We at Green House Kratom have now found ourselves in a very unique position and would like to share the disappointing truths we have learned about the FDA and the rules and regulations that govern it. It is important to note that these problems are not unique to us or to the Kratom industry, in fact some apply to all foods and dietary supplements.
The FDA has many problems. The biggest problem with the FDA I see is that it has been given high authority to dictate new and arbitrary rules that govern just about all products in the US. The key word there is “dictate“, as in dictatorship. Of course the rules are not supposed to be arbitrary, but in fact they are! Take for example Import Alert 54-15: somewhere a small group of FDA officials did a little research (not very much) and found that Kratom has caused some adverse effects in certain individuals. That small group then made the hasty decision that Kratom poses a health risk to the general public and issued Import Alert 54-15 (calling for the seizure of Kratom being imported to the US), but this is where the breakdown of good government and regulation is occurring!
First of all, Import Alert 54-15 claims that Kratom poses a health risk to the general public, but where are the citations for the research that has been done? (Shame on the FDA for not including proper citations.) Without citation, the cause for the Import Alert has been made arbitrarily.
Secondly, where is the opportunity for community review? There is none!
Federal and State legislatures now have systems in place where the general public can review and provide feedback on proposed laws and legislative acts on a daily basis with the help of websites like legiscan.org. This helps ensure greater feedback in public policy making. The FDA on the other hand does not have in place a system for involving the public when making regulations such as Import Alert 54-15, neither before nor after the rule has been made. This is bad policy and needs to be changed.
Thirdly, the FDA has with it’s policy, created a situation where all “new dietary ingredients” (those for sale in the US after 1994) will eventually be deemed unsafe for human consumption, because, surely someone will at some point show some allergic or adverse reaction to each and every one of those new dietary ingredients, and by FDA standards, that is reason enough to make that ingredient illegal, or ban it from import completely.
Most foods have both health benefits and some adverse effects that affect certain people. That is simply a reality. The FDA has been tasked with trying to ensure our products are safe, but when they are confronted with a new dietary ingredient that shows symptoms of any adverse effect, the simplest solution for them is to avoid responsibility and make the product illegal or very hard to get. Of course, it mitigates risk for them! But this is not what the general public wants! People would like to have the freedom to make the decision about what they consume for themselves. With the advent of the internet, it is very easy for people to learn the major pros and cons about an unfamiliar product, and people should be allowed to make their own decision about what they consume to balance risk with quality of life. The government shouldn’t prohibit people from having the freedom to consume a product on the basis that there is a very slight chance that they might have some sort of adverse reaction to it. It is a risk we all take with every food and that is why so many natural products out there should never have been banned or restricted in the first place.
Fourthly, the FDA has created with it’s policy a situation where vendors of dietary ingredients (or foods) can not share a lot of truthful information about their own products because it would then imply that their food is a drug and it would then suddenly have to comply with all the rigorous and expensive testing that pharmaceuticals have to be exposed to. Prune companies for example are not allowed to share evidence that prunes keep you regular. Everyone knows that already, but what if for instance some prune company had done some additional study and found much more detailed statistics on that fact. Shouldn’t they be able to share that without penalty? (provided it is truthful of course.) The public should be given that information, but the FDA has created an environment where natural food companies have to shut-up and conceal all the scientific information that they know about their products. What would ordinarily be a natural progression of good information from the farmer to the consumer is now blocked by FDA policy. It is a huge infringement on the right of free speech to companies, and individuals advocating for those companies. The policy made sense decades ago, before the internet was around to provide information to people about an unfamiliar product, but today it no longer makes sense; food companies should be able to share truthful information about their products whether it is a medical claim or not.
Of course making a blanket change to FDA policy to allow food companies to make medical claims about their products would blur the lines between a food and a drug, but with the advent of the OASIS system, every single adverse event for any new product can now easily be tracked, and so new products registered as new dietary ingredients that trigger a number of adverse events, above a certain threshold rate, could trigger an FDA investigation that could lead to the reclassification of that product as a drug that needs further investigation. That is the simple solution for identifying misclassified products. But even a simple change in policy like this would require massive review of documentation and regulation, and it is not likely to be achieved at my request.
A more complete approach to tackling the revision of U.S.C. 22 would be to account for modern technology and the internet, and change it more radically in it’s entirety. Ideally, USC Title 22 should be amended such that the FDA does not have jurisdiction to dictate the availability of any food, dietary ingredient (new or old), any product, or any pharmaceutical for that matter, except perhaps for those that have been specifically picked to be regulated according to legislation (like scheduled narcotics for example). The role of the FDA should not be to approve or deny new products at this point (the public can now find ways to come to reasonable conclusions via research made available on the internet); the FDA’s role should now be to monitor and report dangerous trends and perhaps enforce good labeling and information sharing policies.
Others have made thoughtful arguments proposing similar amendments to the law as well, here is one such example proposing change: http://www.fdareview.org/index.shtml
The whole point of this though, is that the rules that govern the FDA need some radical changing. The FDA was established to help keep order in times of rapid growth in the U.S. and in a public environment that could not keep up with the new information and changing times. But the advent of the internet has changed all that, and it’s time for the role of the FDA to be scaled back a bit.
It might actually help make the cost of health care less expensive… What do you think?