More than a month ago, U.S. Secretary of Health and Human Services (HHS) Robert F. Kennedy Jr. publicly supported the use of unapproved injectable peptides on Joe Rogan's podcast, an unprecedented move for an HHS Secretary. In recent years, these peptides have rapidly gained popularity among "biohackers" and health enthusiasts.

During the show, Kennedy stated that the FDA plans to change the classification status of more than a dozen synthetic peptides. These peptides were placed on the "Category 2" bulk drug substance list in 2023 due to potential patient safety risks, effectively prohibiting pharmacy compounding.

"For a gray-haired regulatory attorney, learning about such a major policy change on a podcast rather than through the Federal Register or official FDA channels is certainly interesting, but that's the era we live in," commented Edgar Asebey, a partner at the law firm Frier Levitt.

Kennedy claimed that the Biden administration's ban was "illegally" enacted. However, none of the peptides under consideration for reclassification have proven safety and efficacy in clinical trials, nor have they received FDA approval.

Kennedy said he has personally used some of these compounds, including BPC-157 for athletic recovery, as well as MOTS-c, Semax, and Selank, which are often combined with GLP-1 weight-loss drugs to enhance their effects.

If Kennedy succeeds in making these treatments more widely accessible, the move could have broader implications for the highly competitive weight-loss drug sector of the pharmaceutical industry.

Public health trade-offs

Kennedy believes that moving peptides back to "Category 1" (allowing pharmacies to compound them with a valid prescription) would put them back in the hands of "ethical suppliers," as many patients have turned to overseas gray-market alternatives in recent years.

This change would make doctors the gatekeepers for peptide prescriptions—but reclassification is not without new safety risks.

Reclassification could send the wrong signal to the public that using untested and unapproved compounded drugs is safe, despite limited data and insufficient regulation.

"Some of these peptides have better-defined profiles, but all of them have good reasons to remain in Category 2," Asebey said. "These compounds are not pharmaceutical grade."

Many compounds lack the clinical data required for approval because no pharmaceutical company has attempted to patent them. Asebey noted that the opportunity to build patent portfolios around unapproved peptides is minimal, and the private sector lacks the incentive to invest funds to prove their safety and efficacy.

"People are already getting these peptides online," Asebey added. "The compounding industry has little incentive other than profiting from them."

While reclassification aims to legitimize the peptide drug industry, it could also fuel the growth of its darker side.

The growing gray market

In recent years, demand for peptides has surged, partly driven by the success of GLP-1 drugs from industry giants such as Eli Lilly and Novo Nordisk. The global peptide therapeutics market has surpassed $50 billion in annual sales and is expected to nearly double over the next decade.

But as consumers seek cheaper or more accessible alternatives, a gray market for weight-loss drugs has also emerged.

Asebey said thousands of companies sell peptides online that are not intended for human consumption, often labeled "for research use only," thereby circumventing federal regulations. Patients can even purchase experimental weight-loss drugs still in clinical development or drugs not yet approved by the FDA.

Asebey mentioned that retatrutide, an experimental triple agonist still in Phase 3 trials at Eli Lilly, is already available for purchase online. Patients can also obtain Novo Nordisk's combination drug CagriSema, which is currently under FDA review and not yet approved.

According to other reports, customers can order unlimited quantities of unapproved peptides online, which may then be sold and distributed in the United States, potentially at a markup.

This has intensified the already fierce competitive landscape for Eli Lilly and Novo Nordisk, both of which have been engaged in legal battles with telehealth companies and compounders over generic versions of their GLP-1 drugs.

Although direct-to-consumer platforms have reduced the price of weight-loss drugs to around $150 per month, the cost can still be prohibitive, making cheaper alternatives more attractive to U.S. consumers.

Asebey predicts that if the FDA reclassifies certain peptides currently on the "prohibited from compounding" list, the market will shift.

Given the varying price points online and overseas, "some people will seek safer compounded versions, but others looking to save money will continue to buy 'research-only' peptides from an industry that has already moved beyond FDA oversight," Asebey said.