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FDA continues crackdown on Kratom companies

The Food and Drug Administration has sent another round of warning letters to two vendors its said is marketing Kratom products with scientifically unsubstantiated claims. In particular, FDA commissioner Scott Gottlieb said the agency is concerned with companies making claims about the plant’s ability to treat opioid withdrawal and addiction, as well as other serious medical conditions.

“Despite our warnings and previous regulatory and enforcement actions, we continue to find marketers actively selling kratom with unsubstantiated claims,” Gottlieb said. “In support of the public health, we continue to urge consumers not to consume kratom and to seek appropriate medical care from their health care provider. We will also continue to take action against those who put the safety of Americans at risk and who violate federal law by making unsubstantiated health claims about products that they seek to sell.”

The FDA’s efforts earned the agency praise from the Council for Responsible Nutrition.

“CRN commends the FDA’s continued actions against companies that violate federal law by making unsubstantiated disease treatment claims for products such as kratom and appreciates the agency’s commitment to public health,” CRN senior vice president of scientific and regulatory affair Duffy MacKay said. “CRN applauds FDA’s issuance of warning letters to vendors who market kratom products with scientifically unsubstantiated claims including to ‘relieve opium withdrawals.’ Consumer safety and access to safe products and ingredients are critically important to CRN. We recommend that consumers seeking treatment of an opioid use disorder or addiction talk to a qualified healthcare professional or a public health authority.”
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