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Dietary Supplements
 | Food Labeling: Health Claims and Label Statements for Dietary Supplements;
Strategy for Implementation of Pearson Court Decision. Pages 67289-67291 [FR
Doc. 99-31122 ] [TXT]
[PDF] [PRE-PUB]
The Food and Drug Administration (FDA) is informing the public of its strategy
to implement a recent court decision in Pearson v. Shalala (Pearson). The
agency is taking this action to ensure that interested persons are aware of
the steps it plans to follow to carry out the decision. FDA is also announcing
how it plans to process petitions for dietary supplement health claims during
the interim implementation period. |
| Information About
Dietary Supplements, from the Center for Food Safety and Applied Nutrition
and FDA. |
| The Special Nutritionals
Adverse Event Monitoring System, Have you or someone you know has an
adverse reaction after taking a dietary supplement such as a vitamin or herbal
product? You can report thee problems to an on-line monitoring system managed
by FDA's Center for Food Safety and Applied Nutrition. The system, which
collects voluntarily submitted adverse, also tracks problems with "special
nutritionals" such as infant formulas. |
| An FDA Guide
to Dietary Supplements, by Paula Kurtzweil, FDA Consumer,
September/October 1998 |
| National Center for Complementary and
Alternative Medicine, NIH, conducts and supports basic and applied
research and training and disseminates information on complementary and
alternative medicine to practitioners and the public. |
| Office of Dietary Supplements,
National Institutes of Health web site (http://odp.od.nih.gov/ods/). This Web
site provides information about the NIH, Office of Dietary Supplements,
including its origins, programs and activities, and scientific resources, and
is organized to help you quickly and easily find the information you seek.
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| U. S. Court of Appeals, District of Columbia Circuit, January 15, 1999,
Durk Pearson and Sandy Shaw, American Preventive Medical Association
and Citizens for Health, Appellants v. Donna E. Shalala, Secretary, United
States Department of Health and Human Services, et al.,
Appellees, instructs FDA to define the term "significant
scientific agreement" for Health Claims on dietary supplement labels and to
allow the use of disclaimers on labels. The decision is located at
http://www.cadc.uscourts.gov/common/opinions/199901/98-5043a.txt |
| WARNING -- FDA is alerting consumers
not to purchase or consume products, some of which are labeled as dietary
supplements, that contain Gamma Butyrolactone (abbreviated as
GBL). FDA has also asked the companies that manufacture
these products to voluntarily recall them. FDA has received reports of
serious health problems -- some that are potentially
life-threatening -- associated with the use of these products.
Additional
Information, FDA Talk Paper T99-5, January 21, 1999 |
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