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Claims for Dietary Supplements and Functional Food Ingredients

Health study findings abound! One cannot avoid them. Just turn on the evening news or pick up a magazine and you will encounter yet another scientific study whose focus is to demonstrate the healthy aspects of some dietary substance. These studies and their supported findings drive consumer demand for convenient and effective products that provide these health-promoting substances.

These substances are more often extracted, concentrated and sold as dietary supplements, but if these substances were determined GRAS (generally recognized as safe) or approved as food additives, they might be added to foods as “functional food ingredients”. That is to say, ingredients with health-promoting benefits that exceed those based on simple nutritive value. While this sounds reasonable in practice, it becomes more challenging because the FDA does not have a regulatory definition for functional food ingredients. Instead, a functional food ingredient must conform to the regulatory definition of “nutrient supplement” or “health ingredient” if a claim is made. The real hurdle is that claims describing the benefits of a functional ingredient in a manner similar to a “nutrient supplement” are not permitted by FDA without first satisfying the requirement of “significant scientific agreement” by FDA or another “authoritative body.”

Therefore, companies with plans to market their products by promoting health claims must be knowledgeable of both the scientific evidence that substantiates the claims they intend to promote, as well as the regulations governing the claims for dietary supplements and food ingredients.

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