FDA Sends Warning Letters to Companies Selling Illegal Opioid Compound

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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.

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.

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.

The FDA warns that people using these products “are exposing themselves to products that have not been proven safe or effective for any use.”

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 7ΩHMZ, 7-OHMZ, or 7OHMZ; Royal Diamond Imports Inc. dba Roxytabs.com; Hydroxie LLC; and 7Tabz Retail LLC.

The recipients were asked to respond to the letters within 15 business days.

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Source: HealthDay

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