2024-29957. Food Labeling: Nutrient Content Claims; Definition of Term “Healthy”  

  • Table 1 to Paragraph (d)(2)

    Food group Food group equivalent Examples
    (i) Vegetable 1/2 cup equivalent vegetable 1/2 cup cooked green beans; 1 cup raw spinach
    (ii) Fruit 1/2 cup equivalent fruit 1/2 cup strawberries; 1/2 cup 100% orange juice; 1/4 cup raisins
    (iii) Grains 3/4 oz equivalent whole grain 1 slice of bread; 1/2 cup cooked brown rice
    (iv) Dairy 2/3 cup equivalent dairy 2/3 cup fat free milk; 1 oz nonfat cheese
    (v) Protein foods 1 1/2 oz equivalent game meat 1 1/2 oz venison
    1 oz equivalent seafood 1 oz tuna
    1 oz equivalent egg 1 large egg
    1 oz equivalent beans, peas, or lentils 1/4 cup black beans
    1 oz equivalent nuts, seeds, or soy products 1/2 oz walnuts

    (3) You may use the term “healthy” or derivative terms “health,” “healthful,” “healthfully,” “healthfulness,” “healthier,” “healthiest,” “healthily,” and “healthiness” as an implied nutrient content claim on the label or in labeling of a food that is useful in creating a diet that is consistent with dietary recommendations if the food meets the criteria of one or more of the following paragraphs (d)(3)(i) through (vi) of this section as follows:

    (i) An individual food or mixed product that is comprised of one or more of the following foods that are the foundation of a healthy dietary pattern, with no other added ingredients except for water:

    (A) Vegetable;

    (B) Fruit;

    (C) Whole grains;

    (D) Fat-free or low-fat dairy;

    (E) Lean meat, seafood, eggs, beans, peas, lentils, nuts, or seeds.

    (ii) Individual foods.

    (A) An individual food that has a reference amount customarily consumed (RACC) greater than 50 g or greater than 3 tablespoons and meets the conditions per RACC in table 2 of this section; or

    Table 2 to Paragraph (d)(3)(ii)(A)

    If the food is . . . It must contain at least . . . The added sugars content must be no greater than . . . The sodium content must be no greater than . . . The saturated fat content must be no greater than . . .
    Main category Sub-category (if applicable)
    ( 1) A vegetable product 1/2 cup equivalent vegetable 2% DV 10% DV 5% DV.
    ( 2) A fruit product 1/2 cup equivalent fruit 2% DV 10% DV 5% DV.
    ( 3) A grain product 3/4 oz equivalent whole grain 10% DV 10% DV 5% DV.
    ( 4) A dairy product 2/3 cup equivalent dairy 5% DV 10% DV 10% DV.
    ( 5) Protein Foods (i) Game meats 1 1/2 oz equivalent 2% DV 10% DV 10% DV.
    (ii) Seafood 1 oz equivalent 2% DV 10% DV 5% DV, excluding saturated fat inherent in seafood.
    (iii) Egg 1 oz equivalent 2% DV 10% DV 10% DV.
    (iv) Beans, peas, and lentils 1 oz equivalent 2% DV 10% DV 5% DV.
    (v) Nuts, seeds, and soy products 1 oz equivalent 2% DV 10% DV 5% DV, excluding saturated fat inherent in nuts, seeds, and soybeans.
    ( 6) Oils (i) 100% Oil 0% DV 0% DV 20% of total fat.
    (ii) Oil-based spreads whose fats come solely from oil 0% DV 10% DV 20% of total fat.
    (iii) Oil-based dressing containing at least 30% oil and oils meet the requirements in paragraph (d)(3)(ii)(A) or (B)(6)( i) of this section 2% DV 10% DV 20% of total fat.

    (B) An individual food that has a RACC of 50 g or less or 3 tablespoons or less and meets the conditions per 50 g of food in table 3 of this section: ( print page 106164)

    Table 3 to Paragraph (d)(3)(ii)(B)

    If the food is . . . It must contain at least . . . The added sugars content must be no greater than . . . The sodium content must be no greater than . . . The saturated fat content must be no greater than . . .
    Main category Sub-category (if applicable)
    ( 1) A vegetable product 1/2 cup equivalent vegetable 2% DV 10% DV 5% DV.
    ( 2) A fruit product 1/2 cup equivalent fruit 2% DV 10% DV 5% DV.
    ( 3) A grain product 3/4 oz equivalent whole grain 10% DV 10% DV 5% DV.
    ( 4) A dairy product 2/3 cup equivalent dairy 5% DV 10% DV 10% DV.
    ( 5) Protein Foods (i) Game meats 1 1/2 oz equivalent 2% DV 10% DV 10% DV.
    (ii) Seafood 1 oz equivalent 2% DV 10% DV 5% DV, excluding saturated fat inherent in seafood.
    (iii) Egg 1 oz equivalent 2% DV 10% DV 10% DV.
    (iv) Beans, peas, and lentils 1 oz equivalent 2% DV 10% DV 5% DV.
    (v) Nuts, seeds, and soy products 1 oz equivalent 2% DV 10% DV 5% DV, excluding saturated fat inherent in nuts, seeds, and soybeans.
    ( 6) Oils (i) 100% Oil 0% DV 0% DV 20% of total fat.
    (ii) Oil-based spreads whose fats come solely from oil 0% DV 10% DV 20% of total fat.
    (iii) Oil-based dressing containing at least 30% oil and oils meet the requirements in paragraph (d)(3)(ii)(A) or (B)(6)( i) of this section 2% DV 10% DV 20% of total fat.

    (iii) A mixed product that meets the following conditions per RACC:

    Table 4 to Paragraphs (d)(3)(iii)

    If the mixed product contains at least . . . The added sugars content must be no greater than . . . The sodium content must be no greater than . . . Excluding saturated fat inherent in seafood, nuts, seeds, and soybeans in soy products (if applicable), the saturated fat content must be no greater than . . .
    One total food group equivalent with no less than 1/4 food group equivalent from at least two food groups, as specified in paragraph (d)(2) of this section 10% DV 15% DV 10% DV.

    (iv) A main dish product as defined in § 101.13(m) that meets the following conditions per labeled serving:

    Table 5 to Paragraph (d)(3)(iv)

    If the main dish product contains at least . . . The added sugars content must be no greater than . . . The sodium content must be no greater than . . . Excluding the saturated fat inherent in seafood, nuts, seeds, and soybeans in soy products (if applicable), the saturated fat content must be no greater than . . .
    Two total food group equivalents with no less than 1/2 food group equivalent from at least two food groups, as specified in paragraph (d)(2) of this section 15% DV 20% DV 15% DV.
    ( print page 106165)

    (v) A meal product as defined in § 101.13(l) that meets the following conditions per labeled serving:

    Table 6 to Paragraph (d)(3)(v)

    If the meal product contains at least . . . The added sugars content must be no greater than . . . The sodium content must be no greater than . . . Excluding the saturated fat inherent in seafood, nuts, seeds, and soybeans in soy products (if applicable), the saturated fat content must be no greater than . . .
    Three total food group equivalents with no less than 1/2 food group equivalent from at least three food groups, as specified in paragraph (d)(2) of this section 20% DV 30% DV 20% DV.

Document Information

Effective Date:
2/25/2025
Published:
12/27/2024
Department:
Food and Drug Administration
Entry Type:
Rule
Action:
Final rule.
Document Number:
2024-29957
Dates:
This rule is effective February 25, 2025. The compliance date of this final rule is February 25, 2028.
Pages:
106064-106165 (102 pages)
Docket Numbers:
Docket No. FDA-2016-D-2335
RINs:
0910-AI13: Nutrient Content Claims, Definition of Term: Healthy
RIN Links:
https://www.federalregister.gov/regulations/0910-AI13/nutrient-content-claims-definition-of-term-healthy
Topics:
Food labeling, Nutrition, Reporting and recordkeeping requirements, Reporting and recordkeeping requirements
PDF File:
2024-29957.pdf
Supporting Documents:
» FRIA Reference 30 Vranesevic and Stancec 2003
» FRIA Reference 29 Peckham 2019
» FRIA Reference 24 Reedy et al 2014
» FRIA Reference 16 Iles et al 2018
» FRIA Reference 12 Satia et al 2005
» FRIA Reference 9 Lusk 2019
» FRIA Reference 8 Glanz et al 1998
» FRIA Reference 3 Shangguan et al 2021
» Reference 46. Consider Cultural Food Preferences_ FAQ _ FSG Toolkit _ CDC
» Reference 38. NHANES Analytic Guidance and Brief Overview for the 2017-March 2020 Pre-Pandemic Data Files
CFR: (1)
21 CFR 101