FDA’s Synthetic Drug Crackdown

Natural Leaf Kratom 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 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 leaf kratom (<0.01%) and can be mass produced by chemically altering concentrated kratom extracts. These isolated 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.

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

Consumer Education

Both kava root and leaf kratom 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.

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Botanic Tonics Proudly Supports These Organizations

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

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 kratom leaf and extract products
  • 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

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.

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.”