The federal government may soon let compounding pharmacies make peptides that were off limits for years. In the same weeks, reporters are documenting users who took gray market peptides and ended up with migraines, eye pain, and facial numbness. Both stories are getting plenty of press coverage. If you run a peptide company, you need to be closely watching both. Here’s why.
What the MAHA push is trying to do
Health Secretary Robert F. Kennedy Jr. calls himself “a big fan of peptides” and has made wider access an HHS priority. The Make America Healthy Again movement frames it as access and choice with a simple argument. When legal supply is blocked, buyers turn to unregulated online sellers. A regulated pharmacy route should shrink that market, so the MAHA theory goes.
Industry groups say the same thing. The American Academy of Peptide Medicine told the Daily Caller News Foundation it wants a safe, legitimate source to cut into the black and gray markets.
That all seems very reasonable. But it comes with a catch, and the catch is evidence.
Where the policy stands today
In July, an FDA advisory committee voted in favor of six of the seven peptides it reviewed. The vote was close, and it went against FDA scientists, who found the data too thin to show the peptides improve any condition. This week, an interim access policy was sent to the White House budget office for review, according to a government filing. As of today, it is not in effect.
Meanwhile, law firms are telling pharmacies and suppliers not to treat the votes or announcements as a change in legal status. Even if the FDA does decide not to enforce certain rules, that decision would not bind state boards of pharmacy. It would not erase product liability either.
What users are reporting
KFF Health News interviewed people who took experimental peptides such as BPC-157. These users reported migraines, eye pain, and fatigue. One weightlifter described a throbbing eye and numbness on one side of his face. The Washington Post ran the story on October 13. The vendor he bought his product from did not answer the reporter’s questions and was not registered at its listed address.
Peptide supporters say poor manufacturing, not the peptides, causes the harm. The reporting does not settle that and does not identify a singular cause. Here is the thing, though. If a vial is unverified, nobody can answer the question. Not the buyer, not the seller, and not a regulator.
States are already acting
State officials are not waiting for FDA rulemaking. A coalition of state attorneys general has already written to Secretary of State Marco Rubio about ingredients entering the U.S. supply chain from overseas sources, including unapproved drugs like retatrutide. Alabama’s attorney general also settled with a seller of research-grade tirzepatide and semaglutide under the state’s Deceptive Trade Practices Act. Those are consumer protection tools. They work on a different clock than the FDA.
The politics are split too. Foreign Policy reported that the MAHA push for wider access collides with China hawks in Washington. Critics worry that more demand will be met largely by Chinese suppliers. So loosening and tightening regulations are both in play at the same time.
Four moves for operators
First, plan for two outcomes. Build one budget where the policy opens access and one where it stalls. Do not buy inventory or hire staff based on a policy that is not in effect.
Second, document your sourcing. Keep certificates of analysis, supplier registration details, and manufacturing records in one organized file. Law firms point to FDA-registered facilities, cGMP compliance, and COAs as the focus. Those are also accounting records, and your books should match them.
Third, make your marketing match your label. The FDA judges intended use from labeling, ads, claims, and how you distribute. A research use only label does not protect a product that is sold with weight loss claims.
Fourth, ask your attorney and your insurance broker about product liability before you need the answer. What happens if the policy opens and a customer still gets hurt?
The stakes are concrete. Warning letters, manufacturer lawsuits, and state enforcement actions are already landing on sellers of research-labeled peptides. Clean records will not remove that risk. They do put you in a stronger position to answer when someone asks where your product came from.
I am not a lawyer, and nothing here is legal advice. The accounting side is where I can help. A clean set of books and supplier files makes every other conversation easier. And keeping track of where revenues may drop off overnight due to regulatory changes should always be factored into your projections.
About the author
Melissa Diaz, CPA, is a co-owner and partner at High Rock Accounting, which provides outsourced accounting, fractional CFO services, and tax strategy to peptide and cannabis operators. To talk about your books, visit highrock.co/contact.
Enjoyed this article? Consider Sharing
Author
