Tag Archives: sesame

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House Appropriations Bill Highlights Support for Restructuring of FDA

By Food Safety Tech Staff
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The U.S. House of Representatives’ Committee on Appropriations has directed the FDA to unify its food program under a Deputy Commissioner for Foods and highlighted additional priorities for the agency related to cell-cultured meat products, allergen labeling and quantitative pathogen testing.

In its recent bill appropriating funds for the USDA, FDA and related agencies for fiscal year 2024, the committee laid out its priorities for these agencies, including:

Human Foods Program Restructuring. The Committee directed FDA to unify the foods program under an expert, empowered Deputy Commissioner for Foods with full line authority over CFSAN, the food and feed-related activities of the Center for Veterinary Medicine (CVM), and all food-related components of the Office of Regulatory Affairs, including inspection and compliance, food-related laboratories, import oversight, State partnerships, training, and information technology.

Allergen Labeling. The Committee stated that it is concerned about the increase in the diagnosis of food allergies to new and emerging food allergens not currently required to be labeled. The Committee urged the Center for Food Safety and Applied Nutrition (CFSAN) to identify potential future food allergens that would require labeling on food packaging and to implement the required process toward labeling on packaged foods.

Cell Cultured Meat Labeling. In light of the FDA’s first pre-market consultation for a human food made from cultured animal cells, the Committee stated that it is interested in the internal FDA protocols related to pre-market consultations for cell-cultured protein products, specifically whether or not there are special or unique considerations made for these products in pre-market consultation processes. The Committee requested a report outlining the pre-market consultation process for cell-cultured protein products, noting any special accommodations made to comply with the Formal Agreement between the FDA and the USDA and any agency plans to coordinate with its counterparts at USDA on further action regarding the same products.

FASTER Act. The Committee shared its concerns of reports that companies are circumventing the intent of the FASTER Act by intentionally adding sesame to food products to avoid the cost of preventing cross-contamination. FDA is directed to report on implementation of the FASTER Act, including plans to address this issue and an analysis of whether actions by companies in response to the Act’s passage violated federal food safety rules.

Listeria. The Committee directed FDA to apply a risk-based approach and direct its regulatory efforts toward high risk ready-to eat foods that support the growth of Listeria monocytogenes (Lm). Additionally, the Committee encouraged a regulatory approach that encourages industry to adopt quantitative Lm testing schemes and facilitate robust environmental monitoring programs. The Committee directed FDA to work with industry stakeholders to gather supporting information and data to assist with implementation of this Lm approach to align with other international regulatory standards and restore a level playing field for U.S. food processors in the global marketplace.

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FDA Releases Draft Compliance Policy Guide for Food Allergen Labeling and Cross-Contact

By Food Safety Tech Staff
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On May 16, the FDA released a draft Compliance Policy Guide (CPG) to provide guidance for FDA staff on the enforcement policy regarding major food allergen labeling and cross-contact. The guide reflects FDA’s thinking on major food allergen enforcement policy based on the current regulatory framework and latest science. When finalized, it will replace the existing CPG 555.250 for FDA staff.

Among the updates, the draft CPG describes the labeling requirements for major food allergens and proper use of the ingredient list and the “Contains” statement for major food allergen declarations. It also describes requirements for firms to implement controls to prevent or significantly minimize allergen cross-contact. In addition, the draft CPG describes additional allergen labeling violations and directs FDA staff to examine potential product adulteration due to allergen cross-contact as well as potential labeling violations.

The agency stated that it is aware that some manufacturers are intentionally adding sesame to products that previously did not contain sesame and are labeling the products to indicate its presence. While the draft CPG does not specifically address this issue, the FDA said that it recognizes that this practice may make it more difficult for sesame-allergic consumers to find foods that are safe for them to consume—an outcome that the FDA does not support, and that the agency is engaging with stakeholders on this issue. The draft CPG does address the FDA’s enforcement policy for labeling and cross-contact controls for major food allergens, including sesame.

Stakeholders can submit electronic or written comments within 60 days of publication in the Federal Register.

2022 FDA Food Code

FDA Issues 2022 Food Code

2022 FDA Food Code

The FDA has issued the 2022 edition of the FDA Food Code, which contains some significant changes, including:

  • Adding sesame as a major food allergen to reflect that the Food Allergy Safety, Treatment, Education, and Research Act of 2021 established sesame as the 9th major food allergen
  • Informing consumers, in writing, of major food allergens as ingredients in unpackaged food
  • Adding labeling of major food allergens in bulk food that is available for consumer self-dispensing
  • Creating new requirements for the allowance of pet dogs in outdoor dining spaces
  • Revising the definition of intact meat, including enhancements to clarify time/temperature cooking requirements

For the first time, the FDA Food Code specifically addresses food donations, included as part of the Biden-Harris Administration’s National Strategy on Hunger, Nutrition, and Health. The National Strategy, which was rolled out in September at the White House Conference on Hunger, Nutrition, and Health, provides a roadmap of actions the federal government is taking to end hunger and reduce diet-related diseases by 2030.

The FDA noted that the 2022 edition reflects the input of regulatory officials, industry, academia, and consumers that participated in the 2020 biennial meeting of the Conference for Food Protection (CFP).

The Food Code is offered for adoption by local, state, and federal governmental jurisdictions for administration by the various departments, agencies, bureaus, divisions, and other units within each jurisdiction that have been delegated compliance responsibilities for food service, retail food stores, or food vending operations. Alternatives that offer an equivalent level of public health protection to ensure that food at retail and food service is safe are recognized in the Food Code.

View a full list of the Summary of Changes.


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FDA Issues Two New Guidances on Food Allergen Labeling Requirements

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The FDA has issued two new guidance documents on food allergen labeling requirements.

Questions and Answers Regarding Food Allergens, Including the Food Allergen Labeling Requirements of the Federal Food, Drug, and Cosmetic Act (Edition 5); Guidance for Industry updates the previous edition (Edition 4) with new and revised questions and answers related to the labeling of food allergens, including requirements in the Food Allergy Safety, Treatment, Education, and Research Act of 2021 (FASTER Act) and the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA).

The FALCPA amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) by defining the term “major food allergen” and requiring that foods or ingredients that contain a major food allergen be specifically labeled with the name of the allergen source. This law identified eight foods as major food allergens: milk, eggs, fish, shellfish, tree nuts, peanuts, wheat, and soybeans. The FASTER Act adds sesame to the list of major food allergens effective January 1, 2023.

The draft guidance includes:

  • New questions and answers about food allergen labeling requirements, such as the labeling of sesame, milk, and eggs; the labeling of major food allergens in the labeling of dietary supplement products; and other technical labeling issues.
  • Revised questions and answers to update and clarify information presented in earlier editions of the final guidance, such as the labeling of tree nuts, fish, and crustacean shellfish.
  • Images that show examples of labeling requirements.

The agency also issued a final guidance with the same title to preserve the questions and answers from the previous edition (Edition 4) that were not changed, except for editorial changes such as renumbering the questions and reorganizing the information in the guidance.

Stakeholders can submit comments about the draft guidance within 60 days of the November 30 publication of the notice in the Federal Register. Submit comments electronically on www.regulations.gov or by mail:

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-2022-D-0099.

Sesame Seeds

President Biden Signs FASTER Act, Requiring Sesame Labeling on Food Packaging

By Food Safety Tech Staff
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Last week President Biden signed the Food Allergy Safety, Treatment, Education, and Research Act of 2021 (FASTER Act; H.R. 1202) into law. The bill is a significant victory for food allergy advocates, because it adds sesame to the list of allergens that must be labeled on food packaging. HHS must also report certain information related to food allergy research and data collection.

Sesame is the ninth food allergen that must be labeled on food packaging. According to FARE (Food Allergy & Research Education), a non-government food allergy advocacy group, about 1.6 million Americans are allergic to sesame. “Sesame is often used when a label reads ‘natural flavors’ or ‘natural spices’, adding another layer of difficulty when consumers review product labels at their local grocery store,” according to a FARE press release about the bill. “This marks the first time since 2004 that a new allergen has been added to the Food Allergen Labeling and Consumer Protection Act (FALCPA).”

Packages must include the updated labeling by January 2023.