January 2020 EAS in Action

Best Practices in Equipment Sanitation – An EAS On-line Short Course starting January 29, 2020

Join EAS Consulting Group’s Independent Consultants, David Blomquist and Jenifer Kane for a detailed look at how to identify potentially troublesome practices that negatively impact operational food safety and how upgrading existing food safety programs using industry “best practices” can result in compliance with applicable FSMA regulations.

This three-part on-line short course is a must all who play a role in manufacturing food safety, food quality, facility as well as equipment maintenance. Join EAS January 29, February 5 and February 12 for our on-line short course and gain valuable actionable knowledge to improve your programs today. Registration fees apply. Click here to learn more.

EAS Complimentary Webinars – More on Codex, DMF and UDIs and Advanced Managerial Controls

EAS has a packed webinar schedule this winter. From Codex requirements to streamlining Drug Master Files to how Unique Device Identifiers can facilitate your product safety to using Active Managerial Controls in food safety oversight, our consultants can help you to better understand your business… and your FDA requirements. Click here to see our full schedule and to register.

Streamlining DMF – a Complimentary EAS Webinar, February 12, 2020

The preparation of a DMF to support a variety of pharmaceutical applications to FDA is lengthy and cumbersome to develop and produce. But just what documentation and how much detail is required of a DMF and where do companies commonly run into issues during the FDA review of their dossiers? Join EAS Consulting Group independent consultant and expert in DMF preparations, Priya Jambhekar, for a complimentary webinar and overview of the details DMFs should contain and tips for getting it right. Register today.

Unique Device Identifiers – a Complimentary EAS Webinar – March 11, 2020

Unique Device Identifiers (UDI) appearing on device labels, packaging, and sometimes directly on the device itself allows for improvements to patient safety, facilitates and modernizes postmarket surveillance as well as provides for product innovation in an industry that is seeing rapid advancement. Learn the regulatory requirements of UDIs including how to obtain a UDI number, proper measures to update device listings and how to implement best practice systems for ensuring appropriate data tracking. Join EAS independent consultant Jay Mansour on March 11, 2020 at 11 am eastern for this complimentary webinar. Register today.

Proactive Food Safety with Active Managerial Controls – an EAS Webinar in Partnership with the National Restaurant Association

You might think your routine food safety protocol is doing the job, keeping your food and guests safe. This webinar, presented by Charles Otto and hosted by the National Restaurant Association, will show you how your system really stacks up and if it’s as preventative as it should be. You’ll learn how to use self-assessment results to design a system of policies that head off risks. You’ll hear effective ways to train employees and establish an ongoing verification process to ensure the system is being followed. Click here to register for this January 28, 2020 webinar.

FDA’s CTP Updates Industry on Premarket Tobacco Product Applications for Deemed Products

FDLI Logo

FDA CTP’s Public Meeting on PTMAs updated stakeholders on a variety of issues pertaining Premarket Tobacco Product Applications for Deemed Products, including items such as scientific content ensuring applications and information contained are Appropriate for the Protection of Public Health (APPH). FDA reviews chemistry, microbiology, toxicology and more and applicants must ensure establishments referenced in a PMTA submission are “inspection ready” at the time of submission. In addition to chemistry, microbiology and toxicology, FDA will observe the manufacturing process for the proposed APPH product ensuring compliance with FDA-regulated facility Current Good Manufacturing Practice (cGMP) inspection per sections 902 and 906(e)(1) of the FD&C Act. Learn more in FDLI’s Update where Tara Couch, Ph.D., Senior Director for Dietary Supplements and Tobacco Products, co-authored a meeting summary.

Dietary Supplement and FSMA EAS Webinar – On-Demand

Senior Directors Allen Sayler and Tara Lin Couch, Ph.D. presented a webinar on dietary supplements and FSMA. Now available on-demand, this webinar is a must to understand where dietary supplement GMPs (21 CFR 111) and food’s FSMA (21 CFR 117) intersect so that your firm can ensure compliance.

Discussion of Big Data and Real-World Evidence in ISPE iSpeak

ISPE Logo

From Big Data, to Real World Evidence to Value Proposition and Reimbursements, regulators and sponsors must guide new pharma product development and promotion to be consistent with product labeling as the regulatory approval environment becomes more complex. Read on in ISPE’s iSpeak blog written by EAS independent consultant, John Harbell.

Best Practices in Equipment Sanitation – An EAS On-line Short Course starting January 29, 2020

Join EAS Consulting Group’s Independent Consultants, David Blomquist and Jenifer Kane for a detailed look at how to identify potentially troublesome practices that negatively impact operational food safety and how upgrading existing food safety programs using industry “best practices” can result in compliance with applicable FSMA regulations.

This three-part on-line short course is a must all who play a role in manufacturing food safety, food quality, facility as well as equipment maintenance. Join EAS January 29, February 5 and February 12 for our on-line short course and gain valuable actionable knowledge to improve your programs today. Registration fees apply. Click here to learn more.

FDA’s Unique Device Identifier – Regulatory Requirements for Improving Patient Safety and Postmarket Surveillance

March 11, 2020, at 11 AM Eastern

Presented by Jay Mansour

Unique Device Identifiers (UDI) offer enhanced opportunities to evaluate, monitor and improve future safety of medical device products by tracking products from production through patient use. These identifiers appearing on device labels, packaging, and sometimes directly on the device itself allows for improvements to patient safety, facilitates and modernizes postmarket surveillance as well as provides for product innovation in an industry that is seeing rapid advancement.

While the potential for UDIs is vast, many medical device manufacturers and labelers are unsure how to obtain a UDI number, proper measures to update device listings and how to implement best practice systems for ensuring appropriate data tracking.

Join EAS independent consultant Jay Mansour for a look at UDIs, their potential, some potential challenges and how to ensure your products meet FDA’s labeling requirements including tracking mechanisms for the devices themselves.

About the Presenter

Jay Mansour

EAS independent consultant Jay Mansour is a seasoned Medical Device regulatory consultant with 20+ years of experience. He has successfully filed more than 100 510(k) clearances across many technologies and assists clients with QMS turnkey projects, including personnel training, and CE marking products as well as responding to FDA’s 483 and warning letters. He is an expert in Process Validations (software, sterilization and more).

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By submitting this form you will be joining the nearly 20,000 who receive the monthly EASeNews regulatory newsletter. Please note EAS never shares your information and you may unsubscribe at any time.

EAS Consulting Group and National Restaurant Association Present: Proactive Food Safety Using Active Managerial Controls

January 28, 2020, at 2 PM Eastern

Presented by Charles Otto, EAS Independent Consultant and former Environmental Health Officer and Deputy Chief at the Centers for Disease Control and Prevention (CDC)

(registrations for this complimentary webinar are taken through the National Restaurant Association)

While the diligent food safety manager assumes their routine Food Code compliance procedures are sufficient to protect against the introduction of pathogens at their retail establishment, but are they? 

Active Managerial Control (AMC) is a preventive food safety management system (FSMS) that can prevent the risk of foodborne illness through targeted standards, employee engagement, and continuing proactive appraisal. Once issues are identified by self-assessment, quick reaction can facilitate mitigation of those risks before they become a problem for consumers.

Learn how to design and implement AMC risk-based policies, training, and verification procedures for preemptive risk reduction. Explore the details of successful AMC development and implementation with coverage of resources to assist small to large operations. Join EAS Independent Consultant, Charles Otto, for an in-depth look at this crucial safety protocol for retail food establishments and ensure your FSMS is robust and your customers are safe.

In this webinar you will:

  • Understand how AMCs enhance Food Code compliance procedures
  • Learn how to design and implement AMC risk-based policies, training and verification procedures
  • Explore the details of successful AMC development and implementation 

About the Presenter:

EAS Consulting Group’s independent consultant, Charles Otto, is a former Environmental Health Officer and Deputy Chief at the CDC where he provided guidance on all aspects of environmental health to the CDC Vessel Sanitation Program staff, member cruise lines, shipyards, and other global collaborators for the prevention of environmentally-related illnesses. He has worked at FDA as the Assistant Director in the Division of Cooperative Programs as well as the Retail Food Protection Branch where he developed national Hazard Analysis Critical Control Point (HACCP) implementation strategies for retail food protection, interstate travel programs, milk safety, and shellfish sanitation programs and furnished comprehensive field training on proper interpretation and implementation of the model food code standardization exercises conducted in every region of the U.S.

About EAS Consulting Group:

EAS Consulting Group, LLC (EAS) specializes in Food and Drug Administration (FDA) regulatory matters. Our prime focus is to assist domestic and foreign pharmaceuticalmedical devicetobaccofooddietary supplementcosmetic and biologics firms comply with applicable laws and regulations. EAS is staffed with former FDA compliance and inspection officials and industry executives and is assisted by an extensive network of independent consultants with many years of FDA and industry experience.

Headquartered in Alexandria, VA with consultants and auditors located strategically throughout North and South America, Europe, and various Pacific Rim counties, EAS Consulting Group is a sought-after expert in regulatory matters, assisting firms with highly technical submissions such as GRAS, DMF, NDI, ANDA, 510(k) and others, as well as the development of quality systems, label reviews, structure-function claims, GMP audits, and US Agent assistance and more. In addition, EAS assists clients with remediation strategies and responding to Form 483’s, Lists of Observations, Warning Letters, and other FDA communications. EAS experts are often asked to serve as expert witnesses and are routinely asked to speak at worldwide events on technical regulatory issues. EAS is proud to have a solid reputation in the industry as the leading consulting and training firm for FDA regulatory matters. www.easconsultinggroup.com

About the National Restaurant Association

Founded in 1919, the National Restaurant Association is the leading business association for the restaurant industry, which comprises 1 million restaurant and foodservice outlets and a workforce of 15.3 million employees. We represent the industry in Washington, D.C., and advocate on its behalf. We sponsor the industry’s largest trade show (National Restaurant Association Show May 16-19, 2020, in Chicago); leading food safety training and certification program (ServSafe); unique career-building high school program (the NRAEF’s ProStart). For more information, visit Restaurant.org and find us on Twitter @WeRRestaurantsFacebook and YouTube.

Dietary Supplements and FSMA Compliance – Fallacy or Fact?

On-Demand

Tara Lin Couch, Ph.D. & Allen Sayler

In 1994 the Dietary Supplement Health and Education Act (DSHEA) created a new, legal class of products, called “Dietary Supplements”, which are regulated by the FDA as a subcategory of foods. Since DHSEA, the Food Safety Modernization Act (FSMA) of 2011 was passed, and as a category of foods, dietary supplements are now subject to seven major regulations 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 requires, among other things, that a Preventive Controls Qualified Individual (PCQI) develop a food safety plan. Another FSMA requirement is the need for a Foreign Supplier Verification Program (FSVP) when dietary ingredients and dietary supplements are sourced internationally, (estimated to be over half of all dietary supplement ingredients). Unfortunately, the dietary supplement industry is plagued by lack of compliance with these critical FSMA requirements and the FDA is beginning to crack down on firms with increased enforcement actions.

How does the dietary supplement industry, including raw material manufacturers and dietary ingredient suppliers, dietary supplement manufacturers, and dietary supplement brand owners referred to as Own Label Distributors (OLDs) avoid enforcement actions? What aspects of FSMA’s Preventive Controls for Human Foods, 21 CFR 117, apply to dietary supplements and what about other FSMA responsibilities like FSVP?

Join EAS Consulting Group’s FSMA and Dietary Supplement experts Tara Lin Couch, Ph.D., Senior Director for Dietary Supplement and Tobacco Services and Allen Sayler, Senior Director for Food Consulting Services for an overview of the FSMA regulation and a deeper dive into those aspects which specifically apply to dietary supplements. Learn the crucial steps to compliance, including what must be included in a dietary supplement written and documented program as well as the FDA FSMA FSVP requirements applicable to dietary ingredients and dietary supplements sourced from outside the US.

Dietary Supplement OLDs, manufacturers and dietary ingredient suppliers all have an obligation to protect public safety and ensure compliance with all the applicable regulations. Understanding these FSMA requirements and their role in the supply-chain are key to ensuring compliance.

About the Presenters

Tara Lin Couch, Ph.D.
Senior Director of Dietary Supplement and Tobacco Services

Dr. Tara Lin Couch is a Ph.D. Analytical / Organic Chemist with exceptional analytical abilities and over 25 years of diverse laboratory and regulatory experience in academic, field, contract, and manufacturing environments. She is a sought-after expert on issues pertaining to Quality Control in pharmaceutical, dietary supplement and tobacco manufacturing facilities including the establishment of specifications and the development of well-organized, sophisticated laboratories. As a Senior Director for EAS Consulting Group, Dr. Couch has assisted numerous companies with the development, improvement, and implementation of strong Quality Systems that are scientifically sound, efficient, practical, and compliant with all FDA regulations. She also performs mock FDA inspections, gap-analyses, and contractor facility audits. In addition, Dr. Couch provides GMP and laboratory training via seminar, webinar, and on-site presentations.

Allen Sayler
Senior Director of Food Consulting Services

Allen Sayler is the Senior Director for Food Consulting Services at EAS. Mr. Sayler had been an independent consultant for EAS since 2012 and promoted in 2017. His expertise in the areas of food processing, particularly in the area of dairy processing, infant formula, bakery products, food additives, botanical products and food packaging as well as GSFI Third-Party Certification programs such as Safe Quality Foods (SQF) has been of great value to EAS clients. Allen has spent more than 30 years as a food processing and regulatory expert, with half of the time serving the industry and the other have as a state and federal government employee. For twelve of those years, he served as vice president of regulatory affairs and international standards at the International Dairy Foods Association. Prior to that, his government career included working on dairy standards and grading programs at the Dairy Division of USDA’s Agricultural Marketing Service, FDA’s Milk Safety Branch – including a stint as acting chief of the branch and ten years as Assistant Dairy Commissioner for the North Dakota Department of Agriculture. Prior to joining EAS full time, he was a Managing Partner of the Center for Food Safety & Regulatory Solutions. His international experience includes representing the US food processing industry at the Codex Committees on Food Additives, Food Labeling, Food Hygiene and Milk & Milk Products.

Terms and Conditions

By submitting this form you will be joining the nearly 20,000 who receive the monthly EASeNews regulatory newsletter. Please note EAS never shares your information and you may unsubscribe at any time.

Dietary Supplements and FSMA Compliance – Fallacy or Fact?

Tara Lin Couch, Ph.D. & Allen Sayler

In 1994 the Dietary Supplement Health and Education Act (DSHEA) created a new, legal class of products, called “Dietary Supplements”, which are regulated by the FDA as a subcategory of foods. Since DHSEA, the Food Safety Modernization Act (FSMA) of 2011 was passed, and as a category of foods, dietary supplements are now subject to seven major regulations 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 requires, among other things, that a Preventive Controls Qualified Individual (PCQI) develop a food safety plan. Another FSMA requirement is the need for a Foreign Supplier Verification Program (FSVP) when dietary ingredients and dietary supplements are sourced internationally, (estimated to be over half of all dietary supplement ingredients). Unfortunately, the dietary supplement industry is plagued by lack of compliance with these critical FSMA requirements and the FDA is beginning to crack down on firms with increased enforcement actions.

How does the dietary supplement industry, including raw material manufacturers and dietary ingredient suppliers, dietary supplement manufacturers, and dietary supplement brand owners referred to as Own Label Distributors (OLDs) avoid enforcement actions? What aspects of FSMA’s Preventive Controls for Human Foods, 21 CFR 117, apply to dietary supplements and what about other FSMA responsibilities like FSVP?

Join EAS Consulting Group’s FSMA and Dietary Supplement experts Tara Lin Couch, Ph.D., Senior Director for Dietary Supplement and Tobacco Services and Allen Sayler, Senior Director for Food Consulting Services for an overview of the FSMA regulation and a deeper dive into those aspects which specifically apply to dietary supplements. Learn the crucial steps to compliance, including what must be included in a dietary supplement written and documented program as well as the FDA FSMA FSVP requirements applicable to dietary ingredients and dietary supplements sourced from outside the US.

Dietary Supplement OLDs, manufacturers and dietary ingredient suppliers all have an obligation to protect public safety and ensure compliance with all the applicable regulations. Understanding these FSMA requirements and their role in the supply-chain are key to ensuring compliance.

About the Presenters

Tara Lin Couch, Ph.D.
Senior Director of Dietary Supplement and Tobacco Services

Dr. Tara Lin Couch is a Ph.D. Analytical / Organic Chemist with exceptional analytical abilities and over 25 years of diverse laboratory and regulatory experience in academic, field, contract, and manufacturing environments. She is a sought-after expert on issues pertaining to Quality Control in pharmaceutical, dietary supplement and tobacco manufacturing facilities including the establishment of specifications and the development of well-organized, sophisticated laboratories. As a Senior Director for EAS Consulting Group, Dr. Couch has assisted numerous companies with the development, improvement, and implementation of strong Quality Systems that are scientifically sound, efficient, practical, and compliant with all FDA regulations. She also performs mock FDA inspections, gap-analyses, and contractor facility audits. In addition, Dr. Couch provides GMP and laboratory training via seminar, webinar, and on-site presentations.

Allen Sayler
Senior Director of Food Consulting Services

Allen Sayler is the Senior Director for Food Consulting Services at EAS. Mr. Sayler had been an independent consultant for EAS since 2012 and promoted in 2017. His expertise in the areas of food processing, particularly in the area of dairy processing, infant formula, bakery products, food additives, botanical products and food packaging as well as GSFI Third-Party Certification programs such as Safe Quality Foods (SQF) has been of great value to EAS clients. Allen has spent more than 30 years as a food processing and regulatory expert, with half of the time serving the industry and the other have as a state and federal government employee. For twelve of those years, he served as vice president of regulatory affairs and international standards at the International Dairy Foods Association. Prior to that, his government career included working on dairy standards and grading programs at the Dairy Division of USDA’s Agricultural Marketing Service, FDA’s Milk Safety Branch – including a stint as acting chief of the branch and ten years as Assistant Dairy Commissioner for the North Dakota Department of Agriculture. Prior to joining EAS full time, he was a Managing Partner of the Center for Food Safety & Regulatory Solutions. His international experience includes representing the US food processing industry at the Codex Committees on Food Additives, Food Labeling, Food Hygiene and Milk & Milk Products.

Terms and Conditions

By submitting this form you will be joining the nearly 20,000 who receive the monthly EASeNews regulatory newsletter. Please note EAS never shares your information and you may unsubscribe at any time.

Quality Systems for the Cannabis Industry – Preparing for State GMP Regulations

On-Demand

Presented by: Tara Lin Couch, Ph.D., Senior Director, Dietary Supplement and Tobacco Services

As states begin to regulate legalized cannabis, the concern of how Good Manufacturing Practices (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 your manufacturing processes and implementing sound and effective quality systems in order to help you begin to prepare for GMP regulations. Stay ahead of the curve, standardize your product quality and be a leader in your industry.

About the instructor

Tara Lin Couch, Ph.D., Senior Director, Dietary Supplement and Tobacco Services

Tara Couch PhD

Dr. Tara Lin Couch is a Ph.D. Analytical / Organic Chemist with exceptional analytical abilities and over 25 years of diverse laboratory and regulatory experience in academic, field, contract, and manufacturing environments. She is a sought-after expert on issues pertaining to Quality Control in pharmaceutical, dietary supplement and tobacco manufacturing facilities including the establishment of specifications and the development of well-organized, sophisticated laboratories. As a Senior Director for EAS Consulting Group, Dr. Couch has assisted numerous companies with the development, improvement, and implementation of strong Quality Systems that are scientifically sound, efficient, practical, and compliant with all FDA regulations. She also performs mock FDA inspections, gap-analyses, and contractor facility audits. In addition, Dr. Couch provides GMP and laboratory training via seminar, webinar, and on-site presentations.

Spring 2020 EAS Compliance Trainings Scheduled for April in Long Island

EAS has scheduled our spring training seminars in Long Island next year. Join us April 14-15, 2020 for Dietary Supplement Labeling Compliance, April 16-17 for Food Labeling Compliance, and April 16-17 for the Dietary Supplement GMP seminar. Each of our flagship trainings are taught by our internationally recognized consultants and provide an excellent opportunity to not only learn the specific requirements but to do so in a small group setting with plenty of opportunities to practice skill improvement.

Year-End Review

Dear Readers,

Edward A. Steele

As 2019 comes to a close, it is my honor to thank you for your interest in EAS Consulting Group and convey my appreciation for your dedication to improving your understanding of FDA regulatory requirements through our EASeNews, the many articles published in trade magazines and websites, our webinars and regulatory compliance seminars. It has been another banner year for EAS, and it goes without saying, we value the trust you place in us to help you ensure your GMP and FSMA regulatory compliance is sound, your products are appropriately labeled, your technical submissions such as GRAS, DMF, 510(k) and others are prepared with the diligent attention to detail that you, and FDA, expects. Thank you for the trust you place in EAS each day and we will always strive to ensure that trust is well placed.

In particular, as we have received such good feedback on the utility (and, of course, the price) of our complimentary compliance seminars, I am pleased to say we upped our game and by year’s end will have offered 23 webinars hosted by our many talented independent regulatory consultants (most now available on-demand) ranging in topics from GMP observations for dietary supplements and pharmaceuticals to FDA’s move to a new QMS for medical devices, to what exactly is GRAS and what goes into the preparation of a dossier and more. Thousands registered for our webinars this year, which is an amazing accomplishment and indication that we are on the right track ensuring that you have an understanding of FDA requirements.

As always, when more information was needed or additional questions were raised, EAS consultants answered the call, by planes, trains and automobiles, as well as the good old-fashioned telephone, providing worldwide assistance, in many cases on very short notice. We helped firms to thwart or respond to a crisis and provided routine and actionable recommendations for improvements to a variety of issues such as SOPs, SDS, equipment sanitation, labeling challenges and more. Our in-house trainings saw a banner year as clients contracted EAS to dedicate focused training opportunities for some of their most pertinent challenges. We are pleased that more and more firms are taking a proactive approach to regulatory compliance as it is always easier to correct an issue before it becomes a full-blown problem.

I wish you a safe and happy holiday season. If ever EAS can be of assistance, please know we are always just a phone call or email away.

Sincerely,

EAS Signature Ed

Ed

Register Now – EAS Complimentary Webinars Offer Regulatory Solutions to Your Most Complex Problems

EAS will host two complimentary webinars in December and we invite you to join us for some great regulatory compliance information. First, on December 4, Senior Directors Allen Sayler and Tara Couch, Ph.D. will co-present a webinar on FSMA’s applicability to the dietary supplement industry. This will be a fantastic presentation as Allen specializes in FSMA compliance and Tara that of dietary supplement GMPs. You may remember an earlier article co-written by the two on the subject published in EASeNews.

On December 13, Priya Jambhekar, and expert on pharmaceutical submissions, will present a webinar on streamlining the Drug Master File (DMF) process. Learn what documentation is required in a DMF, and how much detail, as well as companies commonly run into during the FDA’s review of their issues.

Join Allen Sayler and EAS Independent Consultant Richard White on January 16, 2020 for a review of how Codex, or internationally harmonized standards, can enhance your company’s trade opportunities by facilitation of food and food ingredient exports. Learn just what Codex standards are and how building your food safety programs around them can ease your export practices.

Safety Data Sheets – A Requirement for Safe Manufacturing Operations

Food Quality and Safety Logo

Food Quality and Safety Magazine published an article written by EAS Independent Consultant Robert Kapp Safety Data Sheets (SDS) covering their importance and utilization in manufacturing operations. SDS, are a critical component, required by law, containing all the basic information about a chemical or product which will help to ensure the user’s safety and health all stages of its manufacture, storage, use, and disposal.

Ready to be an Expert Witness? Concerned about Dietary Supplement GMPs?

If you missed our recent webinars you are now able to view them free on-demand on the EAS website. Our Expert Witness bootcamp, presented by EAS Independent Consultant and General Counsel at Herrick Feinstein, Ronald Levine, and his colleague at Herrick, Leah Kelman, provided a great opportunity to learn what is involved in acting as an expert in legal proceedings and how to market your skills for doing so. EAS is considering a full-day training on becoming and strengthening skills necessary to be an expert witness. If you be interested in participating in an event like that please contact us.

The EAS webinar on Dietary Supplement GMP Observations and Trends presented by Independent Advisor for Quality and Compliance, Robert Fish, offered a detailed look at FDA observations and discussed trends in FDA’s focus as well as tips for compliance.

Issue of the Month Year-End Review

By Amy Scanlin, M.S.

As we began the third year of the current administration many wondered what priorities FDA would have in 2019. Without question, one of the most urgent became the challenge of identifying the cause of vaping illnesses and deaths that continue to confound the Centers for Tobacco Products. Thankfully as of this writing an initial window into a possible cause has been opened and certainly, this is an unfortunate reminder of the multitude of challenges that plague the safety of all our FDA regulated industries. With increasing globalization comes increasing demands on vigilance – placed on all of us – no matter our role, to ensure the products we produce, the methods by which they are sourced, manufactured, packaged, held and transported is done so with a laser focus on regulatory compliance. The adage of “if you see something, say something” is as crucial here as it is in any industry. We all have a role to support FDA’s commitment to safety.

The medical device industry is surely pleased with FDA’s focus on streamlining the incredible burden of bringing new products to market, particularly those that are predicated on earlier products or those that have similar safety and performance. Numerous guidance documents and draft guidance documents were released in 2019 which facilitate more innovation, strengthen security of connected devices, better define appropriate labeling and more. We look forward to the evolution of this industry and playing a supportive role as manufacturers streamline their own processes to work within FDA’s new mechanisms. To that end, EAS added a number of new regulatory consultants with medical device expertise this year who take clients through the process of clinical trials to commercialization to include operational readiness and audit preparation. We are very pleased with our medical device team and hope that if you are not already partnered with EAS as your regulatory consultant you will reach out to Bryan Coleman to learn more about our capabilities.

As you might expect, FDA released a number of food safety guidance documents this year. As the bulk of FSMA compliance dates are behind us with upcoming dates focusing primarily on smaller firms and farms, FDA is moving to an enforcement-based approach of safety. While the industry saw an increased number of recalls, in many cases those recalls were not preemptive, indicating a need to further strengthen our commitment to FSMA’s focus on prevention. Our Team FSMA, led by Senior Director for Food Consulting Services, Allen Sayler is tasked daily with food safety compliance requirements for both domestic and international clients. EAS consultants spoke at trade shows, conducted webinars and authored numerous articles on FSMA throughout the year. An easy way to access those articles, and many others is on the EAS in the News section of our website.

Of great importance to the pharmaceutical industry this year was FDA’s draft guidance which changes the submission organization that FDA will require going forward for Drug Master Files which house the CMCs for Active Pharmaceutical Ingredients (API) or a finished drug dosage form and maintain confidentiality of sensitive intellectual property, while allowing multiple pharmaceutical companies to collaborate in the development of new products. A timely EAS-hosted discussion of DMFs is scheduled December 13, 2019 when Priya Jambehkar, one of our esteemed consultants working with our pharmaceutical clients, will conduct a web-based training on the DMF process with Q&A time at the end.

While the dietary supplement industry did not receive new guidance documents this year, the Agency still had its hands full with enforcement of GMPs, as well as labeling and claims for products. Independent Advisor for Quality and Compliance Robert Fish conducted a very successful and very informative webinar on the subject in November, (found on the EAS On-Demand Webinars page) which discussed some of the more common Agency findings as well as information on strengthening manufacturing compliance. Did you know that some aspects of FSMA also apply to dietary supplements as they are a category of Food? If not, or you would like more information on compliance please join our webinar on the subject December 4, 2020.

As the year 2020 comes into focus, know that we at EAS are staying vigilant in our review and analysis of FDA requirements. Our consultants offer the proactive regulatory solutions in the best interests of EAS clients and we look forward to continuing to serve you and the industry in the coming year.

Your Food Additives May Need GRAS

As innovative food companies develop an array of products to satisfy a discerning consumer, the question of whether food additives intended for use in those products are safe for their intended uses.

According to FDA, “GRAS” is an acronym for the phrase Generally Recognized As Safe. Under sections 201(s) and 409 of the Federal Food, Drug, and Cosmetic Act (the Act), any substance that is intentionally added to food is a food additive, subject to premarket review and approval by FDA, unless the substance is generally recognized, among qualified experts, as having been adequately shown to be safe under the conditions of its intended use, or unless the use of the substance is otherwise excepted from the definition of a food additive. Product development teams must take into account the specific ingredients used and whether those ingredients are GRAS for their intended uses. Those food additives for which GRAS has not been established require a determination of safety for that ingredient through scientific procedures.

Are your food additives GRAS? EAS can help you make that determination. If you need to establish GRAS, EAS can help with the design and execution of safety studies, data organization and preparation of the dossier. Our team of toxicologists and microbiologists have assisted countless EAS clients with GRAS and we’d be glad to discuss your product and its ingredients. Contact Cathryn Sacra to ensure your product innovation meets FDA requirements.