Protecting the Public: FDA Warning Letters

The U.S. Food and Drug Administration (FDA) plays a key role in public health as it is the national agency responsible for regulating food safety, prescription and nonprescription medications, tobacco products, medical devices, biological products. radiation emitting devices, cosmetics, animal foods and feed, and veterinary products.  The FDA regulates not just the manufacture of these products, but also the marketing and distribution of these products to the public.  

When the FDA finds, through its own inspections or evidence from other sources, that a manufacturer or other entity has engaged in activity that violates federal rules, it will issue a warning letter to the offending party.  A warning letter advises the offending party of the manner in which their actions are violating federal laws or regulations and affords that party an opportunity to take voluntary corrective actions.  Offending parties who fail to take corrective actions are subject to sterner FDA enforcement actions such as a recall, seizure, injunction, administrative detention, civil money penalties and/or prosecution for their violations of federal laws.  Warning letters are not a mandated step before the FDA takes more stringent enforcement measures.  If the circumstances involve an egregious violation of the law, such as something that creates the possibility of death or injury to an individual, the FDA will forego issuing a warning letter and take sterner enforcement measures against offending parties.

While warning letters involving a major manufacturer or product might make the national or local news, the majority of warning letters involve lesser known producers or products that won't grab the headlines.  To help public awareness about violations that merit a warning letter, the FDA provides a searchable database of more than 3,100 warning letters issued since the beginning of 2015.  Users can easily drill down into search results to read the actual content of a letter and to find out more about the specific violations of an offending party.  

Since the beginning of 2015, the FDA has, on average, issued almost 47 warning letters each month.  Even with a searchable database, keeping up with that volume of activity can be problematic for consumers.  To help consumers more easily stay abreast of new warning letters, the FDA also makes available a convenient email subscription service.

To stay aware of product safety issues involving FDA regulated products, consumers are encouraged to bookmark and periodically visit the FDA Warning Letter Database and to stay atop of FDA news by signing up for their email subscription service.