The FDA announces decisive steps to restrict non-FDA-approved compounded GLP-1 drugs, targeting misleading claims and strengthening enforcement to safeguard patient safety
Written By: Pharmacally Medical News Desk
Following a dispute between Novo Nordisk and Hims & Hers over compounded semaglutide products, the U.S. Food and Drug Administration on 06 February 2026 released a formal action plan targeting the manufacture and mass marketing of non-FDA-approved GLP-1 drugs. The move signals a tougher regulatory stance on compounded GLP-1 products promoted as alternatives to approved therapies.
FDA leadership signals decisive enforcement
In announcing the action plan, Martin Makary, Commissioner of the FDA, said the agency will take firm steps to restrict GLP-1 active pharmaceutical ingredients intended for use in unapproved compounded drugs.
“Today, the U.S. Food and Drug Administration is announcing its intent to take decisive steps to restrict GLP-1 active pharmaceutical ingredients (APIs) intended for use in non-FDA-approved compounded drugs that are being mass-marketed by companies, including Hims & Hers and other compounding pharmacies as similar alternatives to FDA-approved drugs. These actions are aimed to safeguard consumers from drugs for which the FDA cannot verify quality, safety, or efficacy.”
Makary added that the FDA takes potential violations of the Federal Food, Drug, and Cosmetic Act seriously, underscoring the agency’s focus on patient protection and regulatory compliance.
Crackdown on misleading GLP-1 marketing
As part of the plan, the FDA will intensify efforts to curb misleading direct-to-consumer advertising related to compounded GLP-1 products. The agency reiterated that companies cannot claim non-approved compounded drugs are generic versions of FDA-approved medicines, use the same active ingredient in an equivalent way, or are clinically proven to deliver comparable outcomes.
These clarifications follow warning letters issued in late 2025 and aim to prevent patients from being misled about the safety and effectiveness of compounded alternatives.
Enforcement tools and legal consequences
The FDA said it will use all available compliance and enforcement authorities to address unsubstantiated claims and public health risks. Companies involved in manufacturing, distributing, or marketing unapproved compounded GLP-1 products could face enforcement actions, including product seizure and injunctions, without further notice if violations are not corrected.
GLP-1 drugs and the rise of compounded alternatives
GLP-1 therapies play a growing role in diabetes and obesity care, but only FDA-approved products undergo rigorous review for quality, safety, and efficacy. Compounded GLP-1 drugs do not receive this review, leaving uncertainties around purity, dosing, and clinical performance.
References
FDA Intends to Take Action Against Non-FDA-Approved GLP-1 Drugs, 06 February 2026, https://www.fda.gov/news-events/press-announcements/fda-intends-take-action-against-non-fda-approved-glp-1-drugs
Novo Nordisk Accuses Hims & Hers of Illegal Semaglutide Compounding, Citing Safety Risks, 06 February 2026, https://pharmacally.com/novo-nordisk-accuses-hims-hers-of-illegal-semaglutide-compounding-citing-safety-risks/
FDA to Take Stricter Action on Misleading Drug Ads, Says Commissioner, 16 September 2025, https://pharmacally.com/fda-to-take-stricter-action-on-misleading-drug-ads-says-commissioner/