The Small Entity Compliance Guide sets out the agency’s position “in plain language” regarding the use of the nutrient content claims on dietary supplement products.
It reiterates FDA’s amended regulations published on September 23 1997 in the Federal Register, which had defined the term ‘high potency’ as a nutrient content claim, and had also defined nutrient content claims using the term ‘antioxidant’ – for example in the statements ‘good source of antioxidants’ or ‘high in antioxidants’.
Antioxidants
The guidance confirms that describing the level of antioxidant nutrients present in a food is a nutrient content claim, and may be used on food labels in conjunction with food regulations (21 CFR 101.54(g)).
However, antioxidant nutrient content claims can only be made if the nutrients have an established Reference Daily Intakes (RDI), as well as scientifically recognized antioxidant activity. The scientific evidence must show a nutrient’s effect on free radicals in the body after it is eaten and absorbed from the gastrointestinal tract.
In order to use a ‘high in antioxidants’ 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 10-19 percent of the DRV or RDI per serving.
FDA also clarifies the special requirements that apply to an antioxidant nutrient content claim for beta-carotene. Such a claim can be made, says the agency, if 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 percent of the RDI for vitamin A must be present as beta-carotene per serving.
In addition, an antioxidant claim must also include the names of the nutrients that are the antioxidants – for example, ‘high in antioxidant vitamins C and E’. However, it is instead possible for the label to include an asterisk or another type of symbol to indicate all the included antioxidants throughout the label.
High potency
The guidance also sets out FDA’s definition of ‘high potency’, stating that the term can be used to describe individual vitamins or minerals that are present at 100 percent or more of the RDI.
If the term is used on the labeling of a product that also contains other nutrients, then the label must clearly state which specific vitamins or minerals are being described as ‘high potency’ – for example, ‘Botanical X with high potency vitamin E’.
A multi-ingredient product can be described as ‘high potency’ if more than two thirds of the vitamins and minerals it contains are at or above RDI levels.
Food products that contain nutrients subject to high potency claims must also meet FDA’s policy on food fortification (21 CFR 104.20 [21 CFR 101.54(f)(3)]).
Sugar-free
FDA’s guidance also clarifies that ‘sugar free’ claims can be used on dietary supplements, assuming these meet certain criteria (21 CFR 101.60(c)(1)(i)-(iii)).
These include that the product must also be labeled as ‘low calorie’ or ‘reduced calorie’, or that it must “bear a relative claim of special dietary usefulness”. If a supplement product cannot use low or reduced calorie claims, then it can still use a sugar free claim if it meets the ‘low calorie’ requirements of CFR 101.60.
To view FDA’s guidance for industry, click here.