The United States Food and Drug Administration (FDA) has warned it will take swift action against companies that mass-market unapproved “copycat” drugs by promoting them as if they were similar to FDA-approved products, the agency’s commissioner said. The move comes amid growing concern over safety, efficacy and consumer protection as certain telehealth providers and pharmacies offer cheaper, non-approved alternatives to branded medications.

FDA Commissioner Marty Makary said the regulator cannot verify the quality, safety or effectiveness of drugs that have not undergone the agency’s rigorous approval process, underscoring the risks posed by unapproved versions of prescription medicines. His comments follow the recent launch of a low-cost compounded version of a popular weight-loss drug by an online telehealth company, which has drawn regulatory scrutiny and market backlash.

The FDA’s position highlights longstanding issues with compounded or copycat products that have not been reviewed or authorised by the agency. Without formal approval and clinical testing, such products may not meet required safety and quality standards, creating potential hazards for patients and undermining the integrity of the U.S. drug approval system.

Officials noted that they will pursue enforcement actions where necessary to protect public health, preserve rigorous regulatory standards and ensure that marketed drugs comply with established requirements. Market reactions to the FDA’s stance have already been seen in share price movements of companies involved in promoting unapproved alternatives, illustrating the wider economic and regulatory implications of the issue.

The agency’s warning reflects broader efforts to tighten oversight of drug marketing practices and reinforce the importance of adherence to federal approval pathways. By targeting false or misleading claims about unapproved products, the FDA aims to safeguard consumers and maintain confidence in approved therapies.