FDA Issues Antiox Guide for Small Companies

WASHINGTON—FDA published a small entity compliance guide to help small businesses understand the requirements of its final rule on "Food Labeling;Nutrient Content Claims; Definition for High Potency and Definition of Antioxidant for Use in Nutrient Content Claims for Dietary Supplements and Conventional Foods." Upon examining the final rule, FDA found the regulation could have a significant economic impact on a substantial number of small businesses. Therefore, the agency offers this guidance in plain language in accordance with the Small Business Regulatory Enforcement Fairness Act.

The guidance looks at three labeling claim types: high-potency, antioxidant and sugar-free. It defines high-potency as containing 100-percent or more of the RDI (reference daily intake) for individual vitamins and minerals, but the label must specify which nutrients are high-potency. Further, in order to label an entire product high-potency, two-thirds of its nutrients must be at or above RDI levels. While these qualifications apply to dietary supplements, an otherwise high-potency ingredient added to a food product must adhere to food fortification regulations (21 CFR 104.20).

On antioxidants, FDA confirmed claims describing the level of antioxidant nutrients present in a food are considered nutrient content claims and may be used on the label or in the labeling of a food, in conjunction with food regulations (21 CFR 101.54). However, the nutrient must have an established RDI value (per 21 CFR 101.9) and possess antioxidant activity backed by science showing not only absorption in the gastrointestinal tract, but also effects on free radicals in the body. The agency explained, "To use a "high" claim, the food would have to contain 20 percent 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 percent and 19 percent of the DRV or RDI per serving." For beta-carotene, the resulting level of vitamin A must satisfy the claim requirements. While the labeled claim must state the specific antioxidant(s) included in the claim, it is possible for the label to use a symbol, such as an asterisk, to indicate all the included antioxidants throughout the label.

For sugar-free ingredients, FDA confirmed a dietary supplement may use labeling claims such as "sugar free," "no sugar," or other claims described in 21 CFR 101.60, but the product must also be labeled as low-calorie, reduced calorie or "bear a relative claim of special dietary usefulness." Still, if a dietary supplement does not qualify for the low-calorie or reduced calorie label claim, it may still use a sugar-free claim if the product meets the low calorie requirements of CFR 101.60.

For more information on this guidance, visit FDA online.