The US Food and Drug Administration (FDA) has issued a draft guidance for FDA staff and other stakeholders titled Evaluating the Public Health Importance of Food Allergens Other Than the Major Food Allergens Listed in the Federal Food, Drug, and Cosmetic Act. The draft guidance, when finalized, will outline the FDA’s current thinking on the approach they generally intend to take when they evaluate the public health importance of food allergens that are not one of the major food allergens identified by law in the US. The major food allergens are milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat, and soybeans. Sesame becomes the ninth major food allergen effective January 1, 2023. For the purposes of this draft guidance, they refer to food allergens that are not major food allergens as non-listed food allergens.

Food allergies and other types of food hypersensitivities affect millions of people living in the US and there are more than 160 known food allergens. To protect those with food allergies and other food hypersensitivities, the FDA requires companies to list major food allergens or ingredients that are made from major food allergens in specific ways on the label of packaged foods. The FDA also enforces regulations that require food manufacturers to prevent allergen cross-contact (or, the unintentional incorporation of a major food allergen into a food).

This draft guidance is part of FDA’s efforts to evaluate emerging evidence about non-listed food allergens in a consistent and transparent manner to inform potential future actions. The FDA’s approach to non-listed food allergens focuses on immunoglobulin E antibody (IgE)-mediated food allergies, which are considered the most severe and immediately life-threatening food allergies. The draft guidance discusses the scientific evidence that establishes a food as a cause of IgE-mediated food allergy and the scientific factors, such as prevalence, severity, and allergenic potency, that the FDA intends to consider in its evaluations. The draft guidance also provides the FDA’s recommendations for identifying and evaluating the relevant body of evidence to determine the public health importance of a non-listed food allergen.

The draft guidance also includes information on how stakeholders may submit requests to the FDA to evaluate the public health importance of a non-listed food allergen. They propose stakeholders submit data demonstrating that the food causes IgE-mediated allergy, together with data on prevalence of the food allergy, severity of the allergic reactions, and allergenic potency of the food allergen for the agency to consider in its review. They also propose that stakeholders provide other information, such as the information about the labeling and production of food containing the non-listed food allergen.

To Submit Comments:

To ensure comments about this draft guidance are considered before the FDA begins work on the final guidance, please submit written or electronic comments within 120 days of publication in the Federal Register of the notice announcing the availability of the draft guidance. Submit electronic comments at Regulations.gov, using Docket ID: FDA-2021-N-0553.

If you are unable to submit comments online, please mail written comments to:
Dockets Management Staff
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document’s Docket ID: FDA-2021-N-0553.

For Additional Information:

Federal Register Notice of Availability

Draft Guidance for FDA Staff and Stakeholders: Evaluating the Public Health Importance of Food Allergens Other Than the Major Food Allergens Listed in the Federal Food, Drug, and Cosmetic Act

Food Allergies

Food Allergens/Gluten-Free Guidance Documents & Regulatory Information

The US Food and Drug Administration issued a final guidance titled “Reconditioning Fish and Fishery Products by Segregation: Guidance for Industry.”

The final guidance:

• Clarifies the steps that owners of fish and fishery products, or their representatives, can take to segregate non-violative products from products adulterated with pathogens, unlawful animal drugs, scombrotoxin (histamine) or decomposition, to demonstrate compliance with the Federal Food, Drug, and Cosmetic Act.
• Recommends information that industry should include in reconditioning by segregation proposals.
• Provides uniform guidance and greater transparency to industry and stakeholders on how the FDA evaluates these proposals.

The final guidance does not apply to situations where reconditioning is proposed by means other than segregation, such as by cooking or conversion to animal feed. This guidance finalizes the agency’s draft guidance released in September 2019.

The public may submit electronic or written comments related to this final guidance at any time. Public comments can be submitted electronically to www.regulations.gov using Docket ID: FDA-2019-D-3324. Written comments can be submitted to the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm.1061, Rockville, MD 20852.

Federal Register Notices:

Final Guidance Federal Register Notice April 2022

Draft Guidance Federal Register Notice September 2019

For Additional Information:

Seafood Guidance Documents & Regulatory Information

More on Seafood from FDA

News from AAFC Market Access Secretariat

The Market Access Secretariat of Agriculture and Agri-Food Canada is pleased to announce that the Canadian Food Inspection Agency (CFIA) and their counterpart in Jordan have successfully completed negotiations for Canadian exports of poultry meat into Jordan. This new access is available retroactively since October 4, 2021, and interested Canadian exporters should contact their Local CFIA office to obtain the required certificate prior to exports.

News from AAFC Market Access Secretariat

As of March 31, 2022, the Government of Peru is planning to end the provisions that allow the use of stickers to comply with its front-of-package nutrition warning labelling requirements.

Under the 2018 Law on the Promotion of a Healthy Diet, detailed specifications for the inclusion of octagon-shaped warning labels are required on the front of package of food and beverage products that exceed limits for salt, sugar, saturated fat, and trans-fat set in this regulation. More information on the labelling requirements and limits can be found in the Supreme Decree 012-2018-SA and its amendment Supreme Decree 015-2019-SA (Spanish only).

The use of stickers to comply with the nutrition warning label on the front of the package was extended until March 31, 2022, by Supreme Decree 018-2021-SA (Spanish only).  However, it is unclear at this time whether the Peruvian Ministry of Health will extend the provisions allowing the use of stickers beyond this date. This means that all local and imported food and beverage products that exceed the limits set in the regulation will now be required to have printed warning labels directly on their packaging.

Exporters are encouraged to contact their importers or local partners to ensure that their products continue to meet all labelling requirements established by the Peruvian authorities. The Embassy of Canada in Peru can also assist exporters in finding local packaging companies to comply with these regulations, where appropriate.

They will continue to monitor this issue and keep industry stakeholders informed of any extension of the provisions allowing the current use of stickers.

News from AAFC Market Access Secretariat

On July 9, 2021, President Biden issued an Executive Order on “Promoting Competition in the American Economy,” which creates a White House Competition Council and directs Federal agency actions to enhance fairness and competition across America’s economy.

As part of this Executive Order (EO), the Secretary of Agriculture was directed to submit reports:

1. On the effect of retail concentration and retailers’ practices on the condition of completion in the food industry;
2. On concerns and strategies for ensuring that the intellectual property (IP) system, while incentivizing innovation, does not also unnecessarily reduce competition in seed and other input markets; and to identify and advance any additional administrative actions necessary to promote competition on an ongoing basis.

The EO also directed the Council and member agencies to “identify and advance any additional administrative actions necessary” to promote competition on an ongoing basis. The Secretary of Agriculture (the Secretary) took note of wide-ranging concern from agricultural producers regarding access to and pricing of fertilizer.

The Market Access Secretariat would like to inform you that in response to the EO, on March 17, 2022, the United States Department of Agriculture (USDA) published three notices for public comments in the Federal Register with a 60-day comment period (see below for notices). Comments can be submitted to the USDA on each notice by May 16, 2022.

Comments can be submitted online and should reference the docket number, the date of submission, and the page number of this issue of the Federal Register. Alternatively, comments may also be sent by mail to Jaina Nian, Agricultural Marketing Service, USDA, Room 2055-S, STOP 0201, 1400 Independence Avenue SW, Washington, DC 20250-0201.

Federal Register Notices:

Competition in Food Retail and Distribution Markets and Access for Agricultural Producers and Small and Midsized Food Processors (AMS-AMS-22-0026)

This notice requests comments and information from the public to assist the USDA in preparing the report required by the Executive Order and advancing policy steps to promote competition in the food and agricultural markets.

Competition and the Intellectual Property System: Seeds and Other Agricultural Inputs (AMS-AMS-22-0025)

This notice requests comments and information from the public to assist the USDA in preparing the report required by the Executive Order and advancing policy steps on seeds and other inputs identified in and developed by the report.

Access to Fertilizer: Competition and Supply Chain Concerns (AMS-AMS-22-0027)

This notice requests comments and information from the public to assist the USDA in identifying relevant difficulties, including competition concerns, and potential policy solutions for the fertilizer market.

They would appreciate that you communicate to them any concerns or comments regarding these three notices to inform any potential intervention to the US on these matters.  Please send them to aafc.mas-sam.aac@agr.gc.ca .