by Mala Coomar
“FDA approval” is a buzzworthy label that permeates the world of kava. Consumers are constantly made aware of the fact that kava is not FDA approved and that can often be used to incite antagonistic reactions to kava. Because of this, it is worth taking a step back and understanding what the FDA actually is and what “FDA approval” actually means.
What is the FDA?
The U.S. Food and Drug Administration (FDA) is the federal government agency under the authority of the Department of Health and Human Services that is in charge of overseeing the safety of drugs, biological products, medical devices, animal drugs, and food additives. The scope of FDA’s regulatory authority is thus very broad and can include everything from bottled water and blood/tissue products to microwave ovens and cigarettes. Exceptions to FDA authority include meat, poultry, and some egg products which fall under the jurisdiction of the U.S. Department of Agriculture. The FDA helps recall faulty, unsafe, or contaminated products and also have some authority in the regulation of tobacco products.
According to the FDA website, they are “responsible for advancing the public health by helping to speed innovations that make medical products more effective, safer, and more affordable and by helping the public get the accurate, science-based information they need to use medical products and foods to maintain and improve their health.” They continue their self-proclaimed purpose saying that, “FDA also plays a significant role in the Nation's counterterrorism capability. FDA fulfills this responsibility by ensuring the security of the food supply and by fostering development of medical products to respond to deliberate and naturally emerging public health threats.”
What is FDA Approval?
A product gets “FDA Approval” if it falls under the regulatory authority of the FDA and undergoes “premarket approval” that involves “a review of safety and effectiveness by FDA experts and agency approval before a product can be marketed.” FDA approval is not always required before a product is sold. but the agency does have the authority to act and intervene when safety issues arise.
If something is “not approved by the FDA”, it can mean any of the following:
- the product does not fall under the regulatory authority of the FDA
- the product falls under the regulatory authority of the FDA but it simply regulates it and does not “approve it”
- the product falls under the regulatory authority of the FDA but has not yet been reviewed by the FDA.
Entities that the FDA does not “approve” include the following:
- compounded drugs (a practice in which a pharmacist or a doctor combines ingredients to create medications that meet the needs of individual patients)
- medical foods
- infant formula
- dietary supplements
- the food label including the Nutrition Facts panel
- Structure-function claims on dietary supplements and other foods (one example of this is “calcium builds strong bones”).
How Important is FDA Approval?
According to the FDA, kava does not fall under the category of drugs or foods and is rather considered a dietary supplement. It is thus not capable of getting “FDA approval” and manufacturers do not have to seek FDA approval before selling kava-containing dietary supplements, for instance. The relationship between kava and the FDA warrants further exploration and will be the topic of the subsequent kava conversation.