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Subject:
From:
Mary Jo Wereschagin <[log in to unmask]>
Date:
Wed, 12 Jan 2000 14:52:11 -0500
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<<Disclaimer: Verify this information before applying it to your situation.>>

I received this response from Division of Programs and  Enforcement Policy
Office of Food Labeling Center for Food Safety and Applied Nutrition and
although it is very long I thought you all should have this information.  Maybe
be can make a loud enough voice to get things changed

MaryJo
---------
Dear Ms. Wereschagin:

This is in response to your e-mail of November 29, 1999, to Joseph
Levitt,Director, Center for Food Safety and Applied Nutrition, Food and Drug
Administration, regarding the labeling of all ingredients that are used in the
preparation of foods to protect celiac and other consumers.  Your e-mail
wasforwarded to our office for reply.

We understand your concern regarding your and your daughter's celiac disease.
FDA, as well, is concerned about informing consumers about allergenic substances
in food.

Let me begin by explaining that the Food, Drug, and Cosmetic Act (the
act)requires, in virtually all cases, that labels of food fabricated from two or
more ingredients bear a declaration of each ingredient, by its common or usual
name, in descending order of predominance by weight in the ingredient statement.
There are two very narrow exemptions from these ingredient labeling
requirements.  First, section 403(i) of the act provides that spices,flavorings,
and colorings may be declared collectively without naming each one.  Secondly,
FDA regulations (21 CFR 101.100(a)(3)) exempt, from ingredient declaration,
incidental additives such as processing aids, that are present in a food at
insignificant levels and that do not have a technical or functional effect in
the finished food.  In other words, when an ingredient is used during processing
or is added as a secondary ingredient, and is present at insignificant levels
and has no technical or functional effect in the finished food, the ingredient
may not be required to be declared in ingredient
labeling.

As stated above, FDA recognizes that some foods are a concern to food
intolerant and allergic consumers and is considering whether it is necessary to
clarify or amend its ingredient labeling regulations to ensure that
manufacturers fully understand the circumstances in which allergenic food
ingredients must be declared.  The agency addressed its concerns in a 1996
Notice to Manufacturers about declaration of allergenic substances in food.
Because we had received reports of adverse reactions to foods in which
allergenic substances were likely used as flavors, and not declared by name,FDA
discussed in the notice whether an allergenic ingredient in a spice,flavor, or
color should be required to be declared, 403(i) not withstanding.
On a substance-by-substance basis, the agency has required ingredients covered
by the exemption in section 403(i) to be declared when necessary to protect
individuals who experience adverse reactions to the substance.

Please note that wheat is included in the list of common allergens.  While the
agency recognizes that Celiac disease is a food intolerance and not an
"allergy," that the inclusion of wheat in the list will likely increase the
potential for the Celiac patient to avoid proscribed products.

The agency also discussed, in the notice, its concern with the inadvertent
introduction of an allergenic ingredient to a food.  For example, a bakery that
is manufacturing two food products on one production line, one product with
peanuts and one without, may inadvertently introduce traces of peanuts or peanut
products into the product that does not normally contains peanuts. Good
manufacturing practices not withstanding, the agency is considering how best
to alert sensitive consumers to the inadvertent introduction of allergens into
food since its presence would not be declared in the ingredient statement.

The agency is aware that some manufacturers are voluntarily labeling their
products with statements such as "may contain (insert the name of allergenic
ingredient)."  FDA has advised manufacturers that, because adhering to good
manufacturing practice (GMP) is essential for effective reduction of adverse
reactions, such precautionary labeling should not be used in lieu of adherence
to GMP.  The agency has urged manufacturers to take all steps necessary to
eliminate cross contamination and to ensure the absence of the allergenic food
before relying on "may contain" labeling to protect the consumer.

We have recently received a citizen petition (docket number 99P-2148/CP)raising
concerns similar to those raised in your e-mail and requesting FDA to amend its
food labeling regulations to require the specific ingredient listing of spices
and natural and artificial flavors on the label.  We will forward your e-mail to
the Dockets Management Branch to be included with other letters responding to
the petition.  Please be assured that we will consider all comments before
making a final decision on this issue.

If you have any further questions on this issue, do not hesitate to contact
us.

                              Sincerely yours,

                              Catalina Ferre-Hockensmith
                              Division of Programs and
                              EnforcementPolicy Office of Food
          Labeling Center for Food Safety and
                              Applied Nutrition

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