Diversified Botanics Applauds FDA’s Decisive Action Against Synthetic 7-OH Swift Federal Enforcement Protects Consumers

SALT LAKE CITY , UT, UNITED STATES, July 15, 2025 /EINPresswire.com/ -- Diversified Botanics (DB) today commended the U.S. Food and Drug Administration (FDA) for its rapid and targeted enforcement actions against manufacturers and distributors of synthesized 7-Hydroxymitragynine (7-OH), an unapproved, laboratory-produced opioid reported to be 10–40 times more potent than morphine.

“Removing synthetic 7-OH from commerce is a lifesaving step,” said Ryan Niddel, CEO of Diversified Botanics. “The FDA’s team—led by Marty McCary and the dedicated scientists, investigators, and attorneys across CDER and CFSAN—demonstrated the exact kind of data-driven, proactive regulatory excellence needed to safeguard unwitting consumers across the U.S.”

Lawmakers Led the Charge

DB extends special gratitude to Congressman Jack Bergman (MI-01) and Senator Roger Marshall, M.D. (KS), whose early 2025 letters warned FDA leadership that products containing synthetic 7-OH posed an imminent threat to public health. Their foresight accelerated today’s enforcement.

Senator Harris likewise merits recognition for championing complementary state-level protections.

Separating Science from Pseudoscience

Contrary to online misinformation, 7-OH is not equivalent to natural kratom. Natural kratom leaf (Mitragyna speciosa) contains a broad spectrum of at least 40 indole and oxindole alkaloids.

ISO-17025 laboratory analyses on over 600,000 kg of raw leaf confirm typical alkaloid ratios. Mitragynine typically comprises approximately 60% (0.8–1.4% of dried leaf), functioning as a partial μ-opioid and adrenergic agent.

Paynantheine accounts for around 11% (0.15–0.30% of dried leaf), acting as a 5-HT2A antagonist. Speciogynine represents about 8% (0.10–0.25% of dried leaf) and serves as a smooth-muscle relaxant.

Speciociliatine, roughly 6% (0.07–0.18% of dried leaf), functions as a weak μ-opioid partial agonist. Naturally occurring 7-Hydroxymitragynine constitutes less than or equal to 1% (approximately 120 ppm, ≤0.0002% of dried leaf), as an oxidative metabolite of mitragynine.

Proposed Kratom Consumer Protection & Safety Acts limit 7-OH to ≤1% of total alkaloids, reflecting these empirical ranges and ensuring a pharmacologically balanced profile.

Dr. Robert Redfield, former CDC Director, stated: “The FDA’s expeditious enforcement against synthetic 7-OH exemplifies data-first public health stewardship. It protects consumers while preserving rigorous scientific evaluations of natural kratom.”

Looking Ahead

Diversified Botanics reiterates its full support for the FDA’s mission and calls on all stakeholders—manufacturers, retailers, and policymakers—to adopt the standards embedded in the Kratom Consumer Protection & Safety Act nationwide.

About Diversified

BotanicsDiversified Botanics is an innovative industry leader in botanical wellness, committed to producing safe, effective, and natural products. The company maintains transparent, rigorous scientific standards, offering consumers full visibility into the farm-to-table lifecycle of its products through advanced QR code tracking. Diversified Botanics collaborates closely with regulatory and scientific communities, consistently prioritizing consumer health and safety.

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