By Jeanne Yacoubou, MS
VRG Research Director

Long-time VRG members recently asked us why “…almost every item we pick up to read the ingredients have a disclaimer saying that the item was made on shared equipment that also processes eggs, soy, peanuts and wheat.”

The Food Allergen Labeling and Consumer Protection Act of 2004, (FALCPA), is the reason why manufacturers must list on food labels any of the eight allergens, (milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat and soybeans), determined by the Food and Drug Administration (FDA) to be potentially harmful to the majority of allergy sufferers. Because highly sensitive individuals could have adverse reactions to even very small quantities of allergen present in food due to cross-contamination from equipment on which food containing the allergen was previously manufactured, some companies voluntarily indicate that shared equipment was used. Doing so may protect the manufacturer from legal liability if an adverse reaction occurs from a food product which does not contain the allergen as an intended ingredient but was produced on shared equipment.

Currently FALCPA does not require a “may contain” statement or anything similar such as a shared equipment disclaimer. (Question 13 on this FAQ page: http://www.fda.gov/Food/LabelingNutrition/FoodAllergensLabeling/GuidanceComplianceRegulatoryInformation/ucm106890.htm#q10 and Question 16 on this one: http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/FoodLabelingNutrition/ucm059116.htm) FDA emphasizes only that

FDA advised that advisory labeling such as “may contain [allergen]” should not be used as a substitute for adherence to current Good Manufacturing Practices (cGMPs). In addition, any advisory statement such as “may contain [allergen]” must be truthful and not misleading.

However, in the statement of the Act, there is a paragraph that states that FDA is aware of cross-contamination of major allergens due to shared equipment and requires further research into the subject. (Section 204 on this page: http://www.fda.gov/food/labelingnutrition/FoodAllergensLabeling/GuidanceComplianceRegulatoryInformation/ucm106187.htm).

In December 2005, FDA added this further clarification to its FAQ page (Question 18): http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/FoodLabelingNutrition/ucm059116.htm:
Is a major food allergen that has been unintentionally added to a food as the result of cross-contact subject to FALCPA’s labeling requirements?
No. FALCPA’s labeling requirements do not apply to major food allergens that are unintentionally added to a food as the result of cross-contact. In the context of food allergens, “cross-contact ” occurs when a residue or other trace amount of an allergenic food is unintentionally incorporated into another food that is not intended to contain that allergenic food. Cross-contact may result from customary methods of growing and harvesting crops, as well as from the use of shared storage, transportation, or production equipment.

The Act states in Section 202 that undeclared allergens have become more frequent resulting in more FDA food recalls. FDA provides current information about undeclared allergens in specific food products on its website: http://www.fda.gov/safety/recalls/default.htm. According to Food Safety News, undeclared allergens accounted for more than one in three food recalls during the last quarter of 2011: http://www.foodsafetynews.com/2012/02/recalls-of-fda-regulated-foods-spiked-up-last-quarter/#.UT0aCjdhuSp

The contents of this article, our website, and our other publications, including the Vegetarian Journal, are not intended to provide personal medical advice. Medical advice should be obtained from a qualified health professional. We often depend on product and ingredient information from company employees or company statements. Information does change and mistakes are always possible. Please use your own best judgement about whether a product is suitable for you. Further research or confirmation may be warranted.

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