FDA Issues Warning Letters to Seven Companies Marketing Illegal Opioid Alternative Products Containing 7-Hydroxymitragynine
核心洞察
The FDA issued warning letters to seven companies illegally marketing products containing concentrated 7-hydroxymitragynine (搜索) (7-OH), a compound found naturally in trace amounts in kratom (搜索).
These concentrated 7-OH products, including tablets, gummies, drink mixes, and shots, are being sold online and in retail outlets without FDA approval or proven safety.
The agency warns that 7-OH is not permitted in dietary supplements or conventional foods, and no FDA-approved drugs contain this compound.
The U.S. Food and Drug Administration has taken enforcement action against seven companies illegally marketing products containing concentrated 7-hydroxymitragynine (搜索) (7-OH), a potent opioid compound found naturally in trace amounts in kratom (搜索). The warning letters, issued Tuesday, reflect the agency's growing concern about novel opioid products being sold to consumers without proper regulatory oversight.
Regulatory Violations and Safety Concerns
The FDA's enforcement action targets companies selling concentrated 7-OH products such as tablets, gummies, drink mixes, and shots through online platforms and retail outlets including smoke shops, gas stations, and corner stores. According to the agency, 7-OH is not lawful in dietary supplements and cannot be legally added to conventional foods. Additionally, there are no FDA-approved drugs containing 7-OH, making it illegal to market any drugs containing this compound.
"Consumers who use 7-OH products are exposing themselves to products that have not been proven safe or effective for any use," the FDA stated in its announcement.
Product Concentrations and Market Presence
While 7-OH occurs naturally in trace amounts in kratom (搜索) leaves from the tropical tree Mitragyna speciosa, the University of Florida College of Pharmacy (搜索) indicates that kratom products should contain no more than 2% 7-hydroxymitragynine (搜索). However, some commercial products contain significantly higher concentrations. Hydroxie, one of the companies cited, sells products containing 15 mg to 30 mg of 99% pure 7-OH, while other companies market products ranging from 5 mg to 22 mg of 7-OH.
An estimated 1.7 million Americans aged 12 and older used kratom (搜索) in 2021, according to the Substance Abuse and Mental Health Services Administration's National Survey on Drug Use and Health. Kratom is often used to self-treat conditions including pain (搜索), coughing, diarrhea, anxiety (搜索), depression (搜索), opioid use disorder (搜索), and opioid withdrawal.
Companies Receiving Warning Letters
The FDA issued warning letters 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⦻HMZ, 7-OHMZ, or 7OHMZ)
- Royal Diamond Imports Inc. (dba Roxytabs.com)
- Hydroxie LLC
- 7Tabz Retail LLC
Enforcement Timeline and Requirements
The warning letters specifically address the illegal marketing of products containing 7-OH as an added ingredient or with enhanced levels of the compound. Some products are classified as adulterated conventional foods or dietary supplements because 7-OH does not meet relevant safety standards, while others are considered unapproved new drugs making unproven claims for pain (搜索) relief and anxiety (搜索) management.
The companies have been given 15 business days to respond to the FDA's warning letters and must cease the illegal marketing of products containing added 7-OH or elevated levels of the compound. The agency's action underscores its commitment to protecting consumers from potentially dangerous products that lack proven safety and efficacy data.