Dietary Supplement Legislation Enhances Opportunities to Market “Nutraceutical”-Type Products

Abstract

Passage of the U.S. Dietary Supplement Health and Education Act of 1994 (DSHEA) clears the way for companies to market products that do not meet the strict, established regulatory definitions of “food” (a product used primarily for characteristics such as taste, aroma, or basic nutrition) or “drug” (a product used to cure, mitigate, treat, or prevent disease). The law broadens the definition of “dietary supplements” in such a way that some foods and food ingredients may qualify as “supplements.” It lightens regulatory restrictions on the use of dietary ingredients in dietary supplements, by changing the safety standard for use of ingredients, and by regulating the claims made on new products by policing them once they're placed on the market, instead of requiring preclearance of claims. DSHEA allows manufacturers and retail stores greater freedom in the type of information they may provide on packaging and at the point of sale of products. The law permits “statements of nutritional support” on labels or in other labeling, and enables retailers to sell books, articles, and other publications that provide health-related information.

Key Words:

• 1994 Dietary Supplement Health Education Act
• regulatory definitions
• exemption of dietary ingredients from food additive status
• regulation of labeling of dietary supplements and foods
• safety standards
• statements of nutritional support