Description
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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
1Party submitting a citizen petition; party evaluating whether a food allergen is of public health importance; Party recommended to conduct systematic reviews and evidence scoring.
Regulatory Context
Attributes
1Requirement for substantiation of claims
Related CFR Sections (4)
- 21CFR170.3§ 170.3 Definitions.
For the purposes of this subchapter, the following definitions apply:Read full regulation →
- 21CFR101.93§ 101.93 Certain types of statements for dietary supplements.
- 21CFR101.70§ 101.70 Petitions for health claims.
(a) Any interested person may petition the Food and Drug Administration (FDA) to issue a regulation regarding a health claim. An original and one copy of the petition shall be submitted, or the petitioner may submit an original and a computer readable disk containing the petition. Contents of the diRead full regulation →
- 21CFR101.14§ 101.14 Health claims: general requirements.
(a) Definitions. For purposes of this section, the following definitions apply:Read full regulation →
Related Warning Letters (10)
- 2021-05-25
New Drug/Misbranded
Great Lakes Gelatin Company
- 2020-11-17
New Drug/Misbranded
Half Hill Farm Inc
- 2020-10-20
New Drug/Misbranded
Before Brands Inc
- 2020-10-20
Unapproved New Drugs/Misbranded
Prollergy Corporation/Ready Set Food
- 2020-07-29
Dietary Supplement/Adulterated
Purple Biosciences, LLC
- 2020-07-29
Dietary Supplement/Adulterated
Happy Hour Vitamins
- 2020-07-29
Dietary Supplement/Adulterated
"Vita Heaven, LLC dba Hangover Heaven
- 2020-07-29
Dietary Supplement/Adulterated
Ebnsol, Inc
- 2020-07-29
Dietary Supplement/Adulterated
Double Wood LLC
- 2020-07-29
Dietary Supplement/Adulterated
Mind, Body & Coal LLC
See Also (8)
- Guidance for Industry: Estimating Dietary Intake of Substances in Food (Status: Final)
- Guidance for Industry: Evidence-Based Review System for the Scientific Evaluation of Health Claims (Status: Final)
- CPG Sec 515.100 Confectionery - Use of Non-Nutritive Substances as Ingredients (Status: Final)
- Draft Guidance for Industry: Providing Regulatory Submissions in Electronic or Paper Format to the Office of Food Additive Safety (Status: Draft)
- Guidance for Industry: Food Labeling Guide (Status: Final)
- Guidance for Industry: Assessing the Effects of Significant Manufacturing Process Changes, Including Emerging Technologies, on the Safety and Regulatory Status of Food Ingredients and Food Contact Substances, Including Food Ingredients that Are Color Additives (Status: Final)
- CVM GFI #221 Recommendations for Preparation and Submission of Animal Food Additive Petitions (Status: Final)
- Guidance for Industry: Substantiation for Dietary Supplement Claims Made Under Section 403(r) (6) of the Federal Food, Drug, and Cosmetic Act (Status: Final)