VIVAZEN Applauds Federal Action to Ban Dangerous Synthetic 7-OH and Reaffirms Support for Science-Driven Kratom Reform
'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:
'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.'
About VIVAZEN
For over a decade, VIVAZEN has delivered trusted, high-quality botanical supplements that provide people with functional wellness without compromise. Rooted in centuries of herbal wisdom and backed by modern innovation, VIVAZEN is a functional, feel-good alternative for those who want to live—and feel—on their own terms. Join the millions who trust VIVAZEN to Feel Great™ naturally, and visit feelgreatbotanics.com, opens new tab.
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Paloma Lehfeldtpress@vivazen.com
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SOURCE: VIVAZEN
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