FDA to weigh lifting restrictions on some MAHA-favored peptides

The Food and Drug Administration (FDA) is taking the first steps toward potentially easing access to certain peptide injections that are currently restricted due to safety concerns. 

The agency on Wednesday said it is convening a meeting of an outside advisory panel in July to discuss whether to allow compounding pharmacies to manufacture peptides for ulcerative colitis, wound healing, obesity and more, according to a Federal Register notice. 

The meeting follows repeated pledges by Health Secretary Robert F. Kennedy Jr. to cut red tape and “end the war at FDA” over peptides and other supplements. 

Peptides are chains of amino acids produced naturally in the human body. Some have been widely studied and approved as commercial drugs like insulin and GLP-1s (glucagon-like peptide-1). 

But many of the synthetic versions are being pitched by wellness influencers and celebrities popular with the Make America Healthy Again movement for purposes like anti-aging, muscle building and quick injury recovery, despite little research behind the claims. 

Kennedy has called himself a “big fan” of the products and said he wants to make them more widely available. 

“I’m a big fan of peptides,” Kennedy told podcaster Joe Rogan in February. “I’ve used them myself to really good effect with a couple of injuries.”  

In 2023, the FDA added several of the most popular peptides to a category considered to be too risky for compounding due to potential safety concerns. FDA at the time cited safety risks including cancer and liver, kidney and heart problems, but Kennedy said the agency did not have proof of safety concerns. 

Kennedy told Rogan that former President Biden’s FDA “illegally moved” the drugs onto the list of substances that are barred for compounding, creating a gray market where people can order peptides online from overseas suppliers.  

Many peptides are widely available and inexpensive on platforms like TikTok. 

“With the gray market you have no idea if you’re getting a good product,” Kennedy told Rogan. “And a lot of this stuff that we’ve looked at is just very, very substandard.” 

Kennedy said he wants to make 14 peptides more accessible and move them off the restricted list.  

“My hope is that they’re going to get moved to a place where people have access from ethical suppliers,” he said.  

The meeting in July will consider removing seven peptides, including BPC-157, TB-500 and five others.  

FDA said it was considering BPC-157 for ulcerative colitis and TB-500 for wound healing. Both are currently banned by the World Anti-Doping Agency for use by athletes.