Food Allergy Awareness Month recently passed, but the debate on the newly implemented FASTER Act is still going strong. . . and gaining speed. Over the last few months, comments and letters from the Center for Science in the Public Interest (CSPI), Food Allergy Research & Education (FARE), the American Baker’s Association (ABA), and the U.S. Food and Drug Administration (FDA) along with members of Congress have been floating around with each organization detailing its stance on the baking industry’s response to the FASTER Act’s requirements for Sesame.
A Brief Look at Food Allergen Regulations in the U.S.
In 2004 the Food Allergen Labeling and Consumer Protection Act (FALCPA) was signed into law and identified eight major food allergens (milk, eggs, fish, Crustacean shellfish, tree nuts, peanuts, wheat, and soybeans) that require labeling, known as the Big 8. The source of the allergen is required to be declared in the ingredient statement through parenthetical listing, for example, “Flour (wheat)”, or in a contains statement immediately following or next to the ingredient listing, for example, “Contains Wheat and Milk.” With the passage and signing into law of the Food Allergy Safety, Treatment, Education, and Research (FASTER) Act in April of 2021, the major food allergens definition is amended. So as of January 1, 2023, the major food allergens regulated by the FDA have gained a ninth sibling, Sesame. “The Big 8” is now “The Big 9”. Manufacturers of food regulated by the FDA must declare Sesame on the label of any food products containing Sesame in any form – i.e. as a flour, topping, spice, natural flavor, etc.
Anticipating and Implementing the FASTER Act
Companies had just over a year and a half from the enactment of the FASTER Act (April 2021) to its implementation (January 2023). During the 19 months from enactment to implementation, companies in the baking industry worked to test and implement methods to control the risk of cross contact with sesame. Many felt confident in meeting the law, but expressed concerns about the practical implementation in the manufacturing environment. During a Bake to the Future (Ref. 1.) podcast hosted by the ABA in July of 2021, Meaghan Meyer, Senior VP of Food Safety and Quality (CraftMark Bakery) and Co-Chair of Food Technical Regulatory Affairs Professionals Group (ABA), shared her thoughts on the impact of the FASTER Act may have on bakers.
Meyer stated “I do think there are going to be some concerns. Some of the larger organizations are going to be going through and identifying whether some of their products may need to have formula changes. If they choose to actually formulate away from using sesame products, whether they can segregate certain production lines so that they produce products that contain no sesame versus having to do allergen changeovers. There may be equipment that has to be purchased, so that there’s true segregation between non-sesame and sesame products.
Bakers commonly handle multiple allergens in their bakeries on a daily basis and we have already put in place processes to control them since the 2006 Food Allergen Labeling and Consumer Protection Act was passed over 15 years ago. So we’ve had practice and we know they’re going to be challenges that are going to lead us to potentially having to make process changes or changes in how we schedule our production, but we also know that we can do it. We’ve had the practice, we have the experience.” Although Meyer showed confidence in the baking industry’s competence in responding to the FASTER Act, she also noted that dealing with sesame in manufacturing and production would not be without difficulty. “It comes down to understanding the details around how we manufacture, understanding the nature of the allergen. [Sesame] is a very small seed and it can definitely make its way into places that are hard to see and therefore hard to clean. If you can’t see it, it’s very difficult to inspect it and ensure that there’s no residual left. So it’s going to push Bakers to think more creatively and definitely do deeper dives into their equipment design and their sanitation practices.”
So what’s all the hoopla about?
The intent of the FASTER Act is to make food safer for those suffering with allergens to Sesame by requiring it to be declared as an ingredient or in a contains statement on labels. This came about partly due to the fact that Sesame is often used as a flavoring or spice in foods and simply declared as “spices” or “natural flavors”. Because of the particulate nature of Sesame, many manufacturers and bakers found that sesame is extremely difficult to control within their facilities and that cross-contact cannot be completely avoided. With that in mind, baking companies have reformulated their products to include small amounts of Sesame in order to declare it as an ingredient on the product label and remain in compliance with the FASTER Act.
This is where the debate comes in. The intent of the FASTER Act is to make food safer for those suffering with allergens by requiring Sesame to be declared as an ingredient on labels. The CSPI, FARE, and the 8 members of Congress who supported the FASTER Act condemned bakers for the practice of adding sesame to products. The ABA defended its members noting, companies made this change in formulation in an effort to protect consumers from Sesame allergens. The ABA found cross contact is not completely preventable even with cGMPs, crossover changes, segregation of production, and thorough sanitation practices in place.
On January 30th, just one month after the implementation of the FASTER Act, the CSPI sent a letter (Ref. 2.) to FDA commissioner Robert M. Califf. In the letter, Sarah Sorscher, Director of Regulatory Affairs (CSPI), and Peter Lurie, President (CSPI), urged the FDA to update industry guidance and bar manufacturers from the intentional addition of allergens to products and marked this practice as illogical and a violation of food safety laws.
“The Center for Science in the Public Interest (CSPI) submits this petition . . . to request that the Commissioner of Food and Drugs issue a notice to manufacturers and update its industry guidance to prevent manufacturers from intentionally adding sesame and other major allergens to products when they identify allergen cross-contact risks, a practice that violates food safety rules.”
The letter continues, “Specifically, we request that the Food and Drug Administration issue a notice to manufacturers stating they cannot meet their food safety obligation to mitigate allergen cross-contact risks by, paradoxically, adding sesame or other major allergens intentionally to foods. We also ask that the FDA address this practice through its draft Allergen Questions and Answers document. Finally, we ask FDA to clarify that the ingredients and “contains” statement cannot be used to declare cross-contact risks.”
In a blog post (Ref. 3.) published on ABA’s website on April 26, 2023, author Rasma Zvaners touches on the difficulty of controlling Sesame. Zvaners writes, “We’re nearly five months into the implementation of the FASTER Act, and the baking industry’s priority remains the allergic community’s safety. Sesame seeds are often used as a topping rather than mixed into a product. This usage makes sesame cross-contact much more difficult to control than other major food allergens, and more difficult to fully eliminate the risk of sesame cross-contact from shared equipment, such as an oven that is several hundred feet long.”
Zvaners goes on to point out the work and dedication of the baking industry, “Bakers enforce extensive cleaning and Current Good Manufacturing Practices (cGMPs) in their facilities to protect all consumers. Despite rigorous cleaning protocols, sesame is a uniquely challenging allergen to remove from the baking environment, and even the best practices cannot always remove traces of sesame. . . Given current production operations in hundreds of bakeries coupled with the existing FDA regulatory scheme (which essentially requires recalls for any products with traces of sesame, even if they have the “may contain sesame” statement), including sesame and labeling it as an allergen is the most realistic and safest way to protect allergic consumers.”
The week following the ABA’s blog release, a Bipartisan Congressional Letter (Ref. 4.) was sent to the American Bakers Association, which called the practice of reformulating products to include Sesame dangerous. “We are writing to express our extreme concern and disappointment in the baking industry’s response to the FASTER Act. . . . Instead of acting to protect consumers, manufacturers are adding trace amounts of sesame to their baking products since the passage of the FASTER Act. It appears that this is being done to avoid the costs associated with the processes and systems controls necessary to ensure safe baking practices. The dangerous practice of adding sesame to baked goods that have not previously contained the ingredient, often without notice, undermines the trust that people with food allergies place in the food industry. . . .
Now families are struggling to find products without sesame as previously trusted restaurants and brands have engaged in this dangerous practice of adding sesame. These actions undercut the purpose and intent of the FASTER Act and put the lives of consumers at risk. . . . We strongly condemn these practices and urge your members to take the steps necessary to implement safety control measures.”
The Bipartisan Congressional Letter was followed one day later with a supporting statement (Ref. 5.) from Jason Linde, Senior Vice President of Government and Community Affairs (FARE). “On behalf of the more than 33 million Americans with life-threatening food . . . FARE applauds the actions of . . .congressional food allergy champions in demanding that some members of the American Bakers Association (ABA) stop the practice of adding sesame to bakery products to circumvent the intent of the FASTER Act. We are appalled that instead of complying with the law as promised and eliminating the risks faced by the sesame allergic community prior to the passage of the FASTER Act, bakery manufacturers and brands have instead done the exact opposite. Their intentional action to add sesame to previously safe products is wrong and threatens the lives of Americans with a sesame allergy.”
In response to the Bipartisan Congressional Letter received by the ABA, Eric Dell, CEO and President (ABA), replied in a seven-page letter (Ref. 6.) outlining the process and reasoning behind the decision of some baking industry companies, noting that consumer safety and compliance to the law are the ABA members top priority.
Dell wrote, “We emphasize that the baking industry’s priority remains the allergic community’s safety. . . . Our member bakers have spent considerable time and resources examining their production facilities, determining where and how sesame cross-contact arises and can be controlled, segregating production lines where feasible, implementing state of the art cleaning processes and Current Good Manufacturing Processes (cGMPs) appropriate to a dry production environment, and testing for sesame residues. Despite these efforts, some bakers found that the risk of sesame cross-contact cannot be eliminated for certain products. Moreover, establishing dedicated facilities to produce either sesame containing or sesame free products is generally not feasible for the bread and bun sector, which is typically regional to ensure the delivery of fresh product to consumers local stores.
Faced with the facts that (1) traces of sesame often cannot be eliminated, (2) FDA typically expects recalls for products containing traces of allergens – even for products bearing “may contain” labeling, and (3) allergens present due to cross contact cannot be listed as ingredients in the food, some bakers determined that the only way to comply with the FASTER Act and protect consumers was to intentionally add sesame ingredients so they could be labeled as such to alert allergic customers to the presence of sesame.
This 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 consumers to the risk of cross contact after the implementation of good CGMP’s as has been done in Canada.
The decision of some bakers to add sesame was not reached lightly, but only after concluding that was the best way to protect the public health under existing law and FDA’s regulatory approach.
FDA has long expressed the view that advisory and precautionary labeling such as “may contain” statements cannot be a substitute for good cGMPs but has suggested they may be appropriate where risk remains even after rigorous controls. As a practical matter, however, FDA typically requests recalls of products found to contain traces of allergens, even if the products bore “may contain [allergen]” precautionary labeling and were produced under rigorous cGMPs. This is evident in the fact that undeclared allergens have long been the number one leading cause of food recalls, and many food companies’ experiences with FDA, and even in the same FDA statement seeming to acknowledge that advisory labeling can be appropriate. FDA maintains that it does not take a “zero tolerance” approach to allergen cross contact, but rather evaluates each incident on a case-by-case basis. But this approach is simply unworkable for products for which it is known that there will likely be traces of sesame even after the implementation of rigorous cGMPs. Such products simply cannot be produced and distributed, because they would need to be recalled.
The bakers who determined the need to add sesame to their formulas did so only after exhaustive evaluations, application of state-of-the-art cGMP’s that still resulted in sesame traces, reconsideration of their product offerings, and changing their production practices.
Congress should urge FDA to establish allergen thresholds. The issues surrounding sesame have renewed the need for allergen thresholds.” In mid-May, the FDA released the updated Draft Compliance Policy Guide on Major Food Allergen Labeling and Cross-Contact (CPG) along with a statement (Ref. 7.) concerning the baking sector’s reaction to the FASTER Act. The statement reads, “The FDA is aware that some manufacturers are intentionally adding sesame to products that previously did not contain sesame and are labeling the products to indicate its presence. While the draft CPG does not specifically address the issue of industry adding sesame to products that did not previously contain it, the draft CPG does address the FDA’s enforcement policy for labeling and cross-contact controls for major food allergens, including sesame. The FDA is engaged with various stakeholders on this issue. The FDA recognizes that this practice may make it more difficult for sesame-allergic consumers to find foods that are safe for them to consume – an outcome that the FDA does not support.”
FSQC’s Analysis
In considering the nature of Sesame and the process of baking and manufacturing prior to the FASTER Act, products that did not contain Sesame may have unintentionally been coming in contact with Sesame even with cGMPs and food safety controls. At that time, cross-contact with Sesame in non-Sesame products was being controlled as a quality concern because it was not considered a food safety violation. Under current regulations, if any trace of Sesame is detected in a product that does not list it as an ingredient it must be recalled, even if it bears a “may contain [allergen]” statement.
Although there is back and forth among the various trade groups, regulators, and advocates concerning the addition of Sesame as an ingredient in foods that did not previously contain Sesame, the addition and declaration of Sesame follows the letter, and intent, of the law outlined in the FASTER Act. However, it does narrow the selection available to Sesame allergic consumers, which is understandably frustrating. The situation is a double-edged sword. Adding Sesame lowers the number of available products to consumers with allergies, but implementing true segregation of allergens during production will drive costs up for bakers and manufactures. The added costs will in turn be passed on to consumers. It’s simple commerce/business. The desire for allergic consumers to have more choices available is understandable. But its also true that the feasibility of making changes for bakers and manufacturers is not as simple as it seems. Bakers and manufacturers do not necessarily have the space, equipment, or resources to produce both Sesame and non-Sesame products.
So What’s Next?
The ABA, as well as other food and beverage industry members, have urged the FDA to set allergen thresholds and also allow “may contain [allergen]” labelling statements, which would be precautionary warnings for allergic consumers, but would not replace proper and effective cGMPs, allergen control programs, etc. Many believe allergen thresholds and precautionary statements would provide a more solid foundation for consumers and manufacturers to build upon. By creating a more uniform system for measuring allergens, the FDA and manufacturers would have a clearer, more concise guide on when precautionary labels are appropriate and when a recall is necessary. This would also alleviate much of the difficulty and stress for allergic consumers. Precautionary statements based on set thresholds would provide more information and make more options available to allergic consumers. This approach can alert allergic consumers to the potential presence of an allergen due to instances of unavoidable cross-contact. Many companies have chosen to add Sesame to their products because separating productions lines and extensive sanitation procedures may not ensure Sesame cross-contact does not occur. Although this seems like an easy and effective alternative, it may result in push-back from consumers in the future. Be prepared for future industry and allergen standard changes.
References:
*For the purpose of brevity only excerpts from the interviews and letters quoted above have been used. To read them in full follow the links below.
- Bake to the Future podcast, #33 Bakers Urged to Focus On Sesame Labelling Law, American Bakers Association, July 27, 2021.
https://americanbakers.org/news/bakers-urged-focus-sesame-labeling-law - Petition to FDA to Notify Manufacturers that They Cannot Mitigate Allergen Cross-Contact Risks by Adding Sesame and other Major Allergens to Foods, Center for Science in the Public Interest (CSPI), January 30, 2023
https://www.cspinet.org/sites/default/files/2023-01/Petition%20to%20Prohibit%20Allergen%20Addition.pdf - The Faster Act: Prioritizing Safety Blog, Rasma Zvaners, April 26, 2023
https://americanbakers.org/news/faster-act-prioritizing-safety - Bipartisan Congressional Letter, Congress of the United States, May 2, 2023
https://www.wyden.senate.gov/imo/media/doc/bipartisan_congressional_letter_to_american_bakers_association_5223.pdf - Media Room Statement, Jason Linde, May 3, 2023
https://www.foodallergy.org/media-room/statement-jason-linde-senior-vice-president-government-and-community-affairs-fare - RE: May 2, 2023 Congressional Letter Regarding Sesame and the FASTER Act of 2021, Eric Dell, May 15, 2023
https://online.fliphtml5.com/hmmhj/ltjm/#p=1 - FDA Releases Draft Compliance Policy Guide on Major Food Allergen Labeling and Cross-Contact, U.S. Food and Drug Administration, May 16, 2023.
https://www.fda.gov/food/cfsan-constituent-updates/fda-releases-draft-compliance-policy-guide-major-food-allergen-labeling-and-cross-contact
For further reading check out these additional resources:
• Legislators condemn manufacturers that added sesame in response to allergy labeling law, Megan Poinski/Food Dive, May 4, 2023.
https://www.fooddive.com/news/legislators-condemn-sesame-allergen-added-bakers/649380/
• FDA Criticized for Response to Bakers Adding Sesame Allergen, Wendy Mondello/Allergic Living, May 18, 2023
https://www.allergicliving.com/2023/05/18/fda-criticized-for-response-to-bakers-adding-sesame-allergen/
• Thresholds for Allergenic Foods, Food Allergy Research And Resource Program (FARRP)
https://farrp.unl.edu/thresholds-for-allergenic-foods
• Sec. 555.250 Major Food Allergen Labeling and Cross-contact Draft Compliance Policy Guide, FDA
https://www.fda.gov/media/168000/download
