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Qualified Health Claims

Now you’re entering the gray area of health claims on the food label. Qualified health claims are categorized as such because they do not meet the requirements for significant scientific agreement as set forth by the FDA. Manufacturers must petition the FDA to begin using qualified health claims on labels, and when the claims do appear on packaging, a qualifying statement (such as “supportive but not conclusive evidence shows that_____”) must be included.

The next logical question is this: Just how much evidence is required to petition for a claim? That depends. The FDA has not issued a final ruling on qualified claims, but in the interim, three different categories of evidence are provided in the guidelines—good to moderate level of scientific agreement; low level of scientific agreement; and very low level of scientific agreement.

At this time, food manufacturers are not likely to submit a petition for a claim for which there is a very low level of scientific agreement, but don’t buy a product specifically because of a qualified health claim.

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