7-hydroxymitragynine is not approved for use as dietary supplement, food additive, or drug ingredient<\/p>\n<\/h3>\n
By Stephanie Brown HealthDay Reporter<\/b>
\n<\/b><\/p>\n
TUESDAY, July 15, 2025 (HealthDay News) — The U.S Food and Drug Administration has issued seven warning letters to companies illegally marketing products containing 7-hydroxymitragynine (7-OH), which is found in trace amounts in kratom.<\/p>\n
The agency issued the letters to companies selling concentrated 7-OH products (e.g., tablets, gummies, drink mixes, shots) online and in retail outlets such as smoke shops, gas stations, and corner stores. 7-OH is not permitted in dietary supplements or conventional foods, and there are no FDA-approved drugs containing 7-OH. Furthermore, the marketing of drugs that contain 7-OH is illegal.<\/p>\n
The letters instruct the companies to cease the illegal marketing of products containing added 7-OH or that have elevated levels of 7-OH. These products include adulterated conventional foods and dietary supplements, for which 7-OH does not meet safety standards, as well as unapproved new drugs for pain relief and anxiety management, which are being marketed with unsubstantiated claims.<\/p>\n
The FDA warns that people using these products “are exposing themselves to products that have not been proven safe or effective for any use.”<\/p>\n
Warning letters were sent to the following companies: Shaman Botanicals LLC; My Smoke Wholesale; Relax Relief Rejuvenate Trading LLC dba RRR Trading or EDP Kratom; Thang Botanicals Inc. dba 7\u2126HMZ, 7-OHMZ, or 7OHMZ; Royal Diamond Imports Inc. dba Roxytabs.com; Hydroxie LLC; and 7Tabz Retail LLC.<\/p>\n
The recipients were asked to respond to the letters within 15 business days.<\/p>\n