Regulatory News

• GLP-1 Telehealth: Fewer Than a Third Consult a Doctor

  Fewer than a third of 49 GLP-1 telehealth sites required a real-time doctor consult, a Yale study found, and health-privacy law rarely covers them.

  Sep 19, 2026

• GLP-1 Vision Loss Lawsuits: NAION and the US Label Gap

  Patients are suing GLP-1 makers over NAION vision loss while the same semaglutide risk already sits on EU and UK labels. What the record shows.

  Sep 18, 2026

• Generic Semaglutide Canada: Sandoz Copy of Ozempic Approved

  Sandoz's generic semaglutide is authorized in Canada — the fifth Ozempic copy, for type 2 diabetes. No launch date or price is set: no cheaper Ozempic from it.

  Sep 18, 2026

• 20 State Attorneys General Target Counterfeit GLP-1 From China

  Twenty state attorneys general, led by Alabama, asked the White House on Sept. 18, 2026 to treat Chinese-sourced ingredients in compounded GLP-1 as a threat.

  Sep 18, 2026

• BPC-157 'Wolverine' Peptide Use Surges 33-Fold in US, Study Finds

  A new study and Reuters report show self-administered BPC-157 use grew 33-fold despite FDA Category 2 compounding restrictions and lack of clinical trial data.

  Sep 15, 2026

• Texas Glutathione Recall: Third Pharmacy Pulls Vials Over Endotoxin

  Centric Compounding recalled six compounded glutathione and wellness lots over elevated endotoxin. It is the third Texas pharmacy recall in five weeks.

  Sep 14, 2026

• Counterfeit Retatrutide Tears Oesophagus, Australia's TGA Warns

  Australia's TGA linked a counterfeit retatrutide vial to a torn oesophagus after lab testing found undeclared semaglutide at eight times the usual level.

  Sep 13, 2026

• FDA Warns Online Peptide Sellers: What the Crackdown Means for Buyers

  FDA warning letters dated Aug. 24 hit five online sellers of unapproved weight-loss peptides. What the crackdown means for buyers and how to verify a source.

  Sep 2, 2026

• FDA Warning Letters Flag Five Peptide Vendors' Unapproved GLP-1s

  FDA warning letters dated Aug. 24 target five online peptide vendors accused of selling unapproved GLP-1s behind 'research use only' disclaimers.

  Sep 2, 2026

• Peptide Therapy for Veterans: New Bill Would Direct VA Study

  The PEPTIDES for Veterans Act would require the VA to study peptide-based therapies for pain, recovery, and mental health before any veteran pilot program.

  Sep 1, 2026

• Peptides are having a moment: what the ads don't tell you

  Peptides are everywhere, but most are not FDA approved. Science-first answers on the GLP-1 halo effect, FDA Category 2, and BPC-157/TB-500 safety.

  Aug 30, 2026

• FDA Panel OKs 6 Peptides: What Patients Should Know First

  FDA advisory panel backs six peptides for the compounding list, including BPC-157 — but nothing is approved or legal yet. What patients should know.

  Aug 28, 2026

• Lab Tests Show Black-Market Peptides Miss the Labeled Dose

  Independent lab testing of black-market peptides finds most vials do not match labeled doses, some far higher, while Australia regulator warns on safety.

  Aug 27, 2026

• Safety Groups Sound Alarm on FDA Peptide Compounding Vote

  Safety experts are alarmed after an FDA advisory panel recommended six peptides for the compounding list, citing thin evidence and oversight gaps.

  Aug 26, 2026

• Compounded GLP-1 Ruling 2026: Fifth Circuit Backs FDA Delisting

  Fifth Circuit backs FDA GLP-1 delisting (Aug 27, 2026). Bulk semaglutide and tirzepatide compounding is no longer legal; patient-specific 503A remains.

  Aug 26, 2026

• Peptide Recall 2026: Glutathione Endotoxin Risk, 14 States

  FDA-published recall: Optimal Balance Pharmacy pulled compounded glutathione injections over endotoxin risk in 14 states. Check your peptide lot.

  Aug 24, 2026

• Are Peptides Safe for Teens? Risks & Evidence

  No, unapproved peptides aren't established as safe for teens. The evidence on muscle-growth peptides, looksmaxxing culture, and gray-market dangers.

  Aug 24, 2026

• Compounded GLP-1 Ban: Novo and Lilly's FDA Push Explained

  Novo joined Lilly asking the FDA to ban compounded GLP-1s. Inside the DDC lists, 503B exclusion, and what it means for peptide compounding and the gray market.

  Aug 19, 2026

• Heidi Overton Nominated for FDA Commissioner: What It Means for Peptide Compounding and the 503A Bulks List

  Overton FDA commissioner nomination lands as FDA peptide enforcement intensifies and the 503A bulk substance list decision looms. What to watch.

  Aug 18, 2026

• State Peptide Regulation Fills the Federal Oversight Gap

  State peptide laws are stepping in as federal peptide regulation stays unsettled. Key state actions, trends, and what prescribers and patients should watch.

  Aug 5, 2026

• Undark-STAT Investigation Reveals Hidden History of BPC-157

  A Pulitzer Center-backed investigation traces Predrag Sikiric's 50-year quest behind BPC-157, questioning its evidence base ahead of July's FDA review.

  May 31, 2026

• Leana Wen Warns Wellness Peptide Craze Sidesteps Clinical Trials

  Leana Wen warns wellness peptides replace clinical trials with self-experimentation, as med spas market unapproved compounds without safety details.

  May 28, 2026

• RFK Jr. Forces FDA Peptide Review as Young Men Inject at Epidemic Rate

  RFK Jr. pushes FDA to reverse its 2023 peptide ban as a USA Today opinion piece documents young men injecting unregulated peptides at dangerous levels.

  May 25, 2026

• 45% of Social-Media Peptide Buyers Visited the ER, New Survey Finds

  A Sunlight survey of 1,000 U.S. peptide users finds social-media buyers are 3x more likely to land in the ER, while 75% used AI for dosing guidance.

  May 24, 2026

• ECRI, ISMP Warn Wellness Peptide Market Outpaced Clinical Evidence

  Joint white paper finds 35 of 36 BPC-157 studies were animal-only, gray-market purity as low as 5%, and heavy metal contamination in injectable products.

  May 17, 2026

• Lancet Warns Peptide Craze Outpacing Regulation — BPC-157, Retatrutide

  The Lancet warns social-media peptide use among youth is outpacing regulators, citing BPC-157, CJC-1295, and Retatrutide as primary concerns.

  May 11, 2026

• Australia’s TGA Warns on Illegal Peptides as Global Crackdown Widens

  Australia’s TGA warns on illegal peptide use and border seizures as global regulators escalate enforcement ahead of July’s FDA PCAC meeting on seven compounds.

  May 10, 2026

• Week Ahead: Global Peptide Warnings, GLP-1 Comment Prep, PCAC Watch

  Australia’s TGA peptide warning sets international tone, GLP-1 503B comment prep begins, and PCAC briefing materials for July remain anticipated.

  May 10, 2026

• FDA Compounding Pharmacy Enforcement Intensifies Ahead of July PCAC

  Compounding pharmacy enforcement is intensifying with FDA warning letters and a GLP-1 503B exclusion proposal ahead of the July PCAC peptide meeting.

  May 6, 2026

• Melanotan II Tanning Trend Draws Scrutiny Ahead of July PCAC Review

  WWD covers the Melanotan II tanning trend ahead of July PCAC review, highlighting the regulatory stakes for a peptide at the center of beauty and FDA policy.

  May 5, 2026

• FDA Semaglutide Decision Signals Tougher Peptide Compounding Standard

  The FDA's April 30 proposal to end large-scale GLP-1 compounding uses the same clinical-need standard that will govern peptide compounding after PCAC.

  May 4, 2026

• FDA Proposes Excluding GLP-1 Drugs From 503B Compounding List

  The FDA proposed excluding semaglutide, tirzepatide, and liraglutide from the 503B bulks list. Comments closed July 30, 2026 — no final determination yet.

  May 3, 2026

• FDA Sets July PCAC Meeting to Review Seven Peptide Therapies

  The FDA has scheduled a July 2026 PCAC meeting to review seven peptide therapies including BPC-157, marking a potential shift in regulatory approach.

  May 1, 2026

• Why the Research-Chemical Gray Market Is Not Going Away (And What to Do About It)

  The April 15 reclassification cleared the prescription path for peptides. It did nothing to address the research-chemical channel — which is more dangerous now.

  Apr 26, 2026

• What the July 23–24 PCAC Meeting Will Actually Decide

  The July PCAC meeting will determine final 503A Bulks List placement for the twelve reclassified peptides. The three possible outcomes and what each means.

  Apr 25, 2026

• FDA Removes 12 Therapeutic Peptides From Category 2 — What the April 15 Action Means

  The FDA's April 15 reclassification opens a legal compounding path for BPC-157, TB-500, and 10 other peptides. What it does — and doesn't — change.

  Apr 23, 2026