FDA to act against use of GLP-1 active pharmaceutical ingredients in non-approved drugs


February 06, 2026

1 min read

The FDA announced it planned to restrict use of GLP-1 active pharmaceutical ingredients in non-FDA-approved drugs, including those from Hims & Hers and other compounding pharmacies.

“These actions are aimed to safeguard consumers from drugs for which the FDA cannot verify quality, safety or efficacy,” Martin A. Makary, MD, MPH, FDA Commissioner, wrote in a press release.



Generic FDA News infographic

The FDA plans to restrict the use of GLP-1 active pharmaceutical ingredients in non-FDA-approved drugs, according to a press release.

The FDA also intends to act against direct-to-consumer advertising about non-FDA-approved compounded products.

“Companies cannot claim that non-FDA-approved compounded products are generic versions or the same as drugs approved by FDA,” Makary wrote. “They also cannot state compounded drugs use the same active ingredient as the FDA-approved drugs or that compounded drugs are clinically proven to produce results for the patient.”



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