Responding to FDA Warning Letters

FDA established the practice of sending warning letters to companies about 40 years ago as a way of giving those observed to be violating the law a final chance to come into compliance. Presently, in the supplement industry, warning letters mainly take two formsto those whose responses to FDA cGMP (current good manufacturing practice) inspectional observations are deemed inadequate (e.g., Vianda)  and to those who have not been inspected, but are found to be making serious disease claims for products (e.g., 7 Seas LLC).

A warning letter recipient has 15 working days to respond to FDA and should include the specific steps that you are taking correct these violations." If a company needs more time to correct, it must explain the delay and when it will come into compliance.

FDA issuing a warning letter is serious. It means FDA is prepared to go to court to enforce if the warning letter is ignored. We know FDA means business with warning letters because the press releases for all of the FDA cGMP injunctions and consent decrees have noted that the company was previously warned and was then not found to have come into compliance.

The supplement industry is, in the main, populated with optimists and because of this, a common mistake by those receiving warning letters regarding claims is to correct the claims in the letter and then relax. Read the fine print in the warning letter:This letter is not meant to be an all-inclusive list of violations at your facility or that may exist in any of your product labeling." So, those who correct only what FDA has noted should not be surprised when FDA reappears, often after another review of its website. The same applies to cGMP warning letters. Compliance must be complete, not simply with respect to the items noted.

A warning letter deserves compliance with its terms and with its general message. Expect to have FDA check on compliance within the next year by inspection or website review for claims. Failure to achieve compliance on the next round of inspections could lead to an FDA request that the company sign a consent decree to be filed in U.S. District Court or to a seizure of misbranded products.  

As this article was being written, FDA escalated the tone of its warning in the letter cited above to Vianda, a dietary supplement distributor. In this letter, FDA asserted the strict personal criminal liability nature of violations of the Federal Food, Drug, and Cosmetic Act (FDCA), citing United States v. Park, 421 U.S. 658, 672 (1975), which holds that a party doesn't have to be aware of a wrongdoing to be criminally liable. The act also decrees that responsible agents must devise whatever measures are necessary to ensure compliance with the act or else they will be held accountable for violations. In particular, the act prohibits a person from introducing or delivering for introduction, or causing the delivery or introduction, into interstate commerce a dietary supplement that is adulterated under section 402(g) for failure to comply with dietary supplement CGMP requirements (see 21 U.S.C. §§ 342(g), 331(a)).

This lawyer has been reading warning letters since they became easily available electronically about 22 years ago. Searching through the databases, including FDA and others that go back even earlier, it appears FDA has never before cited the Supreme Courts strict criminal liability decisions. While there are defenses available, especially for those executives relying on contract manufacturers, the rhetoric in this warning letter sends a clear message to those receiving warningscome into compliance promptly or face the consequences.

Anthony L. Young has more than three decades of experience in food and drug law. He is a partner at Kleinfeld, Kaplan and Becker LLP.