Many people do not realize that the vitamins or other supplement they take on a daily basis are not subject to FDA control, approval, or oversight.  “Dietary supplements”, defined by Congress as a product taken by mouth that contains an ingredient intended to supplement the diet, are considered to be “foods” not “drugs” are not subject to pre-market testing requirements or other oversight provided by the FDA for drugs.  Instead, manufacturers and/or distributors are responsible for determining that their product is safe and that any representations made about them are supported by adequate evidence to show that they are not false or misleading.

Put simply, the FDA does not need to approve any dietary supplement prior to or after the time it is sold. In fact, a manufacturer or distributor of these products is not even required to provide the FDA with the evidence it relies on to substantiate its safety or effectiveness claims either before or after bringing the supplement to market.  The supplement manufacturer is also responsible for determining the appropriate serving size or the amount of a nutrient in any form of dietary supplements without FDA review or approval. The FDA does not analyze dietary supplement ingredients before they are sold to consumers, but rather relies on the manufacturers themselves to ensure that the label and ingredient list are accurate. In order for a dietary supplement to be removed from the market, the FDA and not the manufacturer must show that a supplement is unsafe before it can take action to restrict the product’s use.

What can a consumer do to get information about a specific dietary supplement?  To obtain more information than is provided by the label, you may contact the manufacturer directly for information.  If you believe that you have a problem or illness caused by the use of a supplement, see your healthcare provider and report this problem to the FDA.  The Federal Trade Commission (FTC) can also be contacted to complain about false advertising.  The most important protection the consumer has is their common sense:  if a product makes claims that seem too good to be true, they probably are.

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