Nutrition Science and Everyday Application - beta v 0.1

DIETARY SUPPLEMENTS 455
REGULATION OF DIETARY SUPPLEMENTS
A dietary supplement is defined as a product that: 1
• is intended to supplement the diet
• contains one or more dietary ingredients (e.g., vitamins, minerals, herbs or other
botanicals, amino acids, and enzymes)
• can be taken by mouth as a pill, capsule, tablet, or liquid
• is labeled as being a dietary supplement
The Food and Drug Administration (FDA) regulates dietary supplements, but under a
different set of regulations than foods, pharmaceuticals, and over-the-counter drugs. In
1994, the Dietary Supplement Health and Education Act (DSHEA) created new regulations
for the labeling and safety of dietary supplements. Under these rules, the “FDA is not
authorized to review dietary supplement products for safety and effectiveness before
they are marketed.” 3 Therefore, the responsibility falls on the manufacturers and
distributors of dietary supplements to ensure their products are safe before they go to
consumers. The FDA has to prove that the product is unsafe in order to remove it from
the market. This is a big contrast from pharmaceuticals, which must obtain approval from
the FDA, showing substantial evidence that their drugs are safe and effective before reaching
the marketplace.
The FDA issued Good Manufacturing Practices (GMPs) for dietary supplements in 2007.
GMPs are a set of requirements and expectations by which dietary supplements must be
manufactured, prepared, and stored to ensure quality. 4 Manufacturers are expected to
guarantee the identity, purity, strength, and composition of their dietary supplements. 4
Once a dietary supplement is on the market, the FDA tracks side effects reported by
consumers, supplement companies, and others. If the FDA finds a product to be unsafe, it
can take legal action against the manufacturer or distributor and may issue a warning or
require that the product be removed from the marketplace. However, the FDA says it can’t
test all products marketed as dietary supplements that may have potentially harmful hidden
ingredients.
SAFETY OF DIETARY SUPPLEMENTS
With current regulations, the safety of dietary supplements is the manufacturers’
responsibility. Unfortunately, manufacturers don’t always have the public’s best interest in
mind, especially when there is a profit to be gained.