Implementation of FASTER Act Poses Challenge for Industry

The FASTER Act, which went into effect on January 1^st of this year, made sesame the 9^th major food allergen, thereby triggering allergen labeling obligations for foods containing sesame or an ingredient derived from sesame. (21 USC 343(w)). These labeling obligations can be met by either by declaring the allergen (sesame) in the ingredient list in a way that includes the word “sesame” or in a “contains” statement immediately after or adjacent to the ingredient list. There is no mandatory labeling for the presence of unintentional allergens (from cross-contact), although the use of a voluntary “may contain” statement is common.

Implementation of the law has proved challenging for manufacturers that produce both sesame-containing and sesame-free products at the same facility. Good manufacturing practices (GMPs) which are used to prevent cross-contact with other allergens have proved to be insufficient in the case of sesame, which poses unique challenges because of the small size of the sesame seed which is easily dispersed in a facility and difficult to completely remove. This challenge is more significant in the case of sesame seeds than it is with the other major allergens.

Indeed, the risks of cross-contamination are so high that industry does not believe that a “may contain [sesame]” statement sufficiently apprises a consumer of the risk. However, FDA does not permit for the affirmative declaration of the ingredient unless it is intentionally added to the product. Thus, in order to be able to include sesame on the ingredient list and therefore apprise consumers of its presence, some members of the baking industry have been intentionally adding small amounts of sesame to their products. However, an unintended consequence has been that sesame-allergic individuals are consuming familiar products that have been reformulated in this way without reading the ingredient list and therefore are being exposed to higher levels of sesame.

This approach has drawn the ire of a bipartisan group of 8 congressmen, who in a letter to the American Bakers Association earlier this month, chastised the industry for making a change that they argue “undercut[s] the purpose and intent” of the law and endangers consumers. In applauding the “fourteen brands that have confirmed their facilities are dedicated free of sesame,” (bold added) the letter unwittingly summarized the crux of the issue: current GMPs appear to be insufficient to prevent sesame-cross contact. The novel issue calls for novel solutions – either in the law (or its interpretation) or in the food processing space.