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

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. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance. If you cannot identify the appropriate FDA staff, call the appropriate telephone number listed on the title page of this guidance.

Scope & Applicability

Regulatory Context

• 21CFR101.60§ 101.60 Nutrient content claims for the calorie content of foods.

  (a) General requirements. A claim about the calorie or sugar content of a food may only be made on the label or in the labeling of a food if: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 →

• 21CFR104.20§ 104.20 Statement of purpose.

  (a) The fundamental objective of this subpart is to establish a uniform set of principles that will serve as a model for the rational addition of nutrients to foods. The achievement and maintenance of a desirable level of nutritional quality in the nation's food supply is an important public health Read full regulation →

• 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 →

• Food Labeling/Misbranded

  Stew Leonard’s Holdings LLC

  2024-11-26

• Food Labeling/Misbranded

  National Food Industries LLC

  2022-08-30

• Food Labeling/Misbranded

  Picket Fence Creamery LLC

  2022-02-01

• New Drug/Misbranded

  Synaptent, LLC

  2021-12-07

• Unapproved New Drugs/Misbranded

  Nutrishus Brands, Inc.

  2021-07-28

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