FDA Asks DEA to Schedule 7-OH, a Synthetic Alkaloid Found in Kratom

The U.S. Food and Drug Administration (FDA) recommended that the Drug Enforcement Administration (DEA) schedule 7-OH under the Controlled Substances Act.

7-OH is an alkaloid found in the kratom plant, and is able to bind to opioid receptors, leading many to recognize its potential for abuse. FDA is focused specifically on concentrated 7-OH and not kratom, and most 7-OH products found on the market are produced synthetically.

The agency issued a report to inform the public about health concerns related to 7-OH and why it is distinct from the kratom leaf.

“Today, we’re taking action on 7-OH as a critical step in the fight against opioid addiction,” said U.S. Department of Health and Human Services (HHS) Secretary Robert F. Kennedy, Jr. “We will protect the health of our nation’s youth as we advance our mission to make America healthy again.”

“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,” said FDA Commissioner Marty Makary, MD. “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.”

FDA is particularly concerned with products containing concentrated 7-OH that may be appealing to children or teenagers, such as fruit-flavored gummies and ice cream cones. These products may not be clearly or accurately labeled as to their 7-OH content and are sometimes disguised or marketed as kratom, according to the agency. FDA published materials to inform consumers about these products

FDA recently issued warning letters to seven companies for illegally distributing products containing 7-OH, including tablets, gummies, drink mixes, and shots.

FDA also issued a warning to healthcare professionals about the risks associated with 7-OH.

The DEA is reviewing the recommendation, and has the final authority on scheduling, which requires a public comment period as part of the rulemaking process before scheduling action is finalized.

Since FDA first issued warning letters, trade associations including the American Herbal Products Association (AHPA), Natural Products Association (NPA), and the American Kratom Association (AKA) have endorsed FDA’s actions, specifically for targeting concentrated, synthetic forms of 7-OH as a priority rather than the kratom leaf.

“We applaud FDA and HHS for focusing enforcement attention on illicit products masquerading as dietary supplements,” said Robert Marriott, director of regulatory affairs at AHPA. “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.”