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2016-09-07
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Request for Comment on the Status of Vinpocetine
Notices
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D09002ee1bdc149af
United States
Department of Health and Human Services
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United States Government Agency or Subagency
United States
Food and Drug Administration
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United States Government Agency or Subagency
The Food and Drug Administration (FDA or we) is requesting comments related to the regulatory status of vinpocetine. Specifically, we request comments on our tentative conclusion that vinpocetine is not a dietary ingredient and is excluded from the definition of dietary supplement in the Federal Food, Drug, and Cosmetic Act (FD&C Act). This action is being taken as part of an administrative proceeding to determine the regulatory status of vinpocetine. All comments submitted by the comment deadline (see DATES) will be accepted as part of the official record for this proceeding.
81 FR 61700
https://www.govinfo.gov/app/details/FR-2016-09-07/2016-21350
2016-21350
fr07se16-58
4164-01-P
Docket No. FDA-2016-N-2523
https://www.govinfo.gov/app/details/FR-2016-09-07/2016-21350
https://www.govinfo.gov/content/pkg/FR-2016-09-07/html/2016-21350.htm
https://www.govinfo.gov/content/pkg/FR-2016-09-07/pdf/2016-21350.pdf
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81 FR 61700
Request for Comment on the Status of Vinpocetine; Federal Register Vol. 81, Issue
NOTICE
2016-21350
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
2016-11-07
Docket No. FDA-2016-N-2523
4164-01-P
2016-21350
Notice.
The Food and Drug Administration (FDA or we) is requesting comments related to the regulatory status of vinpocetine. Specifically, we request comments on our tentative conclusion that vinpocetine is not a dietary ingredient and is excluded from the definition of dietary supplement in the Federal Food, Drug, and Cosmetic Act (FD&C Act). This action is being taken as part of an administrative proceeding to determine the regulatory status of vinpocetine. All comments submitted by the comment deadline (see DATES) will be accepted as part of the official record for this proceeding.
Submit either electronic or written comments on the notice by November 7, 2016.
Cara Welch, Center for Food Safety and Applied Nutrition (HFS-810), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-2333.
Status of Vinpocetine
,
http://articles.latimes.com/1986-04-15/news/mn-4847_1_vinpocetine
http://ntp.niehs.nih.gov/ntp/htdocs/chem_background/exsumpdf/vinpocetine091613_508.pdf
http://www.fda.gov/food/dietarysupplements/newdietaryingredientsnotificationprocess/ucm109764.htm#new_din
http://www.fda.gov/regulatoryinformation/dockets/default.htm
http://www.google.com/patents/US3892755
http://www.regulations.gov
https://pink.pharmamedtechbi.com/PS008480/AYERST-PLANNING-ON-FIRST-QUARTER-1986-NDA-SUBMISSION-FOR-ALREDASE-TOLRESTAT-IN-DIABETIC-NEUROPATHY-F
https://pink.pharmamedtechbi.com/PS013359/AMERICAN-HOME-PRODUCTS-THIRD-GENERATION-TPA-ENTERING-CLINICALS
Federal Register
Vol. 81, no. 173
Office of the Federal Register, National Archives and Records Administration
2016-09-07
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https://www.govinfo.gov/app/details/FR-2016-09-07
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