Dietary supplements are exempt from the strict regulations applied to the prescription drug industry. A dietary/nutritional supplement is a product that contains vitamins, minerals, herbs or other botanicals, amino acids, enzymes and/or other ingredients intended to supplement the diet. The U.S. Food and Drug Administration (FDA) has special labeling requirements for dietary supplements and treats them as foods, not drugs.
The FDA regulates dietary supplements under a different set of regulations than those covering conventional foods and drug product (prescription and over-the-counter). Under the Dietary Supplement Health and Education Act of 1994 (DSHEA), the dietary supplement manufacturer is responsible for ensuring that a dietary supplement is safe before it is marketed. The FDA is responsible for taking action against any unsafe dietary supplement product after it reaches the market.
DSHEA grants the FDA the authority to establish Good Manufacturing Practices (GMP), which are regulations governing the preparation, packing, and holding of dietary supplements under conditions that ensure their safety. These regulations are to be modeled after current good manufacturing practice regulations in effect for the rest of the food industry.
Information directly from materials provided by the © Institute of Transformational Nutrition, Inc. All Rights Reserved. | transformationalnutrition.com
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