Nestlé Health Science (NHSc), a business unit of Nestle S.A., has taken a minority stake in Before Brands, specialists in early childhood food allergy prevention who manufacture products sold under the SpoonfulOne brand.
The SpoonfulOne line aims to reduce food allergy development risk with 16 key allergens. The core technology is based on research and intellectual property licensed from Stanford University, training the child's immune system through consistent feeding over months to years.
As part of the agreement, Nestlé Health Science has acquired the licensing rights to Before Brands’ products outside the United States. Nestle also has an option to purchase all remaining equity in Before Brands in the future.
"With Nestlé Health Science, we have secured the ideal partner so that we may advance our mission to help families around the world benefit from SpoonfulOne's advanced protein science and the new recommendations that advocate proactive, long-term feeding strategies to reduce food allergy development risk," said Ashley Dombkowski, Ph.D., co-founder and CEO of Before Brands. "Their expertise and global footprint will allow us to accelerate education, commercialization, and distribution activities globally."
Peanut allergies are on the rise
Since 1997, the rate of peanut allergy has tripled, with one in 13 children now affected. The approach is allergy prevention has changed over the years. In 2015, when the results of a clinical trial called LEAP (Learning Early About Peanut allergy) were published in The New England Journal of Medicine.
The study highlighted how early exposure to peanuts produced an 81% reduction in peanut allergy among high-risk children. More than 600 children ages 4 to 11 months either consumed, or strictly avoided, peanuts until age 5. Of the children who avoided peanuts, 17% had a peanut allergy by age 5, compared to only 3% in the peanut-consuming group.
"The prevalence of food allergies among children is increasing, however, studies have shown that consistently exposing children at a very early age to a potential food allergen can reduce the development of an allergy to that food by up to 80 percent. It would be very difficult for parents to achieve this kind of consistent immune-system training to 16 different allergens on their own; SpoonfulOne is a convenient and natural solution that fits with the Nestlé Health Science mission of healthier lives through nutrition,” said Greg Behar, CEO of Nestlé Health Science.
The CDC reports that although food allergy is more prevalent in children than adults, many affected children can “outgrow” food allergies with age. In adults, food allergies tend to be life-long. However, children with peanut, tree nut, seed, fish, or shellfish allergies tend to maintain these allergies for life.
Consumer protection
To help navigate the challenges allergies present, the FDA implemented the Food Allergen Labeling and Consumer Protection Act of 2004. The Act applies to the labeling of foods regulated by FDA which includes all foods except poultry, most meats, certain egg products, and most alcoholic beverages which are regulated by other Federal agencies. The Act requires that food labels must clearly identify the food source names of any ingredients that are one of the major food allergens or contain any protein derived from a major food allergen.
Currently, the FDA requires food manufacturers to list the top eight most common food allergens on packaging: milk, eggs, fish, shellfish, tree nuts, peanuts, wheat and soybeans.
To better address allergy prevention, the SpoonfulOne line is consistent with expert recommendations that advocate inclusion of common food allergens early and often in childhood diets. It comes packaged in pre-measured daily single-serving packets to stir into children’s foods once solid foods have been introduced to their diet.There is no minimum duration that children should be fed the product, explained Dombkowski, because scientists just don’t know yet.
The proprietary SpoonfulOne multi-protein blend was developed by pediatric allergist and protein biochemist, Kari Nadeau, M.D., Ph.D., inventor and co-founder of Before Brands.
"I co-founded Before Brands with Ashley Dombkowski in 2015 as an urgent response to the growing number of children around the world who are developing food allergies," said Dr. Nadeau. "In the US, more than 320,000 children born this year alone will develop a food allergy by the time they turn 18 unless population-wide prevention campaigns are implemented. Given the accelerating rates of childhood food allergy not just in the US but in Europe, China, Australia, and beyond, it is imperative that we think globally about proactive solutions. This collaboration with Nestlé Health Science is a clear step toward our ultimate goal: A world without food allergy."
Safety data
The safety of the product is supported by data from a randomized, blinded, placebo-controlled nationwide independent study led by Jane Holl, MD, MPH, from the Northwestern University Feinberg School of Medicine.
The “Introduction and Maintenance of Early Adaptive Training protein blends in support of Infant Nutritional Goals: safety and acceptability" (the I’M EATING study) included 700 full-term infants, 5-11 months of age without reported severe eczema or diagnosed food allergy.
The data showed that in over 8,800 feedings of SpoonfulOne, no infant was reported to have had any sign or symptoms of an allergic reaction. The product was well-tolerated in real-life, at-home settings.
Nestlé Health Science is already active in infant and early childhood allergies with its range of products for infants (Althéra, Alfaré and Alfamino). Terms of the financing and collaboration with Before Brands were not disclosed.