Insights from the FASTER Act on Sesame as a Major Food Allergen: Why Fears of Manufacturers Intentionally Adding Gluten Grains are a False Equivalency

Overview

Prior to the FASTER Act taking effect on January 1, 2023, it was reported that some food manufacturers had started to intentionally add Sesame to products that previously did not have Sesame in them, and then label those products as having Sesame ingredients. This was really frightening and disappointing to Celiac Journey since we had advocated as allies with the food allergy community for passage of the FASTER Act to require the labeling of Sesame on all packaged foods in the United States.

Manufacturers Intentionally Added Sesame to their Products

It was unfortunate that there were various companies that responded to the FASTER Act by intentionally adding Sesame to their products that did not previously have Sesame, thus making it harder for people with a Sesame allergy to find safe food products to eat. While there were some high profile cases of this bad faith practice, this appears to have been from just a subset of food companies. This was a downstream problem from the FASTER Act, and the FDA's historical lax enforcement of existing laws and regulations under the Food Allergen Labeling and Consumer Protection Act of 2004.

Sesame Allergy Community is Better Protected by the FASTER Act

The Sesame allergy community has been and will be better protected with the enactment of the FASTER Act because Sesame is now classified as a Major Food Allergen which must be declared on all packaged foods. This also impacts the ways in which food service operators at schools and restaurants, for example, rely on the FDA's Major Food Allergens as a guide, when they offer menu ingredient labeling or ingredient filtering in their online menus.

The Baking Industry Represented to Congress that the Industry's Priority Remains the Allergic Community's Safety

On January 30, 2023, the Center for Science in the Public Interest ("CSPI"), filed a Citizen

Petition with the FDA "to Notify Manufacturers That They Cannot Mitigate Allergen Cross Contact Risks by Adding Sesame and other Major Allergens to Foods."

On May 2, 2023, U.S. Senator Ron Wyden (D, OR)., U.S. Representative Doris Matsui (D, CA), and U.S. Representative Patrick McHenry (R, NC), led a letter urging bakers to stop unnecessarily adding Sesame to baked goods and protect consumers with Sesame allergies.

"The wholesale baking industry's top priority is consumer safety." -- Eric Dell, President and CEO, American Bakers Association, Press Release, May 15. 2023

On May 15, 2023, the American Bakers Association wrote to Congress that, "We emphasize that the baking industry's priority remains the allergic community's safety."

Sesame is a Uniquely Challenging Allergen to Remove from the Baking Environment

The American Bakers Association (ABA) claimed that "Sesame is a uniquely challenging allergen to remove from the baking environment, and even the best practices cannot always remove traces of Sesame."

The stated reason is that Sesame "is most typically used as a topping, rather than an inclusion (like Wheat, Eggs, Soy, or Milk are in many baked goods). The particulate nature of Sesame seeds makes them much more difficult to control in the baking production environment...)."

Addition of Sesame Likely Not Needed if FDA Established Allergen Thresholds

The ABA has also claimed that the "addition of Sesame would likely not be needed if FDA would establish allergen thresholds or otherwise set forth clear guidance as to when advisory or precautionary labeling (i.e., 'may contain' statements) may be used to alert allergic customers to the risk of cross-contact..."

Gluten Containing Grains are Most Typically an "Inclusion" in Baked Goods Rather than a "Topping" Like Sesame

With respect to our goals of getting Gluten labeled on all packaged foods in the U.S., just like Gluten must be declared in 87 other countries, Barley, Rye and Oats are more similar to the Top 8 Major Food Allergens rather than Sesame because Gluten containing grains are an "inclusion" in baked goods rather than a topping like Sesame.

The FDA Has Established Gluten Allergen Thresholds

In contrast to Sesame, the FDA established a clear Gluten allergen threshold. On August 5, 2013, the FDA issued a Final Rule and established clear thresholds for Gluten Free labeling (i.e., less than 20 parts per million). This would enable manufacturers to test and know if there is cross contact in their production lines, and if so, measure the amount of Gluten from cross contact. To that end, if Gluten was declared as a Major Food Allergen, then the FDA's Gluten Free threshold already established "clear guidance as to when advisory or precautionary labeling (i.e., 'may contain' statements) may be used to alert allergic customers to the risk of cross-contact." Collectively, this would likely prevent manufacturers from intentionally adding Gluten to products like the ABA said some bakers did with Sesame.

FDA's Response to Adding Sesame to Foods that Did Not Contain Sesame

On July 26, 2023, the FDA responded to CSPI's January 30, 2023 Citizen Petition regarding Sesame allergen labeling by denying two of CSPI’s petition requests and granting one request. In the conclusion to their response, the FDA stated that while the Agency is not taking action with respect to CSPI's Requests 1 and 2, they are "actively looking into and engaging on this practice of companies intentionally adding sesame to foods that, prior to the passage of the FASTER Act, did not contain sesame."

History Informs Us the Top 8 Major Food Allergens Were Never Intentionally Added to Products that Did Not Contain the Top 8 Major Food Allergens

In the United States, we are also not aware of any of the top 8 Major Food Allergens just being added to foods by food manufacturers to avoid the labeling requirement of those Major Food Allergens under the Food Allergen Labeling and Consumer Protection Act of 2004.

History Informs Us that Gluten Containing Grains Were Never Intentionally Added to Products that Did Not Contain Gluten

Given that Gluten is required to be labeled on packaged foods in 87 countries worldwide, many of the multinational consumer-packaged food manufacturers already label Gluten on their products sold in those 87 other countries. As such, labeling Gluten is in the United States would be commensurate with their existing global operations and best practices.

In addition, we are not aware of any multinational manufacturers in the 87 countries around the world where Gluten is required to be labeled intentionally adding Gluten to their food items in those 87 other countries.

Jax Bari, HHS Headquarters, Washington, DC, Require Gluten Labeling

While we would not want any food manufacturer to intentionally add Gluten to a product in the US like some did with Sesame to circumvent the FASTER Act's intended disclosure purposes, that would be a "good" resulting problem to have knowing that Gluten was in fact declared a Major Food Allergen by the FDA.

Please join us in calling on the FDA to require the labeling of Gluten! The requirement to label Gluten is a foundational goal that we have for Gluten, just like Gluten must be declared on all food labels in 87 other countries.

Historical Background of FDA's Inaction & Failure to Protect the Sesame Allergy Community

In response to the 2014 Citizen Petition to require the labeling of Sesame, the FDA's 6 Year response was woefully late and wholly inadequate. According to the Center for Science in the Public Interest, "FDA deliberated for six years on a 2014 petition from CSPI requesting that sesame be labeled as an allergen. While the agency eventually issued a draft guidance in November 2020 providing voluntary recommendations to manufacturers regarding sesame labeling, it never exercised its authorities under 403(x) or other provisions to require labeling and food safety controls for sesame."

In other words, prior to the passage of the FASTER Act, the Sesame allergy community was much more vulnerable due to the FDA's failure to protect the Sesame community with its "Voluntary Disclosure of Sesame as an Allergen: Guidance for Industry."