Kratom warning letters - FDA, FTC combine to tackle opioid claims
FDA and FTC have issued four joint warning letters to kratom companies centered on opioid claims. It’s a move that comes on the heels of FDA rejecting an NDI filing on the ingredient for the sixth time. The companies involved are Herbsens Botanicals, Klarity Kratom, Kratom Exchange and Omni Consumer Products, LLC dba YoKratom. The warning letters were the result of an online search of the companies’ websites and social media pages conducted in May and June 2022. The warning letters allege that the companies have been making disease treatment claims on the products, which were sold primarily in capsule form. Among the disease treatment claims were pain relief, blood pressure, and depression indications. Focus on opioid claims One unifying factor, however, were the claims being made by the four companies to help consumers addicted to opioids or other drugs wean themselves off those substances and to help manage the severe symptoms of opioid withdrawal. That prompted the inclu...