June 2022
FDA
FDA/FTC warn four kratom companies for alleged FD&C drug claims
 FTC warns against alleged addiction treatment claims
FDA and FTC issued joint warning letters to Omni Consumer Products LLC (d/b/a YoKratom), Kratom Exchange, Klarity Kratom, and Herbsense Botanicals for allegedly violative claims on the companies’ websites. FDA alleged the companies had made drug claims specifically rendering the products in question as intended for use in the cure, mitigation, treatment, or prevention of disease. Examples of claims cited by FDA included:
 
  • “White Maeng Da Kratom . . . relieves opiate cravings, depression, and much more.”
  • “[T]his strain is best for the removal of any opioid effects . . . This strain lessens the effects of other opiates and, most of the time, removes the habit of other opiates too.”
  • “Kratom may help handle a wide range of health concerns – from PTSD to addiction.”
 
Of note, FDA cited claims made in blogs hosted by the recipient companies. The agency advised each recipient company that they should take prompt action to correct the alleged violations cited in their letter and that failure to correct the alleged violations may result in legal action without further notice, including, without limitation, seizure and/or injunction.
 
In addition, FTC stated that it is unlawful to make disease claims, mentioning specifically addiction to alcohol, nicotine or drugs, in the absence of sufficient substantiating human clinical studies. FTC stated that no such studies exist for kratom, and instructed recipient companies to immediately cease making any such claims and review all health-related claims made by the company or any affiliate.
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