The Food Allergen Labeling and Consumer Protection Act

The Basics

The Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA) took effect in 2006. It is the first amendment to the Food, Drug and Cosmetic Act (FDCA) that addresses food allergens.

FALCPA identifies and regulates the Big Eight - i.e. the top eight food allergens. These are: milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat and soybeans. These allergens were selected because they are believed to be responsible for 90% of allergic reactions.

The crux of FALCPA is its labeling requirements, which are intended to make the allergen content of a food more clear to consumers. The law requires that many foods labeled on or after January 1, 2006 identify the presence of these eight allergens, either by identifying the food source within the ingredient list (e.g. lecithin (soy)) or immediately following the ingredient list (e.g. Contains wheat, peanuts, milk). With respect to tree nuts, fish and Crustacean shellfish, manufacturers are required to identify the 'specific type of nut or species of fish or Crustacean shellfish.'

Shortcomings

Although FALCPA is a tremendous step forward, it has several shortcomings that consumers must be aware of. First - the Act regulates only eight allergens, meaning that other food allergens (such as corn, cherries, and the like) remain unregulated, and therefore potentially undisclosed on food labels.

There are several categories of products to which FALCPA does not apply, either because they are beyond the scope of the FDCAs regulation, or because they are expressly excluded from the purview of the Act. Because they are not regulated by the Act, the labeling requirements do not apply to these product categories. They include meat and poultry, products served in restaurants, and raw agricultural commodities. Also excluded are 'highly refined oils' because it is believed that the amount of offending proteins in these oils is not significant enough to cause an allergic reaction.

Another very troubling shortcoming is the fact that companies may continue to use labels that were printed prior to FALCPA taking effect. The Act expressly allows companies to sell products that were labeled or on retailers shelves at the time that FALCPA was passed, but it does not on its face contemplate the use of a stock of labels that were pre-printed but not yet affixed to any product. Although there does not seem to be express authorization for this practice, this is the reality of the way the law is being enforced. The implication is that there are companies that continue to use labels that do not make the allergen disclosures required by the FALCPA. The FDA is apparently not required to, and does not, maintain a list of the companies using these old labels. Furthermore, there is no time limit on companies using these outdated labels. Thus, it is virtually impossible for consumers to be certain that food labels in actuality comply with FALCPA.

Also distressing is that there is no procedure in place for reporting companies that are not complying with the new allergen labeling requirements. And because companies may be using an old stock of labels that predates the Act, it may be difficult to determine whether a company is technically out of compliance. The FDA has expressed unwillingness to even accept reports of noncompliance with the Act, and indicates that it simply does not have adequate manpower to police noncomplying manufacturers.

Finally, there are currently no labeling requirements for products that are manufactured on equipment or in facilities that also manufacture any of the top eight allergens. There are several possible and equally undesirable results of the lack of regulation in this area: some companies may place advisory labeling on some of their products (e.g. 'may contain X,' 'manufactured on equipment that also produces Y'), but not on others that are equally at risk of contamination. Another possibility is that companies may place advisory labeling on all of their products, despite there being no shared equipment or other reasonably likely contamination. There may be a motivation to do so on the basis that advisory labeling might reduce the manufacturers' liability for consumers' allergic reactions, and may give the perception of a diminished need to observe good manufacturing practices to avoid cross-contamination.