Food
Allergen Labeling — Finding Common Ground for Government,
Industry, and Healthcare
By Lauren Swann, MS, RD, LDN
Today’s Dietitian
Vol. 7 No. 8 P. 33
How have new regulations in food allergen labeling
affected industry, dietitians, and consumers?
Eleven million Americans can suffer seriously hazardous
reactions within moments of eating a food they shouldn’t.
It’s a condition for which there is no cure and the only therapy
is avoiding the food. Passage of the Food Allergen Labeling and
Consumer Protection Act of 2004 (FALCPA) was a major step to ensure
that consumers will be better informed about the true content of
prepackaged foods that may have formerly contained potential hidden
dangers. Industry, healthcare professionals, and the government
now move forward to fine-tune less obvious details in an effort
to truly construct labeling and products that are risk-free.
The National Institute of Allergy and Infectious
Diseases reports that food allergies affect up to 6% to 8% of children
under the age of 3 and 2% of adults resulting in symptoms such as
hives, swelling, shortness of breath or wheezing, digestive disturbances,
diarrhea and vomiting, or serious cardiac consequences that can
be fatal if left untreated. Food anaphylaxis—the most severe
reaction—results in 30,000 emergency department visits and
150 to 200 deaths annually.
The effect of food allergies goes well beyond the
sufferer, especially for children, the group most likely to be allergic.
Parents and other family, caregivers, day care providers, and school
lunch personnel involved in food shopping, preparation, and storage
must ensure that harmful ingredients are not present, something
particularly challenging for those with multiple allergies to commonly
popular food supply ingredients. For the very sensitive, even trace
amounts from touching food or kissing can trigger a reaction.
FALCPA
Ninety percent of all food allergies are to milk, eggs, fish, shellfish,
tree nuts, peanuts, wheat, or soybeans. Nationwide, unlabeled allergens
resulted in 121 product recalls in the year 2000, more than tripling
from 1990, and reportedly, ingredient labeling thus far isn’t
always well-understood. Earlier this year, The Food Allergy &
Anaphylaxis Network (FAAN) announced that in the “Impact of
Ingredient Labeling Practices for Food-Allergic Consumers”
study conducted by the Mount Sinai School of Medicine, researchers
found that confusion or lack of information about ingredients in
packaged food had caused reactions in one in five of those surveyed.
FALCPA amends the Federal Food, Drug and Cosmetic
(FD&C) Act to require that foods labeled on or after January
1, 2006, clearly state in commonly known food names the identity
of an allergen containing ingredient. For example, “whey,”
“casein,” or “lactalbumin” alone are no
longer enough, they must be further identified as “milk”
in the ingredient list. Companies have two options for this:
• parenthetically listing the commonly known
food name next to the actual ingredient derivative—“Casein
(Milk)”—in the ingredient list; or
• stating “Contains Milk” immediately
following or adjacent to the ingredient list.
Issues Irksome to Industry
Even with the best, most genuine efforts of corporate social responsibility,
manufacturers are dealing with some demanding challenges to comply
with the new law.
For example, the law clearly exempts “any
highly refined oil derived from an allergenic food.” Particularly
when oils are a secondary ingredient—introduced by way of
another ingredient such as flavors, spice blends, or colors—determining
“highly refined” status can be tricky because the oil
was not a direct supplier purchase and determining exact residual
amounts in such minute quantities is not always feasible.
Nancy Siler, MS, RD, LDN, CFCS, vice president of
consumer affairs, Wilton Industries, Inc., says, “Consumers
can be quite demanding and frequently want more information than
is required. We have been tracking 17 allergens and have in our
food database of 1,100 products whether the product contains the
allergen or it is in the plant. Many consumers are provided the
information verbally when they inquire; however, they say they want
everything on the label. This becomes both a space and liability
issue.”
Dietitian Dilemmas
The FAAN study had some good news for food manufacturers—for
86% of those surveyed, labeling strongly influenced product brand
choice and the same number reported contacting the manufacturer
for more information.
Dietitians sometimes make a list of brand name foods
for their patients/clients and then companies change ingredients
without warning or announcement, which can “...create a problem
with brand loyalty,” says Julie Nordlee, MS, clinical study
coordinator, Food Allergy Research & Resource Program, University
of Nebraska Lincoln, who presented during the “Food Intolerance,
Sensitivity, Allergy: Diagnostic and Treatment Challenges”
session at the American Dietetic Association (ADA) 2004 Annual Food
& Nutrition Conference & Expo (FNCE).
FAAN believes that once food companies begin to
comply with the new labeling law, they are likely to see the number
of calls related to food allergen ingredients decline as consumers
realize they can now rely on the label.
Consumers — “Perception
is Reality”
“‘May Contain’ or ‘And/Or’ labeling
is bad,” says Nordlee, citing samplings of 25 to 40 different
allergen label warnings. Yet even the specific type of these “precautionary
statements” can influence consumers differently. Presenting
at the Food Institute’s Food Labeling Seminar held in Newark,
N.J., in March, Robert Hahn of Olsson, Frank & Weeda PC, drew
from surveys where it was found that “people with food allergies
are more likely to pay attention to ‘may contain’; they
take it more seriously than ‘made in a facility with…’
or ‘processed on equipment that makes…’ where
they might, depending on the severity of their allergy, take their
chances.” The Food Allergy & Anaphylaxis Alliance is a
worldwide organization that was established by FAAN in 1999 to facilitate
information sharing among nonprofit organizations working in the
field of food allergy around the world. A 2005 goal of the organization
is to limit the number of precautionary statements, define them
in clear terms, and encourage the development of criteria to minimize
their use.
Government Legislates, Industry
Reacts
Because FALCPA is a self-executing law, labeling compliance is required
by January 1, 2006, without published regulations from the FDA.
Consequently, various industry interpretations can lead to inconsistent
labels. For example, if a food manufacturer—especially a category
leader—chooses to label both a parenthetical common food name
next to the allergenic ingredient and the wording “Contains…”
consumers may begin to expect that they only need to look for the
“Contains” statement at the close of the ingredient
list instead of always reading each ingredient thoroughly, a potential
concern that could also result from the option of bolding or otherwise
making allergenic ingredients more obvious on the label—something
that is not a requirement.
Precautionary statements also have allergy advocacy
groups speculating that if they are used too much it could unnecessarily
limit the already restricted food choices allergic individuals have,
including sudden avoidance of foods they may have previously enjoyed
without problem, such as “lecithin” in a product changing
to a “soy lecithin” listing. The FAAN’s cited
study found that some food allergic consumers err on the side of
caution when it comes to food avoidance. For example, most studies
indicate that there is little risk of allergy from ingestion of
soy oil or soy lecithin for soy-allergic individuals, however, 40%
of those surveyed avoided these ingredients. Nordlee also says dietitians
and consumers have discovered that some food companies’ call
center staff who are unsure whether the ingredient is a potential
problem will usually advise to avoid the food.
While the FDA does not currently object to any type
of precautionary statement such as “may contain,” “processed
in a facility with,” or “processed on equipment that
makes,” the agency does stress that such labeling is not an
excuse for lack of effort to avoid cross-contamination and cannot
be used in lieu of Good Manufacturing Practices (GMPs). Manufacturers
must remain diligent and work to control and avoid allergen contamination
risk. The FDA is looking more closely at this issue and may develop
standards for or restrict use of such phrases in the future.
Across the entire food supply, consistency creates
another concern in that FALCPA amended the FD&C Act, which only
covers FDA-amenable (nonmeat) foods; meat and poultry products are
under the USDA Food Safety & Inspection Service (FSIS), which
is not subject to such legislation, though the FSIS does encourage
consistent voluntary labeling statements.
Besides Allergies — Intolerances
Sulfites, lactose, and monosodium glutamate are all examples of
food intolerances or hypersensitivities. Technically they are not
allergens, but they can still cause various degrees of health problems
in susceptible individuals. Sulfite disclosure is already required,
but among other offensive agents, gluten intolerance prompted a
provision within FALCPA for the FDA to issue a proposed rule to
define and permit use of the term gluten-free in food labeling by
2006 with a final rule by 2008.
Are You Being Served Allergens?
An estimated 40% to 60% of all meals are now eaten either away from
home or are restaurant carry-out or delivery that lack ingredient
labeling. “Foodservice is the most dangerous—fried foods,
etc,” says Lynn Christie, MS, RD, clinical coordinator/dietitian,
Arkansas Children’s Hospital, who also presented at the 2004
ADA FNCE session. FAAN is concerned that FALCPA won’t change
the situation in restaurants—the study revealed that one in
three individuals surveyed had a reaction to food served in or provided
by a restaurant. Further, 63% of those had a food-allergic reaction
from restaurant food on two or more occasions.
However, FALCPA does obligate the FDA to pursue
revision of the Food Code to provide guidelines for preparing allergen-free
foods in food establishments, including restaurants, grocery store
delicatessens and bakeries, and elementary and secondary school
cafeterias.
A few industry aids are now available:
• Phil Lempert’s Food Allergy Buddy
card is described as “a simple tool to communicate effectively
with your server [that] takes the pain out of eating out.”
• SelectWisely offers food translation cards
for allergies, sensitivities, and restrictions customized to a traveler’s
specific food and language requirements.
Such approaches do make waitstaff, chefs, and food
preparers far more responsible for the exact content of dishes served,
and foodservice operations accepting such accountability would need
to be vigilant of a far greater arena of cross-contamination possibilities,
such as a single fry basket used to make french fries as well as
seafood items.
Finding Solutions
Ultimately, food manufacturers, dietitians, and government agencies
all seek the same goal—a food supply that is not hazardous
for people who are allergic to ingredients commonly found in the
mainstream food supply.
Dietitians can:
• continuously reinforce reading labels thoroughly
every time;
• offer customized store tours for people
with allergies and food intolerances;
• advise avoidance of possible cross-contamination
areas in supermarkets such as the deli, salad bar, or fresh self-serve
items and urge clients to stick with clearly labeled prepackaged
foods;
• recommend recipes;
• encourage parents to meet with care providers
and school personnel for children’s needs; and
• because food allergies are not always taken
seriously, educate and communicate with all who may be involved
with meals or snacks for the individual with food allergies.
There is currently no FDA lower limit set for any
allergenic proteins in foods, so more study on threshold levels
is needed to comprehensively assist both individuals and industry
in risk assessment. Dietitians can also work with individuals to
determine whether there are any tolerated amounts of specific foods
or their derivatives—ie, fish gel vs. cod.
Beyond the Current Law
Allergen labeling activities for the FDA extend beyond the initial
compliance date. To evaluate how well cross-contamination is being
addressed, by February 2006 the FDA must produce a report that assesses:
• unintentional cross-contamination within
food production facilities, occurrence within the food industry,
types of food, and feasibility of resolution with GMPs;
• labeled precautionary statements, the manufacturing
conditions under which they are used and their use prevalence;
• consumer preference for cross-contact risk
information on labels; and
• inspections, compliance, types of violations,
and voluntary recalls all relative to cross-contact.
In May, the FDA solicited public comments regarding
a potential allergen labeling consumer preference survey and experimental
study. 2005 Program Priorities include issuing an allergen compliance
program, implementing an enforcement strategy, and developing a
comprehensive food allergen strategy to address considerations such
as cross-contamination problems, and continuing with evaluation
of major food allergen thresholds.
In a letter to Secretary of Agriculture Mike Johanns,
Sen Tom Harkin (D-Iowa) has officially urged the USDA to adopt similar
allergen labeling requirements for meat and poultry products under
their jurisdiction, requiring food labels that inform consumers
of any major allergens.
“In order to avoid confusion for consumers,
I urge USDA to bring its labeling standards in line with the protections
mandated by Congress and that will be required by FDA,” Harkin
said. “Regardless of whether the food is under FDA or USDA
oversight, consumers ought to know what ingredients are in the foods
they buy, especially allergens known to have a risk of major health
problems for some individuals.”
— Lauren Swann, MS, RD, LDN, runs Concept Nutrition, Inc.,
a Bensalem (Philadelphia area) consulting business specializing
in food and dietary supplement labeling and regulatory issues, marketing
communications and freelance writing, and cultural and ethnic foodways.
Resources on the Web
American Academy of Allergy, Asthma and Immunology
www.aaaai.org
American College of Allergy, Asthma & Immunology
www.acaai.org
Asthma and Allergy Foundation of America
www.aafa.org
Food Allergy & Anaphylaxis Alliance
www.foodallergyalliance.org
Food Allergy & Anaphylaxis Network
www.foodallergy.org
Food Allergy Initiative
www.foodallergyinitiative.org
National Institute of Allergy and Infectious Diseases
www.niaid.nih.gov/default.htm
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