, FDA’s NEW Food Labeling Requirements, on May 31, 2018, in Alexandria, VA. This one day update will immediately follow our two-day Food Labeling Compliance Seminar and can be taken as a stand-alone course or a follow-on after attending the two-day seminar. Instructed by EAS Independent Advisor for Labeling and Claims, Elizabeth Campbell and EAS Independent Consultants, April Kates and Gisela Leon, with invited participation by FDA/CFSAN, this course will offer an interactive forum for a deeper dive into some requirements that have presented particular challenges related to applying the new Nutrition Facts Panel requirements. Early-bird pricing is in effect for both courses through April 15, 2018, and the two-day seminar provides 16 CEU credits through the Commission on Dietetics Registration. We have also recently added a second Food Labeling Compliance Seminar in Kansas City, MO on September 24-25, 2018.

Sayler to Speak at Oregon Dairy Industry Association’s Annual Meeting

Senior Director for Food Consulting Services, Allen Sayler will present two sessions at the upcoming Oregon Dairy Industry Association’s 107th Industry Conference taking place in Salem, OR April 10, 2018. Allen’s first discussion will be on FDA’s Enforcement of the FSMA Preventive Control, Sanitary Transport and Food Defense Programs in Dairy Plants. Later in the day, he will moderate a breakout session on the Biggest Changes to Grade “A” Dairy Plant Requirements in the last 50 Years.

Heather Fairman Answers Q&A in Natural Products Insider

EAS Independent Consultant Heather Fairman contributed to a Q&A in Natural Products Insider on Successfully Choosing and Maintaining a Contract Manufacturing Partnership. Heather was part of a panel of experts that discussed contract manufacturing aspects that brand owners should evaluate in a potential contract manufacturer, what should be outlined in an agreement and what ongoing quality assurance (QA) checks a brand owner should conduct during the partnership.

Food Quality and Safety Publishes EAS Authored Article on Audits and the Food Safety System

EAS Independent Consultant, Rob Carper, has written an article on how audits are an integral part of the food safety system for Food Quality and Safety Magazine. “Food safety plans must be monitored and verified throughout the year, making sure the entire written food safety program is being supported with detailed records at the right frequency, capturing operational data,” Carper says. Also, he says, annual audits protect the company and the consumer by ensuring products are manufactured using adequate Food Safety Fundamentals (prerequisite programs and other requirements); Food Safety Plans, such as HACCP; and Quality Plans (a requirement for SQF Level 3 certification).

EAS and HACCP Consulting Group Offer New SQF Course Options

Through EAS’ partnership with HACCP Consulting Group, we are pleased to announce a number of additional SQF courses on Developing and Implementing SQF Systems. Upcoming courses include Stillwater, OK April 10-11and in Philadelphia, PA on May 21-22.

This two-day seminar Developing and Implementing SQF Systems provides instruction, examples, exercises, and tools necessary for successfully implementing an SQF System. It is one step in the qualification process for SQF Practitioners and an excellent choice for all food safety team members.

EAS – CHPA Partner for OTC Focused Webinar Series

EAS staff and independent consultants are presenting numerous topics for Consumer Healthcare Products Association (CHPA)’s OTC Academy Webinar Series.

On March 6th, Senior Director of Dietary Supplements, Tara Lin Couch, Ph.D. will present on Conducting a Scientifically Sound Out of Specification (OOS) Investigation. Our Senior Director for Pharmaceuticals, Bryan Coleman, will present on Managing FDA Inspections on March 27th and EAS Senior Advisor, Robert Fish will discuss Responding to 483s and Warning Letters on April 17th.

Steve Armstrong to Speak on Food Law at Upcoming Innovative Foods Conference

Steve Armstrong will present a session on innovative claims at the third annual law conference in Denver, April 19-20, 2018. Steve will be part an esteemed group of speakers including Susan T. Mayne, PhD, Director, Center for Food Safety and Applied Nutrition (CFSAN) at FDA and US Food and Drug Administration (FDA) and Peter Lurie, MD, MPH, Executive Director and President for the Center for Science in the Public Interest. Learn more about innovative foods and other hot topics in food law.

EAS Consultants Instructing FDLI Introductory Courses

EAS Consulting Group is honored to be a member of the Food Drug Law Institute and is pleased to be invited speakers to a number of upcoming events.

Independent Consultant, Mark Nelson, will present an introductory session on Overview of U.S. Food Law and Regulation of Food at the Intro to Food Lawon April 10th from 8:35-9:35 am. This event will take place at the law firm of Hogan Lovells US LLP. Mark is the retired Director of Scientific Affairs at Nestle where he oversaw a wide range of FDA and USDA regulated products.

Kaiser Aziz speaking at Introduction to Biologics and Biosimilars on New, Emerging, and Continually Interesting Issues – March 21, 2018, 1:45 pm – 3:30 pm This event will be held at the law firm of Holland and Knight in Washington, D.C. Dr. Aziz has been an independent consultant for EAS since 2012 and spent his career at FDA working his way to the position of Director, Division of Mechanics and Material Science in FDA’s Office of Science and Technology where he developed guidance for FDA bio-mechanical, material and Toxicology Research Testing programs.

EAS On-Demand Webinar on Medical Device Quality Audits

Independent Consultant George Gary Calafactor presents our first EAS On-Demand webinar on Medical Device Quality Audits. Medical Device manufacturers understand the tight FDA regulations and legal obligations surrounding devices. From initial safety and effectiveness study design through Pre-Market Applications (PMAs), Pre-Market Notifications (PMN), registration, Good Manufacturing Practices (GMPs) through reporting of adverse events, every detail must be attended to in a thorough and documented quality system. Quality systems are key indicators of a company’s commitment to producing a safe and effective product as well as a company’s good record keeping practices as records are tested and maintained to provide transparency to FDA inspectors in the case of an audit. This webinar focuses on detailed coverage of Medical Device Quality Auditing including.

  • Learning about the types and purposes of audits
  • How FDA and EU audits differ in scope
  • How quality systems link to other systems within the business practices such as
    • Accounting and Finance
    • Purchasing
    • Customer Service
    • Marketing and Sales
    • Informational Technology
  • FDA’s enforcement requirements of quality systems
  • Quality Assurance
  • Quality Control Testing and Evaluation Against Standards
  • How FDA enforces regulations and gaps found during audits
  • Trends found in FDA enforcement for medical devices in recent years

We invite you to view this free on-demand webinar by clicking here.

Food Labeling Compliance Seminar in Alexandria, VA

Just announced, EAS’s popular Food Labeling Compliance Seminar will take place May 29-30, 2018 in Alexandria, VA. This two-day event, which offers 16 Commission on Dietetic Registration continuing education credits, is an opportunity for greater understanding of the requirements of the new nutrition facts panel. Though FDA has delayed enforcement of the new formatting and chemistry reporting requirements, many companies are finding a strategic benefit in understanding the requirements now so that labels can be updated in advance of the compliance date. Learn more about this seminar here. Earlybird discounts rates are in effect through April 10, 2018.

Dietary Supplement Good Manufacturing Practices Online Short Course

For those seeking a broader overview of GMPs, EAS is offering a new two-part online short course which will cover the basics of working in a GMP environment including personal hygiene, sanitation, the use of Standard Operating Procedures (SOPs), and Good Documentation Practices (GDPs). It will also address the top 5 observations cited in FDA Warning Letters since 2010.

This Short Course, based on the 21 CFR 111, Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, provides a great initial training for personnel unfamiliar with GMPs and can serve as a refresher and annual GMP training requirement.

Each session runs 2.5 hours in length and the dates are February 22nd and March 1st from 1:00-3:30 pm ET and is FREE to EAS clients. Registration is $99 for both sessions for non-clients. Click here for more information and to register.

Two Ways to Train on Dietary Supplement Good Manufacturing Practices Compliance (GMPs)

EAS’ popular Good Manufacturing Practices for Dietary Supplements Compliance Seminar has just been announced for April 4-5, 2018 in beautiful downtown Denver, CO. Instructed by Senior Director for Dietary Supplement and Tobacco Services, Tara Lin Couch, Ph.D., EAS Independent Advisor for Quality and Compliance, Robert Fish and Partner at the law firm Rivkin Radler, LLP, Marc Ullman, this is a dynamic opportunity to gain a deeper understanding of GMP requirements, how to develop and update action plans to meet and exceed those requirements as well as FDA’s approach to inspections.

Though the GMPs dictated in 21 CFR 111 have been in place for over a decade, FDA continues to issue numerous Warning Letters for a failure to comply with even the basic tenants of the regulation. Out of 483 inspections conducted in 2015, the agency issued approximately 290 Warning Letters. In light of increased FDA oversight, a thorough review of new industry rules on good manufacturing practices (GMPS) is warranted.

Earlybird rates are in effect through February 15, 2018. Sign up today!

EAS Offers Webinar Series for CHPA

As part of the series EAS is presenting on behalf of CHPA’s OTC Academy, Norma Skolnik will speak to Serious Adverse Events Reporting on February 20th at 2 pm ET. Serious Adverse Events are an important FDA requirement for over-the-counter (OTC) drugs and dietary supplements in the United States. In this webinar, participants will learn the background and history of SAE reporting regulations, the challenges of deciding what constitutes an SAE, when and how to report an Adverse Event as well as the differences between reporting requirements for OTC drugs and dietary supplements vs. requirements for cosmetics.

On March 6th, Senior Director of Dietary Supplements, Tara Lin Couch, Ph.D. will present on Conducting a Scientifically Sound Out of Specification (OOS) Investigation. More information on both webinars can be found in the hyperlinks or by contacting the Consumer Healthcare Products Association.

Product Development and Labeling Service

Product development is a competitive challenge whereby companies attempt to best posture themselves as an attractive option to consumers, an effective competitor against similar products on retail shelves and do so in a manner that meets FDA, USDA and FTC requirements. EAS’ strategic product development and labeling service help companies with all of these challenges and more, providing a comprehensive and holistic approach to product development from ideation to commercialization. A successful product is about more than designing the right label, it must take into account marketing objectives as well as the current regulatory, compliance, and enforcement environments. EAS is proud of this service and the many companies for which we have provided proactive solutions.

We invite you to view a short video on this Strategic Product Development and Labeling service as well as our Industry Service Sheets detailing some of the many challenges within product development and how a partnership with EAS experts would be of benefit.

EAS President and COO to Speak at Keller and Heckman E-Vapor and Tobacco Law Symposium

Keller and Heckman’s Second Annual E-Vapor and Tobacco Law Symposium take place in Irvine, CA February 6-7, 2018. This comprehensive 2-day course will address regulatory issues relevant to e-vapor, e-liquid and tobacco product manufacturers, distributors and retailers including FDA ingredient listings, premarket applications, business and IP issues, environmental issues, litigation, state laws (including Prop. 56 and 65), CPSC, EU TPD, and global regulations. Topics Include:

  • FDA Deeming Rule and Tobacco Control Act Requirements
  • Business and Intellectual Property Issues for Vapor Companies
  • Environmental Issues
  • Litigation
  • State Laws
  • Global Laws

Click here for more information

Armstrong to Moderate Session at FDLI Webinar on First Amendment Issues in Advertising and Product Packaging

Due to overwhelming response at the December FDLI Enforcement, Litigation, and Compliance Conference on the topic of First Amendment Issues in Advertising and Product Packaging, FDLI will be hosting a webinar on subject February 13, 2018, from 2:00-3:30 pm ET. EAS Independent Advisor Steve Armstrong will moderate and panelists include Johan Verheij, Director, Center for Business Law & Regulation, Case Western Reserve University School of Law, August T. Horvath, Partner, Kelley Drye & Warren LLP, and David A. Kluft, Partner, Foley Hoag LLP. For more information on this webinar, click here.

Dietary Supplement Good Manufacturing Practices On-line Short Course

For those seeking a broader overview of GMPs, EAS is offering a new two-part online short course which will cover the basics of working in a GMP environment including personal hygiene, sanitation, the use of Standard Operating Procedures (SOPs), and Good Documentation Practices (GDPs). It will also address the top 5 observations cited in FDA Warning Letters since 2010.

This Short Course, based on the 21 CFR 111, Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, provides a great initial training for personnel unfamiliar with GMPs and can serve as a refresher and annual GMP training requirement.

Each session runs 2.5 hours in length and the dates are February 22nd and March 1st from 1:00-3:30 pm ET and is FREE to EAS clients. Registration is $99 for both sessions for non-clients. Click here for more information and to register.

EAS Webinar Replays Available for Viewing

Two new webinar replays have been added to the EAS Consulting Group website under the Events tab. We hope that you find these webinars informative. Should you have any questions, please reach out to Senior Director for Food Consulting Services, Allen Sayler.

Unraveling The Impact of FSMA On Acidified Food Regulations presented by EAS Independent Consultant and University of Vermont professor Omar Oyarzabal, Ph.D. and FDA Consumer Safety Officer Priya Rathnam.

Key Changes in SQF 8.0 presented by EAS Independent Consultant Susan Moyers, Ph.D., and SQFI Senior Technical Manager Kristie Grzywinski.

EAS Independent Consultants Offer Pharmaceutical Seminars for CfPIE

We are also pleased to announce the expansion of our regulatory training seminars in the area of pharmaceuticals through a partnership with CfPIE (the Centers for Professional Education and Excellence). CfPIE is a training company focusing on technical aspects of pharmaceutical, medical device, biotech, and cosmetics industries and EAS Independent Consultant Priya Jambhekar and independent Advisor for Pharmaceutical Submissions, Albert Yehaskel will instruct courses on Preparation of FDA Submissions and Communicating with FDA, and Stability Programs for Determining Product Shelf Life. The first offering of these courses will be held at the CfPIE headquarters in Malvern, PA in March, with additional courses to follow throughout the year in Boston, Los Angeles and Berlin. Detailed information can be found on the CfPIE webpage.

FDLI Publishes Article on The Value of FDA Pre-Submission Meetings & Enhancements under PDUFA VI Authored by EAS Regulatory Intern

The prestigious FDLI Update November/December 2017 Student Corner included an article written by EAS Regulatory Intern and recent Georgetown University graduate, Rahul. The article, The Value of FDA Pre-Submission Meetings & Enhancements under PDUFA VI, discusses how pharma companies can manage risks through proper communication with FDA throughout the drug development process.

EAS Webinar on the Role of Your US Agent

EAS Senior Director for Pharmaceutical and Medical Device Consulting Services, Bryan J. Coleman and Regulatory Specialist, Victoria Pankovich will co-present an EAS webinar on the Role of Your US Agent in a webinar February 27, 2018, at 10:00 am eastern.

Join us to gain a better understanding of the important basic requirements of the US Agent as well as opportunities to enhance your understanding of FDA oversight of foreign facilities.

You may register for this webinar on the Role of a US Agent by clicking here.

Cirotta to speak at Keller & Heckman Forum on e-Vapor and Tobacco

EAS President and COO, Dean Cirotta will speak at the February 6-7, 2018 Second Annual E-Vapor and Tobacco Law Symposium in Irvine, CA. This comprehensive 2-day course will address regulatory issues relevant to e-vapor, e-liquid and tobacco product manufacturers, distributors and retailers including FDA ingredient listings, premarket applications, business and IP issues, environmental issues, litigation, state laws (including Prop. 56), CPSC, EU TPD, and global regulations. Click here for more information.

Validating a Contract Laboratory – Infographic

Natural Products Insider posted an infographic on considerations for validating a contract laboratory with materials compiled from a number of 2017 Supplyside West Presentations, including that of EAS Senior Director for Dietary Supplements and Tobacco Services, Tara Lin Couch, Ph.D.

EAS Partners with HACCP Consulting Group on SQF 8.0 Seminars

EAS Consulting Group is pleased to partner with HACCP Consulting Group, a Safe Quality Foods Institute (SQFI) Training Center, for training programs aligned with the SQF Code, edition 8.

The next seminar in Chinese Camp, CA, February 6-7, 2018 followed by Dayton, OH, February 26-27, 2018 is on Developing and Implementing SQF Systems. This course provides instruction, examples, exercises, and tools necessary for successfully implementing an SQF System. This is one step in the qualification process for SQF Practitioners and an excellent choice for all food safety team members.

EAS Partners with CHPA OTC Academy for Webinar Series

EAS is pleased to partner with the Consumer Healthcare Products Association (CHPA) starting in January 2018 for a five-part webinar series focusing on a number of topics of interest to the industry. EAS Independent Consultants will present topics on Managing Foreign FDA Inspections, Adverse Events Reporting, Conducting a Scientifically Sound OOS Investigation, Managing Domestic FDA Inspections and Responding to 483s and Warning Letters, all of which are open to CHPA members and non-members.

January’s webinar on Managing Foreign FDA Inspections is presented by Peter Saxon. He’ll discuss regulatory problems often found in FDA inspections, how OAI (Official Action Indicated) results are categorized by the FDA and the ensuing consequences, and on-going steps companies can take in an effort to maintain good oversight of facilities.