In a significant move to safeguard public health, the U.S. Food and Drug Administration (FDA) has issued warning letters to seven companies accused of illegally marketing products containing a powerful compound found in kratom, known as 7-hydroxymitragynine (7-OH). These companies have been selling concentrated versions of the substance in forms like tablets, gummies, drink mixes, and energy shots—many of which are available online and in everyday retail outlets such as smoke shops, gas stations, and convenience stores.What Is 7-OH and Why Is It a Concern?7-hydroxymitragynine is a chemical compound that naturally occurs in very small quantities in the kratom plant. However, in these commercial products, it is either added in high concentrations or manipulated to raise the levels well beyond natural amounts. The problem? 7-OH is not approved by the FDA for use in any dietary supplement, conventional food, or pharmaceutical drug.According to the agency, not only does this make these products illegal, but it also raises serious health and safety concerns. The FDA emphasized that the compound has not been proven safe or effective for treating any health condition and warned that consumers using these products are putting themselves at risk.Illegal and Unsubstantiated ClaimsThe companies receiving the warning letters were accused of marketing their 7-OH products with unproven claims about treating pain, anxiety, and other medical conditions. Some of these products are being sold as dietary supplements or even regular food items, despite not meeting the legal or scientific safety standards required for such classifications.The FDA’s main concern lies in how these products are being presented to the public—as safe, natural remedies—when in fact they may be both unsafe and illegal. “People using these products are exposing themselves to substances that have not been proven safe or effective for any use,” the FDA warned in a statement.The Companies NamedThe seven companies that have been sent official warning letters include:Shaman Botanicals LLCMy Smoke WholesaleRelax Relief Rejuvenate Trading LLC (also known as RRR Trading or EDP Kratom)Thang Botanicals Inc. (doing business as 7ΩHMZ, 7-OHMZ, or 7OHMZ)Royal Diamond Imports Inc. (operating Roxytabs.com)Hydroxie LLC7Tabz Retail LLCAll seven companies have been given 15 business days to respond to the FDA’s concerns. They are required to outline what actions they will take to correct the violations. Failure to respond or take corrective measures could lead to further enforcement actions, including product seizures or legal injunctions.FDA Urges CautionThis latest crackdown reflects the FDA’s ongoing concerns around kratom and its derivatives, particularly products containing high concentrations of 7-OH. Consumers are urged to avoid such products and consult healthcare professionals before using any substance marketed as a pain or anxiety remedy.The agency continues to monitor the market and has signaled it will take further steps if necessary to protect the public from unsafe, misbranded, or illegally marketed products.