Nutrient Content Claims Guidance

Nutrient content claims can lead to litigation and are often cited in warning letters, although they are not typically the primary reason for a letter. Following all the rules can be confusing, so here’s some guidance on how to be compliant. Thank you to the thousands of wonderful weekly Warning Letter Wednesday readers. I hope this helps (smiles).

• “Good Source” Claims 10-19% DV: Terms like “good source,” “contains,” or “provides.” Example: “Good source of magnesium” must have at least 10% DV magnesium per serving.

• “High” & “Rich In” Claims 20%: Terms like “high,” “rich in,” or “excellent source of.” Example: “Rich in magnesium” must have at least 20% DV magnesium per serving.

• “High Potency” Claims: 100% DV: Example: “High potency magnesium” must have at least 100% DV magnesium per serving.

• For multi-ingredient foods, at least two-thirds of the vitamins and minerals must meet these criteria. I actually did not know this until I researched for this post.

• Fiber Claims: When claiming high fiber content, the total fat content must also be disclosed if the food is not low in fat.

• Antioxidant Claims: The nutrients have recognized antioxidant activity like vitamins A, C, and E meet % DV requirements. This means that items without a %DV, like botanicals, cannot be listed as antioxidants. Mentioning the effect on the antioxidant system, however, is not high risk. These rules are nuanced. Learn more here. 

• Include the names of the antioxidant nutrients in the claim, such as “high in antioxidants vitamins A and C.”

• “More” & “Enriched” Claims 10% DV: Terms like “more,” “fortified,” “enriched,” “added,” “extra,” “plus,” and” compared to a reference food.Must comply with fortification 

• Policies, and comparisons with the reference food must be clearly stated.

• Sugar Content Claims: Terms such as “sugar-free” and “no added sugar” can be used in some instances, but they can lead to lawsuits. Here is an excellent article by Todd Harrison, Kristen Klesh, and others. It has a VERY helpful table that can help avoid the common litigation surrounding “not a low-calorie food” requirements. 

• Cholesterol and Fat Claims: This continues to be mentioned in warning letters as a secondary (not the primary reason for a letter) citation. “Cholesterol Free” and “No Trans Fat” claims must be made in accordance with specific FDA guidelines.

• Declarations for mono- and polyunsaturated fats must be made under 21 CFR 101.9(c)(2)(ii) and (iv) if such claims are made unless the food qualifies as “fat-free” under 21 CFR 101.62(b)(1).

Calorie Content Claims

• “Calorie Free” Claims: If the food contains less than 5 calories per serving, terms like “calorie-free” or “zero calories” can be used.
• “Low Calorie” Claims: For foods that provide 40 calories or less per serving for larger servings and smaller servings, if not more than 40 calories per 50 grams.
• “Reduced Calorie” Claims: “Reduced calorie” claims are permissible if the food contains at least 25% fewer calories per serving than a reference food.

Here are some helpful resources.

• Specific Requirements for Nutrient Content Claims
• Nutrient content claims for “good source,” “high,” “more,” and “high potency”