It’s open season for untested peptide injections.Health and Human Services Secretary Robert F. Kennedy Jr. declared on Wednesday that patients will now be allowed broad access to untested and unproven peptide drugs popularized by health influencers. The move has already drawn immediate and intense concern from scientists and medical professionals, who are wary that the decision will result in confusion and harm to consumers.In a sweeping and seemingly unilateral decision by Kennedy, the HHS has directed the Food and Drug Administration (FDA) to not take action against pharmacies that sell six peptides including BPC-157, KPV, and TB-500. According to sources who spoke to the Associated Press, the decision was made without input from scientists at the FDA, who generally oppose the change.“Based on the available evidence, including the recommendations of a recent Pharmacy Compounding Advisory Committee, the Secretary has determined that the policy advances patient choice and freedom while appropriately protecting patient safety,” reads the decision. Kennedy, a fervent supporter of the false conspiracy theory that vaccines cause autism and who has been known to recover and eat roadkill, has praised the compounded meds. Online influencers have touted the compounded drugs — with little to no scientific evidence — as metabolism, energy, and muscle-recovery boosters, among other claims.The peptide boom was kicked off by the explosive success of GLP-1 drugs, the FDA-approved weight loss medication. However, their soaring popularity has given way to a whole new realm of experimental substances that don’t have the rigor of regulated safety testing and clinical trials behind them. The trend has created a confusing and dangerous marketplace in which peptide takers are buying the drugs via sketchy online dealers, in bodegas, and at gas stations — and unsurprisingly, the substances in the vials are often not at all what’s being marketed and some takers have claimed strange and dangerous side effects.In its surprising announcement, the HHS notes that “compounded drugs are not FDA-approved, which means FDA does not review their safety, effectiveness, or quality before they are marketed.”The agency even notes that the drugs continue to be “experimental,” and says that the action is designed to “expand and improve patient access while FDA reviews these substances.”Put simply, the decision doesn’t mean these drugs are FDA-approved, and you’re still taking peptides at your own risk.“Although compounded drugs can serve an important medical need for certain patients, they also may pose risks to patients,” reads the decision. “However, based on the Pharmacy Compounding Advisory Committee (PCAC) meeting and data regarding utilization of peptides, HHS believes that there is significant interest in the use of these peptides in compounding.”FDA approvals aren’t just bureaucratic red tape. The regulator’s tight guidelines are designed to ensure that drugs don’t cause severe outcomes like birth defects or cancer, as well as confirm that the drugs are actually effective.In a statement, HHS told the New York Times that the new policy requires “patient-specific prescriptions, traceable ingredients, quality testing and safety reporting to hold compounders accountable and give patients an alternative to unregulated sellers.” She added that the goal of the policy is in fact to confront “the risks of black-market peptides” and that it “does not grant FDA approval or establish clinical safety and effectiveness.”Former FDA official Peter Lurie, who now serves as the president of the Center for Science in the Public Interest, told the AP that the decision may result in people being “diverted from” FDA-approved medicines “toward this stuff.” As a result, he added, “there will be more unnecessary pain and suffering.”“It does undermine the idea,” Janet Woodcock, a physician and former head of the FDA, told the NYT, “that you would test drugs for safety and effectiveness before they were widely made available.”The pro-unapproved peptide crowd, meanwhile, is predictably thrilled.“This is a big win for patients, providers and medical freedom!” Lee Rosebush, who chairs the American Academy of Peptide Medicine, said in a LinkedIn post.More on peptides: People Taking Gray Market Peptides Say They’re Causing Bizarre Medical IssuesThe post RFK Jr Opens the Floodgates on Experimental Peptides, Alarming Scientists appeared first on Futurism.