Before and After DSHEA

DSHEA
DSHEA is the acronym for the Dietary Supplement Health and Education Act of 1994, which Congress passed by unanimous consent in October 1994. President Bill Clinton signed the legislation into law (PL 103-417) on Oct. 25, 1994.

Dietary Supplements: Foods not Drugs back to DSHEA book page
Dietary supplements have been regulated as a category of foods throughout the history of the Food, Drug and Cosmetic Act. DSHEA reaffirmed that dietary supplements are to be regulated as foods.

Critics of dietary supplements allege that dietary supplements are "unregulated." In fact, virtually all facets of dietary supplement manufacturing, labeling and advertising are covered by extensive regulations issued and enforced by the Food and Drug Administration (FDA) and by the Federal Trade Commission (FTC).

When critics say dietary supplements are "unregulated," what they generally mean is that dietary supplements are not regulated like drugs. This is true because dietary supplements are regarded and regulated as food, not drugs.

Dietary Supplements Defined back to DSHEA book page
DSHEA defines dietary supplements as products intended to supplement the diet.

According to DSHEA, dietary supplements may contain vitamins, minerals, herbs or other botanicals, amino acids, other dietary substances, or combinations or extracts of any of these "dietary ingredients."

Dietary Supplements: Product Form back to DSHEA book page
DSHEA allows consumers access to dietary supplements in a wide range of product forms, such as tablets, capsules, powders, or liquids. They also may be marketed in the form of a conventional food, provided they are labeled as dietary supplements.

Dietary Supplement Ingredients: Old and New back to DSHEA book page
DSHEA made it clear that ingredients of dietary supplements could not be regulated as food additives. Instead, the legislation created two categories of dietary supplement ingredients - old (or "grandfathered") ingredients and "new dietary ingredients."

DSHEA grandfathered all dietary supplement ingredients marketed in the United States before Oct. 15, 1994. These are considered safe for continued consumer use.

Before marketing a "new dietary ingredient," manufacturers must provide FDA with their basis for judging that the ingredient "is reasonably expected to be safe." This information must be provided at least 75 days before marketing a new ingredient.

Safety of Dietary Supplements back to DSHEA book page
DSHEA preserves FDA's legal authority to take immediate enforcement action against any food, including a dietary supplement, that is adulterated (unsafe). A product is considered to be unsafe if it "may be injurious to health." This is the fundamental authority that has permitted FDA to ensure the safety of the food supply since 1906.

DSHEA adds additional authority for FDA to take action against unsafe dietary supplements. The new provision says that a dietary supplement is adulterated (unsafe) if it presents "a significant or unreasonable risk of illness or injury" under the conditions of use suggested in the labeling of the product.

In any legal action, FDA bears the burden of proof to show that a dietary supplement is unsafe.

Labeling Dietary Supplements back to DSHEA book page
DSHEA requires the name of a dietary supplement to include the word "supplement," for example, Vitamin C Supplement, Multivitamin Supplement, Garlic Supplement.

DSHEA requires dietary supplement labels to list the name and quantity of all nutrients or other dietary ingredients in the product and to bear nutrition labeling. FDA regulations implementing these requirements were finalized on Sept. 23, 1997. The regulations require a specific labeling format featuring a prominent box with the heading "SUPPLEMENT FACTS."

Health Claims for Dietary Supplements back to DSHEA book page
DSHEA did not change the law or regulations regarding "health claims," as defined by the Nutrition Labeling and Education Act of 1990. Health claims describe the relationship between a nutrient and a disease.

For all foods, including dietary supplements, health claims generally are permitted on the label only if the statement is preauthorized by FDA and based on "significant scientific agreement." The FDA Modernization Act of 1997 provides the only exception, by allowing health claims based on authoritative statements of scientific bodies.

Example of a health claim: "Especially for teen and young adult women, adequate calcium in a healthful diet may reduce the risk of osteoporosis later in life."

Nutritional Support Statements for Dietary Supplements DSHEA allows dietary supplement labels to provide consumers with useful information in the form of "statements of nutritional support."

Statements of nutritional support describe the role of dietary supplements in affecting the structure or function of the body or in affecting general well-being. Example: Calcium builds strong bones and teeth.

DSHEA requires manufacturers to have substantiation that the nutritional support statement is truthful and not misleading. Also, manufacturers must notify FDA within 30 days of making the label statement.

When a statement of nutritional support appears on a dietary supplement label, DSHEA requires the label to display prominently the following disclaimer:

This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.

Publications Provided to Consumers back to DSHEA book page
DSHEA permits publications to be given to consumers in conjunction with the sale of dietary supplements, provided certain conditions are met, without those publications being considered "labeling." This increases the ability to use materials such as scientific articles to help consumers make informed decisions about dietary supplements.

Good Manufacturing Practices (GMPs) for Dietary Supplements back to DSHEA book page
As foods, dietary supplements are required to comply with good manufacturing practices (GMPs) for foods. GMPs require that:

• food-processing personnel follow sanitary procedures and have suitable training;
• processing facilities be clean;
• processing equipment be designed to permit thorough cleaning and be properly maintained;
• quality controls are in place to assure that raw materials are wholesome; and
• finished products are appropriately packaged, labeled, stored, and shipped.

DSHEA confirmed that dietary supplements must comply with current GMPs and also authorized FDA to establish separate GMPs for dietary supplements. FDA published a notice regarding new dietary supplement GMPs in February 1997, based on a draft submitted jointly by the Council for Responsible Nutrition (CRN) and other industry groups. The new proposal would expand dietary supplement GMPs to require more extensive quality control, testing, and record keeping.

Regulating Dietary Supplement Advertising
back to DSHEA book page
DSHEA did not change FTC's authority to regulate the advertising of dietary supplements. Because of confusion in the industry about FTC substantiation standards, the FTC issued guidelines on dietary supplement advertising in November 1998.

Commission on Dietary Supplement Labels
back to DSHEA book page
DSHEA required the President to appoint a Commission on Dietary Supplement Labels, to consider how best to provide consumers with truthful, scientifically valid information about dietary supplements. The commission, appointed in 1995, issued its final report in November 1997. View the full text of the report.

Office of Dietary Supplements back to DSHEA book page
DSHEA established an Office of Dietary Supplements (ODS) at the National Institutes of Health (NIH) to facilitate the scientific study of the benefits of dietary supplements for promoting health and preventing disease. For information about ODS and its activities, see the ODS homepage.