American Kratom Association Applauds FDA Crackdown on Dangerous Chemically Manipulated 7-OH, Pseudoindoxyl, and “M” Products
Synthetic products posing as kratom mislead and endanger consumers. The AKA Strongly Encourages the Agency to Follow-up with Decisive Enforcement Against Violative Products that Remain on the Market
(Gainesville, VA - July 1, 2025)– The American Kratom Association (AKA) today lauded the U.S. Food and Drug Administration (FDA) for taking decisive enforcement action by issuing a series of Warning Letters against vendors selling products containing dangerous synthesized and chemically manipulated compounds such as 7-hydroxymitragynine (7-OH) and similar concentrated compound products (7-OH in its naturally occurring form appears only in trace amounts in kratom plant material.)
The FDA’s Warning Letters serve as notice to all companies marketing and selling products that contain 7-OH, pseudoindoxyl, and “M” that such products are illegal under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) and that the continued marketing and selling of such products opens the responsible parties up to having their products seized, their actions enjoined, or perhaps even criminal prosecution.
The AKA submitted 18 complaints to the FDA on May 21, 2025, reporting vendors selling chemically manipulated 7-OH, pseudoindoxyl, and “M” products that are identified in the new warning letters that identify illegal therapeutic claims, unlawful product formulations, and deceptive labeling practices that violate federal law and put consumers at significant risk.
The FDA’s warning letters make clear that vendors marketing 7-OH, pseudoindoxyl, and “M” products—including tablets, sublingual strips, drink mixes, and shots — that contain synthetically enhanced and chemically manipulated 7-OH product formulations that are being illegally marketed to treat conditions such as anxiety, chronic pain, fibromyalgia, depression, and more. The agency emphasized that the labeling of these products renders them as unapproved new drugs and adulterated foods under the Federal Food, Drug, and Cosmetic Act.
“This FDA action shines a spotlight on a massive and growing problem in the kratom marketplace,” said Mac Haddow, Senior Fellow on Public Policy for the American Kratom Association. “The companies that received these Warning Letters are just some of a significant number of companies engaged in transparently improper marketing — misleading consumers by branding these 7-OH products as ‘kratom’ while making illegal health claims and using unsafe synthetic or semi-synthetic formulations – and none of these products are kratom. This is a massive fraud on consumers that puts their safety directly at risk.”
According to the FDA’s Warning Letters, companies selling these chemically manipulated super concentrations of 7-OH, pseudoindoxyl, and “M” products are:
-Making Illegal Drug Claims: Marketing products as treatments or cures for serious medical conditions without any scientific substantiation or FDA approval.
-Selling Unsafe Product Formulations: Adding chemically manipulated 7-OH and related products, a compound with known opioid-like effects, to foods and beverages without safety reviews or regulatory clearance.
-Using Deceptive Labeling and Testimonials: Relying on misleading claims and consumer testimonials to promote unproven benefits and hide the true nature of their products.
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. These products distort public understanding of kratom and provide ammunition to critics who want to ban access to the natural kratom plant entirely.
Haddow also emphasized the AKA strongly encourages the FDA to not simply issue Warning Letters but to also aggressively follow up with enforcement actions against companies that continue to market these dangerous chemically manipulated 7-OH-containing products. “FDA’s Warning Letters do not just serve as notice to the specific companies who received them. These Warning Letters serve as notice to an entire industry that products containing chemically manipulated kratom compounds are both violative of the FD&C Act and present a real risk to consumers. We strongly encourage FDA to use the full weight of its authority for products that remain on the market – to include seizing violative products, seeking injunctions to prevent bad players from remaining on the market and in appropriate situations criminal prosecution.”
The AKA continues to advocate for the passage of Kratom Consumer Protection Acts (KCPA) in states across the country to establish clear rules that ban chemically manipulated kratom products, ensure accurate labeling, and hold bad actors accountable.
