Description
This guidance represents the Food and Drug Administration's (FDA's) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations.
Scope & Applicability
Product Classes
1Products containing dietary ingredients intended to supplement the diet; The final product category for which the NDI is intended.
Stakeholders
1Target audience for the compliance guide
Regulatory Context
Attributes
1Reference Amount Customarily Consumed, which is 170 grams for yogurt
Related CFR Sections (5)
- 21CFR101.9§ 101.9 Nutrition labeling of food.
(a) Nutrition information relating to food shall be provided for all products intended for human consumption and offered for sale unless an exemption is provided for the product in paragraph (j) of this section.Read full regulation →
- 21CFR101.13§ 101.13 Nutrient content claims—general principles.
(a) This section and the regulations in subpart D of this part apply to foods that are intended for human consumption and that are offered for sale, including conventional foods and dietary supplements.Read full regulation →
- 21CFR101.54§ 101.54 Nutrient content claims for “good source,” “high,” “more,” and “high potency.”
(a) General requirements. Except as provided in paragraph (e) of this section, a claim about the level of a nutrient in a food in relation to the Reference Daily Intake (RDI) established for that nutrient in § 101.9(c)(8)(iv) or Daily Reference Value (DRV) established for that nutrient in § 101.9(c)Read full regulation →
- 21CFR101.14§ 101.14 Health claims: general requirements.
(a) Definitions. For purposes of this section, the following definitions apply:Read full regulation →
- 21CFR101.72§ 101.72 Health claims: calcium, vitamin D, and osteoporosis.
(a) Relationship between calcium, vitamin D, and osteoporosis. An inadequate intake of calcium or calcium and vitamin D contributes to low peak bone mass, which has been identified as one of many risk factors in the development of osteoporosis. Peak bone mass is the total quantity of bone present atRead full regulation →
Related Warning Letters (8)
- 2024-11-26
Food Labeling/Misbranded
Stew Leonard’s Holdings LLC
- 2022-08-30
Food Labeling/Misbranded
National Food Industries LLC
- 2022-02-01
Food Labeling/Misbranded
Picket Fence Creamery LLC
- 2021-12-07
New Drug/Misbranded
Synaptent, LLC
- 2021-07-28
Unapproved New Drugs/Misbranded
Nutrishus Brands, Inc.
- 2020-10-20
New Drug/Misbranded
Before Brands Inc
- 2020-10-20
Unapproved New Drugs/Misbranded
Prollergy Corporation/Ready Set Food
- 2020-06-30
Unapproved New Drugs/Misbranded
Only Natural, Inc. dba Bio Nutrition, Inc.
See Also (8)
- Guidance for Industry: FDA's Policy on Declaring Small Amounts of Nutrients and Dietary Ingredients on Nutrition Labels (Status: Final)
- Small Entity Compliance Guide: Statement of Identity, Nutrition Labeling and Ingredient Labeling of Dietary Supplements (Status: Final)
- Small Entity Compliance Guide: Trans Fatty Acids in Nutrition Labeling, Nutrient Content Claims, and Health Claims (Status: Final)
- Small Entity Compliance Guide: Nutrient Content Claims Definition for “High Potency” and Definition for “Antioxidant” for Use in Nutrient Content Claims for Dietary Supplements and Conventional Foods (Status: Final)
- Guidance for Industry: Food Labeling Guide (Status: Final)
- Guidance for Industry: Distinguishing Liquid Dietary Supplements from Beverages (Status: Final)
- Small Entity Compliance Guide: Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments (Status: Final)
- Guidance for Industry: A Labeling Guide for Restaurants and Retail Establishments Selling Away-From-Home Foods - Part II (Status: Final)