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Nutrient Content Claims Guidance

Reduce litigation by following labeling rules

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.

Warning: This is for informational purposes only. Please check labels and marketing content with your competent legal or regulatory counsel.

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