Before the Dietray Supplement Health and Education Act was passed in 1994, dietary supplements were subjected to same regulations as other foods.
The FDA defines a dietary supplement as a product which is taken by mouth and contains a "dietary ingredient." The dietary ingredient may include any of the following: vitamins, minerals, herbs, botanicals, amino acids, enzymes, organ tissues, glandules and metabolites. The purpose of these products is to supplement what is missing from the normal diet. Dietary supplements, however, are not regulated the same way as prescription drugs or over-the-counter medication. Consumers need to understand how these products are regulated so that they do not become victim of false claims.
Supplment Safety
According to the Dietary Supplement Health Act of 1994, dietary supplement manufacturers are responsible for ensuring that a dietary supplement is safe before it's marketed. FDA steps into the picture if it is discovered that a product is unsafe. This is generally determined after the supplement has been on the market and consumers have raised complaints. FDA does not require testing of supplements, so if you purchase an unfamiliar product, there's no guarantee that the product is safe or effective.
Marketing
The manufacturer is responsible for ensuring that the claims about its products are true. The Federal Trade Commission regulates the advertising of supplements while the FDA's Center for Food Safety and Applied Nutrition (CFSAN) monitors for products with false or misleading claims.
New Ingredients
New dietary ingredients are an exception as far as requiring the manufacturer to report the ingredient to the FDA and demonstrate that the ingredient is safe. There is a catch to this requirement. Since no authoritative list of ingredients exists prior to October 15, 1994, it is the sole responsibility of the manufacturer to determine whether an ingredient is "new."
Health Claims
The Nutrition Labeling and Education Act (NLCEA) of 1990, the Dietary Supplement Act of 1992, and the Dietary Supplement Health and Education Act of 1994 define a health claim as anything that describes the relationship between a food, a food component or dietary supplement and the risk of a disease. An example of a health claim is the following: "Saturated fat increases cholesterol levels." The FDA approves of health claims as long as there is scientific literature and research which supports the claim. Whenever a manufacturer makes a claim about the function of the supplement, the product must carry a disclaimer which states that the FDA has not evaluated the claim.
Labeling
The FDA requires that the label of a dietary supplement lists the following: descriptive name, name and place of business, complete list of ingredients and net content of product. The product must be labeled as a supplement. Supplements cannot be marketed as treatments or cures.
Adverse Reaction
By law, producers or distributors of supplements must contact the FDA if they receive reports of adverse effects. Should you or somone you know experience an adverse reaction due to dietary supplements, contact your doctor immediately. File a complaint by calling the MedWatch hotline at 800-FDA-1088.
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