“Gas station heroin” took another hit on Wednesday as HHS Secretary Robert F. Kennedy Jr’s FDA recommended a scheduling action to control certain 7-hydroxymitragynine (also known as 7-OH ) products under the Controlled Substances Act (CSA).
The FDA is specifically targeting 7-OH, a concentrated byproduct of the kratom plant; it is not focused on natural kratom leaf products. Users often boil the leaves into a tea to consume. Some of the popular 7-OH products are marked as gummies, other candies and drink mixes.
7-OH is increasingly recognized as having potential for abuse because of its ability to bind to opioid receptors. The FDA has released a new report to educate the public about the health concerns of 7-OH and its distinction from the kratom plant leaf.
Kratom is a tropical tree (Mitragyna speciosa) that is native to Southeast Asia. Kratom is not lawfully marketed as a drug product, a dietary supplement, or a food additive in conventional food in the United States. Although seven states ban kratom entirely, it is widely available in gas stations and convenience stores that sell vapor and tobacco products in the 43 other states.
The U.S. Drug Enforcement Administration (DEA) tried in 2016 to classify kratom as a dangerous Schedule 1 drug, but backed off when there was a public backlash.
Schedule I drugs, substances, or chemicals are defined as drugs with no currently accepted medical use and a high potential for abuse and include heroin, lysergic acid diethylamide (LSD), marijuana (cannabis), 3,4-methylenedioxymethamphetamine (ecstasy), methaqualone, and peyote.
“Today, we’re taking action on 7-OH as a critical step in the fight against opioid addiction,” said Secretary Kennedy, “We will protect the health of our nation’s youth as we advance our mission to Make America Healthy Again.”
There are no FDA-approved 7-OH drugs, 7-OH is not lawful in dietary supplements, and 7-OH cannot be lawfully added to conventional foods.
“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, M.D., M.P.H. “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.”
The widespread availability of 7-OH products is a significant concern for the FDA.
The particular concern is with the growing market of 7-OH products that may be especially appealing to children and 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.
The FDA has also published educational materialsto inform consumers about these harmful products. In June, the FDA issued warning letters to seven companies for illegally distributing products containing 7-OH, including tablets, gummies, drink mixes, and shots. On Wednesday, the FDA also issued a letter to healthcare professionals and warned consumers about the risks associated with 7-OH products.
Under the Controlled Substances Act, drugs, substances, and certain chemicals are placed into one of five schedules based upon their medical use, potential for abuse, and safety or dependence liability. The Drug Enforcement Agency is reviewing the FDA’s recommendation. It has the final authority on scheduling, which requires a rulemaking process that includes a period for the public to provide comments before any scheduling action is finalized.
(To sign up for a free subscription to Food Safety News, click here.)
