Washington, DC—The U.S. Food and Drug Administration (FDA) announced on July 15 that in June warning letters were sent to companies for illegally marketing products containing 7-hydroxymitragynine (7-OH). FDA said the letters reflect “growing concern around novel potent opioid products being marketed to U.S. consumers and sold online and in smoke shops, gas stations, and corner stores.”
On July 29, FDA announced further action: “The FDA is specifically targeting 7-OH, a concentrated byproduct of the kratom plant; it is not focused on natural kratom leaf products. 7-OH is increasingly recognized as having potential for abuse because of its ability to bind to opioid receptors. The FDA is releasing a new report to educate the public about the health concerns of 7-OH and its distinction from the kratom plant leaf.”
HHS Secretary Robert F. Kennedy, Jr., said in the announcement: “Today, we’re taking action on 7-OH as a critical step in the fight against opioid addiction. We will protect the health of our nation’s youth as we advance our mission to Make America Healthy Again.”
FDA Commissioner Marty Makary, M.D., M.P.H., added, “Vape stores are popping up in every neighborhood in America, and many are selling addictive products like concentrated 7-OH. After the last wave of the opioid epidemic, we cannot get caught flat-footed again. 7-OH is an opioid that can be more potent than morphine. We need regulation and public education to prevent another wave of the opioid epidemic.”
About 7-OH
7-OH occurs naturally in trace amounts in kratom, but FDA’s letters focus on concentrated 7-OH products such as tablets, gummies, drink mixes, and shots. The agency explained, “7-OH is not lawful in dietary supplements and cannot be lawfully added to conventional foods. Additionally, there are no FDA-approved drugs containing 7-OH, and it is illegal to market any drugs containing 7-OH. Consumers who use 7-OH products are exposing themselves to products that have not been proven safe or effective for any use.”
Some products cited in the letters are adulterated conventional foods or dietary supplements because 7-OH does not meet the relevant safety standard, FDA said, while others are unapproved new drugs with unproven claims such as relieving pain and managing anxiety. Warning letters were issued to the following companies, which have 15 business days to respond:
NPA, AHPA Applaud FDA Action on 7-OH Products
The Natural Products Association (NPA) applauded FDA’s action on 7-OH following the warning letters. “Based on peer-reviewed research from leading experts, highly concentrated or semi-synthetic 7-OH products pose significant public health risks and have been falsely marketed as ‘kratom,’” said Daniel Fabricant, Ph.D., President and CEO of NPA. “These 7-OH products are not legitimate ‘dietary supplements,’ and NPA encourages FDA in collaboration with the U.S. Department of Justice to take any necessary steps to swiftly remove them from U.S. commerce.”
The trade group expressed deep concerns regarding the lack of evidence and visibility regarding the manufacturing and safety of highly concentrated 7-OH products, and the unknown chemicals in them, making them adulterated under U.S. law. NPA noted that these products, when marketed as dietary supplements, have not been the subject of a required premarket new dietary ingredient notification to establish their identity and safety.
“FDA must use every tool available to remove these highly concentrated 7-OH products from the market,” Dr. Fabricant said. “The laws work well when the agency exercises its will to enforce them.”
NPA also shared the news that Dr. Fabricant and NPA board member Ryan Niddel were among those who attended the July 29 FDA/HHS news conference on 7-OH, with Niddel, CEO of Diversified Botanics, telling The Associated Press that FDA “demonstrated the exact kind of data-driven, proactive regulatory excellence needed to safeguard unwitting consumers across the U.S.”
The American Herbal Products Association (AHPA) also welcomed FDA’s actions: “We applaud FDA and HHS for focusing enforcement attention on illicit products masquerading as dietary supplements,” said Robert Marriott, AHPA Director of Regulatory Affairs. “AHPA’s kratom guidance policy explicitly advises against the use of synthesized 7-OH in any consumable product, and the association promotes the responsible marketing of kratom leaf and its naturally occurring constituents. We support actions that protect consumers while reinforcing the distinction between legitimate herbal products and those that fall outside the boundaries of dietary supplement regulation.”
In 2024, the Global Kratom Coalition praised the AHPA for its inclusion of kratom in its online Botanical Safety Handbook, 2nd edition. The detailed safety information resource used by manufacturers, health professionals, and consumers provides safety details on over 500 species of herbs now including the pharmacological and toxicological profile of kratom.
Kratom’s entry includes in depth analysis of its clinical investigations, adverse effects case reports, and information regarding its traditional use in Southeast Asia. “The inclusion of kratom in the AHPA Botanical Safety Handbook not only underscores kratom’s safety profile but also significantly enhances manufacturers’, healthcare providers’, and consumers’ understanding of kratom,” said Matthew Lowe, Executive Director of the Global Kratom Coalition.
