Comments to FDA on Regulatory Status of Vinpocetine

Michael Harless Administrative Law, Health Law

Today our firm filed comments with the FDA in response to a request for comment on its “tentative conclusion” that the ingredient vinpocetine does not meet the definition of a “dietary supplement.” Our comments explained that vinpocetine fits within the definition of “dietary supplement” as a “constituent of a botanical.” Then we analyzed the four statutory requirements for removal of a dietary supplement from the market, and in this case, at least two of these requirements have not been met. Finally, we addressed the ways in which vinpocetine has been beneficial to Americans with a wide variety of health problems, including symptoms of Alzheimer’s.

Our comments were filed jointly on behalf of the Center for Medical Freedom, U.S. Justice Foundation, The Senior Citizens League, DownsizeDC.org, and Downsize DC Foundation.

Link to comments