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  1. Enforcement Activities | FDA

Over-the-Counter (OTC) Drugs Branch: About Us

As part of the Office of Compliance, the Over-the-Counter (OTC) Drug Team strives to minimize risk to consumers from OTC drug products that are not generally recognized as safe and effective. We do this by monitoring the market and through the timely and efficient removal of violative OTC drug products. 

We rely on both scientific and legal expertise to carry out our duties, which include: 

  • Providing responses to inquiries from industry, other federal, state and local agencies, members of Congress, associations/organizations, and consumer groups regarding the regulatory status of OTC drugs
  • Developing policies based on experience with ongoing and emerging regulatory, political, and social issues
  • Directing district offices by providing detailed instructions and guidance in obtaining important evidence to support enforcement actions
  • Continuously evaluating product ingredients and labeling to determine if they meet scientific and legal standards
  • Identifying and evaluating problems related to the OTC drug industry and initiate solutions to address these problems
  • Knowledge of technological and marketing innovations and trends within the OTC drug industry
  • Assuring the safety and efficacy of OTC drugs, we may take the following actions: Warning letters, untitled letters, regulatory meetings, inspection requests, recommendation for a voluntary recall, seizures, injunctions, and/or criminal sanctions.  
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