CSPI asks FDA to add sesame to list of allergens, mandate labeling

By Elizabeth Crawford

- Last updated on GMT

Related tags: Asthma, Allergy

CSPI asks FDA to add sesame to list of allergens, mandate labeling
FDA should protect the estimated 300,000 to 500,000 Americans who are dangerously allergic to sesame by mandating the ingredient be labeled clearly when in foods and when products are made on the same machinery as foods with the ingredient, the Center for Science in the Public Interest argues.

The agency also should require food manufacturers to follow strict manufacturing practices to ensure cross-contamination or inadvertent addition of the allergen to non-allergic foods is not a threat, the advocacy group adds in a citizen petition​ filed with FDA Nov. 18. It also wants FDA to educate restaurants and food service providers about the potential risks posed by sesame.

These “common-sense measures” ​would give “consumers suffering from sesame allergies the information they need to make informed choices about what foods they eat and to avoid the potentially harmful or fatal consequences of consuming foods to which they are allergic,”​ CSPI says in the petition.

It adds the ingredient is worthy of being added to the current list of allergens for which the Food Allergen Labeling and Consumer Protection Act of 2004 mandates labeling and warnings because sesame is an emerging cause of severe allergy – including life-threatening anaphylaxis – and affects a growing portion of the U.S. population.

“Medical research, from as far back as 1950, have demonstrated that sesame seeds can cause severe IgE antibody-mediated and cell-mediated hypersensitivity allergic reactions, including contact dermatitis, urticarial, angioedema, wheezing, dyspnea through inhalation, rhinitis, asthma and potentially fatal anaphylaxis,”​  CSPI said in the petition.

“These symptoms of allergic reaction to sesame are undistinguishable from the identical symptoms catalogued as the basis for regulation by FDA of the so-called ‘major allergens,’” ​it added.

CSPI’s Chief Regulatory Affairs Attorney Laura MacCleery told Food Navigator-USA that the advocacy group set the threshold for requesting a food allergen be mandatory labeled at whether it can trigger anaphylaxis.

The other major allergens that require disclosure under the Act include milk, eggs, fish, shellfish, tree nuts, peanuts, wheat and soy. In addition, foods must declare the presence of the dye carmine from the cochineal insect.

These allergens – except carmine – were selected for special labeling because in 2004 they comprised 90% of food allergic reactions and were the food source from which many other ingredients derived, such as whey protein from milk, CSPI explained in the petition. Carmine was included later because of the severity of reaction and consumers’ inability to identify it in foods without labeling.

Increase prevalence of sesame in U.S. diet elevates risk

Sesame should be added to the list because the prevalence of the allergy appears to be increasing, CSPI argued. It noted research shows about 0.1% of the population in 2013 suffered from the allergy and the percentage could climb as sesame becomes increasingly prevalent in the American diet.

Sesame has not traditionally been part of the U.S. diet, but it is increasingly consumed by Americans thanks to immigration and the globalization of the food supply, according to research by Kids with Food Allergies, a division of the organization Asthma and Allergies Foundation of America.

Anecdotal evidence also supports the increased prevalence of sesame allergies, CSPI said, pointing to the 3,000 signatures garnered by Brian Heller’s petition on Change.org that asks FDA to require labeling of sesame. Heller started the petition in August after his son suffered a reaction to sesame consumed at a restaurant where staff assured the family the ingredient was not present.

Clear labeling of sesame as such also is necessary because it currently often is listed as an unfamiliar name, including benne, benne seed, benniseed, gingelly, gomasio, halvah, tahini and others, advocates for the change argue.

Precedent for labeling sesame already established

CSPI notes there is precedence for adding allergens to the list of ingredients with mandatory warnings in the U.S. and other global regulators already require sesame to be labeled.

The advocacy group successfully filed a citizen petition and convinced FDA in 2009 to add carmine to the list of allergens that must be labeled. (Read more about the decision HERE​.)

In addition, “it is noteworthy that sesame seeds and sesame products are required to be labeled in Canada, the European Union, Australia and New Zealand,”​ CSPI said. Likewise, Canada considers the ingredient a “priority allergen”​ and beginning in December European restaurants must warn consumers about the presence of 14 common allergens in foods.

Impact on food manufacturers

If FDA approves the petition, adding sesame labeling to packaging in the U.S. should not be a “huge burden”​ for global food manufacturers that already must comply with labeling requirements in other countries, said MacCleery.

However, tracking trace amounts of sesame in “flavorings”​ and other small amounts of blended ingredients for labeling purposes likely would be a burden to food manufacturers if FDA approves the petition, said Anne Glazer, a partner with the law firm Stoel Rives in Portland.

In situations like this, firms might be tempted to hide behind labeling statements that a food “may contain”​ sesame. However, Glazer points out that while there are no regulations requiring or prohibiting the use of such statements, “FDA has advised that advisory labeling, such as ‘may contain’ should not be used as a substitute for inherent good manufacturing practices and must be truthful and not misleading.”

Voluntarily labeling sesame as sesame and adding allergen warnings in a “responsible way” ​to packages might behoove manufacturers regardless of whether FDA approves the petition, Glazer added, noting: “No company wants to sell a product that results in hospitalization or death, so from that standpoint it is in a company’s interest to warn consumers if their product contains a serious allergen, and it is sufficient to do that by calling it out in the ingredient list.”

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2 comments

FDA opens petition for public comment

Posted by brian,

the petition is now open for public comments - from YOU - directly to the FDA. comment here: http://www.regulations.gov/#!submitComment;D=FDA-2014-P-2035-0001

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Deadly sesame allergen must be labelled in foods in USA

Posted by HARINI GANGUR,

Dear CSPI team: I am delighted to hear that finally CSPI is taking the lead to petition to the FDA to
include sesame as a major food allergen. I am severely allergic to sesame seeds and with my near-death experience of allergic reaction to sesame seeds multiple times, haunting me every day, I would like to express my strong support for this petition.

As a little kid, I was visiting my mother’s friend and she gave me some crackers. I suddenly started feeling a scratchy throat and was finding it difficult to breathe. My eyes started swelling and my face started to swell. Parents and other adults were sitting
in a different area of the home, and us children were playing in a different part. The difficultyin breathing turned into a wheezing like sound. My father, who came in for something else noticed the reaction immediately and started telling my mother to dial 911. My mother was looking around, wondering why she had to dial. I was lucky, though, that my father kept insisting and eventually the ambulance arrived. The EMT’s immediately gave me a shot, which now I know is EpiPen. Later on, my dad examined the crackers which I had ate and discovered that they contained sesame seeds, something that was
not mentioned at all on the labeling of the product.
That day, my life was saved as I am lucky that my father, who works at Michigan State
University, is a lead researcher in this country for food allergy, and he caught it. In fact, he and his colleagues have published papers in scientific medical journals that
show how sesame allergy is growing in prevalence and how it can be lethal. Their work published as an article 9 years ago has explained why the USA FDA should include sesame as a major allergen. They also have shown that sesame seeds can cause this type of near death reaction in mouse model. After my diagnosis, I continue to hear from my friends, students and teachers and parents at school, about such reactions to sesame seeds with similar near death experiences of allergic reactions. The rest of the world,
like Europe and Canada, have included it long ago. Based on my experience, it is clear that this sesame allergy is rising in America, and
unfortunately it cannot be outgrown. Although I have been off sesame seeds in food for the past 13 plus years; our home strictly stopped bringing sesame to since I was diagnosed; but still my sensitivity has not gone away; because a recent blood test showed that I still have IgE antibodies in high levels against sesame seeds.

Did my problem stop after the first accidental exposure? The answer is no. It has
Continued because of accidental exposures to sesame in foods, ointments, lotion, bakery items continue to happen because of lack of labelling of sesame in these products Sometimes in a body wash that uses sesame oil or in a sandwich that uses
hummus and or it is not stated in the restaurant’s menu. The server’s deny that it is used,
since they are also oblivious that sesame is a dangerous food allergen. Peanuts have caught major
attention in this country, since many people know that it can be lethal. Sesame although causes similar deadly reactions, most people in restaurant business or lay public are not aware of it all.
For millions of people just like me who are allergic to sesame seeds, it is high time that the FDA include sesame as a major food allergen and mandate the labelling of this deadly food allergen. I am delighted to learn that agencies like the CSPI can help achieve this goal and help save lives of millions of children like myself and reduce visits to the Emergency
Room, saving those important health care dollars.
Respectfully submitted,
Harini Gangur
Junior, Okemos High School,
Okemos, Michigan

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