Description
OMB Control No. 0910-0374Expiration Date: 04/30/2018*See additionalPRA statementsat the end of this guidance
Scope & Applicability
Product Classes
1Category of products covered in the table of contents; Covered by allergen labeling requirements; Guidance on declaring major food allergens for dietary supplements.
Stakeholders
2Entity responsible for submitting NDINs
Entity responsible for submitting NDINs
Related CFR Sections (3)
- 21CFR101.14§ 101.14 Health claims: general requirements.
(a) Definitions. For purposes of this section, the following definitions apply: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 →
- 21CFR101.13§ 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 →
Related Warning Letters (3)
- 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 Implementation of Qualified Health Claims (Status: Final)
- Small Entity Compliance Guide: Health Claims on Calcium and Osteoporosis; and Calcium, Vitamin D, and Osteoporosis (Status: Final)
- Complementary and Alternative Medicine Products and their Regulation by the Food and Drug Administration: Draft Guidance for Industry (Status: Draft)
- Guidance for Industry: Food Labeling Guide (Status: Final)
- Guidance for Industry: Distinguishing Liquid Dietary Supplements from Beverages (Status: Final)
- Guidance for Industry: Questions and Answers on FDA’s Fortification Policy (Status: Final)
- Draft Guidance for Industry: Substantiation for Structure/Function Claims Made in Infant Formula Labels and Labeling (Status: Draft)
- Guidance for Industry: Dear Manufacturer Letter Regarding Front-of-Package Symbols (Status: Final)