FDA panel votes to loosen restrictions for controversial peptides - BBC

ShareSaveAdd as preferred on GoogleMadeline HalpertandKathryn ArmstrongGetty ImagesA US Food and Drug Administration (FDA) advisory panel has voted to loosen restrictions on controversial peptides that have become popular online, but have not been well researched for human usage. The panel narrowly voted to allow specialised pharmacies to produce drugs including BPC-157, TB-500 and KPV, a major regulatory hurdle towards making them available via prescription. Peptides are small proteins that our bodies normally produce and that have long been used to treat medical conditions, including diabetes. But unregulated injectable peptides have exploded in the online wellness community - including among many young influencers - since GLP-1s (weight loss drugs) became mainstream. The FDA does not have to follow the panel's recommendations, but often does. Health Secretary Robert F Kennedy has described himself as a "big fan" of the drugs and has previously vowed to ease restrictions on them after the Biden administration clamped down on the growing industry. Peptides are short chains of amino acids, or small proteins, which our bodies naturally produce. They act as messengers, telling our cells what to do, and play vital roles in our skin health, immune system and helping to control our hormones. Online influencers have been marketing peptides in "stacks" for unproven uses, claiming they can be used as a quick way to look younger, help you heal and improve your skin. They've become popular among teens on TikTok, especially boys, over unproven claims that certain peptides can help with building muscle mass and enhancing your body, with some online using phrases like "biohacking" and "looksmaxxing" to describe the trend. Health experts have cautioned against use of the drugs, citing a lack of clinical trials for humans and the unknown long-term effects of the substances. BPC-157 is one of the most popular peptides among wellness influencers. It is made from stomach protein and is marketed online as being good for gut health, tissue repair and to treat inflammation. It has been studied in animals over its potential to help with muscle healing. The US Anti-Doping Agency (ADA) states that because it has not been extensively studied in humans, "no-one knows if there is a safe dose, or if there is any way to use this compound safely to treat specific medical conditions". The peptide is prohibited for use in sports and is considered a banned substance by the World Anti-Doping Agency. KPV is also touted as being good for gut health, tissue repair - including skin damage, like acne, and for regulating the immune system. Both have been in a grey area when it comes to regulation. They are not illegal to buy or own - and widely available online - but they are not approved for human use, so are not subject to the quality controls that govern pharmaceutical manufacturing. Panel member Elizabeth Rebello, a pharmacist and anaesthesiologist, told the committee she had voted no on BPC-157 "because of the lack of efficacy data" and "safety concerns", Reuters news agency reported. Those who voted yes reportedly cited "the greater good" and "medical freedom" as reasons for their decisions. Several people who work for clinics or businesses selling peptides are on the panel, which will continue deliberating on Friday. BPC-157 and KPV are among seven peptides the panel is considering dropping restrictions on and allowing compound pharmacies, which mix medications that aren't available from standard drugmakers, to produce. Peptide restrictions were introduced during the Biden administration, when FDA officials found the drugs did not meet the safety requirements. Kennedy has worked to reverse those curbs.