Edition 1: HHS's Peptide Policy, Retatrutide's Phase 3 Data and an FDA Warning Letter

Welcome to the first edition of Best Peptides Today. Three stories, each with what happened and why it matters. Every factual claim links to its source.

1. HHS says it does not intend to enforce against some compounding of six peptides, under conditions

What happened. On Oct. 30, HHS published an interim policy, open for public comment, saying it does not intend to take enforcement action against state-licensed pharmacies, federal facilities or licensed physicians that compound BPC-157, TB-500, epitalon, semax, KPV or MOTS-c, if ten conditions are all met. Each peptide is covered only in a specific form and for specific routes, and products can contain only one active ingredient.

Why it matters. This is a statement about enforcement. It is not FDA approval, and it does not add the peptides to the compounding list. The policy text notes that FDA does not review compounded drugs for safety, effectiveness or quality before they are marketed. For BPC-157, FDA’s July presentations found a “lack of evidence” of effectiveness. For TB-500, FDA identified no clinical studies or human exposure data by any route. HHS and FDA’s drug center read that record differently, and the policy document does not reconcile the two.

2. Retatrutide’s phase 3 trials are published. The drug is still unapproved.

What happened. TRIUMPH-1 (NEJM) and TRIUMPH-2 (The Lancet) report large average weight loss over 80 weeks: up to 25.0% versus 3.9% on placebo in adults with obesity, and up to 18.8% versus 5.1% in adults with obesity and type 2 diabetes.

Why it matters. The company’s headline figures are higher than the journals’ because the analyses answer different questions: the company’s figures (September release) estimate the effect had all participants stayed on treatment, and the journal figures are the average effect regardless of whether people kept taking the drug. Retatrutide is investigational, and FDA says it cannot be used in compounding under federal law.

3. FDA says Empower Pharmacy’s compounded GLP-1 products appear to be copies

What happened. In a Sept. 18 warning letter, FDA said compounded semaglutide and tirzepatide products with added ingredients made by Empower “appear to be essentially copies” of approved drugs, and cited sterile-manufacturing violations.

Why it matters. A warning letter is FDA’s position on specific findings, not a ruling. FDA says the deficiencies put patients at risk, but the letter does not report injuries. We did not verify the company’s response. The HHS policy above does not cover semaglutide or tirzepatide.

What to watch

• Regulations.gov lists 11:59 p.m. Eastern on Nov. 13 as the deadline for public comment on the HHS policy.
• A search of FDA’s Drugs@FDA data on Oct. 30 found no product listed under the name retatrutide. Lilly says it plans to submit an application to FDA in the first quarter of 2027.

U.S. regulatory status checked Oct. 31, 2026.