NEW YORK, Oct. 12, 2023 /PRNewswire/ — SnackSafely.com — a leading food allergy advocacy established in 2011 — sent a petition with over 20,000 signatures to the FDA and oversight committees in Congress, demanding approval of nasal epinephrine for use in anaphylactic emergencies.
Anaphylaxis is a life-threatening allergic reaction to a food, drug, insect venom, or environmental substance. Epinephrine is the only drug that can halt and reverse the progression of anaphylaxis, but it must be administered promptly to be effective.
Said Dave Bloom, CEO of SnackSafely.com: “The majority of anaphylactic deaths are due to delays in administering epinephrine, and one primary reason for that delay is fear of the needle that current emergency epinephrine devices employ.
“The FDA recently denied approval of a safe and effective alternative to the epinephrine auto-injector — a nasal spray — that would eliminate this fear and result in more prompt administration when anaphylaxis is first suspected. Furthermore, the FDA’s own advisory panel voted 17-5 to approve a nasal epinephrine candidate for children and 16-6 for adults in May of 2023. Still, the agency suddenly changed direction and denied approval of the device in September.
“The food allergy community desperately needs this alternative mode of delivery, which will eliminate hesitation to administer, lead to better outcomes, and save lives, as is evidenced by over twenty thousand signers of our petition in a single week.
“We call on FDA Commissioner Dr Robert M. Califf, the House Subcommittee on Health and the Environment, and the Senate Subcommittee on Health to act on behalf of this growing and vulnerable community to approve nasal epinephrine now.”
You can find the petition on Change.org by clicking here, and we urge you to lend your support by signing.
SnackSafely.com provides straightforward, actionable information to improve the lives of the estimated 33 million Americans coping with food allergies. We strive to eliminate accidental exposure by leveraging our online properties to educate, advocate, and connect the allergic community with food products, pharmaceuticals, and services that help achieve this goal. Visit us at SnackSafely.com.