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allergens

Food Allergens – Understanding The Hazards

Laurie Post · November 14, 2023 ·

Violations due to food allergen hazards are a major food safety concern globally. In a recent article in the Journal of Food Protection, FDA reviewed recalls associated with major food allergens (MFA) and gluten in FDA regulated foods from fiscal years 2013 to 2019. The review distilled information about the foods most frequently implicated in allergen recalls and the specific food allergens associated with recalled products. The root causes of the recalls that occurred over the time period studied were also examined.


During fiscal year 2013-2019, 1417 allergen related recalls were reported. Most of the recalls (97%) were classified as Class I (51%), posing a reasonable probability of serious adverse health consequences or death or Class II (46%), posing a remote probability of serious adverse health consequences or temporary/reversible adverse health consequences. Of the 1471 recalls, 1415 recalls were due to MFAs, 34 recalls were due to a gluten-free labeling violation, and 23 recalls involved other allergens. Milk was the most common allergen involved in MFA recalls (37.5%), followed by soy (22.5%) and tree nuts (21.6%). Almond, anchovy, and shrimp were the most common allergens recalled within the MFA groups of tree nuts, fish, and Crustacean shellfish, respectively. About 97% of MFA recalls involved one product category and among them, the category of ‘bakery products, dough, bakery mixes and icings’ ranked first (367 recalls), followed by the category of ‘chocolate and cocoa products’ (120 recalls).

The top five recalled food product categories – major food allergens implicated and number of recalls.

Product CategoriesMultiple MFACrustacean
Shellfish
EggFishMilkPeanutSoyTree NutWheatTotal
Bakery
Products,
dough, bakery
mixes, and
icings
8303318922337531387
Chocolate and
cocoa
products
2201042257203120
Multiple food
dinners,
gravies,
sauces, and
specialties
312158201101112110
Snack foods
(flour, meal, or
vegetable
base)
9031456116586
Ice cream and
related
products
12050820223272
Adapted from G. M. Sharma et.al. 2023.

The “mode of discovery” for allergen issues leading to a recall was also examined. These issues were most often detected by consumer and downstream customer complaints.

DiscoveredDescriptionNumbers of recalls % of total recalls
ComplaintIncludes complaint from consumer, downstream customer,
distributor, or others; did not involve allergic or other adverse
reactions
39227.7
FDAIncludes inspection or other means of discovery by FDA19313.6
FirmIncludes recalling firm, manufacturing firm, or responsible firm27919.7
Other governmentIncludes inspection, notification or other means of discovery by
State agencies, other federal agencies, or foreign government
21515.2
ReactionIncludes consumer adverse reaction associated with the
consumption of the product
1258.8
Unknownmode of discovery not identified based on available information to
FDA
21114.9
Adapted from G. M. Sharma et.al. 2023.

Nineteen different root cause categories were identified for the MFA recalls that occurred during the period studied. Overall, allergen labeling and packaging errors were the major sources of issues resulting in 64.6% (N = 914) of total MFA recalls.

Allergen cross-contact, defined as the unintentional incorporation of a food allergen into a food, resulted in 21.3% (N = 301) of total MFA recalls. Sources of unintended allergen presence in food products were related to processing or production such as a mix-up in rework, the use of a wrong ingredient that was not communicated on the product label (5.6% of total MFA recalls), or inadequate sanitation practices (7.1% of total MFA recalls).
1163 recalls out of 1415 MFA recalls were traced to a specific root cause. Considering all sources of
allergen issues, these were identified as the most common root causes:
◼ 662 recalls were traced to errors in labeling and packaging.
◼ 307 recalls were traced to raw or incoming ingredients.
◼ 194 recalls were traced to processing or production errors within the facility.

Root CauseExamples
No carry-through • MFA in sub-ingredient not declared on the final product
• MFA in an incidental additive not declared on final product
Wrong Package • Use of wrong primary or secondary package
• Mix-up of wrong package at supplier or manufacturer level
Wrong Label• Use of wrong label or one labels on the product is wrong
• Label mix-up at supplier or manufacturer level
Terminology• Ingredient is declared but its MFA source is not
Cross-contact• Sanitation issues
• Change-over or sequencing issues
Wrong ingredient• Use of wrong formulation or recipe
• Use of wrong sub-product in a composite product kit
Adapted from G. M. Sharma et.al. 2023.

Identification of allergen controls that could mitigate the source of allergen errors are listed below. Label controls (includes label content controls and label management controls) could have prevented 893 out of 1163 MFA recalls (76.8%), whereas allergen cross-contact controls and supply chain controls could have prevented 16.7% and 6.5% MFA recalls, respectively.

Allergen controlsSource of problemRoot causeNumber of recalls% of total recalls
Cross-contact controlsProcessing or productionIn process171.5
Other cross-contact796.8
Positive allergen test171.5
Rework161.4
Wrong ingredient655.6
Total cross-contact controls19416.7
Label content controls Labeling and packagingComputer error534.6
Foreign language121.0
Knowledge 342.9
No declaration 252.2
Not updated564.8
Partial declaration353.0
Terminology12110.4
Raw or incoming ingredientsNo carry-through23119.9
Total label content controls56748.8
Label management controlsLabeling and packagingWrong label16113.8
Wrong package16514.2
Total label management controls32628.0
Supply Chain ControlsRaw or incoming ingredientsIngredient mislabeled211.8
Other cross-contact221.9
Positive allergen test191.6
Wrong ingredient141.2
Total supply chain controls766.5
Total allergen controls1163100.0
Adapted from G. M. Sharma et.al., 2023.

Recent guidance documents listed below provide useful information for food allergen hazard assessments and associated controls.

CPG Sec 555.250 DRAFT: Major Food Allergen Labeling and Cross-contact | FDA

-Major Food Allergen Labeling and Cross-contact Draft Compliance Policy Guide (CPG)

Update to Draft Guidance for Industry: Hazard Analysis

-Chapter 11: Food Allergen Program

Source of information: FDA.gov

FDA’s Updated Draft Compliance Policy Guide on Major Food Allergen Labeling and Cross-Contact Provides Useful Information to the Food Industry

Laurie Post · June 11, 2023 ·

By Laurie Post, Ph.D.

On May 16, 2023, FDA released a draft compliance policy guide (CPG) that provides guidance for FDA staff, including investigators, on FDA’s enforcement policy regarding major food allergen labeling and cross-contact. While FDA guidance documents should be reviewed as recommendations, unless specific regulatory or statutory requirements are cited, these type of communications from the FDA are useful to industry because they present FDA’s current thinking and polices on significant food safety topics. The current draft CPG updates the 2005 CPG Sec 555.250 Statement of Policy for Labeling and Preventing Cross-contact of Common Food Allergens. The recent draft CPG provides a more detailed perspective on FDA’s current policies on food allergen labeling requirements, allergen cross-contact, voluntary allergen information (e.g., advisory label statements), thresholds, and regulatory actions. FDA states that their regulatory approach in addressing allergen violations will be case-by-case and dependent on the facts of each situation.

Allergen Cross-Contact and FDA’s Regulatory Approach

Allergen cross-contact is the unintentional incorporation of a food allergen into a food that does not contain that allergen as an ingredient. It is defined in FDA’s rule titled, “Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food” 21 CFR part 117.

Allergen cross-contact may occur due to practices such as failure to adequately clean shared equipment, failure to properly segregate allergens, improper rework addition, or improper production scheduling. The draft CPG notes that the likelihood an allergen will be present due to cross-contact can be impacted by factors such as the characteristics of the food, the distribution of the allergen within a food (homogeneous versus particulate), the type of manufacturing process, the equipment used, and the cleaning procedures applied (e.g., dry cleaning versus wet cleaning).

While FDA acknowledges the factors that lead to allergen cross-contact, the draft CPG also confirms FDA’s position that “major food allergens unintentionally incorporated into a food are not to be declared in the ingredient list or the ‘Contains’ statement.” Manufacturers must instead comply with applicable requirements to address the potential for allergen cross-contact through appropriate preventive controls established in 21 CFR Part 117. With a few exceptions, these preventive controls requirements specify that food facilities must implement a food safety plan that includes a hazard analysis to identify known or reasonably foreseeable hazards that require a preventive control and must significantly minimize or prevent allergen hazards so that the food product will not be adulterated (section 402 of the FD&C Act (21 U.S.C. 342(a)) or misbranded (section 403(w) of the FD&C Act (21 U.S.C. 343(w) (21 CFR 117.135).

FDA generally regards a product to be misbranded when case-by-case review of the evidence shows that the product’s label bears incomplete or inconsistent product information regarding major food allergens.

  • The food is formulated to contain a major food allergen as an ingredient and fails to declare on the label the major food allergen in either the ingredient list or the “Contains” statement as required (section 403(w) of the FD&C Act (21 U.S.C. 343(w)).
  • The food is fabricated from two or more ingredients but fails to declare on the label the common or usual name of the ingredient in the ingredient list as required (section 403(i)(2) of the FD&C Act (21 U.S.C. 343(i)(2)).

FDA generally regards a product to be adulterated when a case-by-case review of the evidence, including inspectional evidence or other information, demonstrates that allergen cross-contact may render the product injurious to health (section 402(a)(4) of the FD&C Act (21 U.S.C. 342(a)(4)).

  • When there is evidence of inadequate allergen cross-contact controls, FDA may deem a product adulterated even when the product bears an allergen advisory statement.

For example, inadequate sanitation control, such as failure to adequately clean shared equipment between production runs of products with different allergen profiles, may render the product adulterated. As another example, inadequate allergen label controls, such as failure to check the product label to ensure major food allergen ingredients intended to be in the food are labeled as required, may result in a misbranded product.

If testing detects an allergen in food or FDA suspects an allergen is present because of one or more adverse consumer reactions, but the origin of the allergen in the product is not known, FDA may follow up with the company to obtain additional information such as product formulation, ingredient information, and information about other products made on the same line or in the same process environment.

When analytical test results are available that establish presence of an allergen not intentionally added to the food, the draft CPG directs investigators to consult with the CFSAN/Office of Compliance on the health hazard posed by the product to determine whether the product is adulterated. A case-by-case evaluation of the allergen health hazard will include factors such as estimated exposure to unintended allergen presence per eating occasion, likelihood of product consumption by allergic consumers, any mitigating allergen information on the product, and other evidence such as evidence of insanitary practices, type of allergen control problem resulting in cross-contact, characteristics of allergen residues due cross-contact (e.g., particulates, dusts, etc.), and consumer adverse reactions.

The draft CPG explains that if there is a reasonable likelihood of serious adverse health consequences or death due to allergen misbranding or adulteration, FDA may consider immediate action to remove the food from commerce. If the company does not initiate a voluntary recall, FDA will consider other appropriate actions, such as mandatory recall, administrative detention, and/or suspension of facility registration.


Voluntary Allergen Information
FDA notes that allergen advisory statements such as “may contain [allergen]” may be used to alert consumers to the possible presence of a major food allergen due to cross-contact. They do, however, explicitly state that advisory statements are not a substitute for adherence to CGMPs and preventive controls. In a footnote, FDA states that the “presence of allergen advisory statements may be considered a health risk mitigating factor when allergen cross-contact is appropriately managed consistent with CGMPs, preventive controls, or other controls (e.g., HACCP).” This is a rare instance where FDA publicly acknowledges that advisory statements may be appropriate in certain circumstances. However, FDA also
notes that consumer adverse reactions may provide some evidence that labeling information or other factors did not effectively mitigate health risk from exposure to the allergen hazard in the product. The draft CPG also discusses the use of allergen-free claims and notes that such claims must be truthful and not misleading. FDA states expressly that if a product is labeled “milk-free,” the product should contain no milk allergen in the product. The draft CPG does not detail what controls or processes, e.g., final product testing, are needed to substantiate allergen-free claims.


Thresholds
FDA states in the draft CPG that it has not established a threshold for any major food allergen, but notes
that it is aware of published dose response data that raises the possibility that certain low-level exposure
to allergens “may not pose a health hazard to the majority of food allergic individuals.”
FDA states that where analytical test results are available when making the health hazard determination
discussed above, it will consider the estimated exposure per eating occasion to the allergen in that food.
However, FDA would also have to consider the allergenicity threshold (i.e., the maximum amount of
allergenic food that can be tolerated) of the particular allergic population consuming the product. While not explicit, this appears to indicate that FDA will take into account threshold information on a case-bycase basis when considering whether a product is adulterated due to cross-contact.

Comment Period
FDA asks for comments on the draft CPG by July 17, 2023, although the agency accepts comments on
guidance documents at any time.

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