FDA Warning Letters about Products (2009)

The U.S. Food and Drug Administration (FDA) regulates the labeling and sale of foods, drugs, cosmetics, biologicals, and medical devices in interstate commerce. A warning letter is a serious notice to that a marketer appears to be violating federal law and may be subject to enforcement action if the apparent violation continues. Enforcement actions include seizure of goods, injunctions, criminal prosecutions, fines, and imprisonment.

Most sellers do what the FDA requests. In some cases, the product must be removed from the marketplace. In others, marketing can continue as long as the claims to which the FDA objected are stopped.

If the FDA determines that corrective action has been taken, the office that issued the warning letter may issue a close-out letter. This procedure applies to warnings issued on or after September 1, 2009. The corrective actions must actually have been made and verified—usually, by a follow-up inspection. If the warning letter contains violations that by their nature are not correctable, no close-out letter will issue. Should violations be observed later, enforcement action may be taken without further notice.

Regardless of the outcome, it is wise for consumers to assume that the product is problematic and should be avoided.

Between May and December 2009, the FDA sent warning letters to the following online sellers of products falsely claiming to diagnose, mitigate, prevent, treat, or cure the 2009 H1N1 flu virus:

This page was revised on July 19, 2011.

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