- 20 Mar
FALCPA: Allergen Recalls Continue to be #1 Cause for Food Recalls
Here are some excellent points from a recent seminar I attended by FALCPA:
• Allergen Labeling Options: You decide…
The big 8 allergens: egg, soy, wheat, milk, fish, crustacean shellfish, peanut, tree nut
1. Allergen Information Statements
Ingredients: Semolina, rice flour, rolled oats,
pine nuts, tomato juice, whey, sodium
caseinate, fish gelatin, natural flavoring
Contains: wheat, milk, pine nuts, tuna and
2. Ingredient Statement
Ingredients: Semolina (wheat), rice flour,
rolled oats, pine nuts, tomato juice, whey
(milk), sodium caseinate, tuna gelatin,
natural flavoring (peanuts)
• Bolding is optional
• Precautionary labeling, however, is only available when the presence of allergen cannot be avoided by
– “may contain milk”
– “processed on shared equipment with peanuts”
– “processed in a facility that processes peanuts
• Recall Health hazard evaluation :
– Class I: a reasonable possibility of serious adverse health consequences or death.
– Class II: may cause temporary or medically reversible adverse health consequences.
– Class III: unlikely to cause adverse health consequences.
• We are finding major food allergens where we did not expect to find them (peanut in a ‘natural flavor’, fish extract as a carrier in colors)
• FDA never established “thresholds”
• What is the legal standard to apply?
– Is it “possibility of illness,” which is the standard FDA appears to be adopting?
– Should it be “cause an allergic response that poses a risk to human health?”
– Shouldn’t there be a recognition that if there is only a theoretical possibility of a mild reaction that such a reaction does not pose a risk to human health?”
• We will continue to find allergen in unexpected places and if they are detectable and not declared, there
will be recalled liability
• Companies may gravitate to precautionary labeling to avoid the costs of a recall
FALCPA – FDA resource