FDA Actions to Stop Medication Health Fraud
Medication health fraud presents serious risks to the well-being of individuals and the public. The FDA employs a multi-faceted approach to protect public health. Key strategies and activities involved include:
- The FDA actively monitors the marketplace for medication health fraud products offered for sale that may be in violation of the law.
- The Center for Drug Evaluation reviews reports from sources such as the FDA Adverse Event Reporting System (FAERS), the Center for Food Safety and Applied Nutrition (CFSAN) Adverse Event Reporting System (CAERS), poison centers, medical literature, and consumer complaints.
- The agency also monitors products offered for sale online. FDA actively searches for new concerns with potentially unsafe medication health fraud products marketed with unproven, false, or misleading claims about their products’ ability to diagnose, cure, mitigate, treat, or prevent diseases.
- The FDA conducts product testing to identify hidden drug ingredients and can collect samples from retail or online sellers, manufacturers, imported shipments.
- The FDA provides education to consumers about medication health fraud topics and how to identify products that are potentially unlawfully sold. We maintain a health fraud database of over 1,000 various products. However, this includes only a small fraction of the potentially hazardous products marketed to consumers.
- The agency notifies the public of safety concerns using email notifications, consumer updates, immediate public notifications, and alerts from the Center for Drug Evaluation and Research (CDER).
- FDA provides information on buying medicines safely online, including tips for identifying reputable online pharmacies.
- The FDA takes action when we identify violations of the law. The agency has the authority to issue warning letters, seize products, obtain injunctions, and refer cases to the FDA's Office of Criminal Investigations for additional follow-up. Anyone can report suspected criminal activity to FDA.
- Import alerts inform the FDA's field staff and the public that the agency has enough evidence to detain imported products that appear to be in violation of the law.
- A drug recall is the most effective way to protect the public from a defective or potentially harmful product. A recall is a voluntary action taken by a company to remove a defective drug product from the market.
- Warning letters can be sent to advise companies about violations of regulatory significance. Failure to address these violations may lead to further enforcement actions such as seizure, injunction, or criminal investigation.
- The FDA collaborates with other government agencies, industry partners, and international organizations to share information and coordinate efforts.
- Partnerships with U.S. Customs and Border Protection (CBP) enhance inspection and detection capabilities to prevent potentially harmful products from entering the U.S. through international mail facilities and ports of entry.
- The FDA works jointly with the Federal Trade Commission (FTC) to issue warning letters on various topics related to fraudulent claims.
- Collaboration with the Drug Enforcement Administration (DEA) involves joint warning letters regarding controlled substances.
- The FDA engages in partnerships with foreign governments, regulatory coalitions, and other stakeholders to ensure the safety of drug products entering the U.S.
- FDA and the Commerce Department collaborated on a pilot program with domain name registries which resulted in nearly 30 websites illegally offering opioids for sale becoming inaccessible to the public.
- Additionally, FDA hosts the Online Controlled Substance Summits where we engage with stakeholders from the public and private sector to reduce the illegal availability of controlled substances online.
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