On Oct. 20 we wrote about gray-market peptides sold online, some by the same factories that once fed the fentanyl trade. Now federal policy has changed. Health Secretary Robert F. Kennedy Jr. is temporarily letting six unapproved peptides onto the market through compounding pharmacies. Government scientists warned there isn't enough evidence they're safe or that they work. Lizzy Lawrence, Alex Janin and Liz Essley Whyte reported it in Thursday's Journal, Oct. 29.
Here's what changed. In a policy released Wednesday, Oct. 28, Kennedy said HHS would stop blocking compounding pharmacies from supplying a handful of popular peptides. A compounding pharmacy mixes a drug to order for a patient with a prescription. Until now the FDA barred compounding of these peptides, in part over safety. The FDA still has to decide whether to allow it for good, and the Journal says that could take months. It also reports the new policy could make it harder for the FDA to restrict peptides later.
Peptides are often injected. The sales pitch runs from building muscle to recovery, and some are marketed to treat ulcerative colitis or insomnia. The FDA hasn't approved any of the popular ones. That's the fact to hold onto. The policy changes who may sell them. It doesn't change what's been proven about them.
What each side says
Kennedy has used peptides himself. He says he wants Americans to be able to get them easily. Two sources told the Journal that many FDA staff don't support the decision. Patient-safety groups criticized the agency. Fred Mills of Americans for Safe and Effective Medicines said American consumers "should not be treated like guinea pigs." We have no view on the secretary or the policy. We have a view on your health and your wallet, and that's where we'll stay.
Our read
Insurance and Consumer Protection, M11. "Allowed to be sold" and "proven safe" are two different sentences, and this story is only about the first. A compounded peptide hasn't gone through FDA approval. That matters three ways. First, by our general reading, health plans often won't cover an unapproved compounded product, so expect to pay cash. Second, if something goes wrong, there's no approved label and no manufacturer trial to lean on. Third, compounders vary, and the vial is only as good as the shop that mixed it. None of this says a peptide doesn't work. It says nobody has proven it does, and you'd be paying to find out. Avoid, for the products.
Here's the check this week. If you or anyone in your house is buying a peptide, injected or otherwise, write down three things. The pharmacy's name, who prescribed it, and what it costs each month. Then take the vial to your own doctor and ask about it. Ask your plan whether it's covered. If you pay from an HSA, keep the prescription and the receipt. By our general reading of IRS rules, HSA money is for treating a condition, not for general wellness. Set the monthly cost next to what you put in your retirement account each month. Bring the receipts to your next review and we'll look at the cash flow together.