Hims & Hers to offer unapproved peptides to customers

Hims & Hers will soon be offering some of the unapproved peptides subject to the FDA's enforcement discretion policy announced last month to its customers.

The telehealth company – which was a major player in the market for compounded versions of GLP-1 agonist peptide therapies – has lost no time in offering some of the peptides on the FDA's list, notably TB-500 for tissue repair and muscle recovery and BPC-157 for tissue repair and healing.

TB-500 and BPC-157 are sometimes used together in a 'stack' or combination – known as 'Wolverine' – that is claimed to provide rapid muscle, tendon, ligament, and injury recovery.

Hims & Hers is also offering compounded formulations of other unapproved peptides, including sermorelin, which some people use to counter the reduction in growth hormone seen with ageing and for weight management, and glutathione, most commonly used for antioxidant support, skin brightening/lightening, liver detoxification, and immune health.

A page on Hims & Hers' website, inviting customers to sign up for notifications on the availability of the peptides, notes that they are not FDA-approved and have not been evaluated by the regulator for safety, effectiveness, or quality.

US Health and Human Services Secretary Robert F Kennedy Jr has been both a user and a champion of peptides, raising alarm bells that the policy to suspend enforcement by the FDA, which falls under the HHS' remit, runs counter to the agency's responsibility to protect the public from harm.

An FDA advisory committee that had its roster overhauled by Kennedy earlier this year narrowly voted in the summer to loosen restrictions on peptides, against the advice of FDA staff scientists.

Critics of the enforcement discretion believe that there is widespread confusion among consumers about the status and safety of compounded medicines, mistakenly thinking they have gone through rigorous testing and are FDA-approved, and could expose users to contaminants, impurities, and side effects, particularly when used in stacks.

The Biden administration banned pharmacies from producing 19 formulations in 2023 due to safety concerns.

The market for unregulated peptides has boomed in the last few years, driven by influencers on social media who record themselves injecting products and often make near-miraculous claims for their efficacy, even though they are generally labelled 'for research purposes only' and/or 'not for human consumption'.

International regulators, including the MHRA in the UK, have been cracking down on the trade in these products, monitoring for incidents where a health claim is made for a peptide and launching enforcement operations that have resulted in the seizure of thousands of injectables. Hims & Hers does not make any health claims for the products on its website.

HHS has said the measure is intended to prevent users from sourcing the peptides from unsafe, black market sources, often produced overseas, and to make sure they get them only from "federal facilities and licensed pharmacies and physicians."