FDA Warns Companies Hawking ‘Legal Morphine’ Products

The FDA has sent warning letters to seven companies for illegally marketing products containing added or concentrated 7-hydroxymitragynine (7-OH), a potent metabolite of kratom.

“This action reflects the agency’s growing concern around novel potent opioid products being marketed to US consumers and sold online and in smoke shops, gas stations, and corner stores,” the FDA said in a statement.

Since late 2023, there has been a surge in “kratom” products marketed as “7-OH,” “7-Hydro,” or “legal morphine,” as reported by Medscape Medical News.

7-OH occurs naturally in trace amounts in kratom. By contrast, concentrated 7-OH preparations are 30-40 times more potent at opioid receptors and produce rapid-onset analgesia, euphoria, respiratory depression, and classic opioid-type withdrawal.

As previously reported by Medscape Medical News, research has shown that 7-OH has high abuse potential and may also increase the intake of other opiates.

The FDA warning letters focus on companies illegally selling tablets, gummies, drink mixes, shots, and other products that contain 7-OH as an added ingredient or at concentrated levels.

According to the agency, some products are adulterated conventional foods or dietary supplements because 7-OH does not meet the relevant safety standard. Others are unapproved new drugs with unproven claims such as relieving pain and managing anxiety, the FDA said.

“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,” the FDA warned.

The warning letters were sent to the following companies:

Images of the products being illegally marketed by the seven companies that received warning letters can be viewed online.

The FDA has requested a response from each company within 15 business days.

The American Kratom Association (AKA) applauded the FDA for taking “decisive” enforcement action against vendors selling products containing “dangerous synthesized and chemically manipulated” compounds such as 7-OH and similar concentrated compound products.

Last May, the organization submitted 18 complaints to the FDA over vendors selling chemically manipulated 7-OH and other products with “illegal therapeutic claims, unlawful product formulations, and deceptive labeling practices that violate federal law and put consumers at significant risk,” the AKA said in a statement.

“The AKA has long warned that products containing chemically manipulated products like enhanced 7-OH — especially those sold in concentrated shots and tablets — are not representative of traditional kratom leaf or extracts using FDA-approved food-grade solvents and appear to be intentionally designed and formulated to mimic the effects of opioids,” the organization said.