About FDA

Enforcement

The 1906 Pure Food and Drugs Act only authorized two methods of enforcement to remove violative products from the market:  seizure and criminal prosecution.  Over the years, legal reforms have broadened the FDA's enforcement powers to include injunctions, warning letters, and administrative procedures. 

Throughout its existence, the FDA has also pursued efforts to work with industry to achieve voluntary compliance in order to prevent violative products from being marketed in the first place.  Such efforts have included the review of proposed labeling, creating guidance to industry, disseminating educational materials and implementing voluntary certification programs.

The articles below offer further information on the evolution of FDA's enforcement practices.

Page Last Updated: 02/01/2018
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