FDA’s Synthetic Drug Crackdown

Natural Kratom Leaf Products Are NOT Affected

The Food and Drug Administration (FDA) recently recommended that concentrated 7-hydroxymitragynine (also known as 7-OH) be classified as a Schedule I substance under the Controlled Substances Act. 7-OH is an oxidative byproduct compound found in trace amounts in dried leaf kratom (<0.01%) and can be mass produced by chemically altering concentrated kratom extracts. These isolated concentrated synthetic 7-OH derivatives exhibit serious adverse effects and are illegal on the state and federal levels.

The Food and Drug Administration (FDA) recently recommended that concentrated 7-hydroxymitragynine (also known as 7-OH) be classified as a Schedule I substance under the Controlled Substances Act. 7-OH is an oxidative byproduct compound found in trace amounts in dried kratom leaf (<0.01%) and can be mass produced by chemically altering concentrated kratom extracts. These isolated concentrated synthetic 7-OH derivatives exhibit serious adverse effects, are up to 22 times more potent than morphine, and are illegal on the state and federal levels.

Our Clinical Study →

FDA Press Release →

Dr. Marty Makary →

Crucially, the FDA’s recommendation applies only to products containing concentrated, unnatural levels of 7-OH — NOT products that contain natural kratom leaf like feel free CLASSIC. Dried kratom leaf is a natural, whole-plant product harvested from the Southeast Asian tropical tree known as Mitragyna speciosa. Natural kratom leaf enjoys inherent consumer trust through centuries of safe use, commonly consumed in forms such as capsules, powders, teas, and liquid suspensions. Concentrated synthetic 7-OH products bear absolutely no resemblance to the natural kratom leaf products that are used by more than 23 million Americans.

SEE THE PRODUCTS AFFECTED

Consumer Education

Both kava root and natural kratom leaf provide a range of benefits, but are often misunderstood. Our belief is that consumers have the right to understand what they are consuming. Botanic Tonics proudly supports research and education, upholds the highest quality standards, and advocates for consumer access while prioritizing safe consumption practices. By fostering a better understanding of these botanicals, we can empower consumers to make informed choices.

Botanic Tonics Proudly Supports These Organizations

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Not All Kratom is Equal

There is a lot of misinformation about kratom stemming from the misconception that all kratom is the same. Natural kratom leaf, used for centuries in Southeast Asia, differs significantly from the extracts, concentrates, and isolates sold in the U.S. We are committed to providing consumers with the truth and replacing fiction with facts. At Botanic Tonics, we only use natural kratom leaf.

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See the results of the FDA's own study on natural kratom leaf.

FDA Study

Read scientists’ statements on 7-OH and kratom products.

Kratom Science

Support for Kratom Regulation

Botanic Tonics fully supports the Global Kratom Coalition (GKC) and increased kratom regulations including:

Clear definitions for natural kratom leaf vs. concentrated synthetics
Banning synthesized kratom derivatives
Preventing adulteration of kratom products
Limiting 7OH content to 1%

Implementing robust labeling standards
Ensuring packaging has accurate serving measurements
Requiring vendor and product registration

Kava Root Resources

While kava doesn't face the same regulatory issues as kratom, it is still often misunderstood. Respecting the history and understanding the proper consumption of this botanical is crucial as more people incorporate natural solutions into their lives..

Discover Kava

Explore research papers on kava's health effects.

KAVA Study

Read recent kava research and industry news.

KAVA Research

WHAT IS YERBA MATE?

Yerba mate, Ilex paraguariensis, is a species of holly native to South America.

Traditionally sipped from a gourd and shared among friends, yerba mate has been cherished for centuries in South America as an energizing, communal beverage.

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Elementary School Principal Tedd Wakeman shares how feel free helps him feel good about life.

"feel free gives me not just energy, but a lot more clarity and a positive spin on the things I need to do. Just puts me in a good frame of mind."

Testimonial // Tedd Wakeman

Small business owner Stephanie Stewart shares how the energy and focus she gets from feel free have been a game changer.

"I started to feel really happy, and I was smiling. I thought to myself, ‘Wow, why do I feel so good right now?’ Then I remembered I drank a feel free tonic.”

Testimonial // Stephanie Stewart

Small business owner Stephanie Stewart shares how the energy and focus she gets from feel free have been a game changer.

"I started to feel really happy, and I was smiling. I thought to myself, ‘Wow, why do I feel so good right now?’ Then I remembered I drank a feel free tonic.”