As Congress turns its attention to 7-OH, VIVAZEN® calls on Drug Enforcement Administration, to act promptly to schedule the synthetic lab-made drug to protect Americans

VIVAZEN^®, the nation’s leading botanical wellness company, welcomed congressional scrutiny of 7-hydroxymitragynine (7-OH) as the House Energy and Commerce Subcommittee on Health holds a legislative hearing on H.R. 8000, the End Needless Distribution of 7-OH Act, introduced by Representative Gus Bilirakis (R-FL) and related illicit-drug legislation. The hearing underscores growing concern in Washington about 7-OH, as members of the subcommittee called on the Drug Enforcement Administration (DEA) to promptly move to schedule the synthetic, lab-made drug and protect consumers.

Products containing synthetic or highly concentrated 7-OH raise serious concerns for public health and consumer safety, while also creating confusion in the marketplace by blurring the line between dangerous synthetic drugs and responsibly manufactured botanical wellness products. VIVAZEN^® supports swift action to remove 7-OH from store shelves and ensure consumers are protected from products that may carry heightened risks of toxicity, dependence, and other adverse outcomes.

“Consumers deserve to know what’s in their products and feel confident they are safe, responsibly made, and backed by science,” said Steve Curtis, Founder and Chief Executive Officer of VIVAZEN^®. “We appreciate Representative Bilirakis’ efforts to help elevate this issue and bring greater attention to the risks posed by 7-OH. Yesterday’s hearing is an important sign that policymakers are taking those risks seriously. Congress can help build momentum, but what matters most now is prompt federal action to get 7-OH scheduled and out of the marketplace.”

VIVAZEN^® has a direct and longstanding stake in this issue. For more than a decade, the company has worked to help build a category grounded in responsible manufacturing, rigorous quality standards, and scientific validation. As a functional wellness company that develops clinically tested, GMP-manufactured botanical products, VIVAZEN^® believes the adulteration of botanicals with unapproved and synthetics drugs that are masquerading as natural botanicals, undermines consumer safety and trust. Harmful synthetic compounds like 7-OH and other dangerous lab-made unapproved drugs undermine consumer trust, threaten the integrity of the broader botanical and dietary supplement marketplace, and put responsible operators at a disadvantage.

Unlike companies chasing short-term gains through unregulated synthetic products, VIVAZEN^® has invested in building products the right way — through quality control, responsible sourcing, transparent labeling, and scientific research.

The company’s proprietary kratom extracts have been studied in a double-blind, randomized, placebo-controlled clinical study, which found no severe adverse events and no evidence of dependence or withdrawal symptoms after 28-days of consecutive use. In parallel, VIVAZEN^® is committed to advancing real-world evidence through longitudinal, at-home studies that capture how consumers use, and experience, its products in everyday settings. These findings reflect VIVAZEN^®’s long-held belief that consumer safety and product innovation must go hand in hand.

VIVAZEN^® applauds Representative Bilirakis (R-FL) and other leaders for bringing renewed attention to 7-OH and helping move the issue higher on the federal agenda. Federal policymakers made clear in 2025 that 7-OH warranted action, and the FDA subsequently recommended federal scheduling of 7-OH products but DEA has not yet finalized that process. VIVAZEN^® views yesterday’s hearing as an important step in building momentum for action and continues to urge DEA to complete the scheduling process without delay.

“Responsible companies should not have to compete with new synthetic, unapproved drugs that put consumers at risk and undermine confidence in the entire category,” Curtis said. “We strongly support the growing effort in Washington to address 7-OH, and we urge DEA to finish the job by scheduling it promptly.”

The VIVAZEN^® Commitment

VIVAZEN^® products are formulated with safety and quality in mind. Each product undergoes third-party testing to ensure purity, strength, and compliance with our rigorous quality and safety standards. With increasing concerns about unlawful and potentially harmful products in the market, VIVAZEN^® is committed to providing transparency and educating consumers on the responsible use of botanicals.

About VIVAZEN

For over a decade, VIVAZEN^® has delivered trusted, high-quality botanical supplements that provide people with functional wellness without compromise. Grounded in centuries of wellness practices and backed by modern innovation, VIVAZEN^® products offer functional, feel-good alternatives for those who want to live — and feel — on their own terms. Join the millions who trust VIVAZEN^® to Feel Great™ naturally. Visit us at www.vivazen.com.

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