Three Gen Z venture capitalists from the biotech accelerator Haus Fund hosted a black-tie peptide event last week aboard the SS Jeremiah O’Brien, a World War II Liberty ship, to argue that peptide manufacturing should move to American soil. About 150 guests attended, where four peptide samples were offered and no injections were given. One sample was a topical cream containing GHK-Cu, a popular skincare ingredient, and the other three were dissolvable sublingual strips from peptide startup Afterglow. It is unclear how well the sublingual strips work.
The organizers, Roxana Grunenwald, Yuva Krishnapillai and Elia Ahmadi, used the ship as a deliberate reference to American industrial strength. Guests left with stickers and hats reading “My Peptides Are Made in America.” The push comes as the US Department of Health and Human Services has issued an interim policy decision allowing certain unapproved peptides for compounding, a move that FDA career scientists have not endorsed. At a public hearing in July, FDA scientists said there was not enough evidence proving safety or efficacy for the experimental peptides in question, and some industry experts have warned the decision threatens the current clinical trial framework.
Krishnapillai described the HHS decision as a good first step toward solving the gray-market problem, arguing it lets compounding pharmacies build a supply chain that follows US consumer safety laws and gives the FDA a clearer view of the market. Ahmadi said American consumers have little recourse if something goes wrong when they buy consumer peptides from gray-market sellers in China, while stressing the position is not a blanket criticism of China or Chinese people. Grunenwald said the goal is for peptides to be compounded, produced and verified on American soil, and compared the bio industry to semiconductors and electronics, which she said have already confronted reliance on China for critical minerals.
According to the US Pharmacopeia, 51 percent of all US prescription active pharmaceutical ingredients come from India and the European Union, and China accounts for 10 percent. The vast majority of gray-market research chemicals sold online come from Chinese manufacturers. Grunenwald acknowledged that onshoring will take a lot of money and time but said it is not impossible. Ahmadi said domestic production is needed to enforce US regulations and hold the market accountable to American consumers.
Hims & Hers is also pursuing the American peptide push. Chief medical officer Dr. Anant Vinjamoori said the company purchased an API manufacturing facility in California recently and intends to use it to provide US-made API and US-made product through the whole supply chain, though the company partners with other companies globally to deliver compounded medications outside the US. He said US production gives direct oversight into the whole process, and noted that before the Biden administration moved certain research peptides to the no-compounding list, there was inconsistency between compounding pharmacies even when he prescribed peptides to patients.
Vinjamoori was referring to Peptides Plus, a forthcoming service from Hims & Hers announced after the HHS interim policy. In a blog post, CEO Andrew Dudum wrote that the company spent years building infrastructure in its own US-based peptide manufacturing facility. At launch, the company plans to provide access to Sermorelin, Glutathione, B12, NAD+ and L-carnitine, with BPC-157 and TB-500 to follow when allowable. Some of those substances, such as vitamin B12 and NAD+, are not peptides, while sermorelin and glutathione are already legal, and all of the listed items except BPC-157 and TB-500 are currently available through legal pathways.
More technology news from TechManNews.
