**Michael F. Jacobson, Ph.D.**

**Executive Director**

**Center for Science in the Public Interest**

**Food and Drug Administration Meeting on Food Allergens**

**August 13, 2001**

**A. Source labeling and plain English labels**

Ingredient statements on food labels should be printed in a readable
typeface and should clarify which ingredients might cause allergic
reactions. Unfortunately, all too many ingredient lists are unreadable
due to the small size and the style of typeface used. Consumers
shouldn't have to play the game of "Where's Waldo" when they're
shopping. Labels such as these \[display\] make a mockery of the FDA's
requirement that ingredient lists shall appear prominently and
conspicuously. (21 CFR 101.2(c), 101.4(a)(1))

Also, ingredient labels typically give the chemical names of additives,
such as sodium caseinate, lactose, albumen, or gluten. This Quaker
product, for instance, includes whey and sodium caseinate, without
disclosing that they are milk derivatives. This pasta product (Pasta
Roni) contains sodium caseinate, without disclosing that it is a milk
derivative. It can be tough for the average person to memorize all the
possible derivatives of foods to which they are allergic.

To help people who are sensitive to the eight major allergens and the
raft of less common, but sometimes no less severe, allergens --- as well
as for consumers who use ingredient lists for other purposes --- the FDA
should require all products to bear an entirely redesigned label. Last
month, CSPI formally petitioned the FDA to provide an Ingredients Facts
label that is consistent with the Nutrition Facts panel. The ingredients
label should be printed in clearer, larger print using upper- and
lower-case letters. Major and minor ingredients should be separated out,
and a clear "Allergy Information" statement should alert sensitive
consumers. That section would include such statements as: "Contains
milk, soy, and wheat" or "May contain peanuts." This particular label
was designed by Greenfield--Belser, the same firm that designed the
Nutrition Facts panel. The wording and location of such information
should be as standardized as possible on all packages (unlike the
various alternatives proposed by the industry's Food Allergy Issues
Alliance).

It has been suggested that the sources of various food additives, such
as whey and albumen, be declared after the names of the additives in the
ingredient lists. So labels would state "whey (a milk derivative)." If a
clear Ingredients Facts label with an "Allergy Information" section is
adopted, I'm not sure whether the sources of major allergenic
ingredients also need to be stated in ingredient lists. Focus groups
could explore that matter and the request by the nine attorneys general
that an "A" in a circle be printed on front labels to alert consumers to
the presence of allergens.

While the FDA has focused on the eight most common allergens, I urge it
to at least add sulfites to that list. Sulfites are not allergens, but
still cause life-threatening anaphylactic reactions and must be listed
on labels when present at 10 ppm or more. It is worth noting that the
Codex Alimentarius, an international group that sets food safety and
labeling requirements, includes sulfites (at that level) among the
ingredients that "are known to cause hypersensitivity and shall always
be declared."[^1]

Finally, the FDA should prevent consumer confusion about products that
claim to be non-dairy or wheat free or vegetarian, when they actually
contain additives derived from milk, wheat, or animals. The front label
of this product, for instance, says "vegetarian" and "soy cheese." But
the manufacturer told us that the "natural flavoring" is actually skim
milk, and the ingredient list discloses calcium caseinate, both of which
ingredients people with milk allergies, and strict vegetarians, would
avoid. That kind of misleading labeling should not be allowed.

In sum, people with allergies --- and the rest of consumers --- need a
clear, legible Ingredient Facts statement with an "Allergy Information"
section. That would do wonders to help people avoid the major allergens,
as well as other ingredients about which they are concerned.

**B. Supplemental "may contain" labels**

Contamination of food with undeclared allergens is what makes life so
fearful for people with severe allergies. They live in terror that a
food contains an allergen that is not listed on the label.
Unfortunately, such contamination occurs fairly frequently, as the
FDA/Minnesota/Wisconsin study demonstrated. That study found that in a
selected sample of 85 ice cream, cookie, and candy manufacturers, 21
marketed products containing undeclared peanut or egg ingredients (the
only allergens studied). Similarly, the Oregon Department of Agriculture
tested 62 chocolate candies that were not supposed to contain peanuts
--- but 23 percent (14) of them did contain significant levels. And
University of Nebraska researchers found peanut allergens in four out of
19 packaged foods that neither listed peanuts as an ingredient nor
warned consumers that the products might contain peanuts. In some of
those cases, products may simply have been mislabeled. Others may have
been unintentionally contaminated.

Though actual problems from cross-contamination are very difficult to
identify, at least three reports have been published of cross
contamination causing allergic reactions. In two different cases,
toddlers suffered anaphylaxis due to milk protein in sorbet.[^2]^,^[^3]
Peanut antigen in gingersnap cookies was the cause of a 34-year-old male
physician's reactions.[^4]

"May contain" language is sometimes appropriate to inform consumers of
the presence of possible allergens. But excessive use of such statements
deprive sensitive individuals of choices and may cover up sloppy
manufacturing practices. We strongly support the FDA's position that
such "labeling should not be the norm, and that manufacturers should
strive to eliminate the presence of allergenic materials that are not
intentionally added to a specific food product." (Fed. Reg. July 25,
2001, p. 38593) That policy was first enunciated in Commissioner
Kessler's December 11, 1996, letter to food trade associations stating
that "precautionary labeling should not be used in lieu of strict
adherence to good manufacturing practice to effectively reduce and
eliminate the likelihood of cross contamination, label mix-up, or
employee error." Unfortunately, we have heard that some lawyers are
advising food manufacturers not to test for allergens because of
potential product-liability issues. That kind of thinking underscores
the need for aggressive FDA action.

Consumers *must* be informed whenever an allergen unavoidably might
sneak into a food in which it does not belong. The challenge is to
define when contamination is unavoidable --- and it is appropriate to
say "may contain" --- and when contamination reflects manufacturer
sloppiness and "may contain" labels are not appropriate.

At one end of the spectrum, contamination clearly is avoidable when
companies *intentionally* add "rework" or other material that contains
an allergen into a food that is not supposed to contain that allergen.
On the other extreme, ensuring that every last residue of peanuts is
cleaned out of complex equipment or a shipping container before a food
that is not supposed to contain an allergen is made in that equipment or
shipped in that container may be difficult, especially for small
companies.

When "may contain" statements are appropriate, they should be provided
in an "Allergy Information" section of an Ingredients Facts label:
"Allergy information: Corn, wheat, may contain peanuts." "May contain"
statements should be stated simply, using standardized wording and
without explanatory language, such as "manufactured on equipment that
sometimes also processes peanuts." Such extra verbiage simply adds
clutter, without providing useful information to sensitive consumers.

The industry's Food Allergy Issues Alliance makes a reasonable stab at
deciding when "may contain" language is appropriate, but their proposal
needs improvement. First, companies that only visually inspect --- not
test --- for allergenic ingredients would not use "may contain." Also,
the industry's guidelines are totally voluntary and some of their
lawyers are advising against tests. Five years ago the FDA sent a
warning letter to the food industry to eliminate cross-contamination.
Very little has happened. Let's not pretend that voluntary action is
sufficient. Therefore, the FDA should amend its GMP regulations with a
requirement for companies to take all practical measures to exclude
contamination of foods with unlabeled allergens. Companies should
develop HAACP plans to ensure proper cleaning of shared equipment, use
of separate equipment for allergen-containing and allergen-free foods
whenever possible, regular testing of products for unwanted allergens,
and other measures.

The best way to ensure that companies are using "may contain" only when
possible contamination is unavoidable is regular, unannounced FDA
inspections and testing of products for major allergens. The FDA has
already stated in its April 19, 2001, Compliance Policy Guide that
undisclosed cross-contamination may cause the food to be considered
adulterated. Seizures of contaminated products would protect consumers
and send a clear signal to industry that the FDA is truly concerned
about food allergens and will vigorously enforce its compliance policy.
That kind of independent oversight should encourage manufacturers to
maximize their precautions.

Currently, FDA inspectors rarely visit factories that make cookies,
pastries, and other foods that may contain dangerous and unlabeled
allergens. The FDA simply lacks the funds, and so companies don't even
have to worry about inspections. We urge the FDA to use some of its
budget increases to hire additional inspectors. In addition, we urge the
FDA to seek new funding on the order of \$10 million a year for more
inspectors, more tests, educational efforts, and research on quick,
reliable testing methods. I hope that the food industry would recognize
the value of that investment to the public's health and to its own
reputation and support a funding request.

Finally, to further assist consumers, as the attorneys general
recommended, the FDA should require labels to bear a toll-free telephone
number that people could call to get up-to-date information about
ingredients and possible contaminants. Companies periodically modify
product composition and manufacturing practices. Many people with severe
allergies like to contact companies just to make sure that labels are
correct and that accidental or incidental additives have not crept into
a food that had been safe to eat.

In sum, the FDA should press companies to clean up their manufacturing
practices. "May contain" statements should be used to inform consumers,
but only when cross-contamination is unavoidable. And the FDA should
enforce its policies by conducting more inspections and testing more
products.

**C. Flavorings, spices, and colors and incidental additives**

Currently, food labels are not formally required to disclose allergens
--- such as peanuts, wheat, egg, casein, or carmine --- when they serve
as flavorings, spices, or non-certified colorings. (Section 403(I) of
the FFDCA) However, undeclared colorings and flavorings have caused
occasional allergic reactions. Examples include carmine or cochineal
extract (natural colorings in Popsicles),[^5] saffron and annatto
colorings,[^6] partially hydrolyzed casein in hot dogs,[^7] and
peanut-flour flavoring in a packaged soup.[^8] Also, such spices as
allspice, cardamom, and coriander have caused occasional allergic
reactions.[^9]

While disclosure is not required, on June 10, 1996, Fred Shank, the
director of CFSAN, sent a "warning letter" urging companies voluntarily
to declare on labels any allergenic components of such ingredients. I
agree with University of Nebraska food-allergy experts Steve Taylor and
Sue Hefle who wrote, "If an ingredient is known to be allergenic even on
a rare basis, such as carmine or papain, then it should be declared on
the ingredient statement."[^10]

Some companies, such as Nestle and Procter & Gamble, have told CSPI that
they routinely disclose on labels the presence of any major allergens in
natural flavorings, though they may not disclose other allergens. Other
companies, such as Best Foods, Campbell, General Mills, Pillsbury, and
Quaker, apparently don't any ingredients within flavorings, colorings,
and spices, judging from their refusal to tell us the composition of the
flavorings in products we asked about.

Unfortunately, the FDA has not determined that it has legal authority to
require labeling of those additives when health is at issue. It should
assert that authority by commencing a rulemaking, as requested by the
nine attorneys general more than a year ago. CSPI also will be
submitting a formal request for that action in the near future. The FDA
could take several approaches.

\* It could assert that the general misbranding section (403(a)) of the
Act trumps the flavoring/spices/colors exemption, because the
ingredients can cause severe allergic reactions.

\* Alternatively, for allergenic flavorings, spices, or colors that are
considered Generally Recognized As Safe, the FDA could determine that
those substances are GRAS only if labels disclose their presence.

\* Third, in the cases of approved color additives and food additives,
the Act (sections 721(b) and 409(c)) allows the FDA to set conditions of
use, such as label disclosure. Thus, the FDA should amend its
regulations to specify that any allergenic coloring or flavoring must be
declared on the label, as it has in the past for Yellow 5 dye,
monosodium glutamate, and colorings, flavorings, and spices in
hypoallergenic and infant foods.

We urge the FDA to require disclosure not just of the major eight
allergens, but others as well. To someone with an allergy to corn or
carmine, it's no satisfaction that wheat and shrimp are disclosed. The
costs and inconvenience to companies of providing disclosure is a small
price to pay for protecting the health of sensitive consumers.

Therefore, as a matter of general policy, the FDA should require, not
just "strongly encourage," labels to disclose allergenic ingredients in
flavorings, colorings, and spices. Labels should simply declare: "\....,
natural flavoring (includes peanuts), colors (includes carmine)\...." In
addition, as with other ingredients, an "Allergy Information" section of
the label should highlight the presence of the major allergens that are
present in flavorings, colorings, and spices.

Moving now to incidental additives, those are substances that are
present at "insignificant" levels in food and that don't serve any
technical or functional effect. (21 CFR 101.100(a)(3)) Incidental
additives had never been disclosed on labels, but in 1996 CFSAN director
Fred Shank told the food industry that such additives are not
"insignificant" if they might cause serious allergic reactions and that
they had to be labeled. That policy was incorporated into the FDA's
Compliance Policy Guide on April 19, 2001.

While incidental additives are present at very low levels and, to my
knowledge, have not caused known allergic reactions, it is worth noting
that the EPA recently expressed concern about the allergenicity of
StarLink corn. It banned the presence in food of any amount --- even
less than 20 parts per billion --- of StarLink, even without proof that
it ever caused an allergic reaction. Today, no one is talking about
banning wheat, corn, casein, or other allergen, but only requiring label
disclosure.

The FDA's policy concerning allergenic incidental additives, now stated
only in a policy guideline, should be incorporated into a regulation
that states explicitly that any incidental additive that may cause a
serious allergic reaction should be presumed to pose a risk and be
declared in the ingredient list. If an incidental additive is one of the
major food allergens, or sulfites, it also should be declared in the
"Allergy Information" section of an Ingredients Facts label. Regulations
could allow waivers if companies can demonstrate that the amount of
allergen present is too small to cause reactions.

\# \# \#

[^1]: Codex Alimentarius Commission, General Standard for the Labelling
    of Prepackaged Foods, Codex Stan 1-1985, 4.2.1.4. (Rev.1-1991).

[^2]: Laoprasert N, Wallen NF, Jones RT, Hefle SL, Taylor SL.
    Anaphylaxis in a milk-allergic children following ingestion of lemon
    sorbet containing trace quantities of milk. J Food Prot
    1998;61:1522-4.

[^3]: Jones RT, Squillace DL, Yunginger JW. Anaphylaxis in a
    milk-allergic child after ingestion of milk-contaminated
    kosher-pareve-labeled "dairy-free" dessert. Ann Allergy
    1992;68:223-7.

[^4]: Kemp SF, Lockey RF. Peanut anaphylaxis from food
    cross-contamination. JAMA (letter) 1996;275:1636-7.

[^5]: Baldwin JL, Chou AH, Solomon WR. Popsicle-induced anaphylaxis due
    to carmine dye allergy. Ann. Allergy Asthma Immunol 1997;79:415-9.

[^6]: Lucas CD, Hallagan JB, Taylor SL. The role of natural color
    additives in food allergy. Adv Food Nutr Res 2001;43:195-216.

[^7]: Gern JE, Yang E, Evrard HM Sampson HA. Allergic reaction to
    milk-contaminated "non-dairy" products. New Engl J Med
    1991;324:976-9.

[^8]: McKenna C, Klontz KC. Systemic allergic reaction following
    ingestion of undeclared peanut flour in a peanut-sensitive woman.
    Ann Allergy Asthma Immunol 1997;79:234-6.

[^9]: Hefle SL, Nordlee JA, Taylor SL. Allergenic Foods. Crit Rev Food
    Sci Nutr 1996;36(S):S69-S89.

[^10]: Taylor SL, Hefle SL. Ingredient and labeling issues associated
    with allergenic foods. Allergy 2001: 56: Suppl. 67:64-9.