The FDA does not approve 7-OH for dietary supplements or in food products.
The Trump administration is calling for the compound 7-OH, a popular by-product of the Kratom plant found in diet pills and pain-relief pills, to be scheduled as an illicit drug. Food and Drug Administrator Commissioner Marty Makary has requested that the Drug Enforcement Administration classify 7-OH as a Schedule 1 substance, a classification given to heroin, ecstasy and lysergic acid diethyl amide .
Regulators have sounded the alarm bells on 7-OH, which can be found in tablets, gummies, mixed drinks or shots, due to its "high risk of addiction." It's been used both as a pain reliever and a stimulant, being easily accessible for purchase at gas stations, smoke shops and online. Officials say these products are sold with no “quality control, no dosage control and no warnings.” High potent 7-OH products can cause nausea, vomiting and seizures. “Vape stores are popping up in every neighborhood in America, and many are selling addictive products like concentrated 7-OH," Makary said. "After the last wave of the opioid epidemic, we cannot get caught flat-footed again. 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 FDA does not approve 7-OH for dietary supplements or in food products. Just in June, the FDA sent warning letters to seven companies for illegally distributing products containing 7-OH. The American Kratom Association , a trade group representing the industry, gave the FDA its support in efforts to reschedule 7-OH. “This bold step is a critical milestone in protecting public health and consumer safety from dangerous synthetic products that masquerade as natural kratom,” the AKA said in a statement. A spokesperson for the group said that the FDA’s decision shines a light on a “massive and growing” problem in the kratom marketplace. Back in 2016, the DEA signaled that it intended to classify 7-OH as an illicit substance but decided against it due to public backlash.
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FDA seeks to classify 7-OH as Schedule 1 drug amid addiction concernsThe FDA does not approve 7-OH for dietary supplements or in food products.
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