Vitamins and Dietary Supplements

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• What is a dietary supplement?
• What is a "new dietary ingredient" in a dietary supplement?
• What is FDA's role in regulating dietary supplements versus the manufacturer's responsibility for marketing them?
• When must a manufacturer or distributor notify FDA about a dietary supplement it intends to market in the U.S.?
• What information must the manufacturer disclose on the label of a dietary supplement?
• Must all ingredients be declared on the label of a dietary supplement?
• Are dietary supplement serving sizes standardized or are there restrictions on the amount of a nutrient that can be in one serving?
• Where can I get information about a specific dietary supplement?
• Who has the responsibility for ensuring that a dietary supplement is safe?
• Do manufacturers or distributors of dietary supplements have to tell FDA or consumers what evidence they have about their product's safety or what evidence they have to back up the claims they are making for them?
• What is FDA's oversight responsibility for dietary supplements?
• Does FDA routinely analyze the content of dietary supplements?
• Is it legal to market a dietary supplement product as a treatment or cure for a specific disease or condition?
• Who validates claims and what kinds of claims can be made on dietary supplement labels?
• Why do some supplements have wording (a disclaimer) that says: "This statement has not been evaluated by the FDA. This product is not intended to diagnose, treat, cure, or prevent any disease"?
• How are advertisements for dietary supplements regulated?
• How do I, my health care provider, or any informed individual report a problem or illness caused by a dietary supplement to FDA?

What is a dietary supplement?

Congress defined the term "dietary supplement" in the Dietary Supplement Health and Education Act (DSHEA) of 1994. A dietary supplement is a product taken by mouth that contains a "dietary ingredient" intended to supplement the diet. The "dietary ingredients" in these products may include: vitamins, minerals, herbs or other botanicals, amino acids, and substances such as enzymes, organ tissues, glandulars, and metabolites. Dietary supplements can also be extracts or concentrates, and may be found in many forms such as tablets, capsules, softgels, gelcaps, liquids, or powders. They can also be in other forms, such as a bar, but if they are, information on their label must not represent the product as a conventional food or a sole item of a meal or diet. Whatever their form may be, DSHEA places dietary supplements in a special category under the general umbrella of "foods," not drugs, and requires that every supplement be labeled a dietary supplement.

What is a "new dietary ingredient" in a dietary supplement?

The Dietary Supplement Health and Education Act (DSHEA) of 1994 defined both of the terms "dietary ingredient" and "new dietary ingredient" as components of dietary supplements. In order for an ingredient of a dietary supplement to be a "dietary ingredient," it must be one or any combination of the following substances:

• a vitamin,
• a mineral,
• an herb or other botanical,
• an amino acid,
• a dietary substance for use by man to supplement the diet by increasing the total dietary intake (e.g., enzymes or tissues from organs or glands), or
• a concentrate, metabolite, constituent or extract.

A "new dietary ingredient" is one that meets the above definition for a "dietary ingredient" and was not sold in the U.S. in a dietary supplement before October 15, 1994.

SOURCE: FDA.gov; "Overview of Dietary Supplements," May 7, 2009.