FDA Warning Letters about Products (2018)

September 23, 2019

The U.S. Food and Drug Administration (FDA) regulates the labeling and sale of foods, drugs, cosmetics, biologicals, and medical devices in interstate commerce. All drugs and devices must be labeled with adequate directions for all intended uses. Labeling includes any written, printed or graphic material that accompanies a product. Intended use is determined by the facts at hand. Products not generally recognized as safe and effective by experts are considered “new.” Improper labeling is called misbranding. Marketing a “new” or misbranded drug or device in interstate commerce is a federal crime. Marketing without adequate directions for use is also a federal crime.

When products are marketed improperly, the FDA may issue a warning letter specifying the violations and demanding to know how the problem will be corrected. If a warning is ignored, or if the FDA decides to begin with more forceful action, the agency can initiate court proceedings for a seizure, injunction, or criminal prosecution. Marketers of legitimate products usually correct the problems immediately. Marketers of quack products vary. Some comply, but many stall, attempt to obfuscate, and/or continue to do as much as they think they can get away with.

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

This page was posted on September 23, 2019.