FDA warns 7 companies for 7-Hydroxymitragynine, kratom extract products

EDITOR'S NOTE

FDA has issued warning letters to 7 companies regarding their sale of 7-Hydroxymitragynine (7-OH) and/or kratom extract in products marketed for human consumption. The letters alleged the sale of adulterated dietary supplements, adulterated human foods, or unapproved new drugs, depending on the nature of claims associated with the subject products. In its warning letters to several of the companies regarding products labeled or marketed as dietary supplements, FDA stated that 7-OH is a new dietary ingredient for which there is inadequate information to provide reasonable assurance that such ingredient does not present a significant or unreasonable risk of illness or injury. In separate statements regarding products labeled as conventional foods, FDA stated that 7-OH and kratom extract are unapproved food additives under section 201(s) of the Federal Food, Drug & Cosmetic Act. 

AHPA maintains a guidance policy strongly discouraging the marketing of any product intended for consumption by any route that consists of or contains synthesized 7-OH or other synthesized kratom alkaloids.

The U.S. Food and Drug Administration today announced seven recent warning letters sent to companies for illegally marketing products containing 7-hydroxymitragynine, also known as 7-OH.¹  This action reflects the Agency’s growing concern around novel potent opioid products being marketed to U.S. consumers and sold online and in smoke shops, gas stations, and corner stores. While 7-OH occurs naturally in trace amounts in kratom, the Agency’s letters focus on concentrated 7-OH products such as tablets, gummies, drink mixes, and shots, which may be dangerous. 

7-OH is not lawful in dietary supplements and cannot be lawfully added to conventional foods. Additionally, there are no FDA-approved drugs containing 7-OH, and it is illegal to market any drugs containing 7-OH. Consumers who use 7-OH products are exposing themselves to products that have not been proven safe or effective for any use.

The warning letters address the illegal marketing of products containing 7-OHExternal Link Disclaimer. These letters specifically focus on products containing 7-OH as an added ingredient or enhanced levels of 7-OH. Some products are adulterated conventional foods or dietary supplements because 7-OH does not meet the relevant safety standard. Others are unapproved new drugs with unproven claims such as relieving pain and managing anxiety.

The FDA issued warning letters to:

• Shaman Botanicals, LLC
• My Smoke Wholesale
• Relax Relief Rejuvenate Trading, LLC dba RRR Trading or EDP Kratom
• Thang Botanicals, Inc. dba 7ΩHMZ, 7-OHMZ, or 7OHMZ
• Royal Diamond Imports, Inc. dba Roxytabs.com
• Hydroxie, LLC
• 7Tabz Retail, LLC

The letters requested that the recipients respond within 15 business days.

The American Herbal Products Association (AHPA) distributes dietary supplement regulation and enforcement news as Legal Alerts. The information presented in Legal Alerts represents the views and opinions of the original authors of the content and does not necessarily represent the views or opinions of AHPA. Distribution of dietary supplement regulation and enforcement news as a Legal Alert does not constitute AHPA endorsement of the content or legal advice. Please direct any questions about Legal Alerts to communications@ahpa.org.