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Health Insurance

How are supplement claims regulated?

A Answers (3)

  • ATod Cooperman, MD, Pharmacy, answered
    Dr. Tod Cooperman - How are supplement claims regulated?

    Consumer healthcare specialist Dr. Tod Cooperman explains how supplement claims are regulated in the U.S. Watch Dr. Cooperman's video for tips and information on nutritional supplements.


  • ADebra Fulghum Bruce PhD, Healthcare, answered
    While the dietary supplement industry is not regulated by the Food and Drug Administration (FDA), in 1994 the FDA established standards for manufacturers assuring that supplements bear ingredient and nutritional labeling. For instance, according to the FDA, herbal supplements must state the part of the plant from which the ingredient is derived. Other than that, manufacturers are free to make whatever claims they want on the supplement label or in literature, and there is no assurance that these claims are valid. That’s why you need to be cautious when choosing dietary supplements, including herbal remedies. 
  • ARebecca S. Reeves, Nutrition & Dietetics, answered on behalf of National Lipid Association

    The makers of dietary supplements are allowed to make 4 kinds of claims on the labels of their products.

    1. Nutritional Claims - These are statements about the general effects dietary supplements, vitamins and minerals have on diseases known to be caused by a nutrient deficiency, such as "vitamin C prevents scurvy." But the label must also state how many cases of the disease occur in the US.
    2. Claims of Well-Being – These are statements that could say “makes you feel better." These claims do not require pre-approval by the FDA.
    3. Health Claims – These are statements about known health benefits of certain compounds, such as “folate may reduce the chance of pregnant women delivering an infant with neural tube defects."  The FDA must pre-approve all health claims and requires that they be supported by evidence form scientific studies.
    4. Structure/Function Claims – These are the most confusing claims made to consumers.  They are claims about the effects of the dietary supplement on the structure or function of the body.  Dietary supplements may not make any claims regarding the treatment of diseases.  These claims may contain the following information:
      1. The product’s mechanism of action ("works as an antioxidant")
      2. The product’s effects on cellular structure ("helps membrane stability")
      3. The product’s effects on body’s physiology  ("promotes normal urinary flow")
      4. The product’s effects on chemical or lab test results ("supports normal blood glucose")
      5. Claims of maintenance ("helps maintain a healthy circulatory system")
      6. Claims for common conditions and symptoms related to life stages ("reduces irritability, bloating and cramping associated with premenstrual syndrome")
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