The US Food and Drug Administration (FDA) is the branch of the Department of Health and Human Services that is responsible for ensuring the safety of the United States' food and medicine supply. The FDA's primary goals are to ensure that foods meet certain safety standards (for example, setting and enforcing limits for the amount of harmful substances food products can contain) and that medications are effective in treating the conditions that they are meant to treat. Herbal supplements such as the male enhancement product Extagen are surprisingly not regulated by the FDA. This article looks at a few reasons for this surprising omission.

Historically, the reason that herbal supplements such as ginseng and Extagen have not been FDA regulated is that there is no clear delineated as to whether such supplements are actually food or drugs. Since most herbal supplements also double as food seasonings, a case can be made that they are both food and drugs. However, since drugs are regulated for efficacy and foods are regulated for safety, the manner in which a food-and-drug category would be regulated has never been fully worked out. In the face of this confusion, the agency has decided to simply not take up the issue.

Another reason that Extagen and other herbal supplement products have not been put under the FDA microscope is that the agency is simply overextended with its current duties and could not hope to absorb the extra responsibility that would come with the regulation of herbal products. The approval process for most modern medications takes six years or more and this time period, which has already placed the FDA under political scrutiny, would doubtlessly expand if the FDA were forced to add supplement to their oversight without receiving a massive increase in resources.

While Extagen and other herbal products are not currently FDA approved, the FDA does have some oversight in the labeling of herbal products. For instance, if you look at the website for Extagen, you will encounter a disclaimer that reads that Extagen is not intended to treat or cure any medical condition. This is because the FDA limits such claims to only those medications that have been through their approval process.

While the FDA does not currently regulate supplement products such as Extagen, there is a strong movement within the health industry advocating such oversight. However, such a move will also have to be accompanied by an increase in resources to the agency as well as a possible restructuring.