Government Dismisses FDA Case Against Botanic Tonics, Maker of Feel Free

Federal action underscores growing distinction between whole-leaf botanical supplements and synthetic derivatives

BROKEN ARROW, OK, January 6, 2026 - Botanic Tonics announced today that the U.S. government has dismissed the case U.S. v. 250,000 filled bottles of liquid product et al (Case No. 4:23-cv-00168-GAG-CDL) in U.S. District Court for the Northern District of Oklahoma. The government filed a Notice of Dismissal on December 22, 2024, formally closing the matter.

The dismissal reflects a maturing regulatory landscape in which federal agencies increasingly recognize the fundamental differences between natural kratom leaf — as used in feel free CLASSIC — and concentrated synthetic kratom compounds manufactured in laboratories.

feel free CLASSIC combines two botanicals with centuries of traditional use: noble kava root and natural whole kratom leaf. The product contains no synthetic ingredients, no alcohol, and no chemical extracts.

"This outcome validates what we've maintained from the beginning," a Botanic Tonics spokesperson said. "Our products contain natural kratom leaf, not synthetic kratom derivatives or concentrated kratom extracts. The regulatory framework has evolved to recognize these distinctions, and enforcement resources are now appropriately focused on products that present legitimate public health concerns."

Regulatory Evolution

When FDA visited Botanic Tonics' Broken Arrow facility in 2023, the agency was still developing its approach to the kratom category. At that time, regulators were working to distinguish between natural kratom leaf and concentrated synthetic kratom derivatives like 7-hydroxymitragynine.

The scientific understanding has advanced considerably since then. Natural kratom leaf contains the full spectrum of alkaloids as they occur in nature, in their natural ratios. Synthetic 7-OH, by contrast, represents an isolated, concentrated compound manufactured in laboratory settings. These are fundamentally different products with different risk profiles.

The FDA's own research supports this distinction. The agency conducted a single ascending dose pilot study involving botanical kratom leaf capsules with findings presented in early 2024. The preliminary results, as reported in industry publications, found that kratom leaf powder capsules were well tolerated at all tested doses up to 12 grams under carefully controlled clinical conditions — nearly seven times the amount of kratom leaf in one serving of feel free CLASSIC (1.75 grams). According to the study summary, "the data suggest that at the doses tested, using the specific botanical kratom sourced for the study, and under carefully controlled clinical conditions, kratom was well tolerated." The results have been submitted to a peer-reviewed journal. Building on this research, FDA awarded a grant in September 2024 for a human abuse potential clinical trial on botanical kratom, currently underway.

Federal enforcement actions now reflect this evolving understanding. Recent FDA and DOJ efforts have targeted concentrated synthetic products and unauthorized manufacturing operations, representing a more sophisticated regulatory approach to the category.

Commitment to Quality and Transparency

Throughout this process, Botanic Tonics has maintained its commitment to transparency, quality, and responsible manufacturing practices:

• Sourcing natural kratom leaf through verified supply chains
• Implementing rigorous quality control and testing protocols
• Providing clear product information to consumers and retailers
• Working constructively with regulatory authorities
• Supporting industry efforts to establish appropriate standards for botanical products

"We appreciate the government's thoughtful review of this matter," the spokesperson added. "The botanical supplement industry benefits when enforcement is precise, science-based, and focused on genuine public health priorities. This dismissal represents regulatory maturity in action."

References:

FDA pilot study on kratom leaf: Information available at the link below

Bloomberg coverage of FDA study: Coverage available at the link below

Case Details:

• Case Number: 4:23-cv-00168-GAG-CDL
• Court: U.S. District Court for the Northern District of Oklahoma
• Notice of Dismissal: Document 38, filed December 22, 2024
• Status: Case Closed

About Botanic Tonics

Botanic Tonics is a plant-based, herbal supplement company headquartered in Broken Arrow, OK. Established in 2020, we produce kava-centric tonics under our feel free brand. Our signature product, feel free CLASSIC, is crafted with ancient functional plants to provide mood lift, chilled energy, and enhanced focus. Botanic Tonics' products are manufactured in an FDA-registered, cGMP-certified facility, and we actively support consumer safety regulations through transparent labeling and educational resources. For more information, visit the link below.

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