With an estimated 15 million people in the U.S. consuming kratom, products containing the plant native to Southeast Asia have experienced explosive growth in recent years. Kratom is available in various forms such as powders, capsules and tonics made from kratom leaf material and kratom extracts, and has garnered attention for its ability to potentially enhance mood, energy, and endurance. Also gaining traction in the US are kava-based products which are consumed in hundreds of kava bars across the U.S., and more recently in consumer packaged goods that can be bought at well known retailers across the U.S..
This growth, mainly driven by an increase in consumer demand and expanding awareness of both of these botanical’s, has also fueled an interest in the rich cultural history established over hundreds of years of traditional use among people from Southeast Asia.
While kratom and kava enjoy a rich history of responsible use, there are products that are being sold that are tarnishing their reputation and jeopardizing the integrity of the entire sector. Irresponsible practices such as selling adulterated, synthetic or contaminated products, making unsubstantiated health claims, and printing misleading labels, not only pose risks to consumer safety but also undermine public trust in kratom as a legitimate plant ingredient.
These rogue companies hinder efforts to establish sensible regulations that could benefit both consumers and responsible industry participants. Their behavior invites confusion and misinformation, casting a shadow over the entire kratom and kava community.
Botanic Tonics Supports Regulatory Oversight
As the market expands, Botanic Tonics believes there is a pressing need for regulatory oversight and quality control measures to ensure the safety, efficacy, and consistency of kratom-containing products. Regulations will also demonstrate which companies embrace or shun responsible practices and collaboration within the industry to sustain its growth trajectory while safeguarding consumer welfare. Not content to wait for regulations to catch up, Botanic Tonics is demonstrating leadership through transparency, education, and advocacy for the consumer.
Common Sense Regulation on a State and National Level
Botanic Tonics is actively involved in advocating for regulations on both state and national levels to ensure the safety and quality of kratom products.Through collaboration with legislators, industry stakeholders, and advocacy groups, Botanic Tonics has supported initiatives to establish comprehensive regulations governing the production, labeling, and distribution of kratom products.
By engaging in dialogue and collaboration with regulatory authorities and participating in public hearings and forums, Botanic Tonics is actively promoting responsible practices within the kratom industry, advocating for consumer protection measures, and fostering transparency and accountability among processors and vendors. Botanic Tonics is committed to upholding consumer safety standards, building trust within the community, and contributing to the responsible and sustainable growth of the kratom market.
The Kratom Consumer Protection Act
At the heart of Botanic Tonics’ interest is supporting robust regulations like the bills put forward by Global Kratom Coalition in California and recent amendments to the KCPA in Oklahoma making regulations more robust and up to date with the latest science and market realities.The KCPA encompasses several key provisions aimed at ensuring the safety and integrity of kratom products. One fundamental aspect is the establishment of standards for product labeling, which includes requirements for accurate ingredient lists, serving information, and warnings about potential risks. The bill also protects against the sale of synthetic kratom alkaloids in order to avoid untested ‘kratom-like’ products being sold to consumers. Importantly both bills restrict the sale of kratom to minors. Additionally, the KCPA mandates comprehensive testing procedures to verify the purity, potency, and absence of contaminants in kratom products
This entails conducting laboratory analyses to assess alkaloid content, microbial levels, heavy metal concentrations, and other quality parameters. Another critical component is the prohibition of adulterants and additives deemed harmful or misleading to consumers. Furthermore, the KCPA outlines mechanisms for product registration and licensure, ensuring that only compliant manufacturers and distributors are authorized to market kratom products. By implementing these measures, Botanic Tonics believes businesses can work with regulators to safeguard public health, promote transparency within the kratom industry, and provide consumers with access to safe and accurately labeled products.
FDA: A Positive, Commendable Move to Facts and Science
Botanic Tonics is highly supportive of the FDA as they undertake clinical research on kratom. Clinical research is necessary to expand understanding of kratom consumer safety, guide regulatory decision-making, and impact global health.
With the appointment of James “Jim” Jones, the first-ever Deputy Commissioner of the Human Foods Program, the FDA has demonstrated their commitment to effective regulatory oversight. Jones comes to the FDA with intimate knowledge of the food program having served on the Reagan-Udall Foundation’s Expert Panel that reviewed and made recommendations for the program in 2022. Jones will oversee areas involving human foods for the FDA. Overall, according to food and beverage market trade Food Navigator, the FDA will “pursue access to accurate information that is easy to understand and transparency into how FDA evaluates food safety.”
As noted at the recent 3rd Kratom Symposium, the scientific community strongly encourages further research on the various forms of kratom to help firmly establish, clarify, or dispel inaccuracies. The FDA’s recent leaf kratom Single Ascending Dose (SAD) study and upcoming Human Abuse Potential (HAP) are critical components of the clinical research needed in this space.
The SAD study aims to learn about the safety, pharmacokinetics (what the body does to the substance), and pharmacodynamics (what the substance does to the body) of leaf kratom. This SAD research will help determine the optimal dose range for further clinical development by identifying the maximum tolerated serving and assessing kratom’s effect at various serving levels. Additionally, the single ascending dose data provided valuable data on leaf kratom’s safety profile, showing that leaf kratom is tolerated well in humans even at very high doses.
The FDA has also released a request for proposal for Human Abuse Potential (HAP) research. The HAP research will evaluate kratom through controlled laboratory studies and observational research, which can provide critical insights into its addictive properties and abuse liability, informing regulatory decisions on how kratom should be adequately regulated in the U.S.
The actions by the FDA are needed and should be commended and supported by the industry.
By collaborating with advocacy organizations and prioritizing consumer safety, Botanic Tonics seeks to uphold the long-term viability and credibility of kava culture and the kratom industry. Through responsible practices and robust regulations, Botanic Tonics remains committed to promoting transparency, consumer education, and the sustainable growth of the market. The end goal: ensure these functional botanicals continue to be a safe and beneficial botanical for individuals worldwide.