Spirulina is sold in health food stores and similar outlets as a dietary supplement. There appears to be a lack of understanding about their regulatory status. Until 1994 dietary supplements were regulated as foods by FDA. However, with passage of the Dietary Supplement Health and Education Act of 1994 (DSHEA), Congress amended the food regulations to include several provisions that apply only to dietary supplements and dietary ingredients of dietary supplements. As a result of these provisions, dietary ingredients used in dietary supplements are no longer subject to the pre-market safety evaluations required of other new food ingredients or for new uses of old food ingredients. They must, however, meet the requirements of other safety provisions. FDA defines a dietary supplement as "a product (other than tobacco) that is intended to supplement the diet that bears or contains one or more of the following dietary ingredients: a vitamin, a mineral, an herb or other botanical, an amino acid, a dietary substance for use by man to supplement the diet by increasing the total daily intake, or a concentrate, metabolite, constituent, extract, or combinations of these ingredients." Under DSHEA a dietary supplement is adulterated if it or one of its ingredients presents "a significant or unreasonable risk of illness or injury" when used as directed on the label, or under normal conditions of use. If a dietary supplement contains a new dietary ingredient (i.e., an ingredient not marketed for dietary supplement use in the United States before October 15, 1994), it may be considered adulterated when there is inadequate information to provide reasonable assurance that the ingredient will not present a significant or unreasonable risk of illness or injury. DSHEA was enacted to meet the concerns of consumers and manufacturers to help ensure that safe and appropriately labeled products remain available to those who want to use them, and taking into consideration "that there may be a positive relationship between sound dietary practice and good health, and that, although further scientific research is needed, there may be a connection between dietary supplement use, reduced healthcare expenses, and disease prevention." The DSHEA provides for the use of various types of claims or statements on the label of dietary supplements, although claims may not be made about the use of a dietary supplement to diagnose, prevent, mitigate, treat, or cure a specific disease. A disclaimer must be placed on the label to this effect. Claims related to effects of a dietary supplement on the structure and function of the body are allowed. In this regard there are several structure and function claims made for Spirulina by manufacturers. The structure and function claims that are made for Spirulina point mainly to its immunomodulation, and antioxidant/anti-inflammatory effects. These claims are made on the basis of the review of the scientific evidence to support such a claim. DSHEA stipulates that there is evidence to support the claim but FDA does not require submission of such information for approval of a substance as a dietary supplement. Health Canada, the Canadian equivalent of the US FDA, does require submission of the evidence before approval for marketing of products and because of this allows similar or stronger claims to be made without any disclaimer. For more information on DSHEA the reader is referred to the following FDA website: www.cfsan.fda.gov/~dms/dietsupp.html
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