September 6, 2016
The U.S. Food and Drug Administration is requesting comments on its tentative conclusion that vinpocetine does not fit the definition of a dietary ingredient and is excluded from the definition of a dietary supplement in the Federal Food, Drug, and Cosmetic Act (FD&C Act), and therefore may not be marketed as or in a dietary supplement. This request for comments is part of an administrative proceeding to determine the regulatory status of vinpocetine.
As discussed in more detail in the Federal Register notice, during the 60-day public comment period, FDA is seeking data and information on the following:
- Whether vinpocetine is a dietary ingredient within the meaning of the FD&C Act; and
- Whether products containing vinpocetine are excluded from being dietary supplements under the FD&C Act.
The comment period will close on November 7, 2016.
To electronically submit comments to the docket, visit www.regulations.gov and type FDA-2016-N-2523 in the search box.
To submit comments to the docket by mail, use the following address. Be sure to include docket number FDA-2016-N-2523 on each page of your written comments. Comments will be accepted at any time, but should be submitted no later than November 7, 2016 to ensure that the FDA takes the information into consideration before making further decisions on this issue.
Division of Dockets Management
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852
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