Kratom, a revered botanical supplement, has faced scrutiny from various groups, with the U.S. Food and Drug Administration (FDA) playing a pivotal role in regulating this industry. In this comprehensive exploration, we delve into the FDA’s stance on kratom, its evolving regulations, and recent developments in this dynamic landscape. However, it’s imperative to note that the information provided is for informational purposes only and should not be construed as medical advice.

The FDA’s Role in Kratom Regulation

What is the FDA?
The FDA’s core mission is to safeguard public health by ensuring the safety, efficacy, and security of drugs, biological products, medical devices, and our nation’s food supply. Kratom, being available as a dietary supplement, falls under the FDA’s purview as a key regulator in the industry.

FDA’s Stance on Kratom

The FDA emphasizes the necessity for further research on kratom, expressing concerns about consumer safety and refraining from approving any medicinal uses. This position aligns with their approach to other dietary ingredients and supplements.

Contrary to the FDA’s assertion, kratom is not classified as an opioid by plant genetics, chemical structure, or legal definition. Many individuals use functional kratom as a caffeine alternative, experiencing heightened alertness, mental focus, and increased energy levels without the side effects associated with caffeine consumption.

The FDA’s recommendations for scheduling kratom were not accepted by the Drug Enforcement Administration (DEA), the U.S. Department of Health and Human Services (HHS), and the Expert Committee on Drug Dependence (ECDD) for the U.N. Commission on Narcotic Drugs.

Recent opposition from public health officials and scientists questions the FDA’s stance, emphasizing the potential benefits of kratom when used responsibly. Notably, over $30 million has been invested in kratom research studies by the National Institute on Drug Abuse (NIDA).

Kratom’s FDA Approval and Legal Status

Is Kratom FDA Approved?
Unlike drugs, dietary supplements, including kratom, do not require FDA approval. However, concerns about safety and quality are valid. Bagus Botanicals, adhering to the standard of lab testing each kratom batch to ensure quality control and peace of mind for consumers. 

FDA Actions on Kratom
Over the years, the FDA has taken various actions concerning kratom:

In 2012, the FDA flagged kratom as an unapproved drug and issued an import alert.
2014 saw the FDA issuing a second import alert and banning kratom imports due to contamination reports.
In 2016, the DEA withdrew its intent to classify kratom as a Schedule I drug under the Controlled Substances Act within a month.
Despite these actions, kratom remains legal at the federal level but lacks approved medical status.

Legal Status of Kratom
Kratom’s legality varies across the United States, with some states, cities, and counties imposing restrictions. Notably, Bagus Botanicals refrains from shipping to any address where kratom is deemed illegal.

Frequently Asked Questions (FAQs) on Kratom Regulation

What is Kratom?
Kratom, scientifically known as Mitragyna speciosa, is a tropical tree native to Southeast Asia, specifically in Malaysia, Thailand, and Indonesia. It is available in various strains such as Maeng Da, Bali Kratom, Green Malay, Red Borneo, and White Thai, each offering distinct alkaloid profiles.

Can the FDA Ban or Schedule Kratom?
While the FDA can recommend scheduling certain substances under the Controlled Substances Act, kratom is not currently classified as a federally controlled substance. The FDA’s concerns revolve around safety, addictive potential, and a lack of approved medical use.

FDA Enforcement on Kratom Vendors
The FDA can enforce regulations or legal action against kratom vendors if they market their products under false medical claims.

GMP Standards Program
Bagus Botanicals follows the GMP Standards Program, ensuring that our kratom products meet stringent safety, quality, and labeling standards.

Kratom Legal Status
Kratom is illegal in specific states, including Alabama, Arkansas, Indiana, Rhode Island, Vermont, and Wisconsin, as well as certain cities and counties. Bagus Botanicals encourages customers to check kratom legality in their respective locations.

In conclusion, Bagus Botanicals remains committed to providing high-quality, safe, and clean kratom products while navigating the evolving regulatory landscape. As you explore the benefits of kratom, it’s essential to stay informed and make responsible choices in your wellness journey.