FDA recommends scheduling of 7-OH, distinguishes kratom leaf from illicit products masquerading as dietary supplements

• By: AHPA
• On: 07/29/2025 15:49:33
• In: Regulation / Legislation

July 29, 2025

The American Herbal Products Association (AHPA) welcomes today’s announcement from the U.S. Food and Drug Administration (FDA) recommending the scheduling of 7-hydroxymitragynine (7-OH) to control certain 7-OH-containing products under the Controlled Substances Act. The action, described by Department of Health and Human Services (HHS) Secretary Robert F. Kennedy, Jr., as “a critical step in the fight against opioid addiction,” reflects broader concern over the growing presence of potent, opioid-like compounds being marketed as dietary supplements.

In its announcement, FDA emphasized that its recommendation applies specifically to concentrated or synthetic forms of 7-OH — an alkaloid derivative of the kratom plant — and not to kratom leaf products. 7-OH is recognized for its ability to bind to opioid receptors and significant potential for abuse. In addition to the scheduling recommendation, FDA released a new report informing the public about the distinct risks associated with 7-OH and distinguishing it from kratom in its dried, leaf form.

AHPA has consistently advocated for consumer protection from illegal substances falsely marketed as dietary supplements. Earlier this year, AHPA adopted a guidance policy to distinguish between kratom plant materials and synthetic kratom alkaloids like 7-OH. The guidance notes that, while 7-OH may occur in very low levels in dried, processed kratom leaves due to the natural oxidation of mitragynine, 7-OH is not present in concentrations sufficient to extract it from kratom leaves for commercial uses.

AHPA’s policy strongly discourages the marketing of any product that contains synthesized 7-OH or other synthetic kratom alkaloids. The guidance also advises that such products should not be labeled or marketed as “kratom.” Since 1999, AHPA has maintained a trade requirement that members clearly identify added constituents on labels of bulk botanicals and finished products, and the guidance policy reflects this principle.

“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.”

Today’s announcement follows FDA’s June 2025 issuance of warning letters to seven companies marketing 7-OH-containing products in forms such as tablets, gummies, drink mixes, and shots. The agency also issued a letter to healthcare professionals and a warning to consumers about the risks of these unapproved products.

Under the Controlled Substances Act, substances are scheduled based on their medical use, potential for abuse, and safety or risk of dependence. The Drug Enforcement Administration (DEA) is now reviewing FDA’s recommendation and will initiate a formal rulemaking process, including a public comment period, before making any final scheduling determination.