Food Safety
search
cart
facebook twitter linkedin
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Food Safety
  • NEWS
    • Latest News
    • White Papers
  • PRODUCTS
  • TOPICS
    • Contamination Control
    • Food Types
    • Management
    • Process Control
    • Regulatory
    • Sanitation
    • Supply Chain
    • Testing and Analysis
  • PODCAST
  • EXCLUSIVES
    • Food Safety Five Newsreel
    • eBooks
    • FSM Distinguished Service Award
    • Interactive Product Spotlights
    • Videos
  • BUYER'S GUIDE
  • MORE
    • ENEWSLETTER >
      • Archive Issues
      • Subscribe to eNews
    • Store
    • Sponsor Insights
  • WEBINARS
  • FOOD SAFETY SUMMIT
  • EMAG
    • eMagazine
    • Archive Issues
    • Editorial Advisory Board
    • Contact
    • Advertise
  • SIGN UP!
NewsRegulatoryFDAGuidelines

FDA Issues Draft Guidance on Evaluating Non-Listed Food Allergens

peanut butter jar peanut allergen

Credit: Fertnig/E+ via Getty Images

April 18, 2022

The U.S. Food and Drug Administration (FDA) is heightening its efforts to protect the public from food allergens. The agency recently published a draft guidance that is intended to clarify how FDA will evaluate the public health risk of food allergens that are not one of the major food allergens identified by law in the Federal Food, Drug, and Cosmetic Act. At present, the major allergens are milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat, and soybeans; sesame, the ninth allergen, becomes applicable to the law on January 1, 2023. Under the law, food companies are required to label foods containing any of the nine major allergens and follow regulations that prevent cross-contact.

Regarding non-listed food allergens, FDA’s guidance focuses on immunoglobulin E antibody (IgE)-mediated food allergies, which are known to cause the most severe and life-threatening reactions. The guidance specifies:

  • Scientific factors FDA considers when evaluating the public health importance of a non-listed food allergen
  • Information relevant to labeling and production that FDA considers when evaluating the public health importance of a non-listed food allergen
  • FDA recommendations for how to identify and evaluate the body of evidence applicable to an evaluation of the public health importance of a non-listed food allergen.

The guidance is relevant to FDA staff who are responsible for evaluating the public health importance of a non-listed food allergen, as well as stakeholders who intend to petition FDA to establish regulatory requirements based on the public health importance of a non-listed food allergen or who are interested in how FDA evaluates the public health importance of such food allergens. Stakeholders can submit comments for consideration on the draft guidance at www.regulations.gov.


KEYWORDS: allergens FDA guidance

Share This Story

Looking for a reprint of this article?
From high-res PDFs to custom plaques, order your copy today!

Recommended Content

JOIN TODAY
to unlock your recommendations.

Already have an account? Sign In

  • people holding baby chicks

    Serovar Differences Matter: Utility of Deep Serotyping in Broiler Production and Processing

    This article discusses the significance of Salmonella in...
    Meat/Poultry
    By: Nikki Shariat Ph.D.
  • woman washing hands

    Building a Culture of Hygiene in the Food Processing Plant

    Everyone entering a food processing facility needs to...
    Management
    By: Richard F. Stier, M.S.
  • graphical representation of earth over dirt

    Climate Change and Emerging Risks to Food Safety: Building Climate Resilience

    This article examines the multifaceted threats to food...
    International
    By: Maria Cristina Tirado Ph.D., D.V.M. and Shamini Albert Raj M.A.
Subscribe For Free!
  • eMagazine Subscription
  • Subscribe to eNewsletter
  • Manage My Preferences
  • Website Registration
  • Subscription Customer Service

More Videos

Sponsored Content

Sponsored Content is a special paid section where industry companies provide high quality, objective, non-commercial content around topics of interest to the Food Safety Magazine audience. All Sponsored Content is supplied by the advertising company and any opinions expressed in this article are those of the author and not necessarily reflect the views of Food Safety Magazine or its parent company, BNP Media. Interested in participating in our Sponsored Content section? Contact your local rep!

close
  • Deli Salads
    Sponsored byCorbion

    How Food Safety is Becoming the Ultimate Differentiator in Refrigerated and Prepared Foods

Popular Stories

Top view of several sandwiches

FDA Provides Update on Listeria Outbreak Related to Products of Fresh & Ready Foods LLC

Scientist inspecting food substance with microscope

FDA Announces ‘Proactive’ Post-Market Chemical Review Program to Keep Food Supply Safe

FSM podcast

Ep. 193. Christian Ararat: A Global Perspective on Auditing, Certifications, AI, and Beyond

Events

June 12, 2025

Additive Bans Ahead: Your Guide to Avoiding Risk and Maintaining Agility

Live: June 12, 2025 at 12:00 pm EDT: From this webinar, attendees will learn how ingredient bans will impact product development, labeling, and sourcing.

View All

Products

Global Food Safety Microbial Interventions and Molecular Advancements

Global Food Safety Microbial Interventions and Molecular Advancements

See More Products
Environmental Monitoring Excellence eBook

Related Articles

  • fda logo

    FDA Issues Draft Guidance on Accredited Third-Party Certification Program

    See More
  • FDA logo

    FDA issues draft guidance for industry on reconditioning of fish and fishery products by segregation

    See More
  • juices

    FDA Issues Draft Guidance on Lead in Juice

    See More

Events

View AllSubmit An Event
  • May 15, 2025

    Town Hall: A Candid Dialogue on the Future of Food Safety

    On Demand: The 13th Annual Town Hall at the Food Safety Summit brings together top food safety leaders for an open and dynamic conversation about the most pressing challenges and opportunities in food safety today. 
View AllSubmit An Event

Related Directories

  • BD Food Safety Consultants LLC

    We are a Food Safety Training and Consulting firm located in Naperville, IL. Our primary goal is to provide with effective training and consulting solutions for Food Manufacturing and Distributing companies. Our training services include the following: FSPCA PCQI classes, IAVA Courses, IHA Accredited HACCP classes, FSVP Courses and Internal Auditor Training classes. We also offer Learning Management System for food manufacturing industry. Our LMS provides effective training solutions and easy training reporting system. Consulting service we offer includes complex assistance with preparations for SQF, BRC & FSSC audits, other 3rd party audits, FSMA (PC, FSVP, IA), HACCP, Dietary Supplements compliance & more. We serve our clients worldwide.
  • Food Safety and Quality Consultants LLC

    Food Safety and Quality Consultants, LLC (FSQC) is a professional full-service food safety and quality consulting firm offering a complete line of training, consulting, and auditing services to meet your needs. We will help you turn the complicated into compliance by making your food safety systems simple and effective!
×

Never miss the latest news and trends driving the food safety industry

eNewsletter | Website | eMagazine

JOIN TODAY!
  • RESOURCES
    • Advertise
    • Contact Us
    • Directories
    • Store
    • Want More
  • SIGN UP TODAY
    • Create Account
    • eMagazine
    • eNewsletter
    • Customer Service
    • Manage Preferences
  • SERVICES
    • Marketing Services
    • Reprints
    • Market Research
    • List Rental
    • Survey/Respondent Access
  • STAY CONNECTED
    • LinkedIn
    • Facebook
    • Instagram
    • X (Twitter)
  • PRIVACY
    • PRIVACY POLICY
    • TERMS & CONDITIONS
    • DO NOT SELL MY PERSONAL INFORMATION
    • PRIVACY REQUEST
    • ACCESSIBILITY

Copyright ©2025. All Rights Reserved BNP Media.

Design, CMS, Hosting & Web Development :: ePublishing