by Marion Nestle

Currently browsing posts about: Allergies

May 11 2023

The FDA warns molecular farming companies to watch out for food allergens

I was fascinated to see this article in Ag Funder News (to which I am now subscribing):  FDA warns molecular farming startups of risks if food allergens are not properly managed.  

If companies are putting the genes for animal proteins into crops, they need to be super careful not to introduce proteins known or likely to be allergenic.

The FDA’s  warning letter reminds companies to:

  • Consider the food safety risks posed by allergens
  • Plan early in development to manage the risks
  • Label products properly
  • Pay attention to legal requirements and food safety responsibilities

This took me right back to 1996 when I wrote an editorial for the New England Journal of Medicine about one such incident (scroll down to the third editorial in the pdf).

Investigators thought it would be clever to add a Brazil nut protein to soybeans to enrich the beans—used for chicken feed—in sulfur-containing amino acids especially needed by chickens for feather formation.  Unfortunately, some people are allergic to that protein.

The investigators were especially diligent about checking the allergenicity of the transferred protein.  By a truly remarkable coincidence, everything they needed to establish allergenicity was available.  The soybeans were withdrawn from the market, but all of this was somewhat of a miracle.

As I concluded,

This situation illustrates the pressing need to expand basic and clinical research on food allergies. More information about incidence, prevalence, dietary exposure, antigenicity, immune responses, diagnosis, and treatment would help researchers, regulators, and biotechnology companies predict whether transgenic proteins are likely to cause harm. In the special case of transgenic soybeans, the donor species was known to be allergenic, serum samples from persons allergic to the donor species were available for testing, and the product was withdrawn. The next case could be less ideal, and the public less fortunate. It is in everyone’s best interest to develop regulatory policies for transgenic foods that include premarketing notification and labeling. Industry benefits when the public is convinced that transgenic foods are safe, and stronger federal regulations would encourage such public confidence.

That was in 1996.  I could have written it yesterday.  No wonder the FDA is worried.

Sep 13 2017

FDA approves “qualified health claim” for early introduction of peanuts

I was interested to see the FDA’s announcement that it “acknowledges” and will “exercise enforcement discretion” (translation: will not oppose) a qualified health claim linking the early introduction of peanuts into the diets of young children with severe eczema or egg allergies as a means to reduce their risk of peanut allergy.

Here’s the claim, which the FDA says manufacturers can use right away:

For most infants with severe eczema and/or egg allergy who are already eating solid foods, introducing foods containing ground peanuts between 4 and 10 months of age and continuing consumption may reduce the risk of developing peanut allergy by 5 years of age. FDA has determined, however, that the evidence supporting this claim is limited to one study. If your infant has severe eczema and/or egg allergy, check with your infant’s healthcare provider before feeding foods containing ground peanuts.

The FDA’s decision is based on:

But why a qualified health claim?  Whenever you see one, you know that business interests are at stake.

In this case, the claim is in response to a petition filed by Assured Bites, Inc., maker of Hello Peanut products.  Check the astonishing prices of these products and you can see why this company wanted a health claim, and why it is already advertising it.

Really, you can do this at home.  We are talking here about starting high-risk kids out—under medical supervision—with a small taste of plain, ordinary peanut butter.

The FDA allows qualified health claims because industry wants them for marketing and pressures Congress to force the FDA to allow them.

What’s wrong with qualified health claims?  The qualifications get lost in the marketing.  Parents may think Hello Peanut works better than much less expensive alternatives.

 The FDA documents

Also see

Nov 17 2016

FoodNavigator-USA’s Special Edition: Food allergy and intolerance

FoodNavigator.com does occasional “special editions” in which they collect articles on particular topics from the perspective of their food-industry audience.  This one is on food allergies and intolerances, about which remarkably little is known.  If you are allergic or intolerant, the best you can do is hope for an accurate allergy test or do everything you can to avoid the food that triggers reactions.  Good luck with that since allergies are hard to diagnose and allergenic ingredients sneak into a great many foods and are not always revealed on labels.

FoodNavigator begins with Food allergy 101: Are you up to speed?

Food allergy is on the rise in many countries, but how many people are impacted in the US? We’ve collected some facts and figures from Food Allergy Research and Education (FARE), the world’s largest private source of funding for food allergy research; the CDC (Centers for Disease Control and Prevention); and NIAID, the lead institute at the National Institutes of Health conducting research on food allergy… Display [this site has basic statistics on prevalence and basic definitions of terms]

The lowdown on food allergy and intolerance: In conversation with Dr Steven TaylorMost researchers agree that the prevalence of food allergies is increasing in the US. Yet the amount of money spent on finding out why is surprisingly low, says one food allergy expert… Read

Soup-To-Nuts Podcast: Is low-FODMAP the new gluten-free? For the 45 million Americans who suffer from irritable bowel syndrome, identifying food that they can safely eat without triggering a flare up is a source of deep frustration that also could be a sizable market opportunity for innovative food and beverage companies that can provide an easy solution… Listen now

Allergen-friendly, free-from claims offer marketing potential beyond conventional food, beverageWith the number of Americans with food allergies and sensitivities increasing, free-from claims have become du jour in the conventional food and beverage space, but they remain relatively rare in the supplement segment and as such offer manufacturers a powerful tool to set their products apart. .. Read

Leadbetter’s realigns to focus on allergy-friendly manufacturing: ‘Our growth curve is very steep’San Francisco-based Leadbetter’s Bake Shop has stopped making English muffins, its flagship product, and changed its name to Better Bakeries as it focuses on building an allergy-friendly food manufacturing and co-packing business designed to bridge the gap between Mom & Pop scale operators and the big guns in gluten-free… Read

Elevation Brands CEO: Gluten-free bakery is saturated, but there’s a ton of white space in other allergy-friendly categoriesThe world will probably keep turning without another gluten-free cookie or cracker, but there is a ton of white space for allergy-friendly foods in other parts of the store, and untapped opportunities in c-stores, club stores, schools, and in Mexico, where the gluten-free retail market is set to “explode,” says the CEO of Elevation Brands, the parent company of Ian’s. .. Read

‘First’ entirely gluten-free dining hall opens on US college campusKent State University claims to have opened the first certified gluten-free dining hall on a college campus… Read

Gluten-free products are evolving to be more nutritious, flavorful, Firebird Artisan Mills saysThe gluten free market in the US remains hot, but as the category becomes more crowded, manufacturers must offer products with added appeal to stay competitive – such as a protein boost from pulses or an added dose of fiber and flavor with ancient grains, according to experts… Watch now

PepsiCo rolling out gluten-free Quaker oatmeal range across US retailNational distribution under way following limited launch in selected stores late last year… Read

Enjoy Life Foods: Dedicated allergy-friendly sets in the natural aisle are the best way to merchandise free-from foodsWith one in 13 children diagnosed with a food allergy in the US*, ‘allergy-friendly’ foods are now infiltrating every category in grocery. But right now, it still makes sense for most retailers to merchandise them in a dedicated set rather than spreading them around the store, unless you have very clear signage, says Enjoy Life Foods… Watch now

Early introduction of allergens reduces food allergies, suggests studyResearchers say they have “moderate certainty” that introducing allergenic food such as peanuts or egg at an early age reduces risk of developing allergies… Read

Digestive issues attributed to lactose intolerance may be caused by A1 beta-casein protein, suggests study funded by a2 MilkNew clinical research – funded by the a2 Milk Company – lends credence to its claims that many consumers who believe they can’t tolerate lactose (milk sugar) should really be blaming their digestive discomfort on the A1 beta casein protein in milk products instead. However, more human data is needed before this moves beyond the realm of theory into fact, says the National Dairy Council… Read

Quinn Snacks removes more than gluten from pretzels, shows consumers its supply lineHistorically consumers who wanted a gluten-free alternative to a wheat-based product had to sacrifice nutrition, taste or accept the presence of other common allergens in the ingredient list. .. Read

60-second interview, Beneo: Is rice still the first choice in gluten-free recipe formulation? Rice flours and starches dominated the first generated of gluten-free goods, particularly in the bakery segment, but are they still the #1 choice in formulators’ toolkits? FoodNavigator-USA caught up with Pierre Donck, regional product manager at rice ingredients specialist Beneo Inc, to find out… Read

Jun 27 2016

Israel’s solution to peanut allergies

While in Israel, I kept hearing that peanut allergies are virtually unknown in that country.  Nobody I met knows anyone with problems with peanuts—not Jews, Arabs, children, nor adults.

The explanation?

Bamba (and its Arabic equivalent).

These things are peanut puffs.

Because they melt in the mouth, they are often fed to babies as a first food.  Apparently, babies love them.

How do they taste?  Just as you might expect (peanut-flavored straw?  peanut-flavored Cheetos?).  They are sold everywhere as a snack and I met adults who love them too.

Do they really prevent peanut allergies?  Indeed, there might be something to this idea.

Introduction of peanut products into the diets of infants at high risk of developing peanut allergy was safe and led to an 81 percent reduction in the subsequent development of the allergy, a clinical trial has found…Researchers led by Gideon Lack, M.D., of King’s College London, designed a study called Learning Early About Peanut Allergy (LEAP), based on observations that Israeli children have lower rates of peanut allergy compared to Jewish children of similar ancestry residing in the United Kingdom. Unlike children in the UK, Israeli children begin consuming peanut-containing foods early in life.

Translation:  Bamba.

These researchers also found that allergic reactions did not return even if the children in that trial stopped eating Bamba for a year.

Their studies were funded mainly by NIH and the UK Department of Health, but the researchers also report that their clinical trials unit was supported by the National Peanut Board, Atlanta, and that the manufacturer of Bamba supplied the products.  The lead author, Gideon Lack, reports holding stock in DBV Technologies, the maker of Viaskin Peanut, a product that helps people with peanut allergies tolerate exposure to peanuts.

I’d like to see these studies repeated by fully independent researchers.

In the meantime, pediatric allergists are advising parents to let their babies eat peanut butter (but not peanuts because babies can choke on them).

These allergists—and the authors of the Bamba studies—participated in an American Academy of Pediatrics consensus statement:

There is now scientific evidence (Level 1 evidence from a randomized controlled trial) that health care providers should recommend introducing peanut-containing products into the diets of ‘‘high-risk’’ infants early on in life (between 4 and 11 months of age) in countries where peanut allergy is prevalent because delaying the introduction of peanut can be associated with an increased risk of peanut allergy.

If these studies are right, introducing babies to the widest possible variety of foods as soon as they can handle solid foods (usually at 4 to 5 months) may well help prevent allergies later on.

Addition

A reader just sent another paper from the same authors, this one a randomized trial of six allergenic foods given to breastfed babies at 3 or 6 months of age.  By one analysis, allergies developed 1 to 3 years later in 7.1% of the later-introduction group and 5.6% of the earlier-introduction group—a result that was not statistically significant.  By another, allergies were much lower in the early-introduction group (2.4% vs 7.3%), especially with respect to peanut and milk allergies.  

Feb 26 2015

Fingers crossed: good news about preventing peanut allergies

The New England Journal of Medicine has a new study that suggests the need to rethink whether to feed peanuts to babies.

As the Wall Street Journal explains, peanut allergies can be life-threatening and they are increasing among the population.

Dr. Gideon Lack and his colleagues randomly assigned infants to be fed peanuts (really, peanut butter) until they were five years old.  The children fed peanuts had far fewer peanut allergies than those who were not exposed to peanuts.

Of the more than 500 infants who showed no signs of peanut allergies at the start of the trial, the prevalence of peanut allergies at age 5 was 13.7% in the avoidance group and only 1.9% in the consumption group (see the journal’s video for an easy explanation).

A result like this is extremely unlikely to have occurred by chance.

Dr. Lack got the idea for the study when he noticed that peanut allergies were rare in Israel.  Israeli infants are routinely offered foods made with peanuts, whereas British and American parents have been told not to feed peanuts to young children.

The authors conclude:

Our findings showed that early, sustained consumption of peanut products was associated with a substantial and significant decrease in the development of peanut allergy in high-risk infants. Conversely, peanut avoidance was associated with a greater frequency of clinical peanut allergy than was peanut consumption, which raises questions about the usefulness of deliberate avoidance of peanuts as a strategy to prevent allergy.

The implications are clear: expose young children to peanut butter (the accompanying editorial explains how to do this safely).  And to prevent choking, don’t give them peanuts until they can chew.

Other newspaper articles on this topic:

 

 

Mar 10 2011

The industry’s view on food allergies

Food allergies pose labeling and other problems for food manufacturers.  FoodQualityNews.com summarizes recent stories on what’s happening with food allergies, from the perspective of its European food industry clients.

Enzyme treatment may remove peanut allergens, suggests study: An enzymatic treatment process may effectively reduce allergens in roasted peanuts by up to 100 per cent, according to new research.

FoodNavigator conference to address food allergy challenges: Incidence of food allergies and intolerances is on the rise in Europe, and there are big gains to be made by companies who provide products that are safe and enjoyable for sufferers. Some challenges remain, however, such as appropriate labelling, and future threshold levels. 

The balancing act of allergen labelling: The food industry has a responsibility to label allergenic ingredients as big and bold as they can – but also not to over-egg the slimmest of slim possibilities that a trace amount of an allergen may have slipped into a product.
Germany develops rapid detection systems for food allergens

German researchers are aiming to develop rapid detection systems to identify allergenic substances in foodstuffs, according to a workshop on analytical methods for allergen detection staged in Berlin this week. 

UK leads free-from launches in major European markets: Mintel data: People with food allergies and intolerances in the UK have the more new products to meet their dietary needs than consumers in other major European markets, indicates data from Mintel, but there has been a general increase in launches across the EU in the last six years.

Allergy prediction tool could revolutionise allergen labelling: As allergy diagnoses among children continue to rise, a new online calculator is said to provide fast, cheap and highly accurate predictions, with potential implications for better-targeted on-pack allergen labelling.

Allergies, as I have discussed in previous posts, are difficult to diagnose and it’s hard to avoid something you are allergic to if you can’t figure out what it is.  Rates of food allergies seem to be increasing, for reasons not well understood.  The leading hypothesis is cleaner environments, but research can’t confirm that cause.  This is one area where the trite phrase, more research needed, really means something.

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May 26 2010

Peanut allergies on the increase

A survey report in the Journal of Allergy and Clinical Immunology says that peanut allergies have tripled in the last decade.  Why?  The authors don’t really know although they speculate that children aren’t exposed to as much dirt as they used to be.

Are we really that much cleaner than we were 10 years ago?  I doubt it.  But I would very much like to know why this is happening.

May 30 2009

My latest San Francisco Chronicle column: Gluten Intolerance

My once-every-three-weeks column for the San Francisco Chronicle is set up as a Q and A.  I don’t get many questions through the column, but the few that do come in are often quite challenging.  This one is from a school chef wondering how to deal with kids who might be gluten intolerant – and whether gluten intolerance is becoming more common.  Interesting questions!  Here’s what I had to say about them.  If you have questions about food and nutrition that you’d like me to answer, send them to food@sfchronicle.com (put Marion Nestle in the subject line).