Overview of Dietary Supplements
FDA regulates both finished dietary supplement products and dietary
ingredients under a different set of regulations than those covering
"conventional" foods and drug products (prescription and
Under the Dietary Supplement Health and Education Act
of 1994 (DSHEA), the dietary supplement or dietary ingredient
manufacturer is responsible for ensuring that a dietary supplement or
ingredient is safe before it is marketed. FDA is responsible for taking
action against any unsafe dietary supplement product after it reaches
the market. Generally, manufacturers do not need to register their
products with FDA nor get FDA approval before producing or selling
dietary supplements.* Manufacturers must make sure that product label
information is truthful and not misleading. Under the FDA Final Rule 21
CFR 111, all domestic and foreign companies that manufacture, package,
label or hold dietary supplement, including those involved with testing,
quality control, and dietary supplement distribution in the U.S., must
comply with the Dietary Supplement Current Good Manufacturing Practices
(cGMPS) for quality control. In addition, the manufacturer, packer, or
distributor whose name appears on the label of a dietary supplement
marketed in the United States is required to submit to FDA all serious
adverse event reports associated with use of the dietary supplement in
the United States.
FDA's other responsibilities
include product information, such as labeling, claims, package inserts,
and accompanying literature. The Federal Trade Commission regulates
dietary supplement advertising.
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
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.
The Dietary Supplement Timeline
The Dietary Supplement Health and Education Act, (http://vm.cfsan.fda.gov/~dms/dietsupp.html) defines dietary supplements as a product (other than tobacco) intended to supplement the diet that bears or contains one or more of the following dietary ingredients: a vitamin, mineral, amino acid, herb or other botanical dietary substance for use to supplement the diet by increasing the total dietary intake; a concentrate, metabolite, constituent, extract, or combination of any ingredient described above and intended for ingestion in the form of a capsule, powder, soft gel, or gelcap, and not represented as a conventional food or as a sole item of a meal or the diet. (NIH, Office of Dietary Supplements). NIH, Office of Dietary Supplements
A dietary supplement is also defined as a product which has the following properties (Burke and Read, 1993): Contains nutrients in amounts similar to the level specified by the recommended dietary allowances to intakes (RDA/RDIs) and similar to amounts found in food. Provides a convenient or practical means of ingesting nutrients especially in a sports setting. Allows or aids in achievement of known physiologic or nutritional requirements of an athlete. Contains nutrients in large amounts for use in reversing a known nutritional deficiency. The efficacy of using the supplements correctly has been acknowledged by exercise physiologists and sports nutrition experts.
Dietary supplements are widely available through many commercial sources including health food stores, grocery stores, pharmacies, and by mail. A review of literature on the use of vitamins and minerals among athletes showed that athletes in general use supplements more often than 35-40% of the general population who use supplements and the 20-25% of the adolescents who use supplements (Sobal and Marquart, 1994). Elite athletes had a mean supplement use of 59% and college athletes had a mean supplement use of 43%. Multivitamins were the most frequent type of nutritional supplements. The second most frequent was vitamin C, followed by iron, B-complex vitamins, vitamin E, calcium, and vitamin A. Iron supplements were used more frequently by women athletes and often in very high amounts (Sobal and Marquart, 1994). According to another study more than 50% of elite women distance runners, non-elite women marathon runners and Ironman tri-athletes of both sexes used vitamin and mineral supplements (Haymes, 1991). Supplement use is most prevalent in sports emphasizing muscle size such as weight lifting or body building (Burke, Gollan, Read, 1991).
History of Dietary Supplement Legislation Timeline
The Federal Food, Drug and Cosmetic Act acknowledges vitamin, mineral, and other dietary properties of foods. The FDA uses the drug provisions of the law to stake its claim to reclassify dietary supplements as drugs based on their label claims.
The first recommended daily allowances (RDAs) are published establishing the basis for the FDA's regulation of vitamins and minerals, despite opposing opinions claiming the RDA was not reflective of current scientific advances on the benefits of nutrients in maintaining health.
The FDA publishes proposed new guidelines for labeling and content of dietary supplements, however, public opposition forces further hearings. Finally in 1973, the FDA publishes final regulations classifying any supplements stronger than 150 percent of the RDA as drugs.
After years of debate over nutritional supplements, Congress passes the Proxmire Bill prohibiting the FDA from regulating vitamins and minerals as prescription drugs. The bill represents a major defeat for the FDA, which worked to repeal the bill.
President Bush signs into law the Nutrition Labeling and Education Act (NLEA) which is intended to improve nutritional information regarding health claims made for products. The FDA is given the job of implementing the law, but because of its broad wording, the agency capitalizes on the opportunity to over-regulate safe and beneficial nutritional products.
The Health Freedom Act is introduced in the Senate along with a similar bill in the House of Representatives to protect the rights of U.S. citizens to choose safe and effective dietary supplements.
To allow for further study of nutritional labeling of dietary supplements, an NLEA Moratorium is enacted in late 1992, postponing implementation of the act.
Passage of the Dietary Supplement Health and Education Act (DSHEA) creates a new framework for regulation of dietary supplements by the FDA.
The White House Commission on Dietary Supplement Labels issues its report on the future regulation of this product category.
The FDA publishes regulations for structure/function claim notification.
Congress includes in the Food and Drug Modernization Act a provision allowing dietary supplements to make health claims.
FDA regulations require that a "Supplement Facts" panel appear on dietary supplement labels.
HERE ARE SOME RELIABLE SOURCES OF NUTRITIONAL INFORMATION: