Description
In the Federal Register of April 28, 2014 (79 FR 23262), the Food and Drug Administration (FDA or we) issued a final rule entitled “Food Labeling: Nutrient Content Claims; Alpha-Linolenic Acid, Eicosapentaenoic Acid, and Docosahexaenoic Acid Omega-3 Fatty Acids” (“the rule”).
Scope & Applicability
Product Classes
2Standard food products subject to nutrition labeling; General food labeling context; Standard food products requiring Nutrition Facts.
Category of products covered in the table of contents; Covered by allergen labeling requirements; Guidance on declaring major food allergens for dietary supplements.
Stakeholders
1Entities required to identify food safety hazards and develop control plans
Regulatory Context
Attributes
3The RACC for yogurt is 170 grams.
Established for added sugars
Basis for defining nutrient content claim levels
Related CFR Sections (3)
- 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 →
- 21CFR101.8§ 101.8 Vending machines.
(a) Definitions. The definitions of terms in section 201 of the Federal Food, Drug, and Cosmetic Act apply to such terms when used in this section. In addition, for the purposes of this section:Read full regulation →
Related Warning Letters (1)
- 2020-06-30
Unapproved New Drugs/Misbranded
Only Natural, Inc. dba Bio Nutrition, Inc.
See Also (8)
- Guidance for Industry: Notification of a Health Claim or Nutrient Content Claim Based on an Authoritative Statement of a Scientific Body (Status: Final)
- Guidance for Industry: Dear Manufacturer Letter Regarding Front-of-Package Symbols (Status: Final)
- Small Entity Compliance Guide: Health Claims on Calcium and Osteoporosis; and Calcium, Vitamin D, and Osteoporosis (Status: Final)
- Guidance for Industry: Letter Regarding Point of Purchase Food Labeling (Status: Final)
- Guidance for Industry: Food Labeling Guide (Status: Final)
- Guidance for Industry: Distinguishing Liquid Dietary Supplements from Beverages (Status: Final)
- Guidance for Industry: Voluntary Labeling Indicating Whether Foods Have or Have Not Been Derived from Genetically Engineered Plants (Status: Final)
- Guidance for Industry: Questions and Answers on FDA’s Fortification Policy (Status: Final)