FSIS issues updated food allergen guidelines.

  • The Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA) requires that the label of an FDA-regulated food that contains an ingredient that is or contains protein from a “major food allergen” declare the presence of the allergen in the manner described by the law.  FALCPA does not apply to products under USDA’s jurisdiction, i.e., meat, poultry, and egg products, but the Food Safety and Inspection Service (FSIS) encourages the use of FALCPA-consistent allergen statements.
  • In November 2015, FSIS released an updated guidance document to assist USDA-regulated establishments with evaluating and addressing the risks posed by allergens in their products.  Although the guidance does not impose any legal obligations, it represents FSIS’s current thinking on “best practices” for allergen-related controls, packaging, labeling, storage, checklists, and training, among other topics.
  • Although FALCPA allergen declaration requirements do not apply, USDA-regulated products still must bear accurate ingredient declarations.  The failure to identify the presence of an allergen or an ingredient of public health concern means that the label is false and misleading, and the product is misbranded and adulterated.  In the past few years, the number of recalls of USDA-regulated products attributable to the presence of undeclared allergens has increased.  In particular, several recalls have been related to the use of release agents that contain soy lecithin and the subsequent failure to declare the presence of this ingredient on the label of the finished food.  Particularly because FSIS often takes a stricter approach to requesting recalls where undeclared allergens are present — even where a risk analysis may indicate no reasonable risk of consumer harm — meat, poultry, and egg producers should familiarize themselves with the allergen guidance and develop appropriate compliance strategies to mitigate the risk of allergen-related recalls.