Just under three years ago, the Food and Drug Administration deemed 19 peptide drugs too unsafe to be dispensed by compounding pharmacies, which mix components of approved drugs to create bespoke medication for people who have trouble taking commonly available products.<\/p>\n
Now, under Health and Human Services Secretary Robert F. Kennedy Jr., the agency is poised to reverse itself. That\u2019s despite few clinical studies supporting the effectiveness or safety of these peptides, which are amino acid chains meant to help regulate functions in the body and have become popular among fitness and longevity enthusiasts.<\/p>\n
In February, Kennedy said the FDA acted illegally in 2023 when it categorized 19 peptides as too unsafe for compounders, whose final products aren\u2019t tested or approved by the FDA. Kennedy, who described himself as a \u201cbig fan\u201d of peptides, has used the therapies himself.<\/p>\n
\u201cIt was illegal because they\u2019re not supposed to do that unless there\u2019s a safety signal,\u201d Kennedy said\u00a0on \u201cThe Joe Rogan Experience\u201d podcast<\/a>, referring to adverse events related to medications. \u201cAnd they didn\u2019t have a safety signal. They\u2019re not allowed to look at efficacy. They\u2019re not allowed to say, \u2018Well, we don\u2019t believe these are efficacious,\u2019 or whatever. They can only look at safety.\u201d<\/p>\n But three former FDA officials closely familiar with how the agency created the criteria to assess the peptides in the first place say Kennedy has mischaracterized their work. The agency\u2019s 2023 decision to ban certain peptides was supported by numerous documented safety concerns, they said. FDA regulations also require the agency to assess both safety and effectiveness before approving a substance for compounding.<\/p>\n \u201cIt would be a disruption of the societal pact we have had since 1962 that drugs will be studied to see if they work before they are marketed in the U.S.,\u201d said Janet Woodcock, a former FDA acting commissioner.<\/p>\n If Kennedy justifies reversal of the previous work by suggesting there were no safety concerns, it would give a false imprimatur of safety to more than a dozen unapproved, untested drugs, the officials said.<\/p>\n There\u2019s been little new science on the 19 peptides since the FDA\u2019s 2023 decision to categorize them as unsafe. But demand for the drugs has exploded as influencers have flooded social media with promises of sculpted physiques, glowing skin, luscious hair, rapidly healing injuries, youthful energy and blazing sex lives.<\/p>\n The demand has given rise to a burgeoning gray market, where wellness spas, multilevel marketers and telehealth websites ply the public with vials of \u201cresearch grade\u201d peptides labeled \u201cnot for human use.\u201d<\/p>\n \u201cMore people want to use them,\u201d said Lauren Colenso-Semple, a muscle physiology researcher and science communication specialist who follows scientific studies of peptides as part of her work. \u201cThat\u2019s what\u2019s changed.\u201d<\/p>\n FDA-approved peptide drugs such as insulin and oxytocin have been available for decades. Newer ones such as semaglutide and tirzepatide, broadly known as GLP-1s, have exploded in popularity for weight loss and have shown promise\u00a0for treating other conditions<\/a>, such as addictions and neurodegenerative and liver diseases. The popularity of these drugs has led the public to become more comfortable with injectables and has helped drive attention to other gray-market peptides.<\/p>\n Last year, at a Las Vegas conference promising radical life extension, two women became\u00a0critically ill after being injected with peptides<\/a>\u00a0the FDA had categorized as unsafe. Although\u00a0Nevada regulators investigated<\/a>\u00a0and fined the health practitioners involved in administering the peptides, investigators weren\u2019t able to determine the exact cause of the reaction. The doctor who ran the booth where the women became ill said he didn\u2019t believe that the peptides caused their reactions but apologized for the incident and said he would review his practices.<\/p>\n Related | How Robert F. Kennedy Jr.\u2019s vaccine agenda risks a resurgence of deadly childhood plagues<\/a><\/p>\n The Alliance for Pharmacy Compounding, one of the largest industry associations lobbying for the FDA to change its stance on peptides, acknowledges it knows little about the safety of individual peptides being sold to the public. (Its CEO says it is an advocacy organization, not a scientific one.) But the group argues the public would be safer if peptides were handled by regulated compounding pharmacies instead of the gray market. The FDA should forgo the usual human clinical trials in order to bring about this shift, a spokesperson for the alliance said.<\/p>\n \u201cWhere we don\u2019t have research, clinical trials, what we\u2019ve got a ton of, is, shall we say, testimonials, patient affidavits, attesting to the wonders of the drug,\u201d said Scott Brunner, the alliance\u2019s chief executive officer. \u201cAnd RFK Jr. is one of those testifiers.\u201d<\/p>\n On the Rogan podcast, Kennedy wasn\u2019t clear on exactly how the FDA would let compounders start dispensing peptides, describing it only as \u201csome kind of action\u201d to make \u201cabout 14\u201d peptides \u201cmore accessible.\u201d Nor has he specified which peptides he wants to make available. (Neither the FDA nor HHS responded to ProPublica\u2019s requests for more information.) But several regulatory shortcuts exist and, ultimately, Kennedy could simply declare the ingredients are legal.<\/p>\n \u201cHe has all of the authority,\u201d said Woodcock, likening such a declaration to former HHS Secretary Kathleen Sebelius\u2019 unilateral 2011 reversal of the FDA\u2019s decision to lift age restrictions on the emergency contraception Plan B. (A judge ultimately found\u00a0Sebelius\u2019 move to be arbitrary and capricious<\/a>\u00a0and nullified it.)<\/p>\n \u201cThe secretary can do anything they want.\u201d<\/p>\n The Bulks List<\/p>\n The FDA\u2019s road to regulating compounding pharmacies \u2014 and by extension the peptides they seek to dispense \u2014 has been long and tedious. Much of the regulatory fight has focused on which ingredients compounders should be allowed to use.<\/p>\n Under a 1997 law, the first passed by Congress to regulate the industry, compounders can only use ingredients that are a component of an approved drug, have what\u2019s known as a USP monograph (essentially a third-party certified recipe for a drug used mainly by manufacturers of generics), or are listed as approved substances by the FDA.<\/p>\n This FDA list, known as \u201cthe bulks list,\u201d is at the center of the ongoing peptide debate.<\/p>\n Litigation and pressure from the industry and lawmakers delayed for decades the creation of the bulks list, leaving compounders in limbo on scores of substances, not just peptides.<\/p>\n \u201cEverything was a fight. It was a huge fight,\u201d said one former FDA official who has spent more than 30 years working on compounding policies. The former official asked not to be named to avoid a public debate with the industry.<\/p>\n![\"FILE](\"https:\/\/www.newsbeep.com\/ca\/wp-content\/uploads\/2026\/04\/AP25343789565858.jpg\" "\\"FILE")
\nThe U.S. Food and Drug Administration building is seen in Aug. 2018 behind FDA logos at a bus stop on the agency’s campus in Silver Spring, Md.<\/p>\n
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