The History of FDA's Enforcement Work

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 Office of Regulatory Affairs, which includes virtually all the field offices of FDA as well as a significant presence in headquarters, serves as the agency’s direct connection with regulated industry through its network of investigators and laboratory analysts. ORA works closely with each of the Centers and with other components of the agency to enforce the laws that protect and advance the public health.

Resource on ORA History

• A Chronology of Major Agency Reorganizations Affecting Field Operations
• FDA Law Enforcement Critical to Product Safety
• How to Become a U.S. Food and Drug Inspector
• FDA Goes Global