Paul Gross03.01.09
Branding of nutraceuticals and other natural products like superfruit juices with antioxidant content infers that polyphenol pigments-flavonoids, anthocyanins, ellagitannins, catechins, proanthocyanidins and others with antioxidant activity in vitro-provide health benefits. However, such marketing defies scientific knowledge because there is no physiological evidence that polyphenols have any such action in humans.
In July 2008, FDA republished guidance for industry using antioxidant claims, with the terms specified for the regulation of product labels and marketing literature pertaining to antioxidants.
Stated with the release, FDA declared: "This guidance document restates in plain language the legal requirements set forth in 21 CFR 101.54(f) and (g) and 21 CFR 101.60(c)(1)(iii)(A) concerning dietary supplement use of certain nutrient content claims. This regulation is binding and has the full force and effect of law."
Is an antioxidant claim a nutrient content claim?
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