Dietary supplements are defined by which act?

Dietary supplements are defined by which act?

• A. Defined by DSHEA
• B. Dietary Supplements Act
• C. FDA Dietary Supplement Act
• D. Food and Supplements Act

Answer: (A)

DSHEA, the Dietary Supplement Health and Education Act of 1994, is the law that defines dietary supplements. It created a distinct regulatory category for these products, separate from drugs and conventional foods. Under DSHEA, a product marketed as a dietary supplement must contain vitamins, minerals, herbs, amino acids, or other dietary ingredients and be intended to supplement the diet. The act sets labeling rules (such as the Supplement Facts panel) and what kinds of claims can be made—structure/function claims are allowed if not misleading and with a disclaimer, while disease treatment claims require FDA drug approval. It also places responsibility on manufacturers to ensure safety and truthful labeling, with the FDA able to take action against unsafe products after they reach the market. Importantly, dietary supplements do not require premarket approval like drugs. That combination of definition, labeling, and regulatory expectations is what DSHEA establishes, making it the correct reference for defining dietary supplements.

DSHEA, the Dietary Supplement Health and Education Act of 1994, is the law that defines dietary supplements. It created a distinct regulatory category for these products, separate from drugs and conventional foods. Under DSHEA, a product marketed as a dietary supplement must contain vitamins, minerals, herbs, amino acids, or other dietary ingredients and be intended to supplement the diet. The act sets labeling rules (such as the Supplement Facts panel) and what kinds of claims can be made—structure/function claims are allowed if not misleading and with a disclaimer, while disease treatment claims require FDA drug approval. It also places responsibility on manufacturers to ensure safety and truthful labeling, with the FDA able to take action against unsafe products after they reach the market. Importantly, dietary supplements do not require premarket approval like drugs. That combination of definition, labeling, and regulatory expectations is what DSHEA establishes, making it the correct reference for defining dietary supplements.