Guidance for FDA Staff and Interested Parties: Evaluating the Public Health Importance of Food Allergens Other Than the Major Food Allergens Listed in the Federal Food, Drug, and Cosmetic Act | Guideline Explorer

Description

This guidance addresses substances that are currently consumed in food or have previously been consumed in food, within or outside the United States, such that there is a body of information about adverse reactions experienced by consumers who ingest the substance. This guidance does not address the potential that a substance that would be new to the food supply might be a food allergen. This guidance also does not address scientific research regarding potential cross-reactivity to a known food allergen and how this research could help determine whether a substance in food could be a food allergen.

Scope & Applicability

Product Classes

Major Food Allergen

Defined categories of food allergens requiring specific labeling under the FD&C Act.; Declaration of food source names for major food allergens.

Non-Listed Food Allergen

subject of FDA's evaluation for public health importance

major food allergens

The eight foods identified by FALCPA representing 90% of food allergies.

Dietary Supplement

Products containing dietary ingredients intended to supplement the diet; The final product category for which the NDI is intended.

Stakeholders

Petitioner

Party submitting a citizen petition; party evaluating whether a food allergen is of public health importance; Party recommended to conduct systematic reviews and evidence scoring.

Qualified facility

exempt from certain preventive controls requirements, e.g., very small business

Regulatory Context

Attributes

Allergenic potency

Amount of protein required to elicit a reaction; Factor #4: the allergenic potency; amount of food allergenic protein required to elicit a reaction; Factor #4 in evaluating public health importance; Key criterion used to establish the priority allergen list.; Parameter used to decide priority lists

severity of food allergies

Clinical evidence used to decide priority lists

regional prevalence

Scientific evidence used to decide priority lists

allergen potency

We generally intend to score as Medium allergen potency data

Severity

Seriousness of the effects of a hazard

prevalence

Scientific factor evaluated using epidemiological studies.; Factor #2: Prevalence of an IgE-mediated food allergy in the U.S. population; Key criterion for assessing public health importance of allergens.

potency

Key search term and scientific factor for evaluation.

prevalence rate

The estimated frequency of IgE-mediated food allergy in a population.

Identified Hazards

Hazards

Allergen cross-contact

chemical hazard under 21 CFR 117.130(b)(1)(ii)

food allergy

Subject of risk analysis cycle and hazard scaling

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Related CFR Sections (5)

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 →
21CFR101.91§ 101.91 Gluten-free labeling of food.
(a) Definitions.Read full regulation →
21CFR10.30§ 10.30 Citizen petition.
(a) This section applies to any petition submitted by a person (including a person who is not a citizen of the United States) except to the extent that other sections of this chapter apply different requirements to a particular matter.Read full regulation →
21CFR101.22§ 101.22 Foods; labeling of spices, flavorings, colorings and chemical preservatives.
(a)Read full regulation →
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 →

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