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FALCPA: Allergen Recalls Continue to be #1 Cause for Food Recalls

  • 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
    peanuts

    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
    GMPS
    – “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

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