History

• The FDA regulates all dietary supplements under the Dietary Supplement Health and Education Act (DSHEA) of 1994. Congress enacted DSHEA after public debate about the need for dietary supplements as part of a healthy life, as well as controversy surrounding the FDA's regulatory approach to dietary supplements. Under DSHEA, minerals fall under the definition of a dietary supplement, and the FDA holds responsibility for monitoring safety and taking action against any unsafe dietary supplement product after it is on the market. The FDA's website offers a variety of articles and consumer advisories to assist in determining the safety of supplements. Found on the website are warnings and safety information, labeling and regulatory details.(see Resources)
  
  

Features

• DSHEA places responsibility on the manufacturer to make sure that information on the mineral's label is true and not misleading. If a dietary supplement contains a new ingredient, then the FDA will review that ingredient for safety only, not effectiveness. The FDA can take a product off the market if it is found to be unsafe or it boasts false claims. MedWatch is one FDA program available for reporting adverse reactions to dietary supplements. A form to submit claims is available on the FDA's website. (see Resources) DSHEA also created the Office of Dietary Supplements (ODS) in the National Institutes of Health (NIH), which coordinates scientific research concerning dietary supplements and advises Federal agencies.
  
  

Significance

• As people become more aware of their diet and nutrient needs, the dietary supplement market continues to grow. In 2007, the dietary supplement industry sold $23.7 billion worth of vitamins and minerals. While it is easy to clump all into the category of "vitamins," minerals are actually a separate group of dietary supplements also regulated by the FDA. Most minerals are well studied and it is clear the benefits they can provide our bodies. However, although minerals are widely available in supplement form, a pill should not replace a healthy diet. In some cases, taking too high a dose of certain minerals can cause harm. This is why regulation and monitoring the supplement's safety is important.
  
  

The Facts

• Minerals are needed by the body for a variety of functions, from healthy bones and teeth to muscle contraction. For the most part, you can meet your body's needs for minerals by eating a wide variety of foods. However, there may be cases in which your doctor will recommend a mineral supplement. Common mineral supplements include calcium for bone health and iron for healthy blood cells. Since it is possible to have too much of a good thing, the FDA must monitor for false claims such as a higher dose than listed on the label. The FDA does have the power to remove a product from the market if it is shown to be unsafe.
  
  

Expert Insight

• In a 2009 position paper, the American Dietetic Association (ADA) states that while about one-third of American adults use dietary supplements, a well-balanced diet is the best strategy to promote optimal health. The ADA warns that most consumers are not well informed about the safety and efficacy of the supplements they are taking. This is one reason why the FDA's regulation is important to mineral and other dietary supplements. Dietitians are one group of health professionals who often report adverse effects of supplements to the FDA's MedWatch program.