FDA releases new guidance on food allergens labelling

The U.S. Food and Drug Administration (FDA) has released four guidance documents on standards for food labelling. The guidance, which covers food allergens, ready-to-eat human foods, and labelling of plant-based alternatives, aims to help industry understand and comply with the FDA’s standards.
FDA releases new guidance on food allergens labelling
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The U.S. Food and Drug Administration (FDA) has released four guidance documents on standards for food labelling. The guidance, which covers food allergens, ready-to-eat human foods, and labelling of plant-based alternatives, aims to help industry understand and comply with the FDA’s standards.

The guidance that has been released is as follows:

Guidance for Industry: Questions and Answers Regarding Food Allergen Labeling (Edition 5)

The updates in this final guidance on food allergen labelling were based on questions and comments submitted after the release of the draft guidance. Questions included clarity on labelling requirements of tree nuts, sesame, milk, eggs, incidental additives, highly refined oils, dietary supplement products, and certain specific packing and labelling situations, such as individual units within a multi-unit package.  

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

This guidance outlines the FDA's general approaches to evaluating the public health importance of food allergens that are not one of the nine major food allergens. In U.S. law, those are milk, eggs, fish, Crustacean shellfish, tree nuts, peanuts, wheat, soybeans, and sesame. 

Draft Guidance for Industry: Establishing Sanitation Programs for Low-Moisture Ready-to-Eat Human Foods and Taking Corrective Actions Following a Pathogen Contamination Event

The draft guidance is intended to help manufacturers and processors of Low Moisture Ready-to-Eat (LMRTE) human foods, including powdered infant formula, comply with requirements for current good manufacturing practices, hazard analysis, and risk-based preventive controls to ensure a safe and sanitary food supply.

Draft Guidance for Industry: Labeling of Plant-Based Alternatives to Animal-Derived Foods

The draft guidance offers best practices for naming and labelling plant-based alternatives to eggs, seafood, poultry, meat, and dairy (but not plant-based milk). If finalised, it will help the industry create labels that clearly show what these products are and how they differ so that consumers can make informed choices.

The FDA has asked industry and other interest holders to comment on any draft guidance before they begin work on the final version if they wish for their questions to be considered. Submit comments electronically at http://www.regulations.gov.

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