FDA Regulation of Nutritional Supplements
Under the Dietary Supplement
Health and Education Act of 1994 (DSHEA), manufacturers of nutritional
supplements are responsible for ensuring that their products are safe before
they are marketed. Manufacturers of nutritional supplements do not need to
provide information to the Food and Drug Administration Board, before they
can get a product out on the market. They also do not need the board’s
review and approval of the supplement’s ingredients before selling these
products. FDA
regulation of nutritional supplements can be initiated in the form of
studies, reviews, reports, scientific literature, and public comments. This
was what happened in 1997, when the FDA proposed to limit the amount of
ephedrine alkaloids (also known as ephedra, Chinese ephedra, Ma huang, and
epitonin) in dietary supplements, as it was found to cause a range of side
effects such as dizziness, nervousness, changes in heart rate and blood
pressure, chest pain, stroke, hepatitis, seizure, psychosis, and even death.
For more information on other potentially dangerous dietary supplements, you
can visit the FDA website.
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