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Advocacy Update: FDA Moves Forward on Sesame Labeling

 
Updates:
On Nov. 24, 2020, the Asthma and Allergy Foundation of America (AAFA) and 12 other food allergy advocacy organizations responded to FDA's proposed “Voluntary Disclosure of Sesame as an Allergen: Guidance for Industry.”

The letter urges FDA to swiftly make sesame allergen labeling mandatory, instead of voluntary. While a voluntary system encourages manufacturers to begin labeling sesame, it does not guarantee safety for those with a sesame allergy.

AAFA and the coalition of food allergy advocacy groups will continue to work with the FDA to make sesame allergen labeling mandatory.
Food Allergy Coalition letter to FDA re sesame guidance_Page_1

On Nov. 17, 2020, the U.S. House of Representatives unanimously passed the Food Allergy Safety, Treatment, Education, and Research Act of 2019 (FASTER Act). The passage of this bill by the House represents great bipartisan support for labeling sesame as a major allergen.  AAFA has led the way with advocacy efforts on clear sesame labeling. This includes raising the alarm to include sesame in bills like the FASTER Act and asking the FDA to take action. Though the FASTER Act is unlikely to pass the Senate in the limited number of days left in this Congress, we look forward to working with the next Congress to reintroduce the FASTER Act to get this bill signed into law by the president. We will also continue to push the FDA to regulate sesame as an allergen. Our dual track approach will ensure that people living with sesame allergies are protected as soon as possible.
On Nov. 10, 2020, the FDA released the proposed “Voluntary Disclosure of Sesame as an Allergen: Guidance for Industry.” This remains a promising step in the right direction though it falls short of mandatory labeling of sesame as an allergen.


On Oct. 5, 2020, the Food and Drug Administration (FDA) sent proposed guidance “Voluntary Disclosure of Sesame as an Allergen: Guidance for Industry” to the Office of Management and Budget (OMB) for review. While this voluntary guidance falls short of the mandatory sesame allergen labeling that we have been advocating for, we feel it is a promising step in the right direction. This is a result of the FDA’s 2018 request for comments from the public on sesame allergy and their review of those comments from the food allergy community.

There are two ways to accomplish our shared goal of getting sesame labeled as an allergen in foods – through FDA regulation and through congressional legislation.

The FDA has regulatory authority to designate foods as major allergens under the existing Food Allergen Labeling and Consumer Protection Act (FALCPA). The Asthma and Allergy Foundation of America (AAFA)* has encouraged the FDA to use this regulatory authority to declare sesame as a major allergen since 2014. In the summer of 2018, we met with the labeling team at the FDA to share your stories about the challenges of managing a sesame allergy, and we have continued to follow up with them over the past two years.

Congress can pass legislation that would require the current law to be updated to add sesame as a major allergen. The FASTER Act (H.R. 2117) would require the Centers for Disease Control and Prevention (CDC) to collect more information on the prevalence of food allergies for specific allergens in the U.S. This act would also expand the definition of major allergens to include sesame. It would direct the National Institutes of Health (NIH) to study the economic costs of food allergies in the U.S. AAFA joined with other food allergy organizations to support this bill.

We will continue to watch the regulatory process and keep you updated. We look forward to continuing to work with the FDA to achieve mandatory labeling of sesame as an allergen through regulation. We will also continue to pursue legislative action through the FASTER Act.

*Kids With Food Allergies is a division of AAFA.

Updated November 2020

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Kids With Food Allergies
A Division of the Asthma and Allergy Foundation of America
1235 South Clark Street Suite 305, Arlington, VA 22202
Phone: 1-800-7-ASTHMA (1.800.727.8462)
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