Overview

• The FDA issued warning letters to seven firms, including Shaman Botanicals LLC and My Smoke Wholesale, for selling products with added or elevated levels of 7-hydroxymitragynine.
• Targeted items encompass tablets, gummies, drink mixes and shots marketed as supplements or foods through online retailers, smoke shops and gas stations.
• 7-hydroxymitragynine is a potent mu-opioid agonist occurring naturally in kratom but is not approved for dietary supplements, conventional foods or any regulated drug.
• The agency cautioned that consumers using these unapproved products may be exposing themselves to substances that lack evidence of safety or effectiveness.
• Failure to satisfy the 15-day compliance deadline could prompt further enforcement actions, such as product seizures or injunctions.