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Thursday, May 24, 2012 4:16:10 PM
http://www.health.gov/dietsupp/ch1.htm
6. Statements of Nutritional Support
Section 6 of DSHEA amends the Nutrition Labeling and Education Act of 1990 (NLEA) health claims provisions of FDCA to allow dietary supplement labels to carry any of four types of statements of nutritional support without obtaining premarketing authorization from FDA. According to DSHEA, an acceptable statement of nutritional support is one that:
. . . claims a benefit related to a classical nutrient deficiency and discloses the prevalence of such disease in the United States, describes the role of a nutrient or dietary ingredient intended to affect the structure or function of humans, characterizes the documented mechanism by which a nutrient or dietary ingredient acts to maintain such structure or function, or describes general well-being from consumption of a nutrient or dietary ingredient.
The legislation requires supplement manufacturers to have substantiation of such label claims and to notify FDA within 30 days after first marketing a product with a statement of nutritional support that such a statement is being made. The label must also carry a disclaimer "prominently displayed and in boldface type" that states:
This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.
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