The Global Kratom Coalition (GKC) today applauded the U.S. Food and Drug Administration (FDA) for issuing warning letters to firms marketing “7,” a potent and dangerous novel product that is being illegally sold across the country. (See FDA press release here).
This decisive action by the FDA draws a much-needed line between responsibly used, traditionally consumed kratom leaf and the synthetic or highly concentrated products, like 7, that pose a clear threat to public health.
“The FDA’s move is a critical step in protecting consumers,” said Matthew Lowe, Executive Director of the Global Kratom Coalition. “We have long warned that products like 7 are driving harm and putting lives at risk. The FDA's action sends a clear message: these dangerous products have no place in the marketplace.”
While 7-hydroxymitragynine (7-OH) is a naturally occurring alkaloid in kratom leaf, it is present only in trace amounts in its natural state. The products targeted by the FDA are chemically manipulated to contain dangerously high levels of semi-synthetic 7-OH, significantly increasing the potential for harm. These products have been linked to serious adverse events and are highly addictive.
The Global Kratom Coalition supports rigorous enforcement against these deceptive and harmful products and urges lawmakers and regulators to distinguish clearly between natural kratom and synthetic or adulterated substances.
“The future of kratom depends on responsible regulation,” Lowe added. “We commend the FDA for taking action today and urge continued vigilance in order to protect consumers.”
