US entrepreneurs push for American-made peptides as government eases rules
Representatives of the biotech accelerator Haus Fund and telehealth company Hims & Hers argue that peptides should be made in the US. This follows an interim decision by the US Department of Health and Human Services to allow certain unapproved peptides for compounding.
US entrepreneurs and the telehealth company Hims & Hers are publicly calling for peptide production to be moved to the United States. The push follows a recent interim decision by the US Department of Health and Human Services (HHS) that allows certain unapproved peptides to be used in compounding, meaning medications prepared individually by pharmacies. Peptides are amino acid compounds used as experimental substances and as skincare ingredients.
A party on a wartime ship
Last week, a peptide party took place aboard the World War II cargo ship SS Jeremiah O’Brien, organized by three Gen Z venture capitalists from the biotech accelerator Haus Fund: Roxana Grunenwald, Yuva Krishnapillai and Elia Ahmadi. About 150 people attended, and guests were offered samples of four types of peptides, with no injections. The venue was chosen as a reference to American industrial strength. Guests left with stickers and hats reading “My Peptides Are Made in America.”
Supply chain and risk
According to the US Pharmacopeia, 51 percent of active pharmaceutical ingredients in US prescription drugs come from India and the European Union, and 10 percent from China. Gray-market “research” peptides sold online come mostly from Chinese manufacturers. Ahmadi said American consumers have little recourse if something goes wrong.
The HHS decision is controversial. At a public hearing in July, scientists from the FDA (the US Food and Drug Administration) said there was not enough evidence of safety or efficacy for the peptides in question. Some industry experts warn that the decision threatens the clinical trial framework.
Hims & Hers plans
Hims & Hers bought an active-ingredient manufacturing facility in California last year. Chief medical officer Anant Vinjamoori links it to the upcoming Peptides Plus service, which is planned to offer sermorelin, glutathione, B12, NAD+ and L-carnitine, with BPC-157 and TB-500 to follow when allowable. Some of these substances are not peptides. The company said it would share pricing details in due time.
The decision is only an interim policy, and it is unclear whether it will last.
