Issue View | Council I | 2023 Biennial Meeting

This is a brand new Issue.

Sesame Update To Section 403(w)(1) of the FD&C Act (21 U.S.C. 343(w)(1))

I would like the Conference to consider advocating to update the Food, Drug, and Cosmetic Act (FD&C) to authorize food manufacturers to label products with an advisory warning of cross contamination of sesame, in order to prevent food manufacturers from adding sesame flour to their bread as a substitute for compliance with the Food Allergy Safety, Treatment, Education, and Research (FASTER) Act.

The FASTER Act, which was enacted to "protect" those with sesame allergies by identifying sesame as the 9th "major food allergen" has backfired and resulted in bakeries adding a small amount of sesame flour to bread - not to enhance flavor - but solely to identify sesame as an ingredient, due to their perceived inability to comply with Section 403(w)(1) of the FD&C Act (21 U.S.C. 343(w)(1)). The current law requires that food manufacturers label for the 9 major food allergens. If an allergen is not an ingredient in the food, the manufacturer is prohibited from listing it as an ingredient. In addition, good manufacturing practices are required for food allergen preventative controls. Due to the financial burden of "good manufacturing practices," for decades, it has been an accepted practice for companies to label a product with an advisory warning, such as "made in a facility with ___" or "may contain __" or "made on shared lines with ____", in order to warn of the potential cross contamination of an allergen, without adding that allergen as an ingredient to the food. When the FASTER Act was passed, rather than rely upon this accepted practice, food manufacturers (and in particular bakeries), have become fearful that an advisory warning is insufficient to comply with the FD&C Act. As such, these manufacturers are adding a small amount of sesame flour to their bread for the sole purpose of declaring an allergen. As a consequence of this decision, it has become nearly impossible for a sesame allergic person to find safe bread to eat. Of note, sesame is a unique allergy. Many with sesame allergies are not affected by cross contamination of seeds, due to the fact that the protein that causes a reaction is located inside the seed. The waxy coating of the seed acts as a barrier. Although some people may be sensitive to cross contamination, there are many people who have safely been able to consume bread made in a facility with sesame seeds without any issue. However, it is unlikely that someone with an active sesame allergy can consume sesame flour baked into the bread. People with sesame allergies are no longer able to safely eat hamburgers, hot dogs, pizza, and rolls due to sesame flour being added to these foods to avoid compliance with good manufacturing standards. Children with sesame allergies who rely upon hot lunch programs are now struggling to find safe foods to eat. Restaurants such as Wendy's, Chik-fli-a, Culver's, Olive Garden and Maggiano's are being impacted by their bread suppliers adding sesame to their bread. Of concern, this change is not well known or advertised to the public, and many restaurant managers are not being educated about these changes. As such, those with sesame allergies are at an extremely high risk of an accidental reaction, due to the fact that reliable restaurants where they safely ate weeks ago may no longer be safe for them. It is not a question of if, but a question of when someone will get sick and possibly die from eating a burger at Wendy's because they did not know that sesame flour was added to the bread. Unlike sesame seeds, the small percentage of flour being added is not visible or noticeable; however, also unlike sesame seeds (which are less potent due to how they are digested), a small amount of sesame flour could be deathly.

A preferable law, which would benefit both bakeries and those with sesame allergies, would allow for bakeries to label their packages with an advisory warning to clearly indicate whether 1) Sesame seeds and/or flour is the facility; and 2) Sesame seeds and/or flour is used on a shared line. With this information, a person with sesame allergies can make an informed decision about whether the potential cross contamination is a risk based upon their sensitivity to the allergen. In addition, bakeries will not need to add a small percentage of sesame flour to otherwise sesame-free bread. Of note, people with sesame allergies who can tolerate cross contamination have been safely eating bread from bakeries that use sesame seeds without issue. Adding sesame flour to bread is NOT the answer to protect those with sesame allergies. Rather, truth in labeling and allowing for advisory warnings is the answer to protect those with sesame allergies. It is necessary to update the FD&C Act and codify the permissive use of advisory labels. Although advisory labels have been an accepted practice with respect to other allergens, it is clear that food manufacturers (and in particular bakeries) are not comfortable relying on this practice with respect to sesame seeds. Rather, they need the security and protection of a statute to prevent the fear of litigation. Notice of a risk of cross contamination would prevent litigation. It would be at the consumer's risk to consume food with such a warning. As noted above, those with sesame allergies should be trusted to make their own informed decisions about their health when provided with accurate information about the potential for cross contamination in a facility. However, adding sesame flour directly to bread takes that right away. This is overt discrimination. It is despicable to add a small amount of an allergen to food solely to exclude a class of people. There is a better way. An update to the FD&C Act with respect to advisory warnings is long overdue.