Whenever a manufacturer wants to sell a dietary supplement, it must ensure the product is safe and that any health claims for the product comply with government regulations and laws. The Food and Drug Administration oversees dietary supplements and has the power to order recalls of any product it finds to be unsafe. However, manufacturers have the duty to ensure their products meet safety and advertising requirements before introducing the product.
Three Categories
The FDA categorizes food and dietary supplement labels and claims into three categories: health claims, nutrient and nutritional content claims and structural or functional claims. A health claim is one that describes a relationship between the dietary supplement, or ingredient, and a health condition or a reduced risk of disease, according to the FDA. A manufacturer, when introducing the product, can only make claims that are supported by evidence and are not untrue or unfair.
Labeling Law
The FDA has authority over health claims on dietary supplements through the Nutrition Labeling and Education Act of 1990. The act allows the FDA to allow health care claims if they are supported by an extensive review of the scientific literature that reveals a well-established relationship between the claim and the ingredient or product. for example, a product can include a claim that "high-calcium diets may reduce the risk of osteoporosis" if such a claim is supported by the scientific literature.
Structure and Function
According to the Office of Dietary Supplements, manufacturers can make structural of functional claims about a product as long as the manufacturer submits the text of the claim to the FDA 30 days before releasing the product. However, the manufacturer does not need to get the language approved, but merely submit it. Structural or functional claims are those that describe how a supplement affects the body or its functions, but does not mention a particular disease. Structural claims must have an accompanying disclosure that states the claim has not been evaluated by the FDA and is not intended to diagnose, cure, prevent or treat a disease.
Qualified Claims
The FDA's 2003 Consumer Health Information for Better Nutrition Initiative allows dietary supplement manufacturers to include health claims if the claim is based on emerging evidence for a relationship between the supplement's ingredient and a health effect. The FDA requires that any such health claim must include a qualification that the evidence is not yet well-enough established, and the evidence that does support the claim is limited.
References
- U.S. Food and Drug Administration: Claims That Can Be Made for Conventional Foods and Dietary Supplements
- U.S. Food and Drug Administration: Overview of Dietary Supplements
- U.S. Food and Drug Administration: Guidance for Industry: Notification of a Health Claim or Nutrient Content Claim Based on an Authoritative Statement of a Scientific Body
- Office of Dietary Supplements: Background Information
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