Description
We are issuing this guidance to provide food manufacturers with our current views on sesame as an allergen and to provide recommendations to voluntarily disclose sesame in certain circumstances where such disclosure is not currently required. The guidance is intended to help individuals who are allergic to sesame identify those foods that may contain sesame as an ingredient.
Scope & Applicability
Product Classes
1Defined categories of food allergens requiring specific labeling under the FD&C Act.; Declaration of food source names for major food allergens.
Stakeholders
2Responsible for declaring acceptable market names on labels.
Entities subject to the rule
Regulatory Context
Attributes
2Estimated number of people with a disease, used to determine clinical investigation enrollment.
The required naming convention for ingredients on a label.; The standard naming convention required for ingredients in the list.
Identified Hazards
Hazards
1The focus of Chapter 11 and the FSPCA forms.
Related CFR Sections (3)
- 21CFR101.4§ 101.4 Food; designation of ingredients.
- 21CFR102.5§ 102.5 General principles.
(a) The common or usual name of a food, which may be a coined term, shall accurately identify or describe, in as simple and direct terms as possible, the basic nature of the food or its characterizing properties or ingredients. The name shall be uniform among all identical or similar products and maRead full regulation →
- 21CFR10.115§ 10.115 Good guidance practices.
(a) What are good guidance practices? Good guidance practices (GGP's) are FDA's policies and procedures for developing, issuing, and using guidance documents.Read full regulation →
Related Warning Letters (6)
- 2024-11-26
Food Labeling/Misbranded
Stew Leonard’s Holdings LLC
- 2024-06-25
Food Labeling/Misbranded/False and Misleading
Bimbo Bakeries USA, Inc.
- 2022-08-30
Food Labeling/Misbranded
National Food Industries LLC
- 2022-07-19
Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
H2 Beverages, Inc.
- 2022-02-01
Food Labeling/Misbranded
Picket Fence Creamery LLC
- 2020-10-20
New Drug/Misbranded
Before Brands Inc
See Also (8)
- CPG Sec 585.850 Sweet Potatoes - Sirup Pack (Status: Final)
- CPG Sec 567.100 Antipasto, Common or Usual Name (Status: Final)
- Guidance for Industry: Questions and Answers Regarding Food Allergen Labeling (Edition 5) (Status: Final)
- Draft Guidance for Industry: Labeling of Plant-Based Alternatives to Animal-Derived Foods (Status: Draft)
- Guidance for Industry: The Seafood List FDA’s Guide to Determine Acceptable Seafood Names (Status: Final)
- CPG Sec 555.250 DRAFT: Major Food Allergen Labeling and Cross-contact (Status: Draft)
- Guidance for Industry: Frequently Asked Questions About Medical Foods - Third Edition (Status: Final)
- Draft Guidance for Industry: Labeling of Plant-Based Milk Alternatives and Voluntary Nutrient Statements (Status: Draft)