CRN’s New FDA Warning Letters Database Helps Industry Self-Police


Companies can reference warning letters to learn what not to do, the association says.

FDA warning letters sent to dietary supplement firms are now compiled and searchable in a new, free online database from the Council for Responsible Nutrition (CRN; Washington, DC). Companies can reference warning letters to learn what not to do, the association says.

“Our goal is to help companies in the supplement industry better understand the types of transgressions that will trigger a Warning Letter from FDA, so that all companies can learn from others’ mistakes and identify priorities in FDA enforcement, thereby raising the level of compliance with the law,” said CRN president and CEO Steve Mister in a press release.

Warning letters in the database include those related to good manufacturing practices (GMP) violations; impermissible product claims, such as disease claims; and products containing illegal ingredients. Using the CRN database, companies can search warning letters by date, product name, ingredient, type of violation, and other criteria. So far, the database includes nearly 300 warning letters sent by FDA between January 2008 and August 2014.

FDA allows companies 15 days to respond to a warning letter. Once violations are resolved, FDA issues a closeout letter. While the agency doesn’t always make closeout letters public, CRN’s database lists closeout letters that have been publicly posted.

“While all Warning Letters are serious in their indication that a regulation has been violated, not all Warning Letters are considered equal,” Mister said. “If you look at the three main categories that these letters cover, the most egregious-and the one that consumers should pay special attention to-are the warning letters that address products that are marketed as dietary supplements, when in fact, they contain undeclared drug ingredients.”

FDA does not always issue warning letters for adulterated products; sometimes, the agency will instead issue consumer advisories or seize products. As such, Mister suggested that consumers also check the American Herbal Products Association’s Keep Supplements Clean website, which lists public notices of tainted products.


Jennifer Grebow
Nutritional Outlook magazine



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