LHTF: Modules: Regulation

	Regulation
	Case The mother of a 15-year-old patient is asking you about the best brand of echinacea to buy. She is confused about the some of the details printed on the labels of different products.
	Question According to the Dietary Supplement Health and Education Act, which statement may be included on the label?
		The correct answer is A. Acceptable statements on the label include claims about a structure and/or function relationship, e.g. “supports mood”, “helps to maintain healthy intestinal flora” or “helps to increase energy and vitality”. They can NOT claim that the supplement can cure or prevent diseases.
	Other items are now REQUIRED on the label. These include the term “dietary supplement”, the names and quantities of each ingredient (except for patent formulations), the Latin name and plant part (for herbs), and the disclaimer, “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.” (Answer D is a list of the conditions that echinacea was claimed to treat, in 1871!) MORE INFORMATION These websites have information related to the Dietary Supplement Health and Education Act (DSHEA): "An FDA Guide to Dietary Supplements" from the Food and Drug Administration's publication, the FDA Consumer: http://vm.cfsan.fda.gov/~dms/fdsupp.html “USP or NF on the Label” from the U.S. Pharmacopeia: http://www.usp.org/aboutusp/releases/1999/pr_9905.htm An opposing viewpoint from the herb industry perspective: http://www.metromkt.net/viable/herbs16.shtml
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