MURPHY, BLUMENTHAL, MARKEY CALL ON FDA TO LABEL AND REGULATE ALL SESAME PRODUCTS

Senators: “Given the severity and growing prevalence of sesame allergies...accurate and comprehensive allergen labeling is essential”

WASHINGTON – Today, U.S. Senator Chris Murphy (D-Conn.), a member of the U.S. Senate Health, Education, Labor, and Pensions Committee, U.S. Senator Richard Blumenthal (D-Conn.), and U.S. Senator Ed Markey (D-Mass.) called on the U.S. Food and Drug Administration (FDA) to take swift action to require labeling of products that contain sesame or sesame seeds. Currently, sesame is not required to be labeled as an allergen on food products. The senators heard directly from concerned Connecticut residents about the dangers caused by this lack of labeling for individuals allergic to sesame. In response, the senators wrote a letter to FDA Acting Commissioner Stephen Ostroff requesting that the agency require that sesame – one of the most common allergens in the United States – be listed specifically by name on ingredient lists and that sesame be included in inspections for cross-contact.

“Given the severity and growing prevalence of sesame allergies, we respectfully ask the FDA to move expeditiously under its current authority to require sesame labeling and inspection of sesame cross-contact to help protect the health and safety of our constituents,” wrote the senators. “Without required uniform labeling of the presence of sesame, consumers with this serious allergy have no way of protecting themselves or their family members from its potentially life-threatening consequences. As Congress recognized when it passed FALCPA, accurate and comprehensive allergen labeling is essential.”

Trumbull resident Leah Pucciarelli, whose 7-year-old daughter is allergic to sesame, said, “Of the seven foods my daughter Allison is allergic to, sesame is the most difficult to manage. This is due to both a lack of labeling and also the fact that sesame seeds are used atop many baked goods and can easily fall off during the baking and packaging processes. Not being able to tell by the label if a food is safe means my daughter cannot eat a food unless we've called the company--which sometimes takes days for a response—and even then, because sesame isn't treated as an allergen, we often do not get a clear response and have to forgo the food entirely. When you're trying to nourish a growing child with an already extremely restricted diet, eliminating foods just because of limited information is beyond frustrating.”

Lauren Solinsky, a Weston resident and college junior who is allergic to sesame, said, “For me, it’s scary that something as small as a sesame seed could kill me. As the demand for ‘healthy’ grainy food is increasing, the world is becoming more deadly for those of us with allergies to the grains. Sesame is now found as a ‘flavoring’ or ‘spice’ in many products that you would never expect. Even in the best situations, I can sometimes find an errant sesame seed on food that is prepared specifically for me. I am relieved that many manufacturers are starting to label for sesame on their own, but it is really confusing to keep straight which companies do label and which do not. This applies to lotions and cosmetics as well since many companies are adding sesame oil to their lines. Requiring labeling of all sesame products will drastically improve the health and peace of mind of me, my family, and the thousands of sesame allergic Americans across the country.”

Jaime Eisenberg of Old Greenwich, whose 7-year-old daughter is allergic to sesame, said, “Our daughter's quality of life in a supermarket, at a restaurant, or anywhere else food is sold or prepared would be forever changed if sesame was labeled. Sesame allergies have become just as serious as any nut allergies in our environment today. Labeling sesame products and knowing that this allergen is being addressed would allow my daughter to feel safer and more at ease and would result in fewer reactions and more opportunities for her to eat in safe environments.”

“Currently, the inclusion of sesame as a major allergen in processed food is not explicitly regulated by FALCPA, making it difficult for those with sesame allergy to determine which products may contain this allergen,” said James R. Baker, Jr., MD, CEO of Food Allergy Research & Education (FARE), an organization representing the 15 million Americans with food allergies. “With a significant documented increase in the prevalence of sesame allergy, which can be life-threatening, we are pleased to see Senator Murphy bring attention to the need and means for improving labeling to help families managing food allergies keep themselves and their loved ones safe.”

The Center for Science in the Public Interest Chief Regulatory Affairs Attorney Laura MacCleery said, “Several hundred thousand Americans are allergic to sesame, and their allergy is no less serious and no less life-threatening than that of those allergic to peanuts, shellfish, or other common allergens. The Food and Drug Administration could easily protect these consumers by including sesame among the so-called Big 8 food allergens for purposes of labeling and education. We’re grateful to Senator Murphy, Senator Blumenthal, Senator Markey, and others who similarly wish the FDA would follow the lead of Canada, the European Union, Australia, and other nations that require labeling of sesame and sesame-based ingredients.”


The full text of the letter is below:

The Honorable Stephen Ostroff
Acting Commissioner
Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993

Dear Commissioner Ostroff:

We write to urge the Food and Drug Administration (FDA) to take swift action to require sesame seeds and sesame products to be labeled and regulated in a manner similar to the rules that apply to the eight current labeled major allergens.

Sesame is now one of the most prevalent, and most dangerous, food allergies in the United States. When Congress passed the Food Allergen Labeling and Consumer Protection Act (FALCPA) in 2004 to require the labeling and regulation of allergens then considered the “Big 8” (milk, eggs, fish, shellfish, tree nuts, peanuts, wheat, and soy), it was thought that these categories covered around 90% of all allergies in the United States. However, if FALCPA were enacted today, sesame would be included on this list. Allergists consider sesame to be an emerging allergy concern, affecting an estimated 300,000 to 500,000 people in the United States. Robert Wood, the director of the division of pediatric allergy and immunology at Johns Hopkins University School of Medicine, notes that sesame allergies “have probably increased more than any other type of food allergy over the past 10 to 20 years” and are “now clearly one of the six or seven most common food allergies in the U.S.” In addition to its mounting prevalence, sesame poses a particular danger due to the severity of the allergy: for some, sesame exposure can trigger potentially-fatal anaphylaxis.

A recent Citizen Petition—FDA-2014-P-2035, filed by the Center for Science in the Public Interest and a number of prominent allergists and concerned parents—outlines the need for action in this area. We support the petition’s request that the FDA require sesame to be listed specifically by name on ingredient lists of foods and be made part of inspections for cross-contact, to better protect our many constituents who suffer from such allergies.

FDA has the authority to regulate sesame in the same manner as other major allergens under FALCPA. Under 21 U.S.C. § 343(x), the Secretary may promulgate regulations requiring disclosure of allergens other than the allergens listed in the original statute, and has already done so in the case of the coloring carmine/cochineal. This provision also gives the FDA the authority to determine the manner and extent of such disclosure.

As Congress recognized when it passed FALCPA, accurate and comprehensive allergen labeling is essential to enable allergy sufferers to avoid specific ingredients and potentially fatal reactions. This need is especially critical for sesame, which is often listed under unfamiliar names, like “tahini” and “gingelly,” and is sometimes not identified at all as a component of “spices” or “natural flavors.” Without required uniform labeling of the presence of sesame, consumers with sesame allergies, and the families of children with this serious allergy, have no way of knowing whether sesame is present in the foods they are eating, and cannot protect themselves or their family members from its potentially life-threatening consequences.

FALCPA was enacted to improve allergen labeling so that consumers can identify the presence of an ingredient they must avoid. Given the severity and growing prevalence of sesame allergies, we respectfully ask the FDA to move expeditiously under its current authority to require sesame labeling and inspection of sesame cross-contact to help protect the health and safety of our constituents.

Sincerely,


Christopher S. Murphy
United States Senator

Richard Blumenthal
United States Senator


Edward J. Markey
United States Senator