That system can be followed by “maintenance” packets that continue with 2 grams of peanut powder, to be used until a toddler can eat peanut butter or is old enough to chew and swallow peanuts without choking. Studies indicate that regular consumption of peanuts is necessary to maintain the food tolerance.
Dr. David Erstein, an allergist who founded the company Assured Bites, which makes Hello, Peanut, said he hoped the limited health claim on the package will both raise awareness and increase parents’ comfort level with the new recommendations.
“There are still a lot of skeptics and anxious parents who are nervous,” he said.
And though the research studies concentrated on high-risk kids, he said, “we think this should be helpful for the general population.”
The label cautions parents whose babies are at high risk for allergies because of eczema or an egg allergy to have their baby evaluated by a doctor and undergo skin or blood testing for peanut allergy before using the product.
“The danger is that someone will misinterpret how to use this product and give it to a child who’s already allergic,” said Lianne Mandelbaum, who runs a website for people with food allergies. “People have already come up to me and said ‘this is great news, there’s a cure for your son, you just need to feed him a little of these products that are coming out and he won’t be allergic anymore.’ That could be potentially dangerous.”
The powder is certified organic, dairy-free, kosher and free of genetically modified organisms. The introductory kit is $25 and the maintenance kit costs $20 for about three weeks.
Experts say a less expensive alternative for parents is to mix equal parts smooth creamy peanut butter and warm water to make a souplike baby food.
Smooth, creamy peanut butter, cereals and other products that fit the criteria will also be able to make the claim that they reduce the risk of developing a peanut allergy, F.D.A. officials said. Their availability should make it easier for parents to implement the new approach to preventing peanut allergies, which have increased in prevalence in recent years and are responsible for more deaths from anaphylaxis, or constriction of the airways, than any other food allergy.
“People who don’t have children with these allergies don’t always appreciate the very real danger of a deleterious event that might even lead to death, but even more important, the extraordinary anxiety that pervades the families of children with documented peanut allergies who are afraid of exposing their children, ” said Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, which is part of the National Institutes of Health. “This is not a trivial problem.”
Consumer advocates stressed that parents need to understand that these new products do not treat or cure existing allergies, and emphasized that no peanut products should ever be given to someone who has an established peanut allergy.
“This not a treatment for peanut allergy and it’s important that people understand that,” said Dr. James R. Baker Jr., chief executive of Food Allergy Research & Education, a patient advocacy group. “If a child is allergic, they should not eat peanut under any circumstances.”
But he said it is critical to reduce the development of peanut allergies, and “the easiest way to deal with a food allergy is to keep it from happening.”
The new guidelines encouraging early exposure to peanut-containing foods were developed after several studies in recent years seemed to challenge the advice to ban peanuts in infancy, and culminated in a large long-term clinical trial in England of hundreds of infants at high risk of developing a peanut allergy because of eczema or an allergy to eggs.
Babies who tested positive for an existing peanut allergy were excluded from the study, but the others were randomly assigned either to be fed peanut products regularly or to be denied all peanut-containing foods.
By the time they turned 5, only 1.9 percent of the 530 allergy-prone children who had been fed peanuts regularly since infancy had developed an allergy, compared with 13.7 percent of the children who had abstained from peanuts.
In the United States, the prevalence of peanut allergies among children has been climbing. A recent study by the independent nonprofit FAIR Health found that private insurance claims for anaphylactic reactions to all foods rose nearly 400 percent between 2007 and 2016, but peanuts were the most common food to cause the reaction, responsible for more than one-quarter of the claims. Insurance claims about anaphylactic reactions caused by peanuts increased by nearly 450 percent during the same time period. The analysis was based on FAIR Health’s database of 23 billion privately billed health procedures.
Though many children outgrow food allergies, one-third of the claims involved adults over the age of 18, suggesting some allergies may be a lifelong problem.
“One of the reasons it is even more compelling to avoid the onset of peanut allergies is that other types of food allergies — egg, fish and some others — you often, though not always, outgrow the allergy with age,” Dr. Fauci said. “This is generally not the case with peanut at all. Once you get peanut allergies, you essentially have them forever, which is why it becomes even more important to do this prevention through early exposure.”