FDA Allows Co-Manufacturers More Time to Comply With Supply-Chain Program Requirements

In a nod to one of the more complex aspects of current food manufacturing and FSMA compliance, FDA recently published guidance that it will exercise enforcement discretion for two years over supply-chain requirements for domestic co-manufacturers of human and animal foods, and also under the Foreign Supplier Verification Program (FSVP).

The agency defines “co-manufacturing” as a contractual arrangement whereby a brand owner arranges for a co-manufacturer to manufacture or process food on its behalf. The enforcement delay will give brand owners time to develop new supplier contracts allowing them to share information on ingredient suppliers, such as audits, with their co-manufacturers.

In co-manufacturing, a supply-chain program can be implemented by the brand owner, the co-manufacturer, or both. The agency said it will not take enforcement action against a co-manufacturer that is out of compliance if supplier approval and verification activities are divided between the brand owner and the co-manufacturer.

Co-manufacturers subject to FSMA preventive control requirements and that manufacture or process a raw material or other ingredient received from a supplier are defined as “receiving facilities” under 21 CFR Parts 117 and 507. Receiving facilities that find a hazard in a raw material or ingredients requiring an applied control are required to approve their suppliers for those raw materials or ingredients. But the supply-chain provisions allow an entity other than the receiving facility — such as the brand owner — to conduct supplier verification activities, provided the receiving facility documents its review and assessment of the other entity’s documentation.

When contract prevents a co-manufacturer from being able to review a brand owner’s documentation of supplier verification activities, the co-manufacturer would not be able to verify suppliers based on a review of the brand owner’s documentation. In this situation, the co-manufacturer would need to conduct its own supplier verification activities that might otherwise not be required. The net result would be unnecessary costs to both the co-manufacturer and supplier. If the brand-owner’s supplier approval process is adequate, the co-manufacturers verification activities would not add any greater assurance of safe human or animal food.

In its Guidance for Industry: Supply-Chain Program Requirements and Co-Manufacturer Supplier Approval and Verification for Human Food and Animal Food, the agency said it will not take enforcement action if:

  • A brand owner conducts supplier approval activities;
  • The co-manufacturer describes these activities in its food safety plan; and
  • The co-manufacturer conducts any necessary supplier approval activities not conducted by the brand owner.

Similarly, the agency will not take enforcement action if:

  • A brand owner determines and/or conducts supplier verification activities for its co-manufacturer;
  • The co-manufacturer describes these activities in its food safety plan; and
  • The co-manufacturer conducts any necessary supplier verification activities not conducted by the brand owner — for example, sampling and testing of the raw material or other ingredient.

The agency said it was exercising enforcement discretion “because the guidance represents a less burdensome policy consistent with the public health,” and is immediately in effect. Implicit in all FDA guidance is that the agency has the authority to take an enforcement action under other regulations should it become necessary to protect public health.

Brand owners and co-manufacturers have until November 6, 2019 to be in compliance with supply chain and FSVP requirements.

Our Year in Review

As 2017 draws to a close, it is appropriate to reflect on a year full of change, important milestones and growth not only at FDA but also here at EAS Consulting Group. Both organizations saw new staffing and new initiatives. With the inauguration of President Trump, FDA saw a changing political dynamic with new enforcement policies, and guidance documents; and on the EAS front, new staffing, partnerships and initiatives were aimed at helping the industry conduct efficient, safe and compliant business in order to meet FDA requirements.

Here are some highlights from 2017 which we think best demonstrate the commitment of both FDA and EAS to better the greater good.

On the FDA front:

Most significantly for FDA, Scott Gottlieb was confirmed as the new Commissioner. Under his guidance a number of initiatives are underway in all regulated industries, with some specific highlights in pharma, medical device and food mentioned here.

In the area of pharmaceuticals, the compliance date for Drug Master File electronic submissions was extended until May 5, 2018, giving a bit more time for the industry to get a handle on this complicated process. EAS, which has long assisted pharma manufacturers in technical review of stability data and assembling applications and reports added the additional service of electronic filing preparation and submission over two years ago in anticipation of FDA’s move to this requirement. Those firms who have not already updated their processes to e-CTDs, as they are commonly called, should be fully engaged in doing so now.

The Class II Medical Device industry had a reprieve in July when FDA published a sizable list of class II medical device products that no longer require premarket notification under section 510(k) of the FD&C Act (21 U.S.C. 360(k)), to provide reasonable assurance of safety and effectiveness, subject to certain limitations. Medical device 510(k) filings are a laborious process with many confusing elements. Readers may wish to refer to our August 2017 EAS-e-News issue of the month article, where Independent Consultant Joe Ouellette, discussed some ways to simplify the process. If your company requires 510(k) filling assistance, EAS has many medical device experts who can help with these requirements.

The U.S. Agent verification for medical device facilities process saw a change in October whereby U.S. Agents must now confirm with FDA their consent to act in that role. EAS provides U.S. agent services to countless foreign clients. This is not only an FDA requirement, EAS prides itself on providing comprehensive services in this area with open and free flowing communication between the client and FDA as well as answering questions on various FDA matters which can be confusing. In EAS, foreign firms have a dedicated liaison with the agency.

On the Food Safety Modernization Act front, new enforcement requirement deadlines continued to move forward. May 30 was the deadline for food importers to notify FDA whether their products are subject to FSVP regulations. Our Independent Advisor for FSMA, Charles Breen, writes a monthly column on the latest requirements for EAS-e-News, called FSMA Perspective and we have offered numerous webinars on the various requirements, free replaysof which can be found on our website. You may also be interested in our handy digital FSMA Pocket Guide, downloadable and searchable for easy reference on the go.

A significant change for food manufacturers was a 1.5-year extension of compliance dates for new requirements for updated nutrition information on food labels, including dietary supplements. Public comments were requested through November 1, 2017 on various considerations such as the definition of a single-serving container; a dual-column labeling for certain containers; reference amounts customarily consumed (RACCs); and amending the label serving size for breath mints. Even with this extension, EAS saw record numbers at our recently held Food Labeling Compliance Seminar and continues to provide in-house trainings on the subject as well – an indication that the industry at-large is preparing for compliance in advance of FDA’s deadlines.

On the EAS front:

EAS has seen fantastic growth in the past year. With new regulations and requirements set forth by the agency, novel technologies and products requiring the design and review of stability studies, toxicology, data review and statistical analysis prior to highly technical application submissions, FDA regulated industries have sought our support in meeting these requirements. Through outsourcing expertise to firms such as ours, companies are able to enhance their technical capabilities in a cost effective manner.

To meet these demands, EAS gained two new director level positions, welcoming Allen Sayler as Senior Director, Food and Cosmetics Consulting Services in January. His addition to EAS senior management greatly increased our competencies into the dairy industries. Tara Lin Couch, Ph.D., became Senior Director Dietary Supplement and Tobacco Services in August. Tara’s expertise in the dietary supplement industry has been well known to our clients since 2012 when she first joined EAS as an Independent Consultant. She was appointed to the position of Independent Advisor for Dietary Supplements in 2015. Timothy Stewart, Ph.D. accepted the role of Independent Advisor for Dietary Supplements in October. EAS also added 33 new Independent Consultants, accomplished experts in their fields who have hit the ground running in support of our clients and training initiatives.

We also expanded our partnerships through a relationship with Almater Food Technologists based in Italy. This unique collaboration will enhance the ability of EAS clients who seek assistance in exporting foods into the EU as well as Almater’s clients who seek additional assistance with FDA compliance.

Our Product Development and Labeling Strategic Services initiative, started in 2016, saw huge growth as companies continue to seek advice on how to position their products and guidance on the proper use of various claims such as “healthy”, “natural” and GMO labeling. The success in this area has led to the creation of additional specialized teams of independent consultants who can address client needs requiring multiple areas of expertise.

EAS greatly increased our training capabilities in 2017. Our Food Labeling Compliance seminar was awarded 16 CEUs by the prestigious Commission on Dietetic Registration, lending further credence to the quality of our long running program, and providing an additional service to those participants who seek continuing education credits. We are proud that a number of our Independent Consultants are Lead Instructors for Preventive Controls for Human Foods (PCHF) under the Illinois Institute of Food Technology’s Food Safety Preventive Controls Alliance, and for the Foreign Supplier Verification Program (FSVP) under the International Food Protection Training Institute. EAS also became a training center for the Safe Quality Foods (SQF) 8.0 and Quality courses under the Safe Quality Foods Institute. Finally, Allen Sayler’s popular Dairy Processing 101 three-day seminar has become a new fixture in the EAS training center.

Finally, EAS was honored to be invited presenters at over 30 trade organization conferences and tradeshows and webinars for outside organizations. From the Institute of Food Technologists (IFT), Food Drug Law Institute (FDLI) Consumer Healthcare Products Association (CHPA), National Customs Brokers and Forwarders Association of American (NCBFAA) and the Safe Quality Foods (SQF) our Independent Consultants and home office staff are well recognized and sought-after experts in their areas.

As we look towards 2018 we are anticipating more movement by FDA in areas such as tobacco as the agency seeks input on its new initiative of pursuing lower nicotine levels in cigarettes to non-addictive levels and create more predictability in tobacco regulation. EAS is one of very few consulting firms to offer comprehensive services to the tobacco industry and we take an active role in the trade organization the Tobacco Manufacturers Association.

As always, EAS stands at the forefront of tracking industry regulations and applying those requirements in a practical and meaningful way for clients. We take great pride in our expertise and ability to provide quality regulatory assistance. We welcome your inquiries as to how EAS may help your business and above all wish you a happy and prosperous 2018.