WASHINGTON, D.C. — The U.S. Food and Drug Administration (FDA) has issued warning letters to seven companies accused of unlawfully marketing products containing 7-hydroxymitragynine (7-OH), a potent opioid compound derived from the kratom plant. The enforcement action underscores the agency’s escalating concern over the proliferation of unapproved and potentially dangerous opioid-like substances being sold to consumers through online retailers, smoke shops, and convenience stores.
While 7-OH occurs naturally in trace amounts in kratom, the FDA’s focus is on concentrated forms of the substance — including tablets, gummies, drink mixes, and liquid shots — that are being marketed without approval or safety validation. According to the agency, these products are neither approved drugs nor legal dietary supplements or conventional foods.
“There are no FDA-approved drugs containing 7-OH,” the agency stated, noting that consumers who use such products are taking unverified substances that may pose serious health risks.
The warning letters allege a variety of violations, including the illegal addition of 7-OH to foods or supplements and the marketing of unapproved new drugs. In some cases, products were promoted with unsupported claims such as pain relief or anxiety management — assertions that the FDA emphasized are not backed by scientific evidence and may mislead consumers.
The recipients of the letters are:
- 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
Each company has been given 15 business days to respond to the FDA with a plan to address the alleged violations.
The FDA’s action is part of a broader initiative to monitor and regulate novel opioids and synthetic compounds that have emerged on the consumer market, particularly those that have not undergone formal safety or efficacy evaluations. Regulatory officials continue to urge caution among consumers, emphasizing the potential dangers of ingesting substances that fall outside established legal and scientific frameworks.
For the latest news on everything happening in Chester County and the surrounding area, be sure to follow MyChesCo on Google News and MSN.