RFK Jr. loosens access to unapproved peptides: A health law scholar explains what consumers need to know

Unregulated peptides for weight loss, muscle building, longevity and more are a roaring wellness fad – even though these substances have not been proved safe and effective and have not been approved by the U.S. Food and Drug Administration.

Until now, consumers were getting wellness peptides online through the so-called gray market, where companies rely on legal loopholes to sell them. Due to a push from Health and Human Services Secretary Robert F. Kennedy Jr., a vocal proponent of using peptides, an HHS policy on Oct. 29, 2026, will expand access to six peptides by allowing specialized pharmacies to make and sell them.

I am a health law professor who researches and teaches FDA law and policy. Consumers of peptides will soon have more options, but they should also be aware of the risks.

Drugs versus wellness products

Peptides are short chains of amino acids, which are building blocks for proteins. More than 7,000 peptides occur naturally in the human body. Some peptides – both natural and synthetic – have been developed as medicines, such as insulin and GLP-1 drugs, including Ozempic and Wegovy.

Peptides that are commercialized as pharmaceutical drugs go through clinical trials and are approved by the FDA. But the slew of “wellness” peptides promoted by influencers and sold online or at wellness stores are not evaluated by any regulator.

American consumers have been able to buy wellness peptides online for over a decade. Until 2023 some of these peptides were sold at some specialized pharmacies as well. But that year the FDA restricted access to several wellness peptides due to unnamed “significant safety concerns,” forbidding specialized pharmacies from making and selling them. This did not prevent consumers from buying peptides online and at stores, however.

A push for greater access

Since the early 2020s, the mainstreaming of wellness through the MAHA movement has driven up consumer interest in peptides. Access to nonpharmaceutical, unapproved products such as wellness peptides have long been a cornerstone of Kennedy’s personal philosophy and of the MAHA agenda.

Earlier this year, Kennedy pushed the FDA to review several peptides that the agency had restricted in 2023. Kennedy appointed eight new members to the committee that advises the FDA on these matters, all of whom had ties to businesses selling or promoting peptides. In July 2026 the committee voted 8-6 to expand access to six peptides: BPC-157, Epitalon, KPV, MOTS-c, Semax and TB-500.

The vote came after FDA scientists repeatedly told the committee that there was not enough information about the safety and efficacy of the peptides to justify letting compounding pharmacies sell them.

Some of these peptides are very popular, particularly on social media. For example, wellness influencers refer to the combination of BPC-157 and TB-500 as the “Wolverine stack,” after the Marvel comics superhero, often recommending it for building muscle mass and speeding up postworkout recovery. Kennedy has promoted these peptides in podcasts and as part of his Take Back Your Health tour.

How the new policy works

The new policy allows small compounding pharmacies to sell these six peptides.

Compounding pharmacies are licensed to produce and sell a very small set of drugs that are not reviewed and approved by the FDA. Compounded drugs require a prescription and are meant for patients for whom there is no appropriate drug that is commercially available. For example, patients might need a drug in a strength or form that’s not specifically FDA-approved.

Normally the FDA does not encourage the sale of unstudied products. In this case, the agency is using a policy tool known as enforcement discretion to let these pharmacies know that there will be no legal consequences if they sell the six listed wellness peptides. This policy is often described as having an agency look the other way.

What is enforcement discretion?

When an agency employs enforcement discretion, it means that the law gives it authority to regulate an area but it chooses not to use that authority. This typically happens when the regulator thinks that a product poses very low risk to the public.

For example, during a recent shortage of some weight-loss drugs, the FDA used enforcement discretion to allow some compounding pharmacies to produce the drug to help ease the shortage.

However, if the FDA chooses not to enforce the law and the product poses risks to consumers, the consequences can be severe. The most notable case involved certain types of diagnostic tests, including tests for Lyme disease and breast and ovarian cancer. Several tests were on the market for a long time. For example, a company called Genomic Health started selling a breast cancer screening test in 2008. In 2011 scientists began questioning the accuracy of the test. In 2014 it was confirmed the test had provided false negatives to cancer patients.

The type of blood test that Elizabeth Holmes and her collaborators at Theranos claimed to have developed also belonged to the category of tests over which the FDA was exercising enforcement discretion. That was one of the reasons no one was monitoring Theranos properly, and that helped Holmes and her company hide their fraud for a long time.

What consumers should know

Kennedy and other proponents of peptides have said that it would be better for consumers to be able to buy them at compounding pharmacies, rather than online or at wellness stores, because these pharmacies are licensed to produce some medications that have not been approved by the FDA.

The new policy’s wording echos this sentiment, which implies that oversight by a pharmacist would somehow make these substances safer. However, compounding pharmacies have no obligation to test any ingredients they obtain from outside suppliers.

There is very little oversight of what is actually sold at these pharmacies. Federal law requires the FDA to evaluate drugs before they can be sold and to monitor their production. These requirements do not apply to compounded drugs.

The FDA’s own website notes that the lack of FDA regulation opens the door to “poor compounding practices” and that some compounded products can be unsafe or ineffective.

Under the new policy, there will be more places selling these wellness peptides, but there will still be no regulator checking their safety and efficacy.

More broadly, the FDA’s choice not to regulate peptides can have long-term effects for commercial research. FDA law incentivizes companies to do research on their products. But its new policy on peptides signals that the agency is not interested in having these products studied and evaluated. In my view, that may discourage studies exploring their use, including research that could uncover novel applications for them.