Tom Trautman

Last summer, Congress passed the Food Allergen Labeling and Consumer Protection Act. Several years in the making, this law enjoyed bipartisan support, as evidenced by leadership in the Senate from Senators Kennedy (D-Mass) and Gregg (R-NH).

Effective January 1, 2006, the law requires labeling of major allergens, defined as the eight allergenic foods or food types that cause most allergic reactions: peanuts, tree nuts, eggs, milk, soy, fish, crustacean shellfish, and wheat. These foods or any protein-containing ingredient derived from these foods must be declared in plain language in the ingredient statement or via a “Contains __” statement. So casein, for example, could be listed (1) as “casein (milk)” in the ingredient statement or (2) as “casein” in the ingredient statement, with a “Contains milk ingredient” phrase immediately following the ingredient statement.

The law removes previous exemptions from disclosing components of flavors, processing aids, and the like with respect to the major allergens. Highly refined oils and raw agricultural commodities are exempt from these provisions; other exemptions can be given by the Food and Drug Administration via a petition or notification process or by the Secretary of Health and Human Services if they are deemed necessary to protect public health.

FDA is further directed to, within two years:
• Report on how foods are contaminated with allergens (“cross-contact”).

• Report on how Good Manufacturing Practices might be amended to reduce or eliminate cross-contact.

• Assess how well industry and FDA have addressed cross-contact.

• Conduct, assess, and report on allergen inspections of industry.

• Describe current precautionary labeling approaches, how manufacturing practices lead to these, and how consumers would prefer such information to be communicated.

The food industry worked closely with congressional staffers to make the law practical. Reportedly, one of the early ideas was to call for dedicated equipment for all foods—clearly impossible for large manufacturers, much less small ones. In fact, the major components of this law line up favorably with those of the Food Allergen Labeling Guidelines issued in 2001 by the Food Allergy Issues Alliance. This group of food trade associations defined the major food allergens; committed to the use of plain language for allergenic ingredients; agreed to label allergenic ingredients even if they were otherwise exempt (because they were in flavors, colors, used as processing aids, etc.); and outlined criteria for when precautionary labeling was appropriate. Only this fourth component wasn’t clearly laid out by Congress, but a study on the topic was required.

Nevertheless, a good law that has support from all parties, including the regulated industry, can still present potential problems in terms of implementation. In this case, the major issue is that there are countless ingredients derived from allergenic foods that have traces of protein, yet have typically not been treated as allergens. Examples include soy lecithin, lactose, fish gelatin, wheat starch, and numerous ingredients derived via fermentation, such as enzymes, gums, reaction flavors, or antimicrobials from fermentations using media that contained egg, soy, or wheat.

The term “tree nut” was never defined. Some tree nuts have not shown allergenicity but have an uncertain status with respect to this law: coconut, kola nut, shea nut, nutmeg, and the nut from which annatto food coloring is derived.

Levels of allergen matter. It is well known from work by Steve Taylor at the University of Nebraska and other investigators (see article on page 40) that allergens have threshold levels; exposure below the threshold would cause minimal or no reaction even in allergic individuals. But thresholds have not been officially set for food allergens, so the default standard of the new law is to require labeling of any detectable level of allergenic protein.

Without guidance from FDA and early exemption of many commonly used ingredients that do not present a risk to consumers, the vast majority of the food supply could soon bear allergen labeling. For example, most bread and many other baked goods use soy lecithin as a pan release agent, similar to the cooking sprays consumers use at home. Should all these baked goods now be labeled for soy allergy? Other products could have milk, egg, wheat, or other allergen labels added as well.

Such over-labeling would greatly limit food choices for the food-allergic individual—assuming that they could sort through the confusion. Confusion would come from the realization that thousands of products that were safe before are now allergen labeled. Many might wonder if they had lost their allergic status, since they ate something safely prior to noticing that it was allergen labeled. Worse than the confusion would be the dangerous, risk-taking behavior that an unclear labeling situation would foster: allergen labels will tend to get ignored, including those that should be heeded.

Creating confusion in allergen labeling—and thereby a public health crisis—is clearly not the intent of the law. FDA is seeking data from industry and academia to document the safety of these protein-containing but non-allergenic ingredients. The food industry is committed to working with the agency—and working quickly so appropriate labeling is in place by next January.

by Tom Trautman is Fellow, Toxicology & Regulatory Affairs, General Mills, Inc., 1 General Mills Blvd., Minneapolis, MN 55427, [email protected].