REGULATORY REPORT
By Stefano Luccioli M.D., and Jeremiah Fasano, Ph.D.
Editor: Sue Challis
Evaluating Labeling Exemptions
for Food Allergens:
Challenges for the
Regulators
The Food Allergen Labeling and Con-
sumer Protection Act (FALCPA) was
enacted by Congress to help con-
sumers with food allergies by requiring
labeling of protein ingredients from
major allergenic foods in all products,
unless these proteins qualify for exemption. This article summarizes
the process that has been used by the Food and Drug Administration
(FDA) for considering exemption of ingredients from allergen labeling
under FALCPA and discusses the main scientific issues and consid-
erations behind FDA decisions on allergenic ingredient exemption
submissions evaluated thus far.
Food allergens represent a unique yet diverse group of foods or individual food
proteins to which an ever-increasing number of those in the population have adverse reactions, some with fatal consequences. Food allergy remains one of the
leading causes of anaphylaxis, resulting in 30,000 emergency room visits, 2,500
hospitalizations, and an estimated 150 deaths each year in the United States.
There are no current treatments for food allergies; thus, avoidance of the
causative allergens by relying on ingredients listed on food labels and steering clear
of the foods or food groups that account for most allergic reactions are the mainstays of prevention. This avoidance is not always easy, since major food allergens
tend to be foods commonly consumed in the diet or those found in various ingredients intentionally or unintentionally added to food products.
Despite recommendations for specific labeling of food allergens being found in
congressional documents dating back to the 1930s (prior to the Federal Food,
Drug, and Cosmetic Act), the mandatory labeling of food allergens in food
products has been a more recent phenomenon. With the development of analytical tests for detecting allergens in
food products and a heightened awareness of food anaphylactic reactions as
well as increased allergy prevalence in
the past few decades, monitoring and
subsequent recalls of food products for
undeclared allergens increased substantially. As a result, food manufacturers
voluntarily began alerting consumers of
the possible presence of some allergenic
foods by way of advisory label statements, such as, “may contain (peanuts).”
Prompted by a number of reports in
which consumers experienced adverse
reactions to undeclared allergenic substances in foods, FDA issued a Notice to
Manufacturers1 in 1996 warning about
the presence of undeclared allergens in
spices, flavorings, colorings, and incidental additives, such as processing aids.
At that time, FDA expressed the opinion that any level of allergen in these ingredients could not be deemed
insignificant and would need to be labeled.
At the same time, consumers were
expressing concern that the names of allergenic ingredients listed on food labels
did not identify the commonly recognized name of the allergenic source (e.g.,
“casein” vs. “milk casein”). This practice
made it difficult for consumers to readily eliminate products containing ingredients from a particular allergenic source
from their diets.
These were among the considerations that led to enactment of the Food
Allergen Labeling and Consumer Protection Act of 2004 (FALCPA). Under
FALCPA, a “major food allergen” is defined as one of the following foods or
food groups or is an ingredient that
contains protein derived from one of
the following: milk, eggs, peanuts, tree
nuts, soybeans, wheat, fish, and
crustacean shellfish. FALCPA went into effect on January 1, 2006, and its
requirements apply to products produced on or after that date.
