HHS Authorizes Compounded Access to Six Unapproved Peptides, Bypassing FDA Oversight

Peptide injections have gained popularity in online communities, even as questions persist about their safety and regulatory status.

Image credit:©iStock.com, Mariya Borisova

Biohacking has grown into a major industry. In recent years, unregulated peptide injections have been widely promoted online, driven by consumer demand for compounds that claim to improve health, appearance, or longevity. On October 28, U.S. Department of Health and Human Services Secretary Robert F. Kennedy Jr., a peptide proponent who says he has personally benefited from them, announced that he would streamline patient access to six unapproved peptides.

A Growing Gray Peptide Market

Kennedy said that the six peptides would be cleared for use by compounding pharmacies, which blend ingredients for distribution to patients. This process bypasses the need for Food and Drug Administration (FDA) approval, the process that establishes a compound’s safety and efficacy.

In a related policy, HHS said it would exercise “enforcement discretion” around the compounding of six peptides: BPC-157, Epitalon, KPV, MOTS-c, Semax, and TB-500. This means HHS would not legally pursue compounding pharmacies using these ingredients to produce the substances.

The HHS said the policy would give consumers an alternative to “certain research-use-only peptides supplied by foreign manufacturers that pose a safety risk to US patients.” These peptides are marketed as not for human use, but this is widely seen as a workaround for existing regulations. Instead, they have become the spearhead of a growing gray market.

The six compounds have been promoted on online forums for a variety of uses. The combined use of BPC-157 and TB-500, for example, has been called “The Wolverine Blend” on Reddit peptide communities for its supposed benefits to muscle regrowth and recovery. But FDA researchers say there is insufficient data to conclude whether the compounds work or are safe to use. A survey of 1,000 peptide users concluded that those buying from the gray market visited the emergency room at three times the rate of other users.

HHS spokesperson Emily Hilliard told the New York Times that the new policy would address the risks of these unregulated compounds. She said the policy stated the need for “patient-specific prescriptions, traceable ingredients, quality testing and safety reporting to hold compounders accountable and give patients an alternative to unregulated sellers.”

But drug safety experts sharply criticized the announcement. Shabbir Safdar, executive director of safety group The Partnership for Safe Medicines, said, “Imagine what it means for the nation’s top drug regulator to announce they won’t enforce the laws on people making completely untested compounds and distributing them to the public,” in an interview with NBC News.

FDA Experts Overridden by New Announcement

Peptides are short amino acid chains. Naturally occurring peptides play many roles throughout the body, while approved peptide medicines, like the GLP-1 receptor agonist semaglutide, are widely used to manage diabetes and obesity. But semaglutide was only approved for public use after long and very expensive testing through multiple clinical trials.

These tests are designed to prevent public health disasters like thalidomide, a morning sickness drug that caused birth defects when it was sold around the world in the late 1950s and early 1960s. Strict FDA regulations, defended to the hilt by pharmacologist Frances Oldham Kelsey, prevented the drug’s sale in the US.

The new announcement bypasses concerns from FDA experts, who explained during a hearing in July that the compounds’ risks were still unknown. The hearings ended in non-binding votes recommending the compounding of peptides, shortly after Kennedy appointed several new committee members who had previously sold the peptides.

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