WASHINGTON (dpa-AFX) - The U.S. Food and Drug Administration has recommended that certain 7-hydroxymitragynine products should be categorized under scheduled drug to control the dangerous, illegal opioids as per the Controlled Substances Act.
The FDA said that it is specifically targeting 7-hydroxymitragynine, also known as 7-OH, which is a concentrated byproduct of the kratom plant. It is not focused on natural kratom leaf products. 7-OH is increasingly recognized as having potential for abuse because of its ability to bind to opioid receptors. The FDA is releasing a new report to educate the public about the health concerns of 7-OH and its distinction from the kratom plant leaf.
'Today, we're taking action on 7-OH as a critical step in the fight against opioid addiction,' said 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.'
This recommendation follows a thorough medical and scientific analysis by the FDA and is one of several efforts to address the agency's concerns around the growing availability and use of 7-OH opioid products. 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, according to FDA Commissioner Marty Makary. '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 availability of 7-OH products is a major concern to the FDA, as consumers can easily purchase products with concentrated levels of 7-OH online and in gas stations, corner stores and vape shops. The FDA said it is particularly concerned 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 materials for consumers to be more informed about these harmful products.
In June, FDA issued warning letters to seven companies for illegally distributing products containing 7-OH, including tablets, gummies, drink mixes and shots. Tuesday, FDA said it is also issuing a letter to health care professionals and is warning consumers about the risks associated with 7-OH products.
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