By 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.

Read more food, beverage and agribusiness industry news in the Food & Beverage Litigation Update.