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Nutrient Content Claims Clarified for Small Businesses

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By: Sean Moloughney

Editor, Nutraceuticals World

FDA has published a guide for small businesses concerning the legal requirements associated with food labeling and the use of certain nutrient content claims, including high potency, antioxidant and sugar-free. Current regulation states that “high potency” may be used in a claim on the label to describe individual vitamins or minerals that are present at 100% or more of the Reference Daily Intakes (RDI) per serving. The label must clearly identify which vitamins or minerals contained within a product are high potency. A company can also claim an entire product is high potency, so long as at least two-thirds of the nutrients are present at 100% of the RDI level or more. FDA also said claims describing antioxidant levels are nutrient content claims and may be used on labels of a food when the conditions of use in the regulation are met (21 CFR 101.54(g)). Such claims can only be made for nutrients for which there is an established RDI. To use a “high” claim, the food would have to contain 20% or more of the Daily Reference Value (DRV) or RDI per serving. For a “good source” claim, the food would have to contain between 10% and 19% of the DRV or RDI per serving. Also, a dietary supplement may include a sugar-free claim, provided it meets all of the eligibility criteria set forth in the regulation (21 CFR 101.60(c)(1)(i)-(iii)) and is also labeled as “low calorie,” “reduced calorie,” or “bears a relative claim of special dietary usefulness.”

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