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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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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