United States Government Publishing Office
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2018-04-14
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Highly Concentrated Caffeine in Dietary Supplements; Guidance for Industry; Availability
Notices
D09002ee1bdb9158d
D09002ee1bdb91620
United States
Department of Health and Human Services
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org
United States Government Agency or Subagency
United States
Food and Drug Administration
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org
United States Government Agency or Subagency
The Food and Drug Administration (FDA or we) is announcing the availability of a guidance for industry, ``Highly Concentrated Caffeine in Dietary Supplements.'' FDA considers some dietary supplements that consist of only or primarily pure or highly concentrated caffeine to be adulterated. FDA is issuing this document to provide guidance to firms that manufacture, market, or distribute dietary supplement products that contain pure or highly concentrated caffeine, or are considering doing so. This guidance should help such parties determine whether their products are or would be adulterated under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and to help them understand how to reduce the likelihood that their products will be considered adulterated.
83 FR 16369
https://www.govinfo.gov/app/details/FR-2018-04-16/2018-07836
2018-07836
fr16ap18-82
4164-01-P
Docket No. FDA-2018-D-1189
https://www.govinfo.gov/app/details/FR-2018-04-16/2018-07836
https://www.govinfo.gov/content/pkg/FR-2018-04-16/html/2018-07836.htm
https://www.govinfo.gov/content/pkg/FR-2018-04-16/pdf/2018-07836.pdf
2 p.
16369
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83 FR 16369
Highly Concentrated Caffeine in Dietary Supplements; Guidance for Industry; Availability; Federal Register Vol. 83, Issue
NOTICE
2018-07836
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Docket No. FDA-2018-D-1189
4164-01-P
2018-07836
Notice of availability.
The Food and Drug Administration (FDA or we) is announcing the availability of a guidance for industry, ``Highly Concentrated Caffeine in Dietary Supplements.'' FDA considers some dietary supplements that consist of only or primarily pure or highly concentrated caffeine to be adulterated. FDA is issuing this document to provide guidance to firms that manufacture, market, or distribute dietary supplement products that contain pure or highly concentrated caffeine, or are considering doing so. This guidance should help such parties determine whether their products are or would be adulterated under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and to help them understand how to reduce the likelihood that their products will be considered adulterated.
The announcement of the guidance is published in the Federal Register on April 16, 2018.
Sibyl Swift, Office of Dietary Supplement Programs, Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240- 402-1455.
Guidance:
Highly Concentrated Caffeine in Dietary Supplements
,
https://www.fda.gov/FoodGuidances
https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf
https://www.regulations.gov
Federal Register
Vol. 83, no. 73
Office of the Federal Register, National Archives and Records Administration
2018-04-16
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592 p.
Table of Contents:
AE 2.7:
GS 4.107:
AE 2.106:
KF70.A2
https://www.govinfo.gov/app/details/FR-2018-04-16
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https://www.govinfo.gov/app/details/FR-2018-04-16
https://www.govinfo.gov/content/pkg/FR-2018-04-16/pdf/FR-2018-04-16.pdf
https://www.govinfo.gov/content/pkg/FR-2018-04-16/xml/FR-2018-04-16.xml
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2018-04-14
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FR-2018-04-16
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FR-2018-04-16
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