The Kratom industry has been growing steadily since 2013 and it is now estimated that there are well over five million people that use Kratom on a regular basis to help with a number of ailments and for general well-being. While this rapid growth has been great for the industry, it has left regulators scrambling on how to manage a product that is not supported by governing bodies and has been labeled as an opioid by the FDA, but yet whose popularity is booming and plentiful research is accessible which shows promising attributes for this botanical.
Advocacy groups such as the American Kratom Association have already dispelled many of the negative claims espoused by the FDA through independent scientific studies such as an 8-factor analysis completed in 2017; however, further education is still needed at a state level. In 2019 several states have enacted, or are considering enacting what is known as the Kratom Consumer Protection Act.
What is the Kratom Consumer Protection Act?
The Kratom Consumer Protection Act is a bill that is being drafted and introduced by several states to protect the consumers of Kratom from adulterated and unsafe products that have made their way into the market. Aside from making Kratom products determinably safe, the drafting of these bills is great news for suppliers of Kratom who are choosing to bring clean and safe products to the market.
The three key rules of the regulation are:
- Suppliers must be properly registered and follow FDA cGMP (current good manufacturing process) guidelines for herbal supplements.
- Enhanced or adulterated products are not to be sold.
- Proper labeling of each product is required.
What is cGMP and why is it important in the Kratom industry?
cGMP, which stands for current good manufacturing practice, is ultimately a guidebook put together for a manufacturer who is responsible for handling and validating the products that they are working with, i.e. supplements and foods. From import to consumer, a manufacturer is required to document and validate every step involved in how a product is formulated, tested, packaged, shipped, and recalled.
All herbal supplement suppliers and manufacturers are required to follow cGMP procedures, and to undergo periodic inspections of their facilities and products, so it is only natural that the Kratom industry follows them too –for the purpose of safety, and also for the purpose of dignifying and validating the plant itself.
If a supplier is properly following cGMP procedures at a minimum, they will have documents for lab testing results, recall plans, SOP’s, as well as clean and sterile work environments and manufacturing equipment.
The Kratom Consumer Protection Act, when enacted, enforces all suppliers and manufacturers of kratom products to follow the cGMP rules already in place. This should essentially help rid the industry of suppliers/manufacturers whom are unwilling to follow the rules in keeping the product safe, lab-tested for authenticity and contaminants, and unadulterated. Consumers should then feel safe purchasing from a supplier, and know what they are getting is clean and pure.
Why do we need to keep enhanced or adulterated products out of the market place?
The FDA has made it very clear that they view the alkaloid 7-hydroxymitragynine (that is naturally occurring in Kratom) to be potentially as powerful as morphine; however, kratom in its natural state contains very little 7-hydroxymitragynine. One would generally have to ingest quite a significant amount of raw powder to get an appreciable amount of this alkaloid. Of course, it contains many other alkaloids and various compounds in varying percentages — depending on the sourcing, type, and quality of leaf.
In herbal circles, the effect of this natural panel of chemicals found in the entire herb (as opposed to isolates) is known as the ‘entourage effect’, and is theoretically one reason why herbal therapies can be so gentle and holistic, and yet effective. So, from this perspective, the holistic balance of compounds found in the whole leaf would create a sort of buffer against potential adverse reactions, side effects, and severe chemical dependency — which is, in general, much more likely when using concentrated products that infuse isolated chemicals. So, enhancing a product (in particular in a deceptive or non-forthcoming fashion) can potentially be deleterious to one’s health, which is counterproductive considering that the kratom movement fundamentally is about retaking control of one’s own health and wellness.
It probably goes without saying that kratom products adulterated with pharmaceutical or research chemicals are even more problematic and potentially dangerous, and it serves everyone’s highest good to ensure that they are barred from the market. Although this kind of adulteration appears to be extremely rare, it should of course be eliminated entirely, and any manufacturers who partake in these practices should be held accountable. A part of the language of the Kratom Consumer Protection Act states that those producing, selling, or distributing adulterated kratom products could be fined or incarcerated for doing so.
Required proper labeling
Labels must follow strict cGMP regulations. This means, at a minimum, labels should display any necessary warnings, suggested dosage amounts, ingredients, and documentation for a traceable source of where the product originated. Proper labeling also indicates that packaging should always specify that any health-supportive statements included have not been reviewed by the FDA. As well, there are not to be any disease treatment, cure, or prevention oriented statements, as this would fall out of the envelope of health supplements and into that of medical drugs.
Warnings on packaging that could be pertinent include cautions for combining herbs with pharmaceutical drugs without discussing your regimen and any possible changes with a licensed medical professional, and in cautioning pregnant or nursing women to avoid products, as well, to be safe.
Having dosage suggestions pinpointed on product labels are important to the consumer because it ensures that they don’t have to go digging in random internet forums for dosage advice, which could potentially be unwise if new users start with too high of a dose based off of a random anecdote, resulting in unpleasant side effect and/or general discomfort. This also ensures that heavy metal amounts per dose could and should be very minimal, if not negligible, at proper suggested doses.
Three states have already passed and signed the Kratom Consumer Protection Act into law: Utah, Georgia, and Arizona, with others already engaged in the start of the process. This is a necessary next step for the Kratom industry to embody on a widespread basis, so that this may be the norm, and consumers can trust fully in the products they receive. And surely, with the science on the side of the kratom industry, and with the health of the consumers in mind, there will be more states to fully pass the legislation in the coming months.