Allergen starter kits could give parents a 'false sense of security', experts say
Parents are told to introduce common allergens from around six months old. (Getty Images: hxyume)
In short:
Allergen starter kits promise to make introducing common allergenic foods to babies easier for parents.
However it's unclear whether powdered supplements are as effective at preventing allergies as whole foods.
An assessment is underway to determine whether these packs should be registered as "therapeutic goods" instead of food.
When Kylie's daughter turned four months old, she prepared for the task of introducing allergens to the baby's diet.
Gradually introducing — and continuing — common allergenic foods in the first 12 months of a baby's life is recommended to reduce the risk of allergies.
"It's a big job once you factor in continued exposure and getting it all done before the baby is one," Kylie says.
While Kylie introduced solid foods like peanut butter and cooked egg, some parents have turned to powdered "allergen starter packs".
These kits promise to make introduction easier, but experts fear they're giving parents a false sense of security and some components may trigger allergic reactions.
How early should allergens be introduced?
The guidance to parents hasn't always been clear.
From 1999 to 2007 it was recommended parents should delay introducing allergenic foods until between one and three years of age.
In 2008 there was an about-turn, with parents told to no longer delay introduction, and from 2016 they have been told to introduce allergenic foods "early and often".
This includes cow's milk, egg, wheat, soy, peanut, tree nuts, sesame, fish and shellfish starting between four to six months of age.
In Australia there has been a slowing in food anaphylaxis hospital admissions since guidelines changed in 2016. (Getty Images: Guido Mieth)
"The main thing is to introduce one food at a time so you can identify if there is an allergy," Mimi Tang, paediatric immunologist and allergist at Murdoch Children's Research Institute, says.
If there's no allergic reaction to the food, parents are told to continue feeding it to their baby at least twice a week.
Struggle for time-poor parents
However, as Kylie found out, continuing to include these top nine common allergens in meals can be challenging.
"There are some things that are super-easy like egg, dairy and wheat," Kylie says.
But when it comes to things like soy, shellfish and the various tree nuts, "we've been rubbish".
"We don't eat this range of things all the time," Kylie says.
"I did think the other day, 'Oh, we haven't given her soy for a while. We should probably give her some tofu.'"
Loading...Two major studies contributed to this "early and often" approach to introducing food allergens — the LEAP trial and the EAT trial.
They showed that early introduction was safe and effective.
However only about 42 per cent of participants in the EAT trial stuck to the guidance, demonstrating how difficult the approach can be to maintain.
What do experts say about starter packs?
Allergen "starter packs" are sold on the premise of simplifying the process of introducing allergens for overwhelmed parents.
They provide sachets containing powdered allergenic foods and instructions on how to add them to a baby's diet.
"The aim is to make [allergen] introduction easier," Professor Tang says.
"My concern is, I'm not 100 per cent convinced these products are achieving that goal."
One of Professor Tang's concerns is the amount of allergenic protein contained within these sachets.
The LEAP trial required parents to feed their babies 6 grams of peanut protein a week.
The EAT trial, which tested six common allergies, wanted parents to aim for 4 grams of allergenic protein a week.
On average participants managed 2 grams. Professor Tang says 2 grams did have a beneficial effect, although "not to the same degree".
Because of this result, 2 grams a week is the minimum recommended amount — in the case of peanut butter, that's about two teaspoons spread on toast.
Babies with diverse diets have lower rates of food allergies. (Getty Images: Gabriel Mello)
In the handful of allergen starter packs on the market, the protein content differs from food to food, and from brand to brand.
A single serve is not always 2 grams, so parents still face the task of doing the calculations to ensure their child is getting enough allergenic protein.
Professor Tang also points out that some children might tolerate the powder in the kits, but have an allergic reaction to the solid food.
"There could be a false sense of security."
The peak body for clinical immunology and allergy, the Australasian Society of Clinical Immunology and Allergy (ASCIA), is also concerned about egg sachets provided in some of these kits.
ASCIA, which is in the process of updating its guidance for parents, currently recommends offering babies well-cooked egg, such as mashed hard-boiled egg.
"The egg powder tends to be undercooked or raw pasteurised egg," paediatric immunologist and chair of ASCIA's paediatric committee, Mahila Namasivayam, says.
The process of thoroughly cooking an egg changes the nature of its allergenic proteins, making babies less likely to have a reaction.
"However the less cooked the egg is, the more allergy-causing it is," Dr Namasivayam says.
"People are coming into the clinic with reactions to that powder."
There is currently a clinical trial underway in the United States to compare the efficacy of starter kits to solid foods.
The sponsor of the study is a company that manufactures one of these starter kits.
Who regulates allergen kits in Australia?
In Australia, products intended for consumption can be regulated as food or medicine depending on their ingredients, presentation and claims.
The Therapeutics Goods Administration (TGA) is responsible for ensuring the quality, safety and efficacy of medicines and supplements.
The TGA is currently assessing whether allergen starter kits are a food or a "therapeutic good".
Many of these kits have been created by health professionals, contain their stamp of approval on the packaging, and contain information about allergen introduction conducted in studies to support their use.
For now they fall under the Australia New Zealand Food Standards (FSANZ) Code which lays out the health claims companies can make about food.
However FSANZ isn't responsible for enforcing the Code — that's a matter for state and territory agencies.
According to a FSANZ spokesperson, the Code allows general claims like "calcium is good for your bones", but references to serious disease are considered high-level claims that must be approved and added to the legislation.
"The Code does not include any high-level health claims suggesting that a food can 'reduce the risk of allergies.'"
Packs sold in Australia provide disclaimers that the kits are a food product and not intended to diagnose, treat, cure or prevent any disease.
What's the best way to introduce food allergens?
Kylie wasn't surprised to find out that even parents in a supported research study struggled to follow the guidance on allergen introduction.
"There has not been any thinking about how to make this a protocol that's actually attainable," she says.
"I did say if I needed project management software to manage it, I was out."
Professor Tang acknowledges starter kits have been developed in good faith to address a real issue.
"We know it's difficult. [But] pushing in the direction of medicalised supplements really may not be the right approach."
To effectively reduce the risk of allergies parents must keep the food in the baby's diet. (Getty Images: 10'000 Hours)
Dr Namasivayam says what's most important is maintaining the exposure over a period of time.
"There's no point in doing an allergen starter pack if you can't continue it."
While continued exposure helps prevent allergies, occasional exposure can actually increase the risk of allergies.
It's not all about allergies either. A diverse diet full of whole foods is known to support healthy development.