May contain: allergen labeling regulations.

Author:Besnoff, Sarah

INTRODUCTION I. HISTORY OF ALLERGEN-LABELING LAWS AND REGULATIONS II. CASCADING PROBLEMS: NO THRESHOLDS, NO GMPS, AND NO ADVISORY LABELING A. No Thresholds B. No GMPs C. No Advisory Labels D. Cascading Problems Lead to Uninformed Consumers 1. Advisory Labels Are Currently Meaningless 2. Food Producers Are Permitted to Opt Out of Protecting Food-Allergic Consumers III. CONSUMER-FOCUSED SUGGESTIONS FOR THE FDA REGARDING CONTAMINATION LABELING A. The FDA should establish thresholds for major allergens B. The FDA should incorporate thresholds into amended GMP Regulations and increase enforcement efforts 1. Goal #r. Detecting Cross-Contact 2. Goal #2: Preventing Cross-Contact C. Advisory Labeling Should Be Standardized and Should Reflect Thresholds and GMPs CONCLUSION INTRODUCTION

Nausea; hives; swelling of eyes, nose, and throat; lung failure; (1) and possibly death (2)--these are the symptoms food allergy (3) sufferers can endure if they consume their respective food allergen. (4) Food allergies affect between 2%-9% of the U.S. population. (5) Each year, roughly 30,000 individuals require emergency room treatment, and roughly 150 individuals die from allergic reactions to food. (6)

Even minimal exposure to an allergen can cause an allergic reaction in some individuals. Currently, there is no known cure. (7) Despite some recent successes in medical trials of alternative treatments, (8) the primary option for those suffering from food allergies is still complete avoidance of the allergens themselves. (9)

To avoid allergens successfully, food allergy sufferers must be able to trust information provided by food producers and manufacturers. (10) The average individual does not produce his or her own food; instead, nearly everyone purchases food from grocery stores, farmers' markets, and other commercial suppliers and rely on food labels to determine whether a product is safe for consumption. (11) For food allergy sufferers, the ingredient labels on these packaged foods are lifelines to ensure their safety. (12)

In an effort to protect food allergy sufferers, Congress passed the Food Allergen Labeling and Consumer Protection Act (FALCPA) in 2004. (13) The Act required, for the first time, (14) producers of commercial food products to indicate on a label whether the product contained any of the eight major allergens. (15)

The food allergy community (16) heralded the creation of this legislation. (17) However, the Act left one important concern for food allergy sufferers untouched: advisory label warnings. An advisory label warning is an addition to a food product's ingredient label that alerts consumers to the possibility of contamination, or "cross-contact," with an allergen. (18) Some food allergy sufferers can have allergic reactions to very small amounts of allergens, including food products that were only in cross-contact with allergens. (19)

"Cross-contact" indicates that a "residue or trace amount of an allergen [has] unintentionally crosse[d] over into a product" whose main ingredients do not contain that allergen. (20) Cross-contact can occur when multiple products are manufactured on the same processing line due to "ineffective cleaning, or from the generation of significant dust containing the allergen" during the labeling, storage, or production processes. (21)

Despite FALCPA's major strides forward for allergen labeling requirements, (22) it has failed to create standards for advisory labeling. FALCPA contains no specifications regarding how to list cross-contact warnings, no requirements about how food producers should measure cross-contact or report any discovered risk of cross-contact, and no limitations on what a company can include in its advisory labeling. (23) As such, a cursory perusal of any neighborhood grocery will show a wide variety of warning labels, from no warning to "May Contain..." to "This product was processed on machinery ..." to "We are unable to guarantee...." None of these warnings explain how this risk of cross-contact was measured (if at all), where in the production process this potential contamination may have occurred, or whether this perceived risk of cross-contact is the result of testing, speculation, or, worse, a nervous legal department.

The FDA has yet to enact regulations on advisory labeling. The FDA has not mandated facility inspections or promulgated guidance requirements or final rules for testing cross-contact. A continuing roadblock for effective regulation is that the amount of an allergen that an allergic person will react to is difficult to quantify. Allergists call the amount of an allergen that will cause an allergic reaction the lowest observed adverse effect level (LOAEL) or "threshold level." (24) Any exposure below that level will not cause an allergic reaction, while any amount above it likely will. In 2008, the FDA's Threshold Working Group released a report in which it proposed four different methods for determining thresholds. (25) It concluded that the "application of each is limited by the availability of appropriate data" and only tenuously endorsed moving forward on one method specifically. (26)

Without thresholds, the FDA is limited in its ability to set measurable requirements for good manufacturing practices (GMPs) to prevent cross-contact. (27)

With no clear definition of cross-contact, companies have no guidance for their advisory labeling about whether a perceived, but probably untested, cross-contact risk actually creates a cross-contact problem. Companies are instead incentivized to be overinclusive on their advisory labels, while remaining unmotivated to transform their practices to avoid cross-contact.

Food-allergic consumers deserve to have these problems addressed by the FDA. The FDA should set threshold amounts for each of the major allergens, mandate a high standard for GMPs to avoid cross-contact, inspect facilities more aggressively for cross-contact, and stipulate exact requirements for advisory labeling.

This Comment proceeds in three Parts. Part I addresses the history of allergen labeling laws and regulations, focusing particularly on the immediate history preceding the passage of FALCPA in 2004 and the progress made since. Part II addresses what I title the "cascading problems of advisory labeling" whereby the failure to define threshold levels leads to an inability to define GMPs to avoid cross-contact, resulting in labeling laws that neither quantify nor standardize how companies should warn consumers about their products' cross-contact with allergens. Finally, Part III provides consumer-focused suggestions for the FDA on how to better protect the interests of food-allergic consumers. Throughout this Comment, I seek to present the perspective of consumers with allergies, rather than that of food producers. The Comment concludes with suggestions for follow-up research that could better address the concerns of food producers.


    Over the past century, Congress has passed several statutes requiring food producers to share an increasing amount of information with consumers about the contents of their food products. In 1906, Congress passed the first statute regulating the labeling of food ingredients as the Federal Food and Drugs Act of 1906 (the Wiley Act). (28) In 1938, the Federal Food, Drug, and Cosmetic Act (FFDCA) (29) established the FDA. In 1966, Congress passed the Fair Packaging and Labeling Act (FPLA), which requires the labeling of ingredients on all food products. (30) In 1990, Congress passed the Nutrition Labeling and Education Act (NLEA), which amended the FFDCA to require food producers to include nutrition labels and to list all ingredients on standardized food products. (31)

    The NLEA led to the enactment of a host of FDA regulations about ingredient labeling and opened up a new set of questions regarding the labeling of allergens. In 1996, the FDA released a Notice Letter to food producers clarifying that known food allergens could not be exempted from ingredient declaration under FDA exceptions to the NLEA. (32) First, an FDA regulation exempted any "incidental additive[s]" that are present in a food at "insignificant levels" from the NLEA requirement to list all ingredients. (33) However, the Notice Letter clarified that allergens are never present at "insignificant levels" because "evidence suggests that some allergenic substances can cause serious allergic responses in some individuals upon ingestion of very small amounts of the substance" and "an amount of a substance that may cause an adverse reaction is not insignificant." (34) Second, the Notice Letter encouraged food producers to voluntarily include all allergens in their ingredient labels. (35) The Notice Letter marked the first time the FDA addressed the growing trend of labeling products with "May Contain" advisory-labeling warnings. (36) The FDA stated that these advisory warnings should not be used in lieu of adherence to GMPs. (37)

    In 2001, the FDA released a report titled "Guidance on Inspections of Firms Producing Food Products Susceptible to Contamination with Allergenic Ingredients," which addressed GMPs for avoiding cross-contact at the production, receiving, processing, final testing, and labeling phases of development. (38) Rather than providing specific methods, requirements, or testing procedures, however, the guidelines listed a series of questions that food producers should ask themselves in their self-evaluations of cross-contact risks. (39) The guidelines also provided recommendations to food producers on language to use in advisory labeling, including specific language options. (40)

    In 2004, Congress passed FALCPA, which amended the FFDCA. (41) FALCPA mandates that all food labels clearly state, in plain language, whether the food product contains any "major food allergens" (42) by labeling it with a "Contains" warning followed by the name of the source of the food...

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