EAS Enters Exciting New Expansion Phase

Dear Reader,

Welcome to the January 2020 edition of EASeNews. I am pleased to inform you that on December 10, 2019 we announced that EAS has been acquired by Certified Laboratories (CL), a leading full-service food testing laboratory servicing the food industry since 1926. Their expertise is in microbiology, chemistry, nutritional labeling, food forensics, imports, and problem solving for the food industry. (www.certified-laboratories.com). 

Certified also operates Labstat, a best in class tobacco, nicotine and vape safety laboratory based outside of Toronto (www.labstat.com) as well as Labs-Mart, a dietary supplement, vitamin, and healthy products laboratory. Labs-Mart operates in Edmonton, Vancouver, and Anaheim, California. (www.labs-mart.com).

This acquisition will allow EAS to increase the regulatory consulting services it offers, and our clients will have direct access to world class testing for its products. EAS will continue to operate as an independent company under the EAS Consulting Group name with the existing staff remaining in place. I will be available to serve as an advisor during the transition. Dean Cirotta and Brett Steele will continue their respective roles as President and Vice President of Finance, IT & Administration reporting to Mr. Steven Mitchell, former President of Certified Laboratories, who serves as the CEO for the newly combined organization. In addition, the Commodity Directors (Allen Sayler, Cathryn Sacra, Tara Couch and Bryan Coleman) will remain your points of contact.

I cannot tell you how excited I am to be a part of this new organization that includes industry leading testing facilities. While I have been looking for a way to ease into retirement after a wonderful 55-year FDA and consulting career, this has offered me the opportunity to keep the company intact, provide for future growth, and expand the services we can offer our loyal clients.  I invite you to contact me or the other members of the EAS staff to discuss how the combined companies can provide one-stop shopping for your regulatory, training and testing needs.

The introduction to the next issue of EAS-e-News will come from the Desk of the President, Dean Cirotta. While I will still be here and available, it is time to turn the keys over to Dean and Brett to carry the business on to even great heights. 

Sincerely,

Ed Steele Signature

Ed Steele
Chairman and CEO

Meet New Consultants for January 2020

Jon Anderson

Jon Anderson assists EAS clients with occupational safety standards and compliance, conducting audits and customized trainings for manufacturing plants, distribution centers and warehouses to ensure a culture of safety specific to each work environment. He provides site specific safety programs enabling compliance with best practice and Federal and State OSHA regulations. Prior to consulting Jon was the Head of OSHA Compliance & Educational Product Development at AIB International, Inc.

David Cockram, Ph.D.

David Cockram assists EAS clients in the areas of GRAS, Infant Formula and NDI study design, execution and monitoring in support of safety submissions for novel food and dietary ingredients and nutritional products. He recently retired as Senior Director of Global Regulatory Science and Innovation at Abbott Nutrition. David holds a PhD from The Ohio State University in Nutrition. He is an author or inventor of 25 scientific papers, book chapters, webinars, and patents.

Julie Litz

Julie Litz’s career as a quality director has covered Food, Dietary supplement and Animal Feed industries. She has extensive experience in setting up food safety plans for manufacturing facilities and transitioning a facility from food regulation compliance (CFR 117) to Dietary Supplement regulation compliance (CFR 111). She is HACCP certified and PCQI certified in both Human Food, and Animal Feed. In addition, she has conducted audits at foreign facilities and worked with companies on FSVP compliance. She has also conducted biotechnology research in academic and commercial settings. She has extensive knowledge in validation and verification procedures, clinical trials, IACUC requirements for animal protocols, animal experimentation and expert understanding of biotechnology techniques.

Radhika Rajagopalan

Radhika Rajagopalan works in the pharmaceutical industry and has over 23 years of experience with dosage forms’ CMC sections for both 505(j) and 505 (b2) applications. She is an expert in CMC packages including ADNAs, DMFs (Type 2 and 4), INDs, Bio-INDs, OTC ANDAs, supplemental new drug applications, novel technology approval, drugs in device as well as devices co-packaged with drugs and works with clients to facilitate complex innovator and generic drug product reviews and approvals under User Fee Programs for nanotechnology products, gels, suppositories, modified release dosage forms, parenteral, drugs in device, peptides, semi-solids, and liposomal drug products.

Meet New Regulatory Intern – Gunjan Ohri

Gunjan Ohri is a student at Georgetown University in Washington, D.C. pursuing a Masters in Biotechnology with a focus on Business. At Georgetown, Gunjan’s projects include topics such as Biotechnology Industries, marketing, intellectual properties of Biotechnology companies and financial matrices. Prior to Georgetown, Gunjan studied engineering at SRM Institute of Science and Technology in India focusing on Molecular biology, the business environment, pattern recognition, ethics and IP rights, bioprocess engineering for industries and biochemistry.

When you Need an Expert – Ask EAS!

In this month’s Ask the Expert column, we thought we’d start this new year by taking the opportunity to humbly share why we at EAS are confident that our staff and consultants offer the best expert regulatory knowledge in the industry, providing proactive and accurate solutions to your most pressing challenges.

As a demonstration of that expertise, EAS is an invited member by many trade organizations to participate in working groups, committees and a newly elected member to the prestigious FDLI Board of Directors. You already know EAS is a frequent presenter at conferences, webinars and seminars all over the world. But, did you also know that EAS is actively involved in priority initiatives and collaboration with trade groups? EAS is more than just an association member, we are also a partner – assisting, creating and fostering initiatives and opportunities that help guide the industry’s best practices for meeting FDA requirements.

Here are just some of the examples of our collaborative relationships:

Food Drug Law Institute (FDLI) – EAS President, Dean Cirotta, is on the board of directors, and Tara Couch, Ph.D., Senior Director of Dietary Supplement and Tobacco Products is on the Tobacco and Nicotine Products Committee.

EAS has three staff on the Consumer Healthcare Products Association (CHPA) dietary supplement committee including Cathryn Sacra, Director of Labeling and Cosmetic Services. Additionally, EAS serves on the Regulatory and Scientific Affairs committee.

Allen Sayler, Senior Director for Food Consulting Services is the Lead Delegate to Committee on Food Additives for Codex (join our January 16 webinar to learn more about Codex and how it can improve your food safety processes). He is also on six committees between the International Dairy Federation and the U.S. National Committee of the International Dairy Federation.

EAS also participates on the Advisory and Data Committees for the Global Retailer Manufacturer Association, the Dietary Supplement Committee for the Council for Responsible Nutrition as well as five committees for the International Association for Food Protection.

Bryan Coleman, Senior Director for Pharmaceutical and Medical Device Consulting Services is the Chairman of the Finance Committee for the Food and Drug Administration Alumni Association (FDAAA) and Allen Sayler serves as President.

As you can see, EAS is busy, not only serving our clients but also staying ahead of the curve in a rapidly changing industry. EAS is proud to be invited partners to these and other trade groups and for the role we play in ensuring industries regulated by FDA understand their responsibility for compliance.

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 Cites Multiple Violations for Selling CBD as Supplement, Food, Cosmetic or Animal Food Ingredient

By Gisela Leon, MS, MBA, Independent EAS Consultant

On November 22, FDA published 15 warning letters in a “catch all” effort regarding cannabidiol products. The products range from articles sold as dietary supplements, conventional foods, cosmetics, and animal food. FDA sent out the 15 warning letters to companies in a number of states, including California, Texas, Oklahoma, Colorado, Oregon, New York, Florida, North Carolina, Arizona, and Kentucky based on the content of websites and social media sites. This was not the first time FDA had sent warning letters regarding cannabidiol [CBD]. The first seven CBD warning letters were issued in March 2019.

In the warning letters for dietary supplement products, FDA states that CBD in products sold as dietary supplements does not meet the definition of dietary ingredients in the Federal Food, Drug, and Cosmetic Act (321(ff)(B)(i)(ii)). This provision clarifies that a dietary ingredient cannot be a substance that has been approved as an active ingredient in a drug. FDA has confirmed that CBD is an active ingredient in the approved drug Epidiolex.

FDA has also indicated that it cannot conclude CBD is generally recognized as safe (GRAS) among qualified experts for its use in human or animal food because of gaps in the safety data. Some of the data that exists has raised concerns that CBD is potentially harmful and may cause liver damage or interact with other drugs. Furthermore, studies in animals has shown that CBD may impair sexual behavior in males.

Similarly, FDA states in relevant warning letters that CBD is an unapproved new animal drug because of disease claims. The products are also adulterated animal foods because there is no animal food additive regulation that authorizes the use of CBD and there is no basis to conclude that CBD is GRAS for use in animal foods.

In addition to the lack of regulatory status for CBD as a dietary ingredient or food additive, ­­­­cosmetics, conventional foods and dietary supplements that received Warning Letters are regarded as unapproved new drugs, because of product and websites claims that CBD is intended to cure, mitigate, treat, or even prevent diseases. The manufacturers that received the warning letters cited numerous diseases for which CBD might be helpful. Some of the popular disease claims involve pain relief, anti-inflammatory, diabetes, acne, anxiety, depression and cancer. For example, one Warning Letter cites 45 diseases.

Most warning letters were signed by three FDA compliance directors from Center for Drug Evaluation and Research, Center for Veterinary Medicine and Center for Food Safety and Applied Nutrition. In some of the earlier warning letters FDA also involved FTC – Federal Trade Commission – because of unsubstantiated claims. Both agencies are concerned that some of the efficacy claims may not be substantiated by competent and reliable scientific evidence.

At present, it appears that FDA is only taking enforcement action against CBD products with disease claims. To date, FDA has not written a warning letter solely because a dietary supplement or conventional food contains CBD. These most recent warning letters could have been written to any dietary supplement making disease claims.

Trade associations have petitioned FDA to issueenforcement discretion r that would allow manufacturers to legally market dietary supplements containing CBD. Senate Majority Leader Mitch McConnell introduced language in the Senate Agriculture Appropriation bill that would require FDA to temporarily adopt an enforcement discretion policy in 120 days. The FDA would still be able to take enforcement actions against companies who make disease claims, similar to the recent warning letters.

So, what can be learned from FDA’s actions? The first and most important step for manufacturers would be to “clear” all webpages, social media pages, and third-party referrals of disease statements. As a regulatory strategy, this may buy some time until the controversy about the legality of use in foods and dietary supplements is clarified. For dietary supplements a possible alternative legal ingredient is a full spectrum hemp extract which contains all hemp components – not just isolated CBD. Hemp-derived ingredients are eligible for use as dietary ingredients by virtue of being “botanicals”. However, hemp derived substances must submit a New Dietary Ingredient notification 75-days prior to first marketing the hemp supplement. A less conservative regulatory approach for dietary supplements could be to wait and see if the Senate Agriculture Appropriations bill passes with the CBD language intact which requires FDA to adopt a temporary enforcement policy.

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.

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.

December 2019 Drug and Device Corner

Guidance Document updates on the FDA website

All divisions

  • Certificates of Confidentiality (distributed for comment purposes only) – This draft guidance describes FDA implementation of the revised provisions applicable to the request for, and issuance of, a Certificate of Confidentiality (CoC). The 21st Century Cures Act (Cures Act) (Public Law 114-255) amended the Public Health Service Act (PHS Act), section 301(d) (42 U.S.C. 241(d)) relating to the issuance of CoCs. A CoC is intended to help protect the privacy of human subject research participants from whom identifiable, sensitive information is being collected or used in furtherance of the research.
  • Bridging for Drug-Device and Biologic-Device Combination Products – This guidance provides recommendations to industry and FDA staff on how to approach bridging in new drug applications (NDAs) or biologics license applications (BLAs) for drug-device and biologic-device single entity or copackaged combination products.
  • Requesting FDA Feedback on Combination Products – The purpose of this guidance is to discuss ways in which combination product sponsors can obtain feedback from FDA on scientific and regulatory questions and to describe best practices for FDA and sponsors when interacting on these topics.

CDER

CDER & CBER

CDRH

  • Magnetic Resonance (MR) Coil – Performance Criteria for Safety and Performance Based Pathway – This draft guidance provides performance criteria for magnetic resonance (MR) coils in support of the Safety and Performance Based Pathway. Under this framework, submitters planning to submit a 510(k) using the Safety and Performance Based Pathway for MR coils will have the option to use the performance criteria proposed in this draft guidance to support substantial equivalence, rather than a direct comparison of the performance of the subject device to that of a predicate device.

CDRH & CBER

CBER

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.

You Don’t have to Wait for EAS Labeling Seminars – Buy the Book!

EAS offers our flagship Food Labeling and Dietary Supplement Labeling seminars twice yearly (next event is in April 2020 in Long Island). Those who would like assistance sooner may either bring EAS in-house to conduct tailored training specific to your products and training needs or may purchase the EAS Food Labeling handbook and Dietary Supplement Labeling handbook from the EAS Products page on our website. These handbooks, included in the registration fee for the two-day seminars, offer a wealth of information and details on FDA requirements for labeling foods and dietary supplements – and how to meet them.

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.

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.