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FDA panel considers easing peptide restrictions

FDA panel considers easing peptide restrictions

A Food and Drug Administration advisory panel will vote on recommendations for seven popular peptides. Sarah Silbiger/Getty Images hide title toggle title Sarah Silbiger/Getty Images For the latest stories on the science of healthy living, subscribe to NPR health bulletin. A number of experimental peptide therapies are under scrutiny today in what marks the beginning

A Food and Drug Administration advisory panel will vote on recommendations on seven popular peptides.

A Food and Drug Administration advisory panel will vote on recommendations for seven popular peptides.

Sarah Silbiger/Getty Images


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For the latest stories on the science of healthy living, subscribe to NPR health bulletin.

A number of experimental peptide therapies are under scrutiny today in what marks the beginning of a two day meeting to help determine if compounds will be available in specialty pharmacies.

The Food and Drug Administration advisory panel is considering evidence for seven compounds including some of the most sought after: TB-500, BPC-157 and MOTs-C.

None of them have undergone the type of large-scale trials to establish safety and effectiveness that are required for drug approval by the FDA.

And yet, therapies have attracted enormous attention in the wellness space. They are promoted for injury recovery, muscle growth and fat loss, skin health, improved metabolism, and more.

Proponents argue that current Biden-era restrictions on substance composition (due to safety concerns and lack of data) have fueled a risky gray market of foreign suppliers.

The meeting represents another point of tension between Health Secretary Robert F. Kennedy Jr.’s Making America Healthy Again agenda and the traditional medical and scientific establishment.

Kennedy has publicly advocated lifting restrictions on peptides and has spoken of their benefits.

Meanwhile, FDA scientists are recommending against giving compounding pharmacies the go-ahead to produce any of the seven peptides under consideration. In a review of the evidence, they repeatedly point out that the data comes primarily from preclinical work with animals and is quite limited for humans.

Peptides are chains of amino acids (smaller than a protein) that often act as signaling molecules in our body and carry out many critical functions.

They can be synthesized and administered as drugs, often by injection. Some of them, like insulin, are found naturally in the body. Others are modified versions, as is the case with the successful anti-obesity drug GLP-1.

For example, BPC-157 is based on a peptide found in human stomach juices, while TB-500 is related to a molecule found in many types of cells, called thymosin beta-4.

In June, the FDA reviewed the list for the advisory committee. Many of the new members have ties to the peptide industry. Earlier this week, the agency made more changes and added a handful of temporary voting members, mostly from academic institutions.

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