Aren't dietary supplements unregulated? How does that affect the institution's ability to handle their use?
The regulatory category of "dietary supplements" causes institutions (and clinicians) considerable confusion, both clinically and legally. A key to clarifying the legal issues is understanding the Dietary Supplements Health Education Act of 1994, or DSHEA.
This statute, enacted because of overwhelming consumer interest in making vitamins, minerals, herbs, and other substances more freely available, changed the way the federal Food and Drug Administration (FDA) regulated these substances.
Essentially, the DSHEA affirmed that dietary supplements were to be regulated as "foods," and not "drugs." This means that as a general proposition, so long as they do not make impermissible claims linking their products to treatment or cure of disease, manufacturers of dietary supplements do not have to prove safety and efficacy prior to marketing and distributing dietary supplements interstate.
The legal definition of a dietary supplement is: "a product (other than tobacco) intended to supplement the diet that bears or contains one or more of the following ingredients: (A) a vitamin; (B) a mineral; (C) an herb or botanical; (D) amino acids; (E) a dietary substance for use by man to supplement the diet by increasing the total dietary intake; or (F) a concentrate, metabolite, constituent, extract, or any combination of any ingredient described in clause (A), (B), (C), (D), or (E)." Three of the most popular substances meeting this definition are Echinacea, gingko, and St. John's Wort. These dietary supplements can be found on the shelves of most pharmacies, as well as health food stores.
Manufacturers do not need to register themselves nor their dietary supplement products with FDA before producing or selling them. At present, no FDA regulations specific to dietary supplements establish minimum manufacturing standards, although the FDA likely will issue regulations on good manufacturing practices in the future, to help ensure the identity, purity, quality, strength and composition of dietary supplements.
Many people make the mistake of thinking that the DSHEA leaves dietary supplements unregulated. This is untrue. It is true that because of the DSHEA, the extensive, pre-marketing testing requirements required for new "drugs" do not apply to "dietary supplements." However, under the DSHEA, a dietary supplement is considered unlawfully "adulterated," if it presents a "significant or unreasonable risk of illness or injury" when used as directed on the label, or under normal conditions of use.
In addition, the Secretary of Health and Human Services has authority to remove from the market a dietary supplement that poses an imminent hazard to public health or safety. But, whereas with new drugs, the manufacturer has the burden of proving safety and efficacy, with dietary supplements, the U.S. government has the burden of proving that the product is unsafe, and must be taken off the shelves.
One important aspect of regulation under the DSHEA concerns the labeling of dietary supplements. Under federal law, "labeling" includes what goes on the packaging, inserts, and the promotional material distributed at the point of sale. With passage of the DSHEA, there now are several kinds of claims a manufacturer can make in labeling a dietary supplement, the most common being a disease claim, a health claim, a structure-function claim, a general well-being claim, and a nutrient claim. More information is available in Legal Issues in Alternative Medicine.