Objective Standards for Dietary Supplements
The term "dietary supplement" is defined in section 201(ff) of the Federal Food, Drug, and Cosmetic Act (the Act) as a product (other than tobacco), intended to supplement the diet, that bears or contains one or more of the following dietary ingredients:
Herb or other botanical;
Dietary substance for use by man to supplement the diet by increasing the total dietary intake; or
Concentrate, metabolite, constituent, extract, or combination of any ingredient described above.
A dietary supplement is intended for ingestion in tablet, capsule, powder, soft gel, gel cap, or liquid form. These products are not represented for use as conventional foods or as the sole item in a meal or diet and are labeled as "dietary supplements." Moreover, a dietary supplement may not contain an article that is an approved drug or is authorized for investigation as a new drug, and for which substantial clinical investigations have been initiated and made public, unless that article was marketed as a food or a dietary supplement prior to its approval as a new drug or authorization as an investigational new drug. Vitamin D is an example of a dietary supplement that may soon begin to be marketed as a drug.
The FDA regulates dietary supplements under a different set of rules than those covering conventional foods and drug products (prescription and over-the-counter). Under the Dietary Supplement Health and Education Act of 1994, the manufacturer is responsible for ensuring that a dietary supplement is safe before it is marketed. The FDA is responsible for taking action against any unsafe dietary supplement after it reaches the market. Generally, manufacturers do not need to register their products with the FDA or get FDA approval before producing or selling dietary supplements. However, manufacturers must make certain that product label information is truthful and not misleading.
The FDA's post-marketing responsibilities include monitoring safety (eg, voluntary dietary supplement adverse event reporting) and product information, such as labeling, claims, package inserts, and accompanying literature. The Federal Trade Commission regulates advertising for dietary supplements. Domestic and foreign facilities that also manufacture, process, pack, or hold food for human or animal consumption in the United States are required to register their facilities with the FDA.
Does a Label Indicate the Quality?
It is difficult to determine the quality of a dietary supplement product from its label. The degree of quality control depends on the manufacturer, the supplier, and others in the production chain.
In 2007, the FDA issued Good Manufacturing Practices (GMPs) for dietary supplements, a set of requirements and expectations by which dietary supplements must be manufactured, prepared, and stored to ensure quality. All manufacturers are expected to guarantee the identity, purity, strength, and composition of their dietary supplements. The goal of the GMP is to prevent the inclusion of the wrong ingredients, the addition of too much or too little of a dietary ingredient, the possibility of contamination (by pesticides, bacteria, heavy metals such as lead, etc.), and the improper packaging and labeling of a product.
Medscape Public Health © 2011
Cite this: Olugbenga Obasanjo. Dietary Supplements and the Clinical Encounter - Medscape - Oct 27, 2011.