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FDA Looking More Closely at Allergen Controls … including Sesame

If you have – or have considered – adding a touch of sesame to a food that previously did not have it in order to be compliant with sesame’s new designation as a major food allergen, you should be aware of a new FDA Compliance Policy Guide that we have summarized below.  

FDA issued a new Draft Compliance Policy Guide (CPG) on Major Food Allergen Labeling and Cross-Contact, at least in part, to counter the practice of some manufacturers who “are intentionally adding sesame to products that previously did not contain sesame and are labeling the products to indicate its presence”; as this can make it more difficult for sesame-allergic consumers to find foods that are safe for them to consume, as stated in the Constituent Update.

Although the updated draft CPG does not specifically address the issue, it does address the FDA’s enforcement policy for labeling and cross-contact controls for major food allergens – including sesame. To reflect FDA’s risk-based and science-based approach for the evaluation of potential allergen violations, the draft CPG updates and adds detail on the labeling requirements for major food allergens, proper use of the ingredient list and the “Contains” statement, requirements for firms to implement controls to prevent or significantly minimize allergen cross-contact, and allergen labeling violations.

With the draft CPG intended as a guide for FDA staff on enforcement policies for major food allergen labeling and cross-contact (replacing the 2005 CPG 555.250), it directs inspectors to examine potential product adulteration due to allergen cross-contact as well as potential labeling violations.

What does this mean for FDA inspections of your facility?

From the very start, FDA states: “If an allergen misbranding or adulteration situation presents a reasonable likelihood of serious adverse health consequences or death to humans or animals, immediate action to remove the food from commerce should be considered.” And inspectors are to consider “appropriate actions to remove product from commerce,” (e.g., mandatory recall, administrative detention, or suspension of facility registration) if the business does not initiate a voluntary recall.

In an inspection, particular attention is to be paid to allergen labeling, information a facility submits to justify not labeling, potential cross-contact due to poor CGMPs, inadequate preventive controls, and/or inadequate juice/seafood HACCP controls. Inspectors also are encouraged to collect allergen information (including labels, test results, product photos, consumer complaints, etc.) for further CFSAN review “when appropriate.”

In discussing labeling violations, inspectors are to include key focus on food that is formulated to contain a major food allergen as an ingredient for which:

  • The label does not declare the allergen in either the ingredient list or in a “Contains” statement.
  • The label does not declare the allergen ingredient or the food source of the allergen.

For example, a product contains an allergen-containing ingredient (mayonnaise, whey) but the label does not declare the allergenic sub-ingredient (milk, egg); or a food contains a tree nut or fish, but the label does not declare, or incorrectly declares, the type or species.

Relative to adulteration due to allergen cross-contact, the inspector is to assess the facility’s controls (e.g., CGMPs, preventive controls, HACCP) and whether they significantly minimize or prevent allergen cross-contact. Examples of noncompliance would be inadequate CGMPs that resulted in failure to ensure against cross-contact through personnel practices, plant equipment and utensils, etc.; inadequate sanitation controls for shared equipment or utensils; lack of controls in storage, handling, and use, etc.

If allergenic adulteration occurred, but FDA finds no inspectional evidence, the inspector is to consider other factors, such as levels of allergen found, consumer adverse events, and other relevant information. Additionally, when analytical testing results are available for unintended allergen presence, the inspector is to consult with CFSAN on the health hazard posed by the product. Health hazard from unintended allergen presence will be determined on a case-by-case basis, such as through:

  • Estimated exposure to unintended allergen presence per eating occasion.
  • Likelihood of product consumption by allergic consumers and any mitigating allergen information on product.
  • Other available, appropriate evidence, such as evidence of insanitary practices, type of allergen control problem resulting in cross-contact, characteristics of allergen residues due cross-contact, and associated consumer adverse reaction(s).

Inspectors are also to inspect for incomplete or inconsistent allergen information/misbranding due to discrepancies in allergen information on the label, such as a food bearing an allergen-free claim but having evidence that the food contains an allergen.

While none of the information in the draft CPG is of a “breaking news” level, it is critical that the industry be aware that it indicates the increasing level of importance that allergens – including sesame – are taking in FDA inspections. As many in the baking industry have learned, FDA is very heavily focused on the challenges surrounding allergens and especially sesame. One of the most critical factors is to ensure your GMPs are robust, and that FDA does not consider you are making labeling decisions based on poor GMPs. Thus, it is advised that you conduct your own assessment to assure allergens are being accurately identified in product and labeled, and that you are not adding unnecessary allergens in lieu of good food safety programs. It is also clear that this issue is far from over and until FDA establishes thresholds, this problem is likely to continue. Thus, TAG encourages FDA to embark on a process to set thresholds for allergens, especially sesame.


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