RFK Jr. is right to expand consumer access to peptides

Health and Human Services Secretary Robert F. Kennedy Jr. recently offered a sensible rationale for wanting to expand consumer access to experimental peptides, which have attracted growing interest among fitness enthusiasts and people seeking injury recovery, weight loss, and anti-aging treatments. During an appearance on Fox News’ “The Will Cain Show,” Oct. 20, he explained, “Americans are going to be buying these anyway.” He said the administration wants a regulated marketplace where consumers receive what sellers claim to provide and factories undergo inspection. 

Kennedy’s comments come as the administration considers easing restrictions on pharmacies that compound customized medications containing certain peptides. He is on the right track. Letting pharmacies supply these products gives consumers a better chance of knowing what they are getting and holds suppliers accountable for what they sell.

Peptides are short chains of amino acids, the building blocks of proteins. Many act as chemical messengers, binding to receptors on cells and signaling them to release hormones or alter other bodily functions. Scientists can synthesize these molecules or modify them to produce specific effects. Physicians have prescribed peptide medicines for decades. Insulin is a familiar example. Semaglutide, sold as Ozempic and Wegovy, mimics a hormone that regulates appetite and blood sugar. Each peptide has its own effects, benefits, and risks.

At its July 23 and 24 meeting, the Food and Drug Administration’s (FDA) Pharmacy Compounding Advisory Committee considered seven experimental peptides for the list of substances pharmacies may use in compounding. FDA staff recommended against adding any of them, citing safety concerns and insufficient evidence of effectiveness. The advisory committee nevertheless recommended adding six.  Those votes were recommendations and they did not themselves change the rules.

The market extends well beyond the seven peptides the committee considered. Promoters market BPC-157 and TB-500 for tissue repair, injury recovery, and pain relief. MOTS-c attracts interest for metabolic health, exercise performance, and longevity, while Semax is promoted for mental sharpness and brain health. Products such as CJC-1295 stimulate growth-hormone release and attract consumers seeking muscle growth and faster recovery. These are advertised or hoped-for benefits, and the supporting human evidence varies considerably. The FDA’s July assessments describe substantial gaps in that evidence.

Retatrutide, often called “reta,” has also attracted consumers seeking weight loss. It activates three hormone receptors involved in appetite and metabolism, compared with the single receptor targeted by semaglutide. Researchers are still testing retatrutide in clinical trials, and the FDA has not approved it, although some sellers already offer products bearing its name. The FDA says retatrutide cannot be used in compounding under current federal law. For ordinary pharmacy compounding, the law generally requires bulk ingredients to meet an applicable U.S. Pharmacopeia standard, be components of FDA-approved medicines, or appear on an FDA list of permitted substances. Retatrutide currently meets none of those conditions. It was not among the seven peptides considered at the July meeting.

Consumers may obtain experimental peptides through wellness clinics, telehealth services, and some compounding pharmacies that prepare customized medications. Others buy directly from online sellers who label their products “research use only” yet market them for human use. Availability does not guarantee that a product complies with federal compounding rules. Social media has amplified the promised benefits, often giving consumers testimonials with little discussion of risks.

The evidence varies considerably. A small retrospective study of BPC-157 injections for knee pain reported improvement but lacked a randomized comparison group. Such findings justify further research but do not tell us whether the peptide caused the improvement. A controlled study of CJC-1295 found that it increased growth hormone and a related growth signal. That does not demonstrate faster injury recovery or longer life. Nor can favorable findings from cells or animals tell us whether a particular human dose provides more benefit than risk.

Some peptides have much stronger clinical evidence. Randomized trials of tesamorelin found reductions in abdominal visceral fat among patients with HIV. A recently published phase 3 trial of retatrutide, involving 1,152 adults with obesity or overweight and type 2 diabetes, found an average weight loss of 18.8 percent at 80 weeks in the highest-dose group, compared with 5.1 percent with placebo. Gastrointestinal adverse effects were more common with retatrutide. These results support a specific use in the studied population. They do not establish that every vial sold online contains the trial drug at the stated strength or purity.

Consumers deserve candid explanations of these distinctions. The FDA has raised concerns about impurities, immune reactions, and missing safety data for several experimental peptides. Reliable manufacturing cannot eliminate a drug’s inherent risks or prove its effectiveness, but it can reduce the additional risks of contamination, incorrect ingredients, and inaccurate dosing.

The Center for Science in the Public Interest has urged the FDA to reject the committee’s recommendations. Its concerns about evidence, safety, and financial conflicts among committee members deserve attention. But preserving restrictions also has consequences. Adults who understand the uncertainties may still choose to use these products. Blocking pharmacies from supplying them leaves those consumers with fewer accountable sources and can steer them toward sellers whose manufacturing practices and products are harder to verify.

Kennedy recognizes that demand will persist. Permitting compounding pharmacies to prepare these products under standards for identity, potency, and sterile production would offer willing buyers a more accountable alternative. Pharmacies and clinicians should explain the limits of the evidence, and suppliers should be held accountable for fraud and negligence. Allowing access would not certify every claimed benefit or relieve sellers of responsibility for the products they provide.

Autonomous adults should be free to weigh uncertain benefits against known and unknown risks. Compounding allows clinicians and pharmacists to tailor a drug’s dose or formulation to an individual patient’s needs. Preserving that option gives patients and clinicians more room to make treatment decisions as researchers continue gathering evidence.  Physicians can advise them, researchers can improve the evidence, and regulators can warn them about hazards. None of those roles requires public officials to have the final say over a competent adult’s willingness to try an experimental product. The Center for Science in the Public Interest gives too little weight to that autonomy and to the risks of keeping willing buyers in an underground market.

Kennedy recognizes that consumers benefit from identifiable products and accountable suppliers. His approach points to a practical principle for drug policy: preserve legal access, give consumers accurate information, and hold suppliers accountable for fraud and negligence. Pharmacological differences warrant specific warnings and careful monitoring. Competent adults should retain the authority to decide which risks they accept.

The FDA should permit pharmacies to compound these experimental peptides under standards that minimize contamination and misrepresentation. Blocking accountable suppliers leaves willing buyers with fewer reliable sources and exposes them to additional risks. That reasoning also applies to other substances sold on black or gray markets. Kennedy is on the right track with peptides. His administration should apply that insight consistently.

The post RFK Jr. is right to expand consumer access to peptides appeared first on Reason Foundation.

Source: https://reason.org/commentary/rfk-jr-is-right-to-expand-consumer-access-to-peptides/