Hims & Hers Health's plan to enter the business of selling peptides is looking a lot more realistic.
Health and Human Services Secretary Robert F. Kennedy Jr. announced Wednesday afternoon that the U.S. government will loosen regulations for 12 peptides, which are used like supplements for health reasons, that were put in place in 2023 for safety reasons. The Food and Drug Administration also scheduled a meeting this summer to talk about whether seven peptides can be produced by compounding pharmacies in a move that would make them more widely available.
Hims & Hers already hinted to investors in February that it was gearing up for "future categories like peptides." Its stock $(HIMS)$ rallied on the announcement and closed 13.7% higher on Wednesday, gaining a further 11% in overnight trading.
"The FDA's plans to more clearly define the regulatory status of several peptides is an important step toward moving these treatments out of the gray market and into more trusted channels overseen by vetted healthcare professionals," Pat Carroll, Hims & Hers' chief medical officer, said in a statement.
Peptides are chains of amino acids that carry signals to cells. BPC-157, for example, is popular for muscle recovery, and people who use GHK-Cu say it improves skin health.
They are commonly used by the fitness community and biohackers. On TikTok, people promote which peptide "stack" they are taking. RFK Jr. is a proponent, recently telling the podcaster Joe Rogan that he has taken one. The well-known GLP-1 medications like Eli Lilly's $(LLY)$ Zepbound and Novo Nordisk's (NVO) (DK:NOVO.B) Wegovy are peptides.
But there are also widespread concerns about their safety and efficiency. Peptides aren't supplements and they aren't approved as drugs, and there is little research assessing them in humans. There are also questions about how people are obtaining the peptides they want in a regulatory gray market.
"The growth of the peptide industry also exposes a credibilitygap: Patients sometimes trust telehealth startups and online pharmacies over clinicians," Kaufman Hall consultants told investors earlier this month in a note distributed by William Blair. "Regulation alone is powerless to bridge that gap; the market has spoken."
Hims isn't the only compounding pharmacy getting into the peptide business. Noom just purchased a pharmacy that already makes some of them.
"Whether people are tracking food intake, monitoring sleep or asking about peptide therapies, they're expressing the same underlying shift: from reactive to proactive," Jeffrey Egler, Noom's chief medical officer, said in an email last week. "The tools and therapies change, but the underlying instinct remains."
Comments