The US Food and Drug Administration (FDA) has not been a friend to the food allergy community, which is already overburdened in coping with the disease. From ineffective allergen labeling regulations to arbitrary decisions regarding the approval of epinephrine alternatives, preventable deaths — such as the recent tragedy that befell Órla Baxendale, a 25-year-old dancer who died from eating a cookie — continue to ravage the community.
One way the community can spur the FDA into action is by banding together and voicing our concerns publicly. To that end, there are two petitions circulating on Change.org that we encourage you to sign and share with family, friends, and colleagues.
The first petitions the FDA to quickly approve Neffy, a needle-less emergency epinephrine device that provides an alternative to traditional auto-injectors. Fear of the needle often leads to delay in administering epinephrine when anaphylaxis is suspected, and delay can lead to poorer outcomes and death.
Clinical studies have shown Neffy to be as fast and effective as auto-injectors, and last year, the FDA’s own expert panel voted overwhelmingly to approve the device. However, bureaucracy and poor management have delayed approval pending additional testing, which is expected to be completed toward the end of March. At that point, the agency has six months to decide but can approve the drug much sooner as they have already completed the lion’s share of their analysis.
The second petitions the members of Congress to pass legislation forcing the FDA to fix our broken allergen labeling regulations.
While FDA regulations require the Top 9 allergens to be labeled as ingredients, they allow multiple ways for doing so, injecting ambiguity and confusion into a process that is critical to the safety and well-being of food allergy sufferers.
To make matters worse, precautionary allergen label warnings like “May contain peanuts” and “Manufactured on equipment that also processes milk” are entirely voluntary, contrary to popular belief. Some manufacturers include them, many major brands don’t, and still other manufacturers will warn for one allergen and not another. The voluntary nature of the regulations leads to confusion and often gives consumers a false sense of security that the products they are purchasing are safe.
As we have done in the past, we at SnackSafely.com will forward copies of the petitions and all signatures to the relevant parties as we achieve certain milestones.
We ask that you please sign and share both petitions to give voice to the needs of the community.