FDA Restrictions on Non-Approved GLP-1 API Use and Marketing
The US Food and Drug Administration (FDA) has announced plans to implement restrictions on the use of glucagon-like peptide-1 (GLP-1) active pharmaceutical ingredients in medications that lack FDA approval. This regulatory initiative includes products formulated by compounding pharmacies and telehealth entities, such as Hims & Hers.¹
**Safety and Quality Concerns**
The agency indicates that these measures are necessary to protect public health regarding substances that operate outside the standard approval pipeline. FDA Commissioner Martin A. Makary, MD, MPH, stated, “These actions are aimed to safeguard consumers from drugs for which the FDA cannot verify quality, safety or efficacy.”¹
**Advertising Restrictions**
Concurrent with the restrictions on ingredients, the FDA intends to take enforcement action regarding direct-to-consumer advertising for non-FDA-approved compounded preparations. The agency seeks to prevent misleading comparisons between compounded formulations and approved medications.
Commissioner Makary emphasized that commercial entities must adhere to strict guidelines regarding their claims. “Companies cannot claim that non-FDA-approved compounded products are generic versions or the same as drugs approved by FDA,” Makary wrote.¹ Furthermore, he specified that promotional materials “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.”¹
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Reference
1. FDA plans to restrict the use of GLP-1 active pharmaceutical ingredients in non-FDA-approved drugs. Press Release. Accessed February 11, 2026.
