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Assured Bites, Inc. Petition Approval Marks First-Ever FDA Qualified Health Claim Linking Early Peanut Introduction to Allergy Prevention


News provided by

Assured Bites, Inc.

Sep 07, 2017, 14:18 ET

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NEW YORK, Sept. 7, 2017 /PRNewswire/ -- Assured Bites, Inc., a New York-based family health and wellness company on the forefront of peanut allergy prevention, is pleased to announce the U.S Food and Drug Administration (FDA) has approved its petition for a qualified health claim linking early peanut introduction and the prevention of peanut allergy. This is the first time the FDA has recognized a qualified health claim to prevent a food allergy. Assured Bites' line of Hello, Peanut!® products is the only product of its kind to provide parents a simple and safe way to gradually introduce peanuts to their infants as young as five months of age to reduce the chance of a peanut allergy developing.

Hello, Peanut! is the only product of its kind to provide parents a simple and safe way to gradually introduce peanuts to their infants as young as five months of age to reduce the chance of a peanut allergy developing.
Hello, Peanut! is the only product of its kind to provide parents a simple and safe way to gradually introduce peanuts to their infants as young as five months of age to reduce the chance of a peanut allergy developing.

According to a statement released today by FDA Commissioner Scott Gottlieb, MD, "Along with the information that you currently see on food labels, which disclose when a food contains peanuts or peanut residue, the new advice about the early introduction to peanuts and reduced risk of developing peanut allergy will soon be found on the labels of some foods containing ground peanuts that are suitable for infant consumption." 

"We're pleased the FDA has approved our petition for a qualified health claim linking early peanut introduction and the prevention of peanut allergies," says Dr. David Erstein, board-certified allergist and founder of Assured Bites, Inc. "We hope this will further educate and encourage parents to heed the advice of their medical professionals to introduce peanuts early and often to reduce the chance of a peanut allergy developing."

Hello, Peanut! was launched in 2016 in response to cutting edge medical research and is aligned with the National Institutes of Health (NIH) and National Institute of Allergy and Infectious Disease (NIAID) guidelines released in early 2017, which support early peanut introduction to prevent a peanut allergy. The guidelines are based on the highly publicized Immune Tolerance Network's Learning Early About Peanut (LEAP) study published in the New England Journal of Medicine in 2015, the LEAP-On study, and the Enquiring About Tolerance (EAT) Study.

The Hello, Peanut! Introduction System contains packets of organic peanut and sprouted oat blends designed to be safely mixed into baby food over the course of seven days. The amount of peanut in each packet gradually increases daily. After this introductory phase, Maintenance Packets are recommended for use until the infant can eat peanut in spread or whole form. Hello, Peanut! does not require a prescription or administration by a physician and can be fed to babies at home. It is USDA organic certified organic, non-GMO, dairy free and Kosher (OU).

Hello, Peanut! is geared toward the general infant population who have no known peanut allergies and is not designed to treat or cure peanut allergies.  Infants considered at high risk for developing a peanut allergy (those with severe eczema and/or egg allergy) should be evaluated prior to peanut introduction.

For more information, please visit hello-peanut.com.

SOURCE Assured Bites, Inc.

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