But that doesn’t mean you’ll be seeing BPC-157 “legally” for sale at your local pharmacy tomorrow. There’s another important hurdle the peptides must go through, and it’s a big one: the FDA itself. “The recent 8-6 vote recommending BPC-157 and others for the 503A Bulks List is definitely a milestone for the wellness space,” explains Holt. “But it is important to clarify a common misconception; the FDA itself hasn’t formally loosened restrictions yet.” The vote came from the PCAC, not the FDA, and “their recommendation is strictly advisory, not legally binding.”
According to Holt, “nothing changes” for consumers right now simply because the PCAC’s vote is an advisory one. As he explains, the next step rests with the FDA, which must decide whether to accept the committee’s recommendation or not. If the FDA agrees to it, they have to initiate what is called a “formal notice-and-comment” rulemaking process, which Holt says generally takes well over a year. “Until that process officially concludes and BPC-157 is formally placed on the 503A Bulks List, consumers should understand that the peptide remains highly restricted,” he says. (This would apply to any of the six peptides discussed in the meeting.) “Any clinics currently claiming the peptide is ‘FDA approved’ or fully cleared for commercial human use are making legally false statements. Our social media feeds are already blowing up with incorrect characterizations of the outcome.”
Dustin Robinson, an attorney and founding partner of LumaLex Law, advises businesses in emerging health sectors, including peptides. He says that there is another “much faster” option that could be used in this case: enforcement discretion. “The FDA has a long-standing practice of sorting nominated ingredients into categories, and for the most favorable category it generally says it will not take action against a pharmacy that compounds with that ingredient while the formal process plays out, as long as the pharmacy meets the other legal conditions,” he explains.
If the PCAC recommends a peptide be placed on the 503A Bulk List and the FDA extends that discretion, he says, pharmacies could begin compounding it “well before” the rule is finalized. But Robinson says it’s important to note that the enforcement discretion is not automatic; it’s up to the FDA, and “right now, these specific peptides sit outside it.” The biggest risk to this potential pathway, Robinson explains, is reporting of adverse events, which the FDA describes as “any undesirable experience associated with the use of a medical product in a patient.” Should an adverse event happen, Robinson says it could “negatively impact or delay the rulemaking process.”
As the FDA pointed out in their official meeting recommendation to keep the peptides under their current restrictions, these peptides simply don’t have adequate clinical data behind them; the organization cited a lack of clinical and non-clinical safety information, human data, and evidence of efficacy as reasons why they recommend the peptides remain off the 503A Bulks list. “Most of these compounds still lack robust clinical data proving their safety and long-term efficacy,” Jeffrey Lee, MD, a board-certified plastic surgeon in Boston, previously told Allure. “At this stage, much of what’s circulating is anecdotal: people reporting personal use without clear, evidence-based conclusions about risks or side effects.” In addition, peptides are often marketed for a variety of wellness benefits, from joint and muscle repair to sleep, but for the purposes of the July meetings they were evaluated for specific purposes. For example, BPC-157 was evaluated as a treatment for ulcerative colitis, not workout recovery.
