FDA Set to Discuss Peptide Access as RFK Jr. Champions Deregulation

Clear Facts

• The FDA will convene in July to discuss easing restrictions on over half a dozen peptide injections following Secretary Robert F. Kennedy Jr.’s public advocacy for deregulation
• Peptides are lab-made versions of natural molecules used to treat conditions ranging from insomnia to obesity, though most have not been reviewed for safety by the FDA
• Under the Biden administration, the FDA added nearly 20 peptides to a prohibited list for compounding pharmacies due to safety concerns

The Food and Drug Administration will reportedly weigh easing restrictions on peptides in anticipated talks scheduled for July, according to a federal notice released Wednesday. The meeting will discuss relaxing limits on more than half a dozen peptide injections.

Peptides are short chains of amino acids — the building blocks of proteins — that play key roles in biological functions, according to the National Institutes of Health. Peptide drugs are lab-made versions of natural molecules in the body that are designed to mimic or influence biological signals to treat disease, experts say.

In the federal notice, the FDA identified these drugs — used for conditions ranging from insomnia to obesity — for potential inclusion on a list of substances that can be safely compounded by pharmacies. This follows Health and Human Services Secretary Robert F. Kennedy Jr.’s push to deregulate peptides, which he’s spoken about publicly, although most peptides have not been reviewed for safety by the FDA.

Kennedy has discussed using the substances for personal injuries. In a recent interview on “The Joe Rogan Experience” podcast, he stated that he’s a “big fan of peptides.”

The HHS secretary mentioned that he’s “very anxious” to make some peptides “more accessible.”

“My hope is that they will get moved to a place where people have access from ethical suppliers,” Kennedy said, alluding to the FDA taking action.

Peptides have gained popularity among wellness influencers and fitness gurus as a means of building muscle, healing injuries or appearing younger. Peptides act like a signal to hormones and the human body.

Similar to how GLP-1s (glucagon-like peptide-1 agonists), such as Ozempic, suppress appetite and trigger weight loss, peptides can signal other functions, like the release of growth hormones. Certain peptides up for review by the FDA, like BPC-157, are marketed for tendon healing, gut healing (in cases like ulcerative colitis), injury recovery and inflammation reduction, although the FDA has warned about the risk of unapproved peptide treatments.

The FDA wrote in a February advisory that “compounded drugs should only be used in patients whose medical needs cannot be met by an FDA-approved drug.”

“Patients should obtain a prescription from their doctor and fill the prescription at a state-licensed pharmacy,” the agency wrote.

The current peptide market has been referred to as the “Wild West” due to lack of regulation. In an interview, Dr. Peter Lurie, a former FDA official who now leads the Center for Science in the Public Interest in Washington, D.C., commented that “the Wild West is about to become wilder.”

“I don’t see why one would take the path of proper drug approval if there is now this less rigorous, alternative path to market,” he said.

Under the Biden administration, the FDA added nearly 20 peptides to a list of substances that should not be produced by compounding pharmacies. The panel of pharmacy advisers at the time noted that the peptides did not meet criteria for safety.

Let us know what you think, please share your thoughts in the comments below.