Buyer Be Aware

Here are some facts about dietary supplements:

• Manufacturers are responsible for making sure that their dietary supplement is safe. They do not need to register with FDA or get FDA approval before producing or selling their product. Investigations into whether a supplement may react adversely in combination with certain drugs, and in certain people, are not required. Should numerous reports of a bad reaction surface once a product reaches the market, the FDA will intervene. Then it is up to the FDA to show that the product is unsafe.
  
  
• Often some scientific evidence supports a manufacturer's claims about a given supplement. But the current law allows manufacturers to make their claims without ever submitting such studies to the FDA. Manufacturers are required to have substantiating evidence on hand in case the FDA chooses to investigate.
  
  
• Manufacturers are responsible for ensuring that their product's ingredient list is accurate. But some supplements have been shown to contain different amounts of the active ingredient from bottle to bottle within the same brand. In one case, Aurora Health Care withdrew its brand of St. John's wort from 70 retail pharmacies in 1999 when a reporter discovered that the product contained only 5.3% of the amount of active ingredient claimed on its label.
  
  
• The FDA specifically prohibits manufacturers from claiming that dietary supplements can treat or prevent actual disease. Products may only describe ways in which they affect the body's "structure or function" with statements such as "supports the immune system." In a new ruling, products can now claim to treat certain "life stage" conditions, such as acne associated with adolescence, or morning sickness during pregnancy. Supplements must carry a disclaimer clarifying that such statements have not been evaluated by the FDA.

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