FARE hails Senate vote on adding sesame to ‘big 8’ allergen list, accelerating process it claims might otherwise take ‘years’

Under the FASTER Act (S.578)​​, sesame would be added to the ‘Big 8’ list of allergens subject to ‘Contains​…’ labeling on US food labels (milk, eggs, peanuts, tree nuts, fish, crustacean shellfish, wheat, soy).

The Department of Health and Human Services (HHS) would also be required to issue a report 18 months after the bill is enacted that would outline the government’s progress on collecting data on food allergy prevalence and severity; developing effective food allergy diagnostics and therapeutics; and preventing the onset of food allergies.

It would also need to outline progress on “the scientific criteria for defining a food or food ingredient as a major food allergen​,” which food allergy advocacy group FARE​ ​claims is currently unclear:

“Right now, there is no clear process for adding future allergens to be labeled nor is there a defined and publicly known scientific criteria for accomplishing this goal. ​Therefore, we need data to drive insight to make decisions on prevalence of food allergens.”​

Asked about the approach to appeal directly to lawmakers rather than waiting for the FDA to issue further guidance or propose rulemaking, a spokesperson for FARE told us:

“During last year’s Energy and Commerce Committee mark-up on the FASTER Act, Health Subcommittee Chair, Rep. Anna Eshoo (D-CA-18), reported that when she talked to the FDA about how long it would take them to label sesame, she was told 5-7 years. This response is what led her Subcommittee to move the FASTER Act forward.”​

The spokesperson added: “FARE and Congress believe that on behalf of the 1.6m Americans allergic to sesame and the hundreds of thousands of parents and loved ones making shopping decisions on their behalf, that we must have a solution to this problem.”​

As for the difference between the FASTER Act of 2021 and the bills that passed in Congress last year, the spokesperson said: “The FASTER Act bills that passed the House and Senate last year were different from each other in a number of ways. This new legislation is a compromise of those two bills. While the House version calls for a one-year transition for industry, the one passed in the Senate calls for a two-year transition.​

“We are confident that with the help of our tens of thousands food allergy advocates across the country that the House will once again pass the FASTER Act during 117th Session of Congress. This bill will save lives, provide transparency, eliminate fear and anxiety, and help reduce health care costs by eliminating some of the thousands of emergency room visits made each year by those suffering from food allergies.”​

FDA: ​‘It appears that sesame allergy may be an increasing problem in the US population’​

The FDA has been looking at sesame for some time, and recently issued draft guidance​​ (Nov 2020) encouraging food manufacturers to voluntarily​ declare all uses of sesame in the ingredient list on food labels (notably in flavors and spices), or when the common or usual name, such as 'tahini,' does not specify sesame.

In the draft guidance, it noted: “It appears that sesame allergy may be an increasing problem in the US population... Gupta et al.’s ​​​[2018] study​​​ showed that two-thirds of children with reported sesame allergy experienced an emergency department visit, which is higher than reported visits for any of the major food allergens.”​

More concerningly, it said, “Severe reactions were reported more frequently in children with a sesame allergy than for children with allergies to the major food allergens.”​

But there are gaps in the data, it added: "The lack of US prevalence data based on clinically confirmed cases of food allergy was also highlighted in the [2017] NASEM report​​ and constitutes a gap in assessing the true prevalence of sesame allergy and other food allergies."​

FDA: '​It can take several years to develop a regulation'

Speaking to FoodNavigator-USA this week, the FDA said its 2020 voluntary guidance was "an important first step as we explore other potential actions to protect consumers who may have allergies to sesame or other food allergens beyond the major eight."​

A spokesperson said: "The FDA does not have the authority to add to the statutory list of major food allergens but does have the authority to designate other allergens and require labeling. ​The framework the FDA is developing will help to determine if the FDA should pursue rulemaking or take other steps for other allergens."​

Asked about FARE's characterization of the timeline, the spokesperson said: "The Agency has acknowledged that it can take several years to develop a regulation and allow time for implementing the changes, regardless of the issue."​

Quizzed about the process by which we should decide which food allergens should be subject to mandatory allergen labeling, the FDA added:

"To make further progress on addressing food allergens that are not covered under the Food Allergen Labeling and Consumer Protection Act (FALCPA), including sesame, the FDA is developing a science-based and transparent framework that will identify what data are needed and what factors should be considered in determining the public health importance of a food allergen other than the eight major food allergens defined in the Food Allergen Labeling and Consumer Protection Act of 2004. ​

"This would help the FDA determine if additional steps are needed to address specific allergens, including sesame."​

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