Tag Archives: allergen labeling

peanuts, allergens
Allergen Alley

Allergen Advisory Labeling

By Food Safety Tech Staff
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peanuts, allergens

We’ve all seen the vague warnings on food labels, such as “May contain tree nuts” or “This product was made in facility that also processes dairy.” At the Food Safety Consortium in October, Steven Gendel, principal of Gendel Food Safety and former FDA Food Allergen Coordinator, offered guidance on when and how these advisory—also known as precautionary—labels should be used by food companies. In his presentation “Allergen Advisory Labeling,” Gendel made clear that these statements are not regulatory requirements and are not to be used for a company’s benefit (i.e, to shield the company from liability). They are for consumers and should be used only to protect consumers in situations where there is a potential risk of cross contamination that cannot be controlled through regulated cross contamination efforts and may cross the threshold of safe levels for allergic consumers.

Steve Gendel, USP
Steven Gendel

When to Use Allergen Advisory Labels

Advisory labels are to be used after a company has taken all necessary steps to eliminate allergen cross contamination and ensure the absence of allergens, and is unable to prevent the risk of cross contamination. “Companies should have a written justification for using an advisory label statement,” said Gendel.

How to Calibrate Risk

The risk to consumers with allergies is based on a combination of how much of the allergen is present and how much of the product is likely to be consumed. This means that risk should be based on how much of the product the consumer is likely to consume, not the labeled serving size. Take, for example, a small bag of chips that includes nutritional information for two servings per bag. If the consumer is more likely to eat the entire bag in one sitting, the allergen dose should be based on the exposure from one full bag of chips. “The dose can justify use of an allergen advisory label,” said Gendel. (For guidance on dose, the United Nations Food and Agriculture Organization (FAO) has established allergen threshold levels.)

It is also important to note that precautionary or advisory labels are for potential cross contamination risks only. “There is no minimum dose for an ingredient,” said Gendel. “If an allergen is an actual ingredient in the product, it must be on the ingredient label.”

 

 

U.S. House of Reps seal

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.