Key Provisions of DSHEA

The following provisions of DSHEA ensure that millions of Americans have access to safe, affordable dietary supplements:

Definition
DSHEA defines a dietary supplement as any product that contains one or more dietary ingredients, such as vitamins, minerals, herbs or other botanicals, amino acids or other ingredients used to supplement the diet. Dietary supplement ingredients may not be regulated as food additives or drugs.

Safety
The legislation maintains the U.S. Food and Drug Administration's (FDA) authority to safeguard the public against any unsafe product. A dietary supplement can immediately be removed from the market if the FDA believes that it presents a public health hazard.

New Products
Before marketing a new dietary ingredient, a manufacturer must supply the FDA adequate safety information at least 75 days before marketing. A "new dietary ingredient" is one that is first marketed after October 15, 1994.

Structure/Function Claims
Under DSHEA's provisions, dietary supplement makers may include on product labels truthful and non-misleading claims that describe the role of a nutrient in supporting wellness. (Examples of truthful claims include: calcium builds strong bones; antioxidants protect against cell damage.) These claims are referred to as structure/function claims or nutritional support claims. Manufacturers must have proof for these claims and notify the FDA within 30 days of first marketing the supplement.

Consumer Education
Articles from scientific journals or other publications may be distributed by dietary supplement sellers as long as they are not false or misleading, do not promote a specific brand, present a balanced view of the scientific evidence and are displayed separately from dietary supplements.

Labeling
A dietary supplement label must list the name and quantity of each active ingredient; identify the product as a dietary supplement; and for herbal supplements, identify the part of the plant from which it is taken. Nutrition labeling must be presented in a format appropriate to the product.

Good Manufacturing Practices (GMPs)
Under DSHEA, supplements must comply with current good manufacturing practices. The FDA is authorized to issue special regulations on GMPs for dietary supplements, modeled after food GMPs.

Office of Dietary Supplements
DSHEA's passage established an office within the National Institutes of Health to coordinate research on dietary supplements and disease prevention, develop a database of supplement research, and advise the Secretary of Health and Human Services on supplement regulation, safety and health claims.