The US Department of Health and Human Services (HHS) has introduced rules that will allow six peptide products to be prepared and distributed by registered compounding pharmacies. The products have been personally promoted by health secretary Robert Kennedy Jr and popularised by social media influencers for problems ranging from tissue repair and muscle recovery to aspects of sleep, metabolism, inflammation and pain. However, there is scant clinical evidence that these peptides are effective and none of them have been approved as treatments by the US Food and Drug Administration (FDA). People therefore typically obtain these peptides through online black- and grey-market distributors and ‘wellness’ clinics.
The HHS change follows a recommendation in July from the FDA’s pharmacy compounding advisory committee, which narrowly voted to recommend allowing compounding of these six peptides (BPC-157, epitalon, KPV, MOTS-c, Semax and TB-500). That would permit licensed pharmacies to prepare and sell these products, without FDA endorsement of their safety or efficacy. That vote happened a month after the makeup of the committee was revised, with seven of the eight new members having active businesses involved in supplying peptides, raising significant conflict-of-interest allegations.
However, FDA staff regulators advised strongly against allowing these materials to be released for compounding, and the FDA is not bound to follow its committees’ advice. Rather than the FDA itself adding these peptides to its list of allowed compoundable drug substances, its parent agency, HHS, has now said it will use its discretion not to enforce the rules, providing State-licensed pharmacies meet certain conditions when compounding these peptides.
One could argue that, since it’s highly likely that many Americans are going to seek out these peptides one way or another, having them prepared at regulated premises that adhere to established quality standards is better than buying online from a random Chinese seller. However, the FDA staff regulators repeatedly raised various potential issues around confirming the identity of the peptides or their salts, along with issues around impurities and microbial contamination.
The situation brings to mind the story of 17-alpha-hydroxyprogesterone caproate (17-OHPC), which was marketed as Makena for reducing pre-term births, but was eventually withdrawn after being shown to be ineffective. When KV Pharmaceutical took advantage of an FDA programme to run some trials and re-establish market exclusivity, it also jacked up the price, prompting the FDA to relax its enforcement to enable compounders to supply cheaper versions of the drug.
But there was a bigger problem, as science sleuth Sholto David explains in this video. For years, across both the scientific literature and company marketing materials, 17-OHPC had been repeatedly confused with the female reproductive hormone progesterone (of which it is a derivative, but with very different chemical and biological activity). Because 17-OHPC was routinely referred to as a ‘progesterone shot’ or ‘intramuscular progesterone’, many of the prescriptions sent to compounders were interpreted as specifying the hormone itself, not 17-OHPC, leading many women to receive painful injections of the wrong drug.
Although the precedent that HHS is setting is worrying, the purpose here is not to point fingers at the state-licensed compounding pharmacies that will distribute these peptides under the new rules, or suggest they will shirk their quality assurance responsibilities. The issue is that relaxing enforcement rules opens the door to countless other, less scrupulous, providers to try and exploit that veneer of official endorsement. That risks fuelling even more widespread use of injectable products with questionable benefits and real risks.
