Under the terms of the 1994 Dietary Supplement Health and Education Act, dietary supplement manufacturers do not need to get approval from the Food and Drug Administration, or FDA, before they sell their products. The manufacturers have the responsibility to determine if a product is fit for human consumption before they bring it to market. However, the FDA has the ability to investigate supplements and order their removal if it finds them to be unsafe.
Dietary Supplements
A dietary supplement, according to the DSHEA, is any product taken by mouth that is intended to supplement a person's diet. Dietary supplements are not considered drugs, and contain "dietary ingredients" such as vitamins, herbs, botanicals, amino acids and enzymes. These supplements must be safe for human consumption, and the manufacturer has the responsibility to ensure this is so. The manufacturer must also ensure that any claims made by the supplement's advertising or marketing must be supported by evidence.
Unsafe Products
Once a manufacturer markets or sells a dietary supplement, it can continue to do so as long as the FDA does not determine the product is unsafe. If the FDA wants to remove a product from the marktplace, it has to investigate the product and prove that it poses a health risk. Because the FDA can only remove a product after it has found it to be unhealthy, there is a necessary lag between the consumer's exposure to the product and its removal for negative health effects. The FDA recommends that consumer investigate all dietary supplements carefully before deciding to use them
Recall List
Whenever the FDA issues a recall, it lists the recalled product on its website: fda.gov. The FDA categorizes the recalls under several categories, including food, drugs, animal health and others. The agency also maintains a history of weekly "enforcement reports" on its websites. These reports contain information about all the recalls or enforcement actions the agency has taken against unsafe dietary supplements. You can search these reports with keywords, by year or by week.
Adverse Health Effects Reports
The DSHEA also requires dietary supplement manufacturers to report any adverse health effects of which it is aware to the FDA. The FDA's website allows visitors to search through these reports, known as "Adverse Event Reports." These reports often serve as warning that a product may be unhealthy, and the FDA uses these to investigate potentially unhealthy products.
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