How are nutritional supplements regulated?

The Dietary Supplement Health and Education Act (DSHEA), which passed in 1994, completely describes the regulation rules and process. In summary: Under DSHEA, the company is responsible for determining that the dietary supplements it manufactures or distributes are safe and that any representations or claims made about the product are substantiated by adequate evidence to show they are not false or misleading. Under DSHEA, once the product is marketed, the Food & Drug Administration (FDA) has the responsibility for showing that a dietary supplement (DS) is "unsafe," before it can take action to restrict the product's use or removal from the marketplace. However, manufacturers and distributors of DS must record, investigate and forward to FDA any reports they receive of serious adverse events associated with the use of their products that are reported to them directly. FDA is able to evaluate these reports and others to identify early signs that a product may pose safety risks. Also as of 2011 all DS manufacturers must follow Current Good Manufacturing Practices (cGMPs), which means testing is required for all raw materials and finished products. These new regulations focus on practices that ensure the identity, purity, quality, strength and composition of dietary supplements. If you are worried about safety, here is some comforting information: The Townsend Letter, April 2010, reported that according to the most recent information collected by the US National Poison Data System, (174 page annual report of the American Association of Poison Control Centers, published in the journal Clinical Toxicology), there was not even one death cause by a dietary supplement. Additionally, there were zero deaths from multiple or B vitamins, zero deaths from vitamins A, C, D or E , zero deaths from minerals, and zero deaths from any other vitamin or herbal products. No man, woman or child died from nutritional supplements. Compare this to a report published in JAMA that said that an estimated 2,216,000 (1,721,000 to 2,711,000) hospitalized patients had serious adverse drug reactions (ADRs) and 106,000 (76,000 to 137,000) had fatal ADRs, making these reactions between the fourth and sixth leading cause of death.  And just to clarify, these were patients who received the correct doses of the correct drugs administered by the proper health care professional that still had so many ADR's that it is a leading cause of DEATH!

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