The Global Kratom Coalition (GKC) has applauded the U.S. Food and Drug Administration’s recent warning to Hydroxie, LLC, for marketing synthetic 7-hydroxymitragynine (“7”) products as dietary supplements. The FDA’s June 25, 2025, letter cited Hydroxie for multiple violations, classifying its “7” products—including tablets and drink mixes—as unapproved drugs and adulterated foods that pose significant public health risks.
GKC Legislative Director Walker Gallman called the move “a major step in a broader effort to remove dangerous ‘7’ products from store shelves and online marketplaces.” The coalition, alongside scientists and public health experts, has long warned that such synthetically enhanced products are deceptively marketed as natural kratom or supplements, undermining consumer safety and trust.
Experts warn that these potent synthetic opioids, sold in everyday retail settings, could fuel addiction and severe health outcomes. The GKC urges regulators to continue cracking down on these products to protect public health.
Read the full article at WRAL.
