VIVAZEN, a leading natural wellness company, issued the following statement today commending the U.S. Department of Health and Human Services (HHS), the Food and Drug Administration (FDA), and the Drug Enforcement Administration (DEA) for taking decisive action this week to protect consumers from the dangerous synthetic 7-hydroxymitragynine (7-OH) and to establish a clear regulatory distinction between adulterated products and natural kratom.
“As someone who has experienced the benefits of kratom firsthand, I’ve long been an advocate for ensuring that this important botanical is safely and responsibly available to customers. This is a milestone for consumer safety, scientific integrity, and public health,” said Steve Curtis, CEO of VIVAZEN. “We fully support the FDA and HHS in taking this courageous action in drawing a clear line between the naturally occurring alkaloids in kratom and the synthetic opioid-like compound 7-hydroxymitragynine. These are not the same substance, and conflating them has harmed consumers and held back meaningful botanical research. We further urge the agency to use the full extent of its power to immediately remove 7-OH products from store shelves.”
7-hydroxymitragynine, often produced by chemically oxidizing kratom’s primary alkaloid, mitragynine using industrial oxidants like bleach and pool shock, can be present at potent and dangerous concentrations in adulterated products that falsely claim to be “kratom.” In contrast, natural kratom leaves contain only trace amounts of 7-OH, if any, and have been safely used by millions of Americans.
VIVAZEN has long been at the forefront of science-first kratom formulation, ensuring all of its products are rigorously tested, contain no synthetic alkaloids, and comply with evolving state and federal safety standards.
“What’s happening now is the beginning of regulatory maturity,” said Curtis. “FDA’s own data now confirms the safety and tolerability of mitragynine at levels up to 140 mg. NIH-funded studies also show kratom enhances, rather than suppresses, respiratory activity, exactly the opposite of synthetic 7-OH. This bifurcation is necessary and overdue.”
VIVAZEN encourages the following actions by HHS and FDA:
- DEA scheduling of 7-hydroxymitragynine as a synthetic opioid with high abuse potential.
- National recall and enforcement actions against companies producing or selling 7-OH products masquerading as kratom.
- Removal of outdated FDA web content misrepresenting kratom and publication of new, science-based summaries reflecting peer-reviewed evidence.
- Establishment of a regulatory framework that distinguishes natural kratom from synthetic derivatives, aligning with standards for dietary botanicals.
“Consumers deserve clean, transparent, and trustworthy products,” Curtis added. “At VIVAZEN, we’ve built our brand on safety and integrity, and we welcome this renewed focus on scientific truth. We look forward to working with policymakers and regulators to protect the future of kratom and the millions who rely on it.”
