FDA Targets Non-Approved GLP-1 Drugs Amid Safety Concerns

FDA Commissioner Martin Makary announces enforcement actions against companies marketing non-approved GLP-1 drugs, citing safety risks and misleading advertising practices.

The U.S. Food and Drug Administration is taking decisive action against companies marketing non-FDA-approved GLP-1 drugs, particularly those being promoted as weight loss alternatives to approved medications like Ozempic and Wegovy. In a statement released February 6, 2026, FDA Commissioner Martin A. Makary warned that the agency intends to restrict GLP-1 active pharmaceutical ingredients (APIs) used in compounded drugs that are being mass-marketed by companies including Hims & Hers and various compounding pharmacies.

Safety Concerns Drive Regulatory Action

The FDA's primary concern centers on the inability to verify the quality, safety, or efficacy of non-approved GLP-1 products. Unlike FDA-approved medications that undergo rigorous clinical trials and manufacturing oversight, compounded versions lack standardized quality controls and comprehensive safety data.

"We take seriously any potential violations of the Federal Food, Drug, and Cosmetic Act," Commissioner Makary stated, emphasizing that the agency will use "all available compliance and enforcement tools" to address unsubstantiated claims and public health concerns.

Crackdown on Misleading Marketing

Beyond the safety issues, the FDA is specifically targeting deceptive advertising practices. Companies have been sending warning letters since fall 2025 regarding promotional materials that make false or misleading claims about non-approved GLP-1 products.

According to the FDA, companies cannot legally:

Claim that non-FDA-approved compounded products are generic versions or identical to FDA-approved drugs
State that compounded drugs use the same active ingredient as FDA-approved medications
Assert that compounded drugs are clinically proven to produce results for patients

These restrictions aim to prevent consumers from being misled about the nature and effectiveness of compounded alternatives to approved GLP-1 medications.

Enforcement and Legal Consequences

The FDA has made clear that entities involved in manufacturing, distributing, or marketing unapproved compounded GLP-1 products face serious consequences. The agency warned that failure to address violations may result in legal action without further notice, including seizure of products and injunctions against continued operations.

This aggressive enforcement stance reflects the FDA's assessment of the public health risks associated with these products, particularly given the widespread interest in GLP-1 medications for weight management.

Context of GLP-1 Drug Shortages

The regulatory action comes amid ongoing concerns about GLP-1 drug availability. While the FDA has clarified policies for compounders as the national GLP-1 supply begins to stabilize, the agency maintains that compounded versions should only be used when FDA-approved drugs are unavailable and when medically necessary.

The FDA's drug shortages list plays a role in determining when compounding is appropriate, but the agency emphasizes that mass marketing of compounded GLP-1 products as alternatives to approved medications remains problematic regardless of supply conditions.

Understanding the Risks

Compounded drugs, by their nature, lack the manufacturing consistency and quality controls of FDA-approved medications. For GLP-1 drugs specifically, this raises concerns about:

Inconsistent dosing and potency
Contamination risks during compounding
Lack of long-term safety data
Unknown drug interactions
Variable absorption and effectiveness

These risks are particularly concerning given the popularity of GLP-1 medications for weight loss and the potential for widespread use of non-approved alternatives.

FDA's Broader Mission

The action against non-approved GLP-1 drugs aligns with the FDA's broader mission to protect public health by ensuring the safety, effectiveness, and security of drugs, vaccines, medical devices, and other products. As part of the U.S. Department of Health and Human Services, the agency maintains responsibility for regulating a wide range of products that impact American consumers' health and safety.

The crackdown on non-approved GLP-1 drugs represents a significant regulatory intervention in a market that has seen explosive growth due to the popularity of weight loss medications. By targeting both the safety concerns and the misleading marketing practices, the FDA aims to protect consumers from potentially dangerous products while ensuring accurate information about available treatment options.