Washington, D.C.Citing growing concerns about its potential for abuse and attractiveness to young users, the U.S. Food and Drug Administration (FDA) has suggested new limits on goods containing 7-hydroxymitragynine (7-OH), a potent and unregulated opioid chemical produced from the kratom plant.
After a thorough scientific and medical examination, the FDA plans to classify 7-OH under the Controlled Substances Act. The government made clear that this advice only applies to concentrated synthetic or semi-synthetic byproducts of kratom leaves, which have been shown to have effects similar to those of opioids, and not to natural kratom leaf products.
Health and Human Services Secretary Robert F. Kennedy, Jr. stated that we are taking action on 7-OH today as a crucial step in the battle against opioid addiction. As we work to Make America Healthy Again, we will safeguard the health of our country’s youth.
Many 7-OH compounds are more powerful than morphine and are offered for sale in places like gas stations and vape shops. They are frequently packaged as gummies and other tasty snacks to appeal to kids and teens, FDA Commissioner Dr. Marty Makary continued. Consumer understanding is further complicated by the fact that some of these items are mislabeled or disguised as kratom.
In June, seven businesses that sold 7-OH-containing tablets, shots, and drink mixes received warning letters from the FDA. Along with launching an educational campaign to assist consumers recognize and steer clear of these potentially harmful items, the agency also sent a letter to healthcare providers today.
According to Makary, vape shops selling addictive drugs like 7-OH can be found in almost every neighborhood. We cannot afford to make the same mistakes that were made during the previous opioid crisis.
7-OH is not permitted in food products or dietary supplements, and there are currently no FDA-approved medications that contain it. After reviewing the FDA’s suggestion, the Drug Enforcement Administration (DEA) will begin a rulemaking process that will include a public comment period prior to any final scheduling decisions.
The FDA has released public education materials regarding the dangers of 7-OH products and their differences from conventional kratom.
Customers can visit www.fda.gov or call 888-INFO-FDA with any queries.
