DSHEA Summary

The Dietary Supplements Health and Education Act of 1994 (DSHEA) amended previous statutes to encompass dietary supplement-specific provisions including the definition of a "dietary supplement", product safety, nutritional statements and claims, ingredient and nutritional labeling, good manufacturing procedures, and the classification of "new" dietary ingredients.

Under the DSHEA, a dietary supplement:

• is a product (other than tobacco) that is intended to supplement the diet, which contains one or more of the following dietary ingredients: a vitamin, a mineral, an herb or other botanical, an amino acid, a dietary substance to supplement the diet by increasing the total daily intake, or a concentrate, metabolite, constituent, extract, or combinations of these ingredients.
• is ingested in pill, capsule, tablet, or liquid form.
• is not represented for use as a conventional food or as the sole item of a meal or diet.
• is labeled as a "dietary supplement."

DSHEA addresses safety concerns by imposing the burden of proof of ingredient safety on the manufacturers of dietary supplements, just as has traditionally been done in the food industry. DSHEA also regulates third-party literature regarding dietary supplements: informational materials (i.e., articles, fact sheets, etc.) may be displayed in commercial retail sites provided they are displayed separately from the product, do not contain false or misleading information, and do not promote a specific brand of supplement.

Perhaps most importantly, DSHEA regulates the labeling of dietary supplements. Under this provision, any claims to prevent, treat, or cure a specific disease are expressly prohibited (unless approved by the FDA). For example, a claim linking folic acid and the reduced risk of neural tube birth defects may be allowed, but a product label that claims the product "cures cancer" or "treats arthritis" is not allowed. Manufacturers, however, can make statements about nutrient deficiency diseases, as long as these statements disclose the prevalence of the disease in the United States. Also, statements describing the supplement's effects on the "structure and function" or general "well-being" of the body are allowed, as long as they are truthful and bear the statement "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." The product label must identify the product as a dietary supplement (ie, "Powdered Garlic Dietary Supplement").

Finally, like food products, dietary supplements must bear nutritional labeling. This information must include the name and quantity of each dietary ingredient, and if the ingredient is botanical in origin, must state the part of the plant from which the ingredient is derived.

Supplement manufacturers may not use ingredients that were not marketed before October 1994, unless the ingredient was already in common use with a history of safety usage similar to its use today. Manufacturers wishing to use new dietary ingredients must notify the FDA 75 days before marketing the product, and must provide the FDA with evidence demonstrating that the ingredient "will reasonably be expected to be safe."

DSHEA also grants the FDA the authority to establish good manufacturing processes (GMPs) governing the production of dietary supplements.

For a more information about the DSHEA Act, go to:

FDA's Summary of DSHEA
http://vm.cfsan.fda.gov/~dms/dietsupp.html

Full text of DSHEA at HealthWorld Online
http://www.healthy.net/public/legal-lg/fedregs/S784_ENR.HTM>http://www.cfsan.fda.gov/~dms/dietsupp.html