Dietary supplements are classified as foods, not drugs, by the FDA. This means that, as long as all ingredients are recognized as safe for consumption, the product is allowed on the market. Therefore, the regulation of these products is much less vigorous than for drugs.
As an informed consumer, you should take note of the following:
a) Supplements do not need approval from the Food & Drug Administration before they are marketed.
b) The manufacturer is responsible for determining that the product is safe; the FDA does not test it for safety before it is sold.
c) Supplement companies don’t have to provide the FDA with any evidence that the supplements are safe, unless the company is marketing a new dietary ingredient that was not sold in the USA prior to 1994.
d) At this time, there are no federal guidelines on practices to ensure the purity, quality, safety & composition of supplements
e) There are no rules to limit the serving size or amount of a nutrient in any supplement.
f) Once a supplement is marketed, it is the FDA’s responsibility to prove that a product is unsafe before it can be removed from the market.
Taken from: Nutrition For Life, 3rd edition, by Thompson & Manore.