By Shook Of Counsel John Johnson

The U.S. Food and Drug Administration’s (FDA) regulatory requirements for food companies, including manufacturers and importers, remain largely unchanged during the COVID-19 outbreak. However, COVID-19 is disrupting plant operations and supply-chains, which companies must be mindful of as they continue to function within the regulatory requirements:

  • Food safety remains FDA’s top priority. The agency is continuing to work with companies to implement food recalls, and FDA will conduct mission critical, for-cause inspections when necessary.
  • Monitor email inboxes for a message from an FDA investigator indicating that the agency is requesting records to conduct a remote inspection. FDA has indicated that these remote inspections will start for food importers to determine their compliance with the Foreign Supplier Verification Program (FSVP).
  • Current Good Manufacturing Practices (cGMPs), Food Safety Plans, Hazard Analysis Critical Control Points (HACCP) Plans and FSVP must continue to be implemented. In doing so, companies must remember to:
    • Continue implementing their personnel hygiene and plant sanitation procedures, which may need to be modified or made more frequent. Because COVID-19 does not appear transmitted by food or food packaging, FDA does not have specific guidance on controlling for COVID-19 but instead refers companies to other resources: Centers for Disease Control and Prevention (CDC), Occupational Safety and Health Administration (OSHA) and Food and Beverage Issues Alliance.
    • Conduct a hazard analysis for changes made and, if necessary, conduct validation and verification and amend the applicable plan and supporting records. Document appropriately throughout these processes.
    • Recognize FDA’s policy acknowledging that an onsite audit of an ingredient supplier or a foreign supplier is not possible or advisable during the COVID-19 outbreak so a company may select an alternative verification activity during the crisis. If selected, a company must document its reliance on this policy and then follow the regulations for conducting the selected verification activity.
  • When selecting an alternative or temporary supplier, a company must remember to either approve the supplier according to its normal procedures or follow its program for using an unapproved supplier.
  • When conducting a hazard analysis for an alternative or temporary supplier for a food or alternative ingredients, thoroughly inspect the formulation (including sub-ingredients) against the regulations, product labels and product specification sheets. Never assume the alternative food is identical to the previous one; the alternative may contain a different ingredient that affects the food’s compliance. A company must look out for:
    • Major Food Allergens or ingredients derived from them; the Major Food Allergens are milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat and soybeans.
    • Other allergens or sensitivity ingredients, such as sulfites, Yellow No. 5 and carmine/cochineal extract.
    • Non-permitted ingredients, such as cyclamates and unapproved colorants (e.g., Ponceau 4R, Green S or lutein).

The need for safe food is a constant and is arguably even more important during the COVID-19 outbreak. It is imperative for a company to vigilantly implement the requirements to seek to avoid the need for a food recall and possibly FDA compliance activities.

About The Author

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For decades, manufacturers, distributors and retailers at every link in the food chain have come to Shook, Hardy & Bacon to partner with a legal team that understands the issues they face in today's evolving food production industry. Shook attorneys work with some of the world's largest food, beverage and agribusiness companies to establish preventative measures, conduct internal audits, develop public relations strategies, and advance tort reform initiatives.

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