On 17 June 2026 the FDA’s Center for Drug Evaluation and Research issued a warning letter to Wholesale Peptide of Brooksville, Florida, after reviewing the firm’s website in May 2026. The letter names two products, “Prostamax” and “Gonadorelin”, as unapproved new drugs under section 505(a) of the FD&C Act, quoting site copy stating that Prostamax … Read more
The FDA issued a further round of warning letters on 8 June 2026, including to Altru Telehealth, Medica Weight Loss and FITISH, continuing the enforcement line it opened in September 2025 and widened in March 2026. Sources: Altru Telehealth · Medica Weight Loss · FITISH
The FDA proposed not to include semaglutide, tirzepatide and liraglutide on the 503B bulks list — the roster of substances outsourcing facilities may legally compound from bulk. The agency stated it had reviewed the nominations it received and did not find sufficient evidence of a clinical need for any of the three. If finalised, the … Read more
The FDA restated the conditions a compounded drug must meet to qualify for the section 503A and 503B exemptions, and addressed a practice common in compounded GLP-1 products directly. It said a product combining semaglutide with another active ingredient, giving vitamin B12 (cyanocobalamin) as its example, may still be considered essentially a copy of a … Read more
On 31 March 2026 the FDA’s Center for Drug Evaluation and Research issued warning letters to five websites selling injectable peptides to US buyers: Lovega LLC dba Pink Pony Peptides, Gram Peptides, Prime Sciences, Mile High Compounds and PekCura Labs. Each cites unapproved new drugs sold over the internet under sections 301(d) and 505(a) of … Read more
The FDA issued warning letters to 30 telehealth companies over false or misleading claims made about compounded GLP-1 products sold on their websites. It was the second wave of letters aimed at telehealth firms since the agency opened a broader campaign against misleading direct-to-consumer drug advertising in September 2025, and the largest single action against … Read more
The FDA issued over 50 warning letters to US and international companies compounding or manufacturing semaglutide and tirzepatide. The cited conduct centered on marketing compounded GLP-1s as “generic versions” of the approved drugs, or making direct comparative claims against them. Sources: FDA warning letter database · Wilson Sonsini analysis
The FDA established a “green list” import alert covering GLP-1 active pharmaceutical ingredients, intended to stop unverified foreign-sourced APIs from entering the US market. Ingredients from facilities the agency has inspected or evaluated, and which appear to meet its manufacturing standards, are listed; APIs from any other source become subject to detention without physical examination. … Read more