Cannabis Industry Journal
February 27, 2019
Cannabis Industry Journal
February 27, 2019
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.
February 25, 2019
Natural Products Insider
February 19, 2019
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Product development in the dietary supplement industry has never been more competitive. With new companies and products arriving in the marketplace at rapid speed, the pressure is on to develop something new and exciting for the consumer in order to stay ahead of the competition.
When developing new products, one area that cannot be overlooked is that of regulatory compliance with the Dietary Supplement Health and Education Act of 1994 (DSHEA), and FDA’s Good Manufacturing Practice requirements for dietary supplements per 21 CFR 111, Current Good Manufacturing Practice (cGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements,and appropriate labeling of the dietary supplement product in accordance to 21 CFR 101, Food Labeling.
Join EAS Independent Consultant, Steve Cammarn, Ph.D., for a discussion on principles and techniques for a phased-approach of the development of vitamin, mineral, and supplements, 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.
Stephen Cammarn, Ph.D., is an independent consultant with EAS Consulting Group. Previously, Dr. Cammarn served 34 years as a leader in healthcare R&D and Quality Assurance with The Procter & Gamble Company. Stephen led and managed organizations that spanned the Americas, EMEA, and Asia, responsible for global Pharmaceutical Development and Quality Assurance for healthcare products. He has expertise in formulation, design, process, technical support, quality and regulatory aspects of pharmaceuticals, OTC medicines; vitamins, minerals and supplements; oral care products and devices, and foods. Stephen also holds numerous patents and has developed, obtained FDA approval for and launched numerous new products, and has led work to remediate contractor firms after FDA observations and Warning Letters. Stephen also has extensive experience in due diligence, joint ventures, and partnerships. Stephen holds an undergraduate degree in Chemical Engineering and a Ph.D. in Industrial Pharmacy. Stephen has also served as adjunct faculty with the University of Cincinnati College of Pharmacy, as well as on numerous community boards.
In the industries regulated by FDA compliance issues are of great importance. When disputes arise, the regulatory compliance status of a product or facility is often a key issue and can make a significant difference in how the matter will be resolved. In such cases, it is critical to have the assistance and advice of experts who are both experienced and knowledgeable in FDA regulations and industry practices, and who will be perceived as independent and objective. Whether a dispute is resolved via mediation or litigation it is imperative to have a well-respected and knowledgeable expert witness acting on your firm’s and client’s behalf. EAS independent advisors and consultants are routinely called to serve as expert witnesses in a variety of cases and provide the in-depth, detailed attention required.
Our team of former high-level FDA officials and industry executives average over 25 years of regulatory experience and include some of the most well-known and highly respected names in the industry. As new standards evolve and regulations are issued, EAS keeps abreast of the changing regulatory landscape, allowing us to deliver up-to-date guidance and advice to our clients. Our experts have the knowledge, qualifications, and experience necessary to explain and clarify the issues to our clients and the courts while establishing credibility and persuasiveness as witnesses.
Agencies, judges and juries, want to hear from well-respected and knowledgeable expert witnesses. The need is there, whether the issue is recalls, labeling claims, safety audits, or almost any other challenge to a facility or a product. A good expert witness is not just a person with wisdom about a topic, the expert must also be able to communicate to, connect with, and convince the decision maker. It is not easy to find experienced experts who are more than just a great resume, however, EAS provides consultants who can become part of your legal team, writing expert opinions, participating in depositions or being called to the stand as your expert witness.
If EAS can be of assistance as you prepare for your next litigation or mediation challenge, please reach out to me directly. I will personally assure that EAS will match the specific needs and requirements of your case with an expert whose knowledge and experience enhances your client’s legal standing.
President and COOs
EAS Consulting Group
Natural Products Insider
February 5, 2019
Tara Lin Couch, Ph.D.
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.
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.
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!
By James Hoadley, Ph.D.
Each month EAS Independent Consultants answer one question sent in by our readers. This month’s question is answered by James Hoadley, Ph.D., an expert in food and supplement labeling and content claims and long-time instructor for our popular Food and Dietary Supplement Labeling Compliance Seminar. Prior to consulting Jim was the Senior Regulatory Scientist, Nutrition at FDA’s CFSAN Office of Nutritional Products, Labeling and Dietary Supplements
Question: I am a smaller company that produces maple syrup and honey sold in jars. Does the 2018 Farm Bill mean I no longer have to comply with the 2016 FDA Nutrition Facts requirements for these two single-source products?
Hoadley: One of the NUTRITION FACTS changes introduced in the FDA’s 2016 revisions to nutrition labeling regulations was a new line in the Nutrition Facts for Includes __ g added sugar. When a food contains sugars, but not added sugars, then the “Includes X
|2018 Farm Bill. SEC. 12516. LABELING EXEMPTION FOR SINGLE INGREDIENT FOODS AND PRODUCTS.|
The food labeling requirements under section 403(q) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 343(q)) shall not require that the nutrition facts label of any single-ingredient sugar, honey, agave, or syrup, including maple syrup, that is packaged and offered for sale as a single-ingredient food bear the declaration “Includes X g Added Sugars.”.
Congress joined in the party by placing an ‘added sugars’ section in the miscellaneous provisions of the 2018 Farm Bill. The 2018 Farm Bill has decreed that FDA shall not require any single-ingredient sugar, honey, agave, or syrup product to bear the “Includes X
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!
Independent Consultant Thomas Dunn discusses packaging trends in an article for Natural Products Insider. Packaging is an important component of overall product design as it protects, preserves, escorts and describes the products consumed. As consumers demand more sustainable packaging, companies are working hard to meet that demand with innovative and cost-effective products.
Welcome to the February 2019 edition of EAS-e-News, the free news publication dedicated to FDA regulated industries. I’d like to begin by bringing your attention to our many new educational opportunities. From our many complimentary webinars to regulatory compliance seminars EAS brings the best in regulatory education to you through our extensive network of independent experts. In this issue, you’ll find numerous opportunities to learn in real time in addition to our wealth of on-demand webinars available for viewing at your convenience.
On that note, two recent additions to our complimentary webinar offerings include one on the requirements for Qualified Individuals, hosted by Independent Advisors Domenic Veneziano and Charles Breen, and regulatory challenges and opportunities for companies preparing New Infant Formula Notifications, presented by EAS Independent Advisor Robert Martin, Ph.D., and Independent Consultants Robert Burns, Ph.D. and Timothy Morck, Ph.D.. More information can be found in the EAS in Action section of this issue.
Our Issue of the Month is written by Independent Advisor for FSMA, Charles Breen, and discusses two very similar sounding terms, Qualified Individual and Preventive Controls Qualified Individual, which have two very different meanings. Our Ask the Expert is written by James Hoadley, Ph.D. and discusses the provision in the recently signed Farm Bill which covers “added sugars” and when the “includes X g added sugars” can be omitted from a label.
Also in this issue, we introduce a new section called “Did you Know?” which will provide a brief spotlight of concern to FDA
Further, EAS has just released our newest Video Short, on cannabis quality issues and how EAS Consulting Group can help companies navigate as the industry pushes for for developing sound Good Manufacturing Practices.
Lastly, we are so pleased that there is at least a temporary solution to reopen the federal government after the longest shutdown in our nation’s history and we hope for a lasting resolution that enables both sides of the aisle to find common ground. The shut down has had numerous negative impacts, including severely curtailing operations at FDA and USDA, are we are thankful, at least for the moment, that our federal employees are able to get back to the business at hand by serving the public.
Thank you as always for your interest in EAS and EASeNews. You are one of the 16,000 who receive our newsletter and we take great pride in bringing you relevant content and compliance solutions. Please let me know if you have any questions on this issue or other areas of FDA compliance.
Chairman and CEO
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.
Ron Levine has 40 years of experience advising consumer products companies in complex commercial matters. In addition to providing consulting services for EAS, he serves as the General Counsel of Herrick, Feinstein LLP, a law firm with offices in New York and Newark, NJ. He has practiced with Herrick since 1984, where he was a partner from 1985-2018. He served as Chair of the firm’s Litigation Department for 15 years.
A pragmatic advisor who helps clients anticipate, minimize and resolve the financial and reputational damage arising from claims and potential claims, Ron specializes in crisis management, for food and beverage manufacturers, and advises on class action litigations and investigations, including serving as an expert witness, related to labeling, the Food Safety Modernization Act (FSMA), advertising claims, product recalls, FDA regulations and other concerns.
The EAS Expert Witness team is greatly enhanced with the addition of Ron. By strategically matching the regulatory purview of the case at hand with our former high-level FDA and industry executives, EAS offers in-depth analysis of FDA and other Federal and state laws as well as standard industry best practices. Ron, along with Steve Armstrong, EAS Independent Advisor for Food Law and Regulation and former Chief Counsel for Campbell Soup Company and Bruce Silverglade, an EAS Independent Consultant and a Principal with the law firm Olsson Frank and Weeda Terman Matz, PC, lead the EAS Expert Witness team of consultants providing detailed and critical services to firms in all FDA commodity areas.
There has been an increasingly growing volume of litigation in the slack fill area. This is a daunting issue for food manufacturers and is complicated by a dearth of clear guidance which ultimately leads to a lack of understanding of the many competing requirements and increases a company’s risk for legal challenges. In fact, there are at least five levels of law where one should look for guidance with slack fill, including international, federal, state, local and common law. Answers on how to interpret and piece the various laws and rulings together
If you are one of the many who
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.
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
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!
With the Federal Register (FR) publication unavailable, the FDA has published
FDA-2018-D-1387. For questions about this document regarding CDRH-regulated devices, contact the 510(k) Staff at 301-796-5640. For questions about this document regarding CBER-regulated devices, contact the Office of Communication, Outreach, and Development (OCOD) at 1-800-835-4709 or 240-402-8010.
FDA’s CDRH recently released a Safety and Performance-Based Pathway Guidance Document describing a new abbreviated submission process for 510(k)s which aims to simplify submissions for devices which meet performance standards developed by FDA rather than showing outright equivalence in safety/efficacy to the predicate device. This new pathway has the potential for reducing the administrative burden of building a lengthy clearance dossier as well as be a slightly faster way to gain review and clearance. More information will be forthcoming as FDA issues future guidance on the application of this Safety and Performance-Based Pathway to certain types of devices with corresponding FDA-identified performance criteria. Industry may suggest device types for which FDA should consider identifying performance criteria.
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.
By Charles Breen
The Food Safety Modernization Act (FSMA) Preventive Control for Human Foods (PCHF) regulation (21 CFR 117) signed into law in 2011 offers a wealth of opportunity (and a requirement) for companies to improve their food safety procedures and protocols through the implementation of a preventive strategy against foodborne risks. As part of this regulation, food manufacturers must require that employees are qualified to perform their assigned tasks in a manner that protects food safety and prevents against adulteration. In addition, each company must have at least one employee, preferably located at the food manufacturing facility, who functions as a Preventive Controls Qualified Individual (PCQI). The PCQI functions as the responsible party overseeing the development and execution of all food safety programs and must have the knowledge, skills and abilities to perform these tasks based on their education, on the job experience or a combination.
Also, as part of FSMA, the Foreign Supplier Verification Program (FSVP) Final Rule for importers of human and animal food requires in Part 1 Subpart L that food manufacturers enlist a “Qualified Individual” who has responsibility for ensuring that all foreign suppliers of foods or food ingredients imported for consumption or further manufacturing in the U.S. produce their products in a manner consistent with FSMA requirements. This FSVP Qualified Individual (QI) must also have the knowledge, skills and abilities (KSAs) appropriate to evaluate foreign supplier compliance through their education OTJ experience or a combination of both.
The FSMA PCHF regulation calls for a PCQI while the FSVP regulation calls for a QI. Though the terms are nearly the same and the regulations are related, they have different meanings. What exactly is the difference, in FDA’s view, of a PCQI and a QI, and how can companies determine that they are meeting FDA’s intent?
PCHF’s big focus is on preventive controls for all food manufacturing facilities producing foods or food ingredients that will be consumed in the US. FDA requires that risk be assessed and mitigated so the risk no longer has public health significance, and that specific controls or mitigations steps be evaluated for effectiveness by a PCQI. A new term in the PCHF Final Rule, the requirement for a PCQI applies to covered domestic and foreign facilities producing human and animal food, generally those that need to register under section 415 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), (though there are, as expected, some exemptions). Though one PCQI can develop food safety plans for multiple facilities, it is important to note that each plan must be specific to the facility and address the unique processes and hazards within.
As a PCQI, considerations for biological, chemical and physical hazards must be thoroughly understood and assessed. Biological hazards include parasites and disease-causing bacteria; chemical hazards include radiological exposure, pesticides, drug residues, natural toxins, food decomposition, unapproved additives and food allergens; and physical hazards include items such as glass, rocks, metal parts or other foreign objects. FSMA requires that a food safety plan that specifically controls each of them must be developed by the PCQI.
FDA accepts that either training or education (or a combination thereof) can provide the knowledge and skills required to perform PCQI duties as long as they equal a standardized curriculum recognized as adequate by FDA, such as that designed by the Food Safety and Preventive Controls Alliance (FSPCA) and instructed by FSPCA “Lead Instructors”. EAS offers the FDA-recognized FSPCA PCQI training curriculum, taught by Lead Instructors, as part of our comprehensive suite of in-house seminars and workshops.
Many who have already received training in HACCP, SQF, , BRC, IFS or FSSC22000 may still need additional training due to additional requirements for Good Manufacturing Practices requirements and Preventive Controls specified under PCHF in Part 117. FDA does not require, but it does recognize a formal FSPCA certificate verifying competency in Preventive Controls, for participants who successfully complete FSPCA PCQI workshop.
Companies importing finished food and food ingredients for further processing into the U.S. must have an FSVP QI to develop their FSVP food safety assessment program. An FSVP QI may be employed by the FSVP “Importer” or the Importer can contract with a private individual or consulting company like EAS Consulting Group to perform the FSVP QI responsibilities. A FSVP QI must evaluate the overall food safety risk of a food or food ingredient provided by a foreign supplier utilizing various documents originating from the foreign supplier and determine whether the foods or food ingredients meet FDA’s strict food safety requirements found in the PCHF and FSVP regulations. Much like PCHF’s PCQI, the FSVP QI will use the foreign supplier’s documents and the nature of the imported food or food ingredient to assess whether adequate controls are in place for potential biological, chemical and physical hazards. In addition, the FSVP QI will assess food safety risk by looking at whether their foreign supplier has been the subject of an FDA warning letter or import alert, their food safety performance history, results from testing, private or government audit results, and the supplier’s record of correcting problems.
Once the QI has determined that a foreign supplier’s risks have appropriate controls, they will continue to monitor their performance by conducting appropriate supplier verification activities including some combination of onsite audits, reviewing supplier relevant food safety activities and sampling and testing of a food. By regulation, these evaluation activities must be performed no less than every three years, or sooner if the FSVP importer becomes aware of new information concerning food safety or the foreign supplier’s performance. It is our recommendation that these evaluation activities be updated annually as the food manufacturing environment is constantly changing and performing food safety risk assessments of a foreign manufacturer once every three (3) years may result in a significant food safety issue being allowed to continue for too long.
In addition to a QI’s assessment duties for a food importer, the FSVP Importer must also make sure their US Customs Broker identifies them for each incoming food or food ingredient shipment on the US Customs and Border Protection “ACE” electronic database as the FSVP Importer. The information must include the FSVP importer’s name, mailing address, and a unique facility identifier (UFI) recognized as acceptable to FDA. At present, FDA recognizes only DUNS numbers as an acceptable UFI.
Everyone with a role in importing foreign sourced foods should be familiar with applicable FSVP requirements including US Customs Brokers,foreign exporters, foreign food manufacturers, and US importers. This comprehensive approach is required under FSMA’s PCHF and FSVP regulations, intended to improve the nation’s level of protect food safety protection. FSPCA has developed an FDA-recognized FSVP training curriculum and EAS offers this in a workshop format in addition that of FSPCA’s Preventive Controls training curriculum.
The microscope under which food safety assessments are evaluated has never been as detailed and is being scrutinized by FDA as now. With the possibility for potentially damaging regulatory enforcement consequences, many firms need to review, upgrade and have an outside, objective assessment of their food safety plans, whether they are domestic food manufacturers that have to comply with FSMA’s PCHF regulation or foreign food manufacturers that have to comply with both FSMA’s PCHF and FSVP regulations. An objective outside compliance assessment of a food manufacturer’s food safety plan needs to evaluate both the written plan and the effectiveness of its implementation. Third parties, such as EAS, can perform this objective outside assessment using a team approach to bring the correct level of expertise for development of an in-depth understanding of food manufacturer’s existing food safety system. The use of outside objective and qualified third-party private organizations such as EAS to evaluate and test the food manufacturer’s food safety program is part of any food manufacturer’s due diligence effort and can also offer a greater peace of mind to senior management of the facility and company owning the food manufacturing facility. Murphy’s Law says that if something can go wrong, it will. With a detailed food safety strategy in place, those risks can be identified and minimized before they become a problem.
Also, look for EAS in the News for articles such as:
FDLI Update: “FSMA After One Year: Advancing and Building Food Safety Systems for the 21st Century”, Steve Armstrong, EAS Independent Advisor, Food Law and Regulation