US health secretary Robert F Kennedy Jr (RFK Jr) has debuted a policy that allows specific licensed professionals to use a range of unapproved wellness peptides in compounding.
Through RFK Jr’s Enforcement Discretion Policy, pharmacists, licensed physicians or outsourcing facilities under the direction of a licensed pharmacist will now be able to use six active peptide bulk drug substances when creating compounded drugs – despite none of them having secured a regulatory greenlight from the US Food and Drug Administration (FDA).
Go deeper with GlobalData
Discover B2B Marketing That Performs
Combine business intelligence and editorial excellence to reach engaged professionals across 36 leading media platforms.
Under the new policy, HHS will allow for the compounding of BPC-157, a peptide focused on bone healing, as well as anti-ageing and insomnia-focused compound, Epitalon, anti-inflammatory and immune-boosting peptide, KPV, metabolism-regulating MOTS-c, cognition-enhancing Semax and exercise recovery-focused molecule, TB-500. Currently, a lion’s share of the data behind the effectiveness of these drugs is derived from preclinical studies, while little is known about their activity in humans.
The HHS’ new policy echoes the recommendation of the FDA Pharmacy Compounding Advisory Committee’s (PCAC) July recommendation to allow compounding with these six peptides, despite FDA staff at the agency’s drug evaluation centre taking an opposing stance.
Unapproved peptides head to the mainstream
RFK Jr’s call to ink the Enforcement Discretion policy marks another step by the health secretary to legitimise and improve the availability of wellness and longevity-focused peptides across America.
While these unapproved drugs have traditionally remained on the fringe of the wider health and wellness movement, they are now gaining notable cultural relevance – with peptide combinations like BPC-157 and TB-500, colloquially known as the Wolverine stack, becoming increasingly embedded into the mainstream consumer market. This trend is primarily driven by the soaring popularity of wellness influencers active on social media platforms.
According to researchers from the University of Queensland’s School of Public Health, there were more than 130,000 posts on Instagram focused on peptide-related content as of May 2026, while videos on the topic garnered more than 230 million views on TikTok at the same time point.
Reacting to HHS’ new policy, the Alliance for Safe Online Pharmacies’ (ASOP) board chair and former FDA drug security, integrity and response director, Dr Leigh Verbois, said: “Expanding access is not a substitute for evidence of safety and effectiveness, nor is it a solution to the illegal online market.”
“Compounded drugs are not FDA-approved, and a policy of enforcement discretion does not establish that these peptides are safe or effective. Policymakers must maintain evidence-based safeguards while taking meaningful action against illegal online sellers that put consumers at risk.”
ASOP also warns of the swirling illicit online peptide market, which they say could put patients at significant risk due to its unregulated nature – a possibility it says could be further exacerbated by inviting new market entrants following the debut of the Enforcement Discretion policy.
In recent months, the FDA has cracked down on the sales of online, black market weight loss peptides, while pharma companies like Eli Lilly also launch their own initiatives to curb the impact of the illicit medicines trade.
Unlike Verbois, the Alliance for Pharmacy Compounding’s CEO, Scott Brunner, was generally positive about the policy development, noting it as “an important step for patients.”
“We’ve said all along that the question isn’t whether patients are using these peptides – they are,” Brunner commented, adding that allowing state-licensed pharmacies to prepare these medications “pursuant to legitimate prescriptions, using appropriately sourced and tested API” offers as safer alternative to current sources.
However, he caveats that access must come with meaningful safeguards. “That’s why APC has consistently advocated guardrails focused on API quality and traceability, serious adverse event reporting, and utilisation data,” said Brunner.
“We’re encouraged that the HHS policy addresses those priorities, including requiring API from FDA-registered manufacturers, verification and review of certificates of analysis, extensive testing and documentation, and reporting of serious adverse events and product quality issues,” Brunner concluded.
