Food Allergen Labeling: Using "common sense" when assessing safety

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So, I saw a tweet the other day referencing the below Mount Sinai info about labeling and using "common sense".  It makes me a bit uncomfortable.  I know ... who am I (just a mom) to question the experts (I seem to be doing a lot of that lately  ) ... but the other part of me thinks its important to try and explain my concerns.



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Related top-level USA food labeling thread:
Food Allergen Labeling

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Tweeted by @NutFreeWok

https://www.facebook.com/permalink.php?story_fbid=1516028438644631&id=1380759788838164

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Mount Sinai Jaffe Food Allergy Institute

For those patients who need to avoid foods that are not considered major allergens such as sesame or mustard, these may be hidden in a vague ingredient term. Using common sense in these situations is advised. For example, it is unlikely that a cherry lollipop will contain sesame or mustard flavoring; however, caution is warranted when purchasing savory items such as salad dressings, marinades or prepared foods that may have these ingredients as "secret" flavoring agents.

Bold/Blue mine.

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Typical reminder / disclaimer - I am just a mom.  I am not a medical or legal expert.  Talk with your own allergist if you have questions about info in this thread.

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Here are a few links with basic food labeling info for those who are just beginning to learn about food allergen labeling.


http://allergicliving.com/2014/01/06/how-to-read-a-label-when-you-have-food-allergies/

http://www.kidswithfoodallergies.org/resourcetopic.php?topic=pfood-safety-labeling

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To explain my concerns about using "common sense" for non-top8 label reading, I thought a good place to start would be to look at the state of labeling pre-FALCPA because that's basically the situation us non-top8 folks are currently in.

"Common sense" sounds a lot easier than it really is.  Allergenic proteins can turn up in products that you would never think they would.  "Common sense" was not the advice given to those dealing with the big-8 allergens at that time.  The "common sense" approach is likely to sometimes fail.

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FDA

Public Meeting On: The Challenge of Labeling Food Allergens

8/13/2001

http://www.fda.gov/ohrms/dockets/dockets/00p_1322/tr00001_01.pdf

http://www.fda.gov/ohrms/dockets/dockets/00p_1322/tr00001_02.pdf

http://www.fda.gov/ohrms/dockets/dockets/00p_1322/tr00001_03.pdf


Ms. Kate Winkler (from the Office of Congressman Lowey)
Pages 20 & 21

ingredient statements are written for scientists, not consumers. For example, how many people know that surimi is another term for egg. Food allergic children should not be expected to decipher terms like "casein, albumin, or muso."

Too many manufacturers are preparing multiple products with the same cooking utensils or on the same production lines without properly cleaning the equipment. These practices must stop.

Dr. Michael Jacobson (Co-Founder of CSPI)
Pages 27 - 30

Consumers shouldn't have to play the game of "Where's Waldo" when they're shopping to find the ingredients they're concerned about.

labels typically give the chemical names of additives such as sodium caseinate, lactose, albumen, or gluten.

It can be tough for the average person to memorize all the possible derivatives of foods to which they're allergic.

The front of this product, for instance, says "vegetarian and soy cheese," but the manufacturer told us that the natural flavoring is actually skim milk

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Anne Munoz-Furlong (Founder of FAAN)
Pages 33

The first stop is when we go to the doctor and get a diagnosis, the doctor makes a diagnosis and tells the patient to go home and avoid milk or eggs or wheat.

Page 93

some patients are making the decision on their own to ignore these statements. This to me is playing Russian roulette. The other concern I have about this is that we are talking about children and it concerns me greatly that parents and others are making decisions because they're so confused about what's going on out there.

Dr. Michael Jacobson (Co-Founder of CSPI)
Page 98

Contamination of food with undeclared allergens is what makes life so fearful for people with severe allergies. They live in terror that a food contains an allergen not listed on the label.

Pages 101 - 103

At one end of the spectrum, contamination clearly is avoidable when companies intentionally add rework or other material that contains an allergen into a food that is not supposed to contain that allergen.

I think the time has long past for all this total voluntary flexible action on the part of industry.

the FDA should amend its GMP regulations with a requirement for companies to take all practical measures to exclude contamination of foods with unlabeled allergens.

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Dr. Wilcox
Page 106

Much of the industry discussion on good manufacturing practice and labeling focus on the eight major allergens. Does your organization agree that at this time that's the appropriate focus or do you think additional efforts also need to be placed on the less common allergens?

Anne Munoz-Furlong
Page 106

My belief is that if we focus on the eight major allergens, we've covered 90 percent of the problem, and once we clear that up, we should start looking in other areas, but keep it to the eight so that we can focus there.

Dr. Michael Jacobson (CSPI)
Pages 133 - 137

undeclared colorings and flavorings have caused occasional allergic reactions

We urge the FDA to require disclosure not just of the major eight allergens but others as well. To someone with an allergy to corn or carmine, it's no satisfaction that wheat and shrimp are disclosed.

The cost and inconvenience to companies of providing disclosure is a small price to pay for protecting the health of sensitive consumers.

The FDA's policy concerning allergenic incidental additives should be incorporated into a regulation that states explicitly that any incidental additive that may cause a serious allergic reaction should be presumed to pose a risk and be declared in the ingredient list.

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Anne Munoz-Furlong
Pages 138 - 141

First of all, from the consumer's perspective, we know that strict avoidance is the only way to avoid an allergic reaction. We know that major allergens can be included in flavors, spices and colors and incidental additives. We also know that they are currently not required to be listed on the label, and that children have had allergic reactions to proteins even in low levels that you're going to find them in these categories.

A good example of this came to us several years ago when a cereal was put on the market. Within weeks after launching this cereal, we started to receive calls all over the country about children having allergic reactions. We contacted the manufacturer. They found that, in fact, the flavorings contained milk ingredients.

     When a consumer sees natural flavors on the market, they have several options. The first one is avoid that product completely. If any of you have ever looked at the ingredient statement, you will know that if you avoid the products that say flavors, colors, or spices, you're going to have no food choices at all.
     The second is to take a chance. Again, we're talking about children, so this is not acceptable as an option.
     The third is to decide to call the manufacturer and ask very specifically does the flavor contain whatever the protein you're trying to avoid.

other companies will consider this information proprietary and will not release it

We have had some companies tell our members that if they have a reaction, their doctor can call the company, and then they will divulge all this information.

Some of the companies will provide the information, but in writing, and it takes several weeks to get this information that will not satisfy the need of our members to get information quickly.

reactions occur because someone is eating something they think is safe

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Anne Munoz-Furlong
Pages 158 - 159

The question about whether the milk allergic individual, what their understanding of milk products and byproducts are is going to be depend on each individual. The people that are more aware of it, probably the parents, the people closer to the patient, are going to be very aware that yogurt or butter are milk derived. People as we move away from the circle of care for that child may not necessarily make the connection and we see this over and over again when we're talking to grandparents and other caregivers of the child.

should we look at only the top eight or all of the allergens

What we would recommend again is to stay focused on the 90 percent of that problem. Once we figure out what the solutions are there, we can hopefully then quickly come by and address some of these other issues.

Victoria Geduld (a mom)
Pages 168 -169

For the millions of allergic people, there are tens of millions who are affected. Think of the number of people who are involved in feeding a single child.

In order for my daughter to trust her food supply and get back to the business of being a child, any allergens must be included in the ingredient section.

Julie Mendel Reinhard (a mom)
Page 173

I am unable to rely on the label itself to know if the food is safe for my son, and yet strict avoidance is the only sure way to keep him safe.

Mr. Janicki
Pages 191-192

     Now, there is one area where I think my experience as a businessman makes me an expert and that's the talk about voluntary compliance rather than mandatory compliance.
     Now, I think the voluntary efforts that have been spoken about today should be applauded, but they cannot really eliminate potential problems. Some companies will be more proactive than others, but there will always be companies that will drag their feet and not comply.
     It's the nature of industry to resist regulation and to minimize costs. What we have here is a balance between cost and public health and it's the FDA's mandate to decide in favor of public health.
     When statements are made about advisory labeling with "may contain" wording, I think that what was identified as unavoidable cross-contamination in many cases really means contamination that's too difficult to avoid or too expensive to eliminate. Again, I think it's the FDA that has the responsibility to protect the public and not leave these critical decisions up to individual companies to make

Mary Thorpe
Pages 192 - 194

reading labels myself I notice that some cans of tomato paste list wheat flour as an ingredient. Don't ask me why it has to be there, but it is.

soy sauce has wheat in it most of the time. When soy sauce is a secondary ingredient, you don't know. So we have to avoid these things unless the labeling were there.

There are other products like citric acid, MSG, stabilizers, monodiglycerides, dextrines, that can be made from different sources

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Carol Roberts (grandmother)
Page 198

what I thought about is we have a lot of people in this country who don't speak English. We have a lot of people in this country who don't know how to read. We have a lot of people in this country who don't have any knowledge whatsoever about what hydrolyzed protein or caseinate or any of these things are.

Rebecca Dugal
Pages 201 - 202

I'm entering the fourth grade at nine and a half

Most adults I am with prefer just not to give me food.

Since labels aren't clear, I don't eat many foods I may be able to eat.

Leila Leoncavallo (allergy mom & former CSPI employee)
Pages 209 - 210

I don't want my daughter to be a guinea pig to find out when food is safe and when it's not safe. I want to see the label in place in addition to the good manufacturing practices by all of these companies.

I know a lot of people have expressed concerns with the issue of reducing food choices. My daughter's food choices are already reduced. I have to call all of these companies to find out whether this is on dedicated equipment or not. Her choices are reduced. I just want her to have safe food choices. I don't think that having voluntary guidelines is going to make a bit of difference. It has to be regulated.

Labeling must be mandatory or the situation will simply be no different than the status quo. We will still need to call companies to get this information. This method is not only time consuming and frustrating, but it's often unreliable

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Dan DuBravec (had been chairperson for CSA USA)
Pages 212 - 214

I've been taking notes kind of through the session here, and these are some of the statements I've heard today:
   "Is looking into it," "starting baseline surveys," "suggested guidelines," "encouraging members to declare," " devoting energy to," "needs to look into further," "contemplating issue," "looking at practices," "area that needs attention," "struggling with for decades."
    My main point I want to get across is that I think the time is now for the mandatory food labeling.

You know we thoroughly look at labels, and we go in the frozen food department and we pick up a package of frozen broccoli, let's say. Now, it could say it contains broccoli, right, and water. You would never assume or even think that in packaging that it may be dusted with flour, but that does happen, and in terms of--I mean I have a sheet right here telling me that. You know I came in. I was just so shocked, and I had been with CSA for a long time, and this was even surprising to me that, you know, just buying frozen vegetables that I have to be cautious about that.

Dr. Jerry Shier (allergist from AAAAI)
Page 219

In conclusion, although I sit here today representing a large body of health care providers, I can tell you first hand that labeling systems need fixing, and that there are many Americans, especially parents of children, that have a fear that is indescribable, a fear of food that can be paralyzing.

Sarah Gitlan
Pages 223 - 225

I am ten years old.

When I learned to read, five years ago, in kindergarten, I started with Dr. Seuss, Mother Goose, and ingredient labels.

I knew that Dr. Seuss and Mother Goose wouldn't lie to me, but ingredients labels, I couldn't be so sure.

who would guess that a common popcorn brand would use the words "natural flavors" to mean peanuts?  And who would guess that the words "vegetable protein" and "plant protein" would be food companies' code words for tree nuts.

Reading ingredients is a large part of food allergic children's lives. So large that the Food Allergy and Anaphylaxis Network published this story:

     A mother was trying to teach her food allergic child not to talk to strangers. So, she asked her daughter, if a stranger in a car pulled up and offered you a candy bar, what would you do? Without missing a beat, the little girl responded I would ask them to read me the ingredients.

Carol Schrager (Sarah's mom, FAI & FAAN member)
Page 226

Raising a food allergic child without complete and accurate ingredients labeling is like walking through a mine field.

So we turn to you, the Food and Drug Administration, the agency charged with protecting American lives by regulating the practices of food and drug manufacturers.

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http://www.fda.gov/ohrms/dockets/dailys/00/may00/053100/cp001.pdf

& Melissa's

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When Food Is Poison: The History, Consequences, and Limitations of the Food Allergen Labeling and Consumer Protection Act of 2004

By Laura E. Derr

http://www.fdli.org/resources/resources-order-box-detail-view/when-food-is-poison-the-history-consequences-and-limitations-of-the-food-allergen-labeling-and-consumer-protection-act-of-2004

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In an email that I saved from 4/3/2008, James J. Kelly gave me permission from FDLI to quote from this article online so that it could be discussed in allergy group.

You are free to discuss and quote from that article as you like.

I was in a different online forum at the time that no longer exists ... before I made this my food allergy home.

Even though our conversation was brief, he was one of the kindest people that I've "met" during this food allergy journey.   

Part of the email conversation also involved an FDLI employee named Anita Britton.

I never really used the permission too much because for several years, there was a public version of the entire paper posted at a LEDA law site for anyone to read.

I'm just a mom and I don't know much about copyright issues, but obviously, if FDLI ever wants any of these quotes deleted, they should be deleted immediately.

This is an article that I wish all USA allergists would read.  It's one of my top 2 favorite allergy articles. Before I read it, I was a confused mom of a newly diagnosed food allergy child ... after I read it, I felt that I had a good understanding of USA food allergen labeling.

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I feel that there is still a lot of confusion regarding non-top8 labeling, so to me, this is a good enough reason for me to use that permission and quote from that paper in this thread.

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Pages 78 & 79

The FALCPA was passed in response to the fact that the information contained on the label has been inadequate to meet the needs of food-sensitive individuals.

Few people without thorough research would suspect that corn protein is found in iodized salt and orange juice, that products labeled "non-dairy"⁸¹ and bread may include milk protein, that soy protein may be present in canned tuna, and that turkey⁸² and cheese⁸³ may contain wheat protein. In today's world of great scientific and technological advances in food production—where most food is processed (rendering ingredients unknown unless communicated to consumers)⁸⁴ and even nonprocessed foods can be contaminated with allergens⁸⁵—virtually any food item may have the potential to poison a food-sensitive individual.

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Page 80

The FDCA requires that all ingredients appearing on the food label be listed according to their "common or usual name."⁹¹ For many ingredients, the "common or usual" name of a food hardly is common or usual. Consumers have long desired more easily comprehensible ingredient terminology.⁹²
Given the following list of food ingredients—bulgur, couscous, durum, farina, modified food starch, hydrolyzed vegetable protein, kamut, spelt, artificial flavors, semolina, and buckwheat—few people would expect that the only ingredient in this list that is certain not to contain allergenic wheat protein is the one ingredient actually containing the word "wheat": buckwheat. Terms like albumin, lecithin, livetin, lysozyme, emulsifier, globulin, ovalbumin, and vitellin indicate the presence of egg protein. And the words caramel color, casein, caseinate, high protein flavor, lactalbumin, natural flavoring, solids, and whey can signal the presence of milk protein in a food product.⁹³

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Page 83

Second, FDA regulations have exempted incidental additives, such as processing aids, from ingredient declaration when they are present in a food at "insignificant" levels and do not have a technical or functional effect in the finished product.¹¹⁴ FDA, thus, has recognized that "in some cases food labels may not provide consumers with food allergies with information about all the ingredients that are in the foods that they eat."¹¹⁵

In addition to the spices, flavorings, and colorings and incidental additives exemptions, manufacturers were not required to disclose information about the source of certain listed ingredients, nor the way in which the ingredient was processed. For example, "starch" and "modified food starch" can be derived from corn or wheat. "Hydrolyzed vegetable protein" may contain a variety of grains, vegetables, or animal products, many of which contain the proteins of known allergens. Manufacturers simply could list "caramel color" on the label without identifying whether the ingredient was produced using sugar or wheat. "Lecithin" and "gelatin," which also may contain a variety of allergenic proteins, did not require elaboration.¹¹⁶

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Page 137

Beyond the Big Eight Allergens: The Neglected Food Allergy Sufferers

As the co-founder of Food Allergy Survivors Together notes on her website for food-sensitive individuals, "If we have just one allergen not in the 'big eight,' this legislation is virtually useless to us. I know it will help some people with food allergies, but not all of us. Many (er, most!) ingredients will still be able to hide under guises."⁴⁰⁹

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Page 138

A corn allergy is particularly debilitating. Adverse reactions to corn include life-threatening anaphylaxis and some reactions can require hospitalization. Corn is present in most processed foods. It can be the source of, or involved in, the processing of over 170 different ingredients that do not mention the word "corn" on the label (e.g., alcohol, artificial sweeteners, baking powder, bleached flour, brown sugar, citric acid, dextrose, fructose, fruit juice concentrate, honey, hydrolyzed vegetable protein, iodized salt, maltodextrin, saccharin, vanilla, xanthum gum, and yeast).⁴¹¹ Much of the wheat supply is cross-contaminated by corn. Adequate identification of the actual source foods in compound ingredients is imperative for these individuals to have any food choice freedom at all.⁴¹²

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Page 150

Whether the FALCPA should have included more allergens— and more importantly, whether FDA should authorize the inclusion of more allergens in the future—thus warrants critical consideration.

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ok, I guess that's enough quoting to really illustrate what those with non-big8 allergens are still dealing with.