A Series for FDA-Regulated Food Industry - Part 1: The Big Picture

Footnotes for this article are available at the end of this page.

An old adage is that an “ounce of prevention is worth a pound of cure.” Perhaps no setting is a more appropriate example of this than a company whose business centers on food products regulated by the Federal Food and Drug Administration. Prevention and resolution of FDA-related regulatory compliance issues is the first step in mitigating or altogether preventing FDA enforcement actions. A sound regulatory compliance strategy is usually one that is based on individual products the company places into commerce, and takes into consideration the relative roles of both the company and those of its partners in the manufacturing and production chain.

Depending on the specific type of food and the role a company plays in bringing it to market, establishing and maintaining compliance with the Federal Food, Drug, and Cosmetic Act (the “FD&C Act”) and the regulations administered by the FDA can be a relatively simple and quick matter, or it can be complicated and continue to evolve over the lifecycle of the products marketed. A good overall approach to achieve compliance with FDA regulations is to ensure that the company’s culture is one that emphasizes safety and proactively takes measures to put into place appropriate processes and procedures, including Good Manufacturing Practices, Hazard Analyses, and Risk-Based Preventive Controls for Human Food regulation, prior to an FDA inspection or enforcement action.

An Enforcement Example

In March 2021, FDA sent a Warning Letter to a food manufacturer based on the misbranding provision of the FD&C Act, which prohibits a food that is misbranded from introduction or delivery for introduction into interstate commerce.1  FDA found that the finished product labels did not declare the major food allergens included in the food product, i.e., pecans and milk. According to the Warning Letter, the products were mislabeled because, in one instance, a supervisor placed the wrong roll of labels on the labeling machine, resulting in the use of an incorrect bottom label and ingredients statement. In another instance, a line worker placed the wrong label on one side of the labeling machine. Both of these actions, which likely could have been prevented with appropriate processes and surveillance, created hazards to public safety and constituted violations of the FD&C Act. The letter serves as a good example of the types of violations that might be prevented by a culture of safety.

AGG Observations

  • FDA statutory and regulatory requirements vary depending on the type of risk-based quality controls mentioned above, the type of food the company will market, and the FDA’s approach to ensuring such compliance.
  • Companies should work towards implementing a culture of safety and compliance by reviewing existing procedures and processes and identifying areas of non-compliance with FDA regulations.
  • Companies should also implement robust monitoring and surveillance activities to ensure employees and other personnel comply with company procedures and processes.
  • Consider if products are regulated by regulatory bodies outside of the FDA, including the U.S. Department of Agriculture, Federal Trade Commission, and more.

For questions, please contact Robert Durkin.


[1] The Warning Letter is available here; 21 U.S.C. § 331.