What types of claims are there and which are allowed?
A Health Claim is an explicit, or implied characterization of a relationship between a substance and a disease, or a health-related condition. This type of claim requires significant scientific agreement and must be evaluated and authorized by FDA prior to use, such authorization is only provided to FDA-approved Drugs. The approval process is lengthy and very expensive.
A health claim or Drug claim describes the effect a substance has on reducing the risk of or preventing a disease, e.g., "calcium may reduce the risk of osteoporosis," or "helps to prevent blindness"
A Structure/Function claim describes the role of a substance intended to maintain the structure or function of the body. Structure/function claims do not require preapproval by FDA. Examples of such structure/function claims are more categorical, and include: Bone Health, Immune Support, etc.
The FDA authorizes only the following types of structure/function claims:
- A statement that claims a benefit related to a classical nutrient deficiency disease and that discloses the prevalence of such disease in the U.S.;
- A statement that describes the role of a nutrient or dietary ingredient intended to affect the structure or function in humans, or characterizes the documented mechanism by which a nutrient or dietary ingredient acts to maintain such structure or function; or
- A statement that describes the general well-being from consumption of a nutrient or dietary ingredient.
Manufacturers making structure/function claims in their products' labeling must possess substantiation that such statements are truthful and not misleading. They must also include the standard DFA disclaimer and notify FDA no later than 30 days after the first marketing of the product that they are making the statement.
Why these claims may be made at all - and, in fact, why supplements still exist and may be marketed to consumers - is the direct result of the Dietary Supplement Health Education Act (DSHEA) of 1994, when people demanded their right to natural medicines and prevented regulators from removing them from the market altogether. Your right to choose the remedies you want is constantly at risk.
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