The FDA and the Unproven Peptide BPC-157

In July 2026 the Food and Drug Administration (FDA) convened an advisory committee to discuss whether specialized pharmacies should be allowed to compound seven popular but unproven peptides.[1] Prior to the meeting, FDA scientists recommended against adding any of the peptides to an agency list, known as the 503A bulks list, that would allow the substances to be compounded. Body Protection Compound-157 (BPC-157) was the first peptide discussed.

Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. has used unproved peptides, has a personal interest in the substances and has pledged to ease FDA regulations. Prior to the meeting, HHS stacked the FDA’s Pharmacy Compounding Advisory Committee by directing the appointment of new members, some of whom have promoted the use of peptides and have financial conflicts of interest.[2]

Testifying at the meeting, Public Citizen’s Health Research Group urged the committee to recommend that the FDA not permit compounding of BPC-157.[3] Disregarding the evidence, the advisory committee rejected the FDA’s recommendation and voted 8-6 with one abstention to recommend that BPC-157 be added to the 503A bulks list.[4] As of early October 2026, the FDA had not announced its decision.

Drug compounding

The FDA defines compounding as “a practice in which a licensed pharmacist, a licensed physician or, in the case of an outsourcing facility, a person under the supervision of a licensed pharmacist, combines, mixes, or alters ingredients of a drug to create a medication tailored to the needs of an individual patient.”[5] Compounded drugs are not FDA approved, meaning that the agency has not reviewed their safety, effectiveness or quality prior to marketing.

Peptides and BPC-157

Peptides are short chains of amino acids, typically two to 50 amino acids in length, that act as chemical messengers in the body and sometimes degrade quickly. Proteins are longer chains of amino acids.[6]

Some peptides are approved and widely used drugs. For example, insulin is a peptide, and the glucagon-like peptide-1 (GLP-1) drugs that are widely used for type 2 diabetes and weight loss are peptides.[7]

BPC-157 is a peptide with 15 amino acids, derived from a protein fragment in human gastric juice. However, naming conventions are inconsistent and the BPC-157 that is marketed is not well characterized. “BPC-157” can refer to inconsistent formulations of either the naturally occurring peptide (BPC-157 free base) or its synthetic form (BPC-157 acetate), with potentially different safety and efficacy profiles.

Although BPC-157 was discovered in the early 1990s, there is still no adequate evidence about its safety or effectiveness for any use in people.[8] Clinical trials have been limited in scope; some trials have not been published or their results otherwise made public.[9]

Regardless of the lack of evidence, BPC-157 is popular with fitness and wellness influencers, health coaches and others who stand to benefit financially from its use.[10] Influencers and others flood social media with misleading information on the alleged beneficial properties of BPC-157 — including protecting gastrointestinal health, muscle and joint health, and promoting wound healing. Joe Rogan, the host of one of the nation’s most popular podcasts, has used BPC-157 and has mentioned the substance many times on his show.[11]

In 2023 the FDA identified potential significant safety risks for 19 peptides, including BPC-157, and subsequently prohibited their use in compounding.[12],[13] Under Kennedy’s HHS, however, the FDA is being pressured to allow the compounding of many of these peptides, including BPC-157. Because the FDA has not approved BPC-157 for any indication and no approved product is available, BPC-157 is diverted from supplies intended for research — not human use — or procured illegally on the black market.[14]

The FDA received two nominations from compounding pharmacies to add BPC-157 to the 503A bulks list for the treatment of ulcerative colitis, Crohn’s disease, celiac disease and tendonitis. The proposed routes of administration are oral capsules, subcutaneous injections, nasal spray, rectal suppositories and a transdermal cream.

Effectiveness of BPC-157

The purported mechanism of action of BPC-157 is unknown, no dedicated receptor in the body for BPC-157 has been identified, and a dose-response relationship has not been established.

For the treatment of ulcerative colitis, a chronic inflammable bowel disease that often requires longterm treatment, FDA scientists identified one randomized, placebocontrolled trial that evaluated BPC-157. This trial was completed by 46 participants with mild to moderate ulcerative colitis who received the peptide as an enema (which was not one of the proposed routes of administration) or placebo once daily. Not only was this trial small, but it lasted only two weeks. Moreover, because the results were only reported in a meeting abstract, important details such as the primary endpoint, the inclusion or exclusion criteria, and the statistical design are not known.

The FDA could not identify clinical data supporting the peptide’s use via any of the proposed routes of administration. Importantly, the FDA has approved multiple drugs for the treatment of ulcerative colitis, including adalimumab (HUMIRA, biosimilars and interchangeable biosimilars), golimumab (SIMPONI, SIMPONI ARIA and interchangeable biosimilars) and guselkumab (TREMFYA).

FDA scientists could not identify any clinical trials assessing the effectiveness of BPC-157 for Crohn’s disease, Celiac disease or tendonitis. The FDA also evaluated 25 nonclinical studies, which agency scientists said should be “interpreted with caution.”[15]

Safety of BPC-157

The FDA scientists identified five clinical studies that assessed the safety of BPC-157. Although no serious adverse events were reported, all five studies were small, including between two and 26 participants, and very short. Some studies covered only a single procedure, and none lasted longer than two weeks. Moreover, only exploratory doses of BPC-157 were evaluated and limited information on how safety was monitored in these studies is available. Information about the routes of administration is lacking.[16]

There is no evidence about the longterm safety of BPC-157 for ulcerative colitis.

Additional concerns

Impurities or changes in the chemical composition of BPC-157 that may be triggered by the manufacturing process or storage conditions can increase the risk of immune responses, particularly when the substance is injected.

The lack of consistency in the nomenclature and chemical structure of BPC-157 is a safety risk; individuals may receive varying versions with possible variable clinical effects.

What You Can Do

Although interest in peptides, including BPC-157, has increased dramatically in recent years, the substances’ supposed benefits are largely based on anecdotal evidence. There is no evidence that BPC-157 is safe or effective, and there is no FDAapproved version. We recommend that you Do Not Use BPC-157, even if the FDA allows the substance to become available through compounding pharmacies.

References

[1] Food and Drug Administration. FDA briefing document. Pharmacy Compounding Advisory Committee (PCAC) meeting. July 23-24, 2026. https://www.fda.gov/media/193342/download. Accessed September 4, 2026. 

[2] Roubein R, Weber L. RFK Jr.’s plan to boost peptide access just got more complicated. The Washington Post. June 30, 2026. https://www.washingtonpost.com/health/2026/06/30/fda-staff-recommendation-undercuts-rfk-jrs-push-expand-peptides/. Accessed September 4, 2026. 

[3] Public Citizen. Public Citizen testimonies before the Food and Drug Administration’s Pharmacy Compounding Advisory Committee regarding BPC-157, MOTS-c, and emideltide. July 23, 2026. https://www.citizen.org/article/testimonies-before-fda-advisory-committee-regarding-bpc157-mots-c-and-emideltide/. Accessed September 4, 2026.  

[4] Public Citizen. Stacked FDA peptide advisory committee delivers for RFK Jr. July 23, 2026. https://www.citizen.org/news/stacked-fda-peptide-advisory-committee-delivers-for-rfk-jr/. Accessed September 4, 2026.

[5] Food and Drug Administration. Human drug compounding. June 15, 2026. https://www.fda.gov/drugs/guidance-compliance-regulatory-information/human-drug-compounding. Accessed September 14, 2026.

[6] Willyard C. Is the peptide craze backed by science? The promise behind the hype. Nature. 2026;654(8118):312-314.

[7] Ibid.

[8] Food and Drug Administration. FDA briefing document. Pharmacy Compounding Advisory Committee (PCAC) meeting. BPC-157 – related bulk drug substances: BPC-157 (free base) and BPC-157 acetate. https://www.fda.gov/media/193343/download. Accessed September 4, 2026. 

[9] Talpos S. The hidden history of BPC-157, a favorite MAHA peptide. Stat News. June 1, 2026. https://www.statnews.com/2026/06/01/bpc-157-researcher-predrag-sikiric-addesses-skeptics-questions/. Accessed September 4, 2026.

[10] Food and Drug Administration. FDA briefing document. Pharmacy Compounding Advisory Committee (PCAC) meeting. BPC-157 – related bulk drug substances: BPC-157 (free base) and BPC-157 acetate. https://www.fda.gov/media/193343/download. Accessed September 4, 2026. 

[11] Tiller N. BPC-157: Miracle drug or Joe Rogan experiment? Psychology Today. August 29, 2026. https://www.psychologytoday.com/us/blog/the-claims-department/202608/bpc-157-miracle-drug-or-joe-rogan-experiment. Accessed September 14, 2026.

[12] Food and Drug Administration. Certain bulk drug substances for use in compounding that may present significant safety risks. September 27, 2024. https://web.archive.org/web/20241112124122/https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks. Accessed September 4, 2026. 

[13] Damon A. RFK Jr. may reverse a peptide ban he calls “illegal.” Former FDA officials say he mischaracterized their work. ProPublica. April 3, 2026. https://www.propublica.org/article/peptide-safety-fda-compounding-pharmacies. Accessed September 4, 2026. 

[14] Knoepfler P. Did Kennedy just stack the deck on FDA oversight of peptides? Stat News. April 29, 2026. https://www.statnews.com/2026/04/29/rfk-jr-peptides-upcoming-fda-policy-shift-compounding-drugs/. Accessed September 4, 2026.

[15] Food and Drug Administration. FDA briefing document. Pharmacy Compounding Advisory Committee (PCAC) meeting. BPC-157 – related bulk drug substances: BPC-157 (free base) and BPC-157 acetate. https://www.fda.gov/media/193343/download. Accessed September 4, 2026.

[16] Ibid.