Statement from FDA Commissioner Scott Gottlieb, M.D., on the FDA’s new consideration of labeling for sesame allergies

Food allergies have touched the lives of most of us. Thousands of Americans experience life-threatening, food-related reactions each year, and an estimated 20 people die from them annually. In some cases, such reactions occur despite a careful reading of packaged food labels by conscientious consumers. To me, that’s unacceptable. The FDA is committed to advancing our efforts to help ensure that Americans have access to the information they need about common allergens in packaged foods.
In particular, the undeclared presence of allergens in foods – the leading reason for food recalls – continues to be a significant public health issue and an area of active policy consideration by the agency.
Federal law requires that foods containing one of the eight “major food allergens” – milk, eggs, fish, shellfish, tree nuts, peanuts, wheat and soybeans – declare the food source of the allergen using its common or usual name on food labels. When this law, the Food Allergen Labeling and Consumer Protection Act, was passed by Congress in 2004, these eight food groups, out of more than 160 identified food allergens, accounted for 90 percent of serious food allergic reactions occurring in the U.S. Before this legislation was enacted, the FDA had found that 25 percent of sampled foods containing ingredients derived from peanuts or eggs failed to list these allergens on the label. Now, the situation has vastly improved. The current law imposes strict requirements that foods containing one of these eight major allergens be clearly marked for the presence of these allergens, and we work closely with companies on quickly recalling such products from the market if they are mislabeled.
Unfortunately, we’re beginning to see evidence that sesame allergies may be a growing concern in the U.S. A handful of studies, for example, suggest that the prevalence of sesame allergies in the U.S. is more than 0.1 percent, on par with allergies to soy and fish. Because sesame is not recognized as a major allergen, right now it’s not required to be declared as an allergen on food labels. In fact, it may not always be specifically listed in the ingredient statement. Products with “natural flavors” or “spices” listed on their label may contain small amounts of sesame. And people allergic to sesame might eat food labeled as containing “tahini” without knowing that tahini is a paste made from sesame seeds. Fear of not knowing whether a food contains sesame may lead some people to unnecessarily limit their diets to avoid possible exposure.
The FDA is advancing a new effort for the consideration of labeling for sesame to help protect people who have sesame allergies. As a first step, today the agency issued a request for information, so we can learn more about the prevalence and severity of sesame allergies in the U.S., as well as the prevalence of sesame-containing foods sold in this country. These include foods that, under current regulations, may not be required to disclose sesame as an ingredient. Specifically, we’d like to hear from epidemiologists, nutritionists, allergy researchers, and physicians concerning their clinical experiences and relevant findings. We’re also looking for feedback from the food industry and consumers to help us gain a more complete understanding of the risks and to learn more about the potential impact of any future regulatory action that could include new disclosure requirements for sesame. All of this will help inform our next steps.
In addition to our growing concerns about sesame allergies, this request for information is designed, in part, to help inform our response to a citizen’s petition to the FDA from medical professionals and consumer advocacy groups who asked us to require that sesame-based ingredients be listed specifically by name on the ingredient lists of all food labels. We take the concerns of people with sesame allergies seriously.
Protecting Americans from the health risks posed by food allergens has long been a central part of the FDA’s mission. And we’ve worked diligently over the past several years to implement innovations to speed the detection of allergens in mislabeled foods to curb potential cases of allergic reactions.
For example, scientists in the FDA’s Center for Food Safety and Applied Nutrition developed the xMAP Food Allergen Detection Assay three years ago that can detect all of the major food allergens, with the exception of fish, in just six hours. This new tool is being used to help safeguard the food supply by detecting the presence of undeclared food allergens that result from cross-contact during manufacturing.
Before the adoption of this new technology, it used to take far longer to test potentially mislabeled foods that were suspected of causing dangerous allergic reactions. I’m pleased to announce that the agency’s researchers are now working to expand this assay to include sesame. This will help us better detect and track allergic reactions that may be caused by undeclared sesame from cross-contact during manufacturing.
Through all of these efforts, our goal is to help Americans with food allergies better navigate the products they find in the marketplace, by arming them with reliable information that allows them to prevent dangerous allergic reactions while ensuring that we set reasonable expectations for food manufacturers to successfully meet labeling requirements. Gaining a better understanding of the state of the science on food allergies and how these allergens impact consumers, particularly sesame allergies, is an important and necessary first step toward our consideration of new policies that could require labeling for sesame allergens.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.