203 stories across all digests
Regulatory coverage on Peptide News Digest tracks how the FDA, MHRA, EMA, and state agencies handle peptides — what they let through, what they pull, what they redefine.
The compounding fight has dominated 2025 and 2026. GLP-1s came off the FDA shortage list in early 2025; the agency moved compounded semaglutide and tirzepatide toward Category 2 on the 503A bulks list; and a wave of state legislation tried to either preserve or shut off telehealth access. The PCAC has spent meetings on BPC-157, GHK-Cu, and other research peptides that have built consumer demand without clinical infrastructure behind them.
Stories here name the agency, the substance, and the action. Browse the latest below, or jump to specific tags like #fda, #compounding, #peptide-policy, or #503a.
The FDA announced it will convene the Pharmacy Compounding Advisory Committee on July 23-24 to evaluate whether seven or more peptides — including BPC-157, TB-500, and other popular wellness peptides — should be added to the list of substances eligible for pharmacy compounding. The announcement follows HHS Secretary RFK Jr.'s February pledge to reclassify 14 restricted peptides.
The GLP-1 mass tort litigation (MDL 3094) before Judge Karen Marston in the Eastern District of Pennsylvania now includes 3,363 cases alleging gastroparesis and other injuries. Expert discovery closed in late March, with Daubert motions due April 28 and summary judgment motions due April 30. A Science Day on vision loss claims is set for June 2.
Scientific American reports that the FDA's decision to convene an expert advisory panel — rather than unilaterally reclassifying peptides — signals a more cautious approach than RFK Jr.'s original February pledge suggested. The panel will weigh limited safety data against surging consumer demand and a growing black market for unregulated peptide products.
The FDA asked Eli Lilly for additional safety data on liver injury linked to Foundayo (orforglipron), plus post-marketing trials to assess cardiovascular event risk and delayed gastric emptying. A lactation study was also required. The letter, signed April 1, was published April 14 — just two weeks after the drug's fast-track approval under the National Priority Voucher program.
Australia's Therapeutic Goods Administration warned of rising imports of unapproved peptide products promoted on social media, citing risks including severe allergic reactions, systemic inflammatory response, infection, and organ damage. Named products include BPC-157, GHK-Cu, TB-500, retatrutide, and CJC-1295 — often supplied as injectables.
The FDA published updated guidance clarifying compounding requirements now that semaglutide and tirzepatide shortages have been resolved. The statement reaffirmed enforcement deadlines for 503A and 503B pharmacies while acknowledging ongoing legal challenges from the Outsourcing Facilities Association.
The American Diabetes Association published new pharmacologic obesity treatment standards in its journal Diabetes, Obesity, and Cardiometabolic Care, calling on clinicians and policymakers to eliminate weight stigma. Over 40% of people with class II obesity report weight-based discrimination that impedes treatment access.
The Week reports that India's GLP-1 market is surging following semaglutide patent expiry in March, with doctors warning that self-medication — particularly through unapproved online channels — poses serious risks including pancreatitis and thyroid complications. Experts emphasize the need for clinical oversight and proper dose titration.
ProPublica published a major investigation into the FDA's planned reversal on 19 restricted peptides, warning that reclassification under HHS Secretary RFK Jr. could expose consumers to inadequately tested drugs. The Alliance for Pharmacy Compounding acknowledged it knows little about the safety of individual peptides being sold to the public.
A federal grand jury indicted Utah osteopathic physician Justin Bradley Watkins for obtaining non-FDA-approved peptides including tirzepatide, semaglutide, BPC-157, and retatrutide from a Chinese supplier, affixing fake labels, and selling them to over 200 patients without disclosing their unapproved status.
The FDA granted Apotex Corp. the first-ever tentative approval for a generic semaglutide injection equivalent to Ozempic/Wegovy. Actual market entry is blocked by Novo Nordisk patents until ~2032, but the milestone proves a complex peptide injectable can meet FDA generic equivalence standards.
Novo Nordisk received accelerated FDA approval for Wegovy HD, a higher-dose injectable semaglutide offering ~21% weight loss, with aggressive discount pricing to fight Lilly's market share gains.
HHS Secretary RFK Jr. announced 14 previously restricted peptides — including BPC-157, TB-500, CJC-1295, Ipamorelin, and AOD-9604 — are being moved from Category 2 back to Category 1, restoring legal compounding pharmacy access.
The FDA is intensifying enforcement against compounding pharmacies selling unapproved GLP-1 products, threatening seizure and injunction. Hims & Hers was specifically named following the February 2026 TrumpRx launch.
Health Canada warned Canadians against injecting unauthorized peptides purchased online, citing risks of organ damage and infection from products misleadingly labeled 'For Research Use Only.'
Semaglutide injections officially removed from the FDA drug shortage list, though localized availability issues persist. Tirzepatide shortage status remains contested by the Outsourcing Facilities Association.
Health Canada issued a public advisory warning against unauthorized injectable peptide drugs sold online for weight loss, anti-aging, and bodybuilding. Seized products include BPC-157, CJC-1295, retatrutide, and others, with cited risks of liver/kidney damage, blood clots, and cancerous tumours.
In-depth feature on peptide mania in wellness culture. HHS Secretary RFK Jr. wants to make unapproved wellness peptides more available to the public. The piece distinguishes FDA-regulated peptides from the largely untested 'wellness' peptides embraced by those mistrustful of mainstream medicine.