The FDA, Dietary Supplements, and Kava
As introduced in the previous Kava Conversation, the FDA classifies kava as a “dietary supplement” and requires it to be labeled as such. Dietary supplements are defined by U.S. law as “products taken by mouth that contain a ‘dietary ingredient’” and can come in many forms including tablets, capsules, powders, energy bars, and liquids.
Dietary supplements can include any of the following:
- vitamin products
- mineral products
- amino acids products
- enzyme supplements
- herbal products
- other substances that can be used to supplement the diet
The FDA’s general position on dietary supplements is that users should consult with a health care professional before using any dietary supplement; that many supplements contain ingredients that have strong biological effects; and that such products may not be safe in all people. Thus the FDA’s general advice regarding dietary supplements is that “[d]ietary supplements are not intended to treat, diagnose, cure, or alleviate the effects of diseases”, “using supplements improperly can be harmful”, and “some supplements can have unwanted effects before, during and after surgery.” The FDA highlights that garlic, for example, can potentially result in increased bleeding as a side effect. On a similar note, the FDA also references possible side effects of kava saying that it can “act as sedatives and can increase the effects of anesthetics and other medications used during surgery.”
The FDA emphasizes the importance of being a safe and informed consumer noting that while some dietary supplements may have potentially harmful effects or be counterfeit products from unscrupulous manufacturers, “many dietary supplements have clean safety histories.” Multivitamins, for instance, are one example of a dietary supplement that cannot attain FDA approval but is generally widely recognized as having no negative side effects.
Why isn’t kava FDA approved?
Although dietary supplements—including kava—fall under the regulatory control of the FDA, they are not capable of getting FDA approval. However it does fall under the regulatory control of the FDA and they have authority to intervene if and when safety issues surrounding kava arise.
The FDA regulates dietary supplements and dietary ingredients differently than “conventional” foods and drug products. The Dietary Supplement Health and Education Act of 1994 states the following (taken directly from the FDA website):
- “Manufacturers and distributors of dietary supplements and dietary ingredients are prohibited from marketing products that are adulterated or misbranded. That means that these firms are responsible for evaluating the safety and labeling of their products before marketing to ensure that they meet all the requirements of DSHEA and FDA regulations.”
- “FDA is responsible for taking action against any adulterated or misbranded dietary supplement product after it reaches the market.”
On March 25th, 2002, the FDA issued a consumer advisory that “kava-containing dietary supplements may be associated with severe liver injury.” It is worth highlighting that the FDA consumer advisory—like the former so-called German kava ban—did not refer to the kava plant or the traditional kava beverage but rather “supplements containing the herbal ingredient kava” that were promoted for relaxation, sleeplessness, menopausal symptoms and other uses. The advisory stated that “[k]ava-containing products have been associated with liver-related injuries – including hepatitis, cirrhosis, and liver failure – in over 25 reports of adverse events in other countries.” Because of these reports, the FDA believed that U.S. consumers should be informed of this potential risk. Though, the FDA noted that “liver damage appears to be rare” and that they need to “investigate the relationship, if any, between the use of dietary supplements containing kava and liver injury.” No legal action was taking regarding this advisory and it has since been archived. It is worth noting that the FDA advisory was based, in part, on the same data and alleged cases that the former so-called (and now illegal) German kava ban.
Criticism of the FDA
Somewhat ironically, the FDA has been criticized for both excessive regulation AND insufficient regulation.
In May 1999, the FDA approved a painkiller called Vioxx concluding that it did not show an increased risk of heart attack or stroke. However, over the years it was discovered that Vioxx did in fact have detrimental side effects including doubling the consumer’s risk of having a heart attack or stroke. As many as 55,000 patients may have died from heart attacks and strokes directly caused by the drug.
Granting Vioxx FDA approval was a massive failure on the part of the agency and is one of the many lapses that prompted criticisms of the agency and calls for reform. Response to this lapse included a 1.8 million dollar 2006 report by an Institute of Medicine committee that assessed the U.S. Drug Safety System and FDA. The committee found major deficiencies in the FDA system and called for a whopping 25 sweeping changes into to improve drug safety.
The overarching recommendations to improve the FDA included the following:
- clarifying the FDA’s regulatory authority: the report stated that “the FDA lacks the clear, unambiguous authority needed to enforce sponsor compliance with regulatory requirements and instead relies on the prospect of productive negotiations with industry”
- requiring symbols to alert consumers of new products and to denote heightened regulatory attention
- establishing performance goals for safety
- holding industry and researchers accountable for making drug safety study results public
- having appropriately adequate resources for drug safety
The fourth recommendation is especially applicable to kava because, in the past, there have been issues with institutions being able to access and verify the alleged cases of liver toxicity.
A number of additional critics have also accused the FDA of under-regulation, over-regulation, and FDA bias. The aforementioned report heavily addressed under-regulation. When it comes to over-regulation, advocates for the supplement industry have criticized the FDA for prohibiting dietary supplements manufacturers for making claims regarding the effectiveness of their product even if they are backed by scientific research. Ron Paul—a Republican congressman who is also a physician—argued that this FDA policy resulted in the “censorship of truthful health claims” and that new policies are needed in order to stop the FDA “from censoring truthful claims about the curative, mitigative, or preventative effects of dietary supplements.”
In the context of kava, this means that scientifically proven claims regarding the possibly curative, mitigative, or preventative effects of kava cannot be made because of the current FDA policy. Rather, only limited “structure/function claims” can be made as the FDA inadvertently prohibits “the distribution of scientific articles and publications regarding the role of nutrients in protecting against disease.”
The FDA has also been accused of having a bias and making decisions motivated by bureaucracy or politics. There have been allegations of undue pharmaceutical industry influence as well as Criticism of the FDA’s rejection of medical cannabis. Former Commissioner of the Food and Drugs Administration Dr. Herbert L. Ley, Jr told the New York Times about the FDA’s inability to protect consumers because of the “constant, tremendous, sometimes unmerciful pressure” from the drug industry, drug company lobbyists, politicians, etc.
In 2005, the FDA issued a statement that medical marijuana did not have any merit—a claim which contradicted much scientific research at the time and thus believed by many to be politically motivated. Likely due to the constantly increasing pervasiveness and legality of both medical and recreational marijuana in the U.S., the FDA’s position changed over time but could still be read as political. The FDA’s current webpage on marijuana, for instance, makes vague and general statements such as “[t]he FDA understands that caregivers and patients are looking for treatment options for unmet medical needs” and “[o]ver the last few decades, there has been significant interest in the potential utility of marijuana for a variety of medical conditions, including those that already have FDA-approved therapies.” These statements appear to state the majority/public opinion rather than explicitly address the merits (or lack thereof) of scientific research on medicinal marijuana and explicitly stating a position one way or another on that matter.
FDA Decisions Are Not Absolute
The FDA, as a supposedly legitimate government authority, is meant to be a reliable reference for consumers to determine what is or is not safe to consume. However the nature of FDA approval and its role as a regulatory authority can result in misconceptions and misunderstandings. Moreover, the FDA does not provide ironclad judgements and has been criticized heavily by both governmental and non-governmental organizations.
The FDA is undoubtedly and important and revered governing body that consumers rely on as a safeguard for the products they consume. This safeguard is especially important when it comes to pharmaceuticals and other treatments individuals might be seeking out. However, the FDA is not a perfect organization and has been criticized for past and present lapses in judgement or political motivations/biases. And as the Institute of Medicine committee report emphasized, several agency reforms and improvements need to be made.
The decisions that the FDA makes are not absolute. Contrary to what consumers might expect, FDA approvals and official positions are fluid and dynamic—evidenced by the agency’s presently changing position on medicinal marijuana.
Dietary supplements, like kava, are in their entirety not even eligible for “FDA approval” due to a technicality. Such technicalities have been argued as censoring consumers from the potential health benefits of kava or herbal medicinal products containing kava. These technicalities can also add a needless stigma to the kava plant, the traditional kava beverage, an integral part of Pacific Islander culture, and an increasingly growing community of kava-users outside the Pacific Islands.