Article: The new qualified health claims process; examining FDA's new qualified health claim rating system.(Capitol Comments)

On July 10th, FDA announced the publishing of an interim guidance document regarding the qualified health claims process. The interim guidance is aimed at permitting a wide variety of qualified health claims that would have been considered by the Agency to be impermissible in the past. Before discussing the guidance, this column will first discuss what constitutes a health claim.

Health Claims in General

As a general matter, health claims discuss the relationship between a particular food, nutrient or dietary ingredient and a disease. Disease is defined in general terms as damage to an organ, part, structure or system of the body such that it does not ...

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