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!

What Does the 2018 Farm Bill Say About Sugar, Honey, and Agave?

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.

If you’d like to ask a question of our experts, contact us here. To learn more information on our Food and Dietary Supplement Labeling Seminars please visit our webpage.

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 g added sugars” line may be omitted from the Nutrition Facts and replaced by a “Not a significant source of added sugars” footnote. The term added sugar includes both sugars that are added during the processing of foods, and sugars packaged as such; e.g., a bag of sugar or a bottle of honey would need to declare its entire sugar content as added sugar. Including the single ingredient sources of sugar as added sugar was unpopular and confusing. FDA’s rationale was that when you purchase a bag of sugar, you are going to use it to add to food, so its use is as added sugar. In the past year FDA attempted to make the added sugar declaration more palatable for producers of products like honey and maple syrup by allowing for an enforcement discretion option of footnoting the added sugars declaration with a statement such as “†All these sugars are naturally occurring in honey.” The footnote option was not enough to sugar-coat the “Includes X g added sugars” requirement in some segments of the food industry. Though your product no longer has to declare added sugar, it still needs to comply with all other requirements for Nutrition Facts. 

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 g added sugars” declaration in its Nutrition Facts. The Farm Bill is an omnibus bill that directs agriculture and nutrition policies; it gets renewed at 5-year intervals. The 2018 Farm Bill covers the years 2019-2023. Provisions of the 2018 Farm Bill go into effect January 1, 2019.

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!

2019 February From the Desk of the Chairman

Dear Reader,

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 regulatory industries. This month we discuss Slack Fill. Did you know this is a growing area of litigation for food manufacturers? The many regulations surrounding slack fill are confusing at best and EAS is here to help if this issue is one that your firm faces.

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.

Sincerely,

Ed Steele
Chairman and CEO

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.

Meet New Consultant for February 2019

Ronald J. Levine

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.

Ron Levine

Slack Fill – EAS Experts are Here to Help

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 is not found on the FDA website, and moreover, it is very difficult to predict how a consumer attorney will interpret them as they attempt to bring suits against the industry.

If you are one of the many who have questions concerning how to find, understand, interpret and implement policies and practices regarding slack fill, call EAS’ team of experts who can assist in navigating this very complicated and confusing issue. 

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!

January 2019 Drug and Device Corner

With the Federal Register (FR) publication unavailable, the FDA has published Safety and Performance-Based Pathway on the Guidance Document webpage. Full details will be available in the Federal Register once that site is again functioning. The existing Docket Number for this document is 

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.

Guidance Document updates on the FDA website

CDER

ANDA Submissions – Amendments and Requests for Final Approval to Tentatively Approved ANDAs

CDER & CBER

Rare Diseases: Common Issues in Drug Development

Labeling for Human Prescription Drug and Biological Products Approved Under the Accelerated Approval Regulatory Pathway

Immunogenicity Testing of Therapeutic Protein Products —Developing and Validating Assays for Anti-Drug Antibody Detection

REMS Assessment: Planning and Reporting

CDRH

Coordinated Development of Antimicrobial Drugs and Antimicrobial Susceptibility Test Devices

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.

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.

Qualified Individual and Preventive Controls Qualified Individual – What’s the Difference?

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 PCQI

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. 

FSVP’s QI

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.

More Like This?

EAS offers a wealth of additional learning opportunities on FSMA and FSVP. Check out the On-Demand Webinars page under Resources of our website for more topics like this including:

  • FSVP – What Does it Mean for your Business? – Presented by Charles Breen and Susan Moyers, Ph.D.
  • FSVP – What Does it Mean for your Business? – Presented in Spanish, Gustavo Gonzales, Ph.D.

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


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!

Drug and Device January 2019

Guidance Document updates on the FDA website

All centers:

Developing and Labeling In vitro Companion Diagnostic Devices for a Specific Group or Class of Oncology Therapeutic Products

CDER:

Noncirrhotic Nonalcoholic Steatohepatitis With Liver Fibrosis:  Developing Drugs for Treatment

Post-Complete Response Letter Meetings Between FDA and ANDA Applicants

Current Good Manufacturing Practice—Guidance for Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act

CDER & CBER:

New and Revised Draft Q&As on Biosimilar Development and the BPCI Act (Revision 2)

Questions and Answers on Biosimilar Development and the BPCI Act

The “Deemed to be a License” Provision of the BPCI Act Questions and Answers Guidance for Industry

Interpretation of the “Deemed to be a License” Provision of the Biologics Price Competition and Innovation Act of 2009

Biomarker Qualification: Evidentiary Framework

Data Integrity and Compliance With Drug CGMP Questions and Answers

Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics

Developing and Submitting Proposed Draft Guidance Relating to Patient Experience Data

CDRH & CBER:

User Fees and Refunds for Premarket Approval Applications and Device Biologics License Applications

CDRH:

Recommendations for Dual 510(k) and CLIA Waiver by Application Studies

Select Updates for Recommendations Select Updates for Recommendations Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices

Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use

Blood Glucose Monitoring Test Systems for Prescription Point-of-Care Use

Clarification of Radiation Control Regulations For Manufacturers of Diagnostic X-Ray Equipment

Breakthrough Devices Program

CBER:

Bacterial Risk Control Strategies for Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion

Labeling of Red Blood Cell Units with Historical Antigen Typing Results

CVM:

Studies to Evaluate the Metabolism and Residue Kinetics of Veterinary Drugs in Food-Producing Species: Study Design Recommendations for Residue Studies in Honey for Establishing MRLs and Withdrawal Periods

FDA De-Listing of Synthetic Flavors

Steve Armstrong

Q: FDA’s recent announcement delisting seven synthetic flavors caused a flurry of conversation and some confusion within the flavor and extract world. Would you clarify?

Armstrong: Thank you for the question and the opportunity to clear up confusion on FDA’s October 8, 2018 Constituent Update on the removal or delisting of seven synthetic flavors from the list of approved food additives. FDA was clearly reluctant to take this action, but it did so because several activist groups had petitioned for the delisting and then went to court to force FDA to take the action.

FDA made clear in its announcement in the Federal Register that it was only de-listing the synthetic form of these substances, which are labeled as “artificial flavors.” This means that a flavor manufacturer need only remove these synthetic substances from its flavor portfolio. These include synthetically-derived benzophenone, ethyl acrylate, eugenyl methyl ether (methyl eugenol), myrcene, pulegone, and pyridine. In addition, the FDA also is amending the food additive regulations to no longer provide for benzophenone’s use as a plasticizer in rubber articles intended for repeated use in contact with food.

In the Federal Register notice published on October 9, 2018 the agency said its revocation of the approvals “does not affect the legal status of foods containing natural counterparts or non-synthetic flavoring substances extracted from food.” FDA noted that each of the seven synthetic substances has a natural counterpart in food or in natural substances used to flavor foods. For example, they say, “benzophenone is present in grapes, ethyl acrylate is present in pineapple, eugenyl methyl ether (methyl eugenol) is present in basil, myrcene is present in citrus fruit, pulegone is present in peppermint, and pyridine is present in coffee.”

According to the Federal Register notice and the communication on FDA’s website, companies may continue to use the seven flavors provided they are only made from the natural extracts and are labeled as “natural flavors.” Companies using these synthetic flavors have 24 months from the publication of the rule in the Federal Register to identify suitable replacement ingredients and reformulate their food products.

This is an unusual situation and one precipitated by the Delaney Clause, an antiquated section of the Food, Drug, and Cosmetic Act. That section of the law prohibits FDA from approving a food additive if, after appropriate testing, it is found that the additive induces cancer in humans or animals. The clause is absolute. It does not provide FDA any leeway for applying a scientific risk assessment, even in situations where, as in the present case, the usage levels of an additive are low and inherently self-limiting, meaning exposures well below any area where they could possibly present any cancer risk. However, the petitioners had submitted data showing high levels of these synthetic substances did induce cancer in lab animals.

So, even though FDA had no concerns about either the synthetic or natural versions of these seven flavors, which had been used for decades, with no concerns about their safety as presently used in foods, the Delaney Clause required that the agency, as a legal matter, take the action requested by the petitioners. Six of the seven were delisted in response to these citizen petitions; the seventh (Styrene) was delisted because it is no longer in use. The agency clearly did not like having to take his step, but the Delaney Clause gave it no choice. The decision to de-list, it said, was required as a legal matter, not a scientific one. It’s possible that this action may signal an effort by the flavor and extract industry to modify the Delaney Clause.

2019 Produce Compliance Dates for FSMA

January 28, 2019, marks the compliance date for four categories of produce growers:

  • Sprouts from Very Small Farms (with certain exemptions), 
  • Sprouts from Very Small Farms eligible for a qualified exemption to comply with other requirements in 112.6 and 112.7, 
  • Other small farms, (except those with certain water requirements), and 
  • Small Farms eligible for a qualified exemption to comply with other requirements in 112.6 and 112.7

must come into compliance.

FSMA’s Final Rule on Produce Safety, Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption, and FDA’s helpful Small Entity Compliance Guide concerning determination of business size (based on annual monetary value of the food farms sell directly to qualified end users) are two important resources for farms growing and harvesting produce for consumption without further processing.

Recent foodborne illness outbreaks from romaine lettuce illustrate why it is prudent to take a fresh look at some specific areas where the introduction and harboring of pathogens can wreak havoc and cause devastating public health and economic consequences.

FDA’s recently announced that the list of possible growing areas identified as the source of the E. coli outbreak in romaine lettuce has been narrowed to three California counties, and one farm in particular. However, FDA concedes that this does not explain all of the illnesses. As of December 13, 2018, traceback information from five restaurants in four states have identified 11 different distributors, nine different growers, and eight different farms as potential sources of the contaminated lettuce, so it is likely that the outbreak cannot be explained by a single farm, grower, harvester, or distributor. FDA continues to investigate.

It’s also not only E. coli causing produce industry woes. Listeria monocytogenes prompted recent recalls of pre-packaged salad products and asparagus, as did a summer outbreak of Cyclospora in melons and lettuce. 

Why are these events continuing to happen? FSMA’s many requirements were designed to prevent just such occurrences. Are growers not complying with the regulations because they are too difficult to understand, or too difficult to follow? Or are these outbreaks examples of Murphy’s law, that no matter the risk mitigation strategy, if something can go wrong, it will?

The answer, in my view, is yes to all three – and I’ll add that sometimes downstream consequences are not fully understood until it is too late. 

Take for instance, this past summer’s E. coli outbreak in romaine lettuce. The fact that after so many months FDA still cannot pinpoint the exact source of the outbreak suggests these companies and areas under investigation appear (at least on the surface) to be largely in compliance. As of this writing, Whole Genome Sequencing testing has identified only one result where an agricultural water reservoir sediment contains the same E. coli O157:H7 strand implicated in the outbreak. However, the agency says it isn’t clear how the water became contaminated and that additional illnesses demonstrate that this reservoir cannot be the only cause of such a widespread outbreak. 

As compliance dates for various sized produce and sprout farms arrive, FDA will continue to transition from an educational to a regulatory approach for FSMA and supplier enforcement. Prudent companies will take a step back and review their supplier, manufacturing, agricultural and transportation protocols to ensure that all conceivable entry points for microbiological, chemical and physical hazards are controlled, and, when problems do occur, quickly testing entry points to identify and reduce impacts.

Just because something hasn’t yet happened at your facility doesn’t mean it won’t, and don’t assume that just because something happens at one of your suppliers or distributors, that your company won’t see negative repercussions. Food safety is everyone’s business.

EAS stands ready to help you with all aspects of FSMA compliance. Contact us or more information end-users and we invite you to view our many industry information sheets to learn more about our services with regards to foods, FSMA and other FDA requirements for all product areas.

Meet New Consultants

Timothy Morck, Ph.D.

Timothy Morck provides expertise in nutrition-related research, product development, regulatory and public policy and global scientific affairs. Dr. Morck’s career includes clinical nutrition practice, research, and medical school faculty appointments, scientific association management, entrepreneurial personalized nutrition start-ups, and executive and senior management positions at several global food, nutrition and pharmaceutical companies including The Dannon Company, Mead Johnson Nutritionals, Abbott Nutrition, Nestle Health Science and Nestle Corporate Affairs. The interplay between the legal, scientific, and regulatory framework surrounding medical foods has been a particularly sharp focus for him. He received a B.S. in animal science from Penn State University, followed by MS and Ph.D. degrees in nutrition (biochemistry & physiology minors) from Cornell University.

Paula Trumbo, Ph.D.

Paula Trumbo works with clients on food and dietary supplement labeling, claims, and other nutrition related issues for compliance with FDA regulations. Prior to consulting, she led FDA’s Nutrition Science Review Team responsible for the pre-market review of the scientific evidence for food labeling, including health claims, meeting the definition of dietary fiber, and amendments to the Nutrition and Supplement Fact label. She was the US delegate to the Codex Committee on Nutrition and Foods for Special Dietary Uses. Prior to joining the FDA, Dr. Trumbo served as Study Director for a number of study panels at the Institute of Medicine’s Food and Nutrition Board and was Associate Professor of nutrition at Purdue University. Dr. Trumbo has a PhD in biochemistry with minor in nutrition.