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FDA fires warning letters at online peptide vendors selling BPC-157, TB-500 as drugs

Regulatory 85/100
June 17, 2026↗ source

Across 2025-2026 the FDA's Office of Compliance issued a string of warning letters to internet peptide retailers - including USApeptide.com (February 2025), Gram Peptides (March 2026), and Wholesale Peptide (June 2026) - alleging they are selling unapproved new drugs in violation of Section 505(a) of the FD&C Act. The letters single out products marketed for healing, recovery, and research that the agency says carry disease-treatment claims triggering drug status. Named substances include BPC-157, TB-500 (thymosin beta-4), CJC-1295, ipamorelin, and GHK-Cu. The enforcement runs in tension with the July 2026 PCAC vote recommending several of these same peptides for the 503A compounding list, but legally the two tracks are separate.

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