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 or in labeling 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% RDI level or more.

The high potency claim can be applied to foods, but that fortification must be in accordance with the policy on food fortification in 21 CFR 104.20 (21 CFR 101.54(f)(3)).
   
FDA also said that 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. There must be scientific evidence that after it is eaten and absorbed from the gastrointestinal tract, the substance participates in physiological, biochemical, or cellular processes that inactivate free radicals or prevent free radical-initiated chemical reactions (21 CFR 101.54(g)(2)).

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 (21 CFR 101.54(g)(3)).

Beta-carotene may be the subject of an antioxidant claim when the level of vitamin A present as beta-carotene in the food is sufficient to qualify for the claim. For example, if the claim is “good source of antioxidant beta-carotene,” then at least 10% of the RDI for vitamin A must be present as beta-carotene per serving (21 CFR 101.54(g)(3)). The names of the nutrients that are the antioxidants must appear in the claim (i.e. “high in antioxidant vitamins C and E”), or be denoted with a symbol, such as an asterisk.

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.” However, a supplement that is prohibited from bearing a “low calorie” or “reduced calorie” claim can still use a sugar-free claim provided it meets the “low calorie” requirement in 21 CFR 101.60.