The Tragedy Behind the Tragedy of Órla Baxendale’s Death


News of the tragic death of 25-year-old Órla Baxendale has awakened the world to the dangers that come with a food allergy diagnosis, when the simple act of eating a cookie can bring calamity to an entire family.

Cookies United, the company that manufactured the cookie that took Órla’s life, changed the ingredients adding peanuts and eggs. Stew Leonard’s, the company that white labeled the cookies (i.e. branded them under their own name), did not update their labels to reflect the new ingredients in keeping with US allergen labeling regulations known as FALCPA.

Órla, who had a peanut allergy and was by all accounts meticulous in avoiding peanuts, unknowingly consumed her allergen and suffered anaphylaxis which lead to her death.

While both companies blame each other for the mislabeling, one thing is for sure: the procedures between the companies to ensure proper labeling broke down. The FDA must investigate this catastrophe and decide where additional regulations regarding whitelabeling need to be put in place.

But there’s a deeper problem that few are talking about, one that poses a constant threat for the food allergy community: voluntary precautionary allergen labeling (PAL).

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Including PAL warnings like “May contain milk” and “Made on equipment that also processes tree nuts” are entirely voluntary on the part of the manufacturer. Some include them, many major brands don’t, and still others warn for one allergen and not another. The FDA has little to say about PAL warnings as they are unregulated.

Had a prescribed, standardized PAL warning been in place when the cookies in question were first introduced, they would have bore a warning, something like “Made in a facility that processes peanuts and eggs.”

Knowing the little we know about Órla from her family’s statements, it’s unlikely she would have purchased the cookies in the first place, knowing there was the potential for cross-contact and mistakes in labeling.

And that is a tragedy for the estimated 33 million Americans in the US with food allergies: they have no idea how the majority of packaged foods in the US are manufactured with respect to their allergens of concern. Worse yet, they are lulled into a false sense of security when a product doesn’t include a PAL warning or an app suggests the product as safe based on the lack such a warning.

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We need better. The FDA must step up and close this loophole that continually endangers the food allergy community.

To that end, we’ve circulated a petition to members of Congress demanding legislation that will force the FDA to act. Please consider signing and sharing the petition with family, friends, and co-workers.

In the meantime, did you ever wonder how manufacturers decide whether to include voluntary PAL warnings? The details may shock you. See our expose below entitled When a Manufacturer Says ‘Trust Us’ Regarding Allergens.

When a Manufacturer Says ‘Trust Us’ Regarding Allergens


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Dave Bloom
Dave Bloom
Dave Bloom is CEO and "Blogger in Chief" of

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