.

DEPARTMENT

OF HEALTH

& HUMAN SERVICES

December 18,2002

Food and Drug Administration
Chicago District
550 West Jackson Blvd., 15th Floor
Chicago, Illinois 60061
Telephone: 312-353-5663

WARNING LETTER
CHI-6-03
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
Ms. Betsy D. Holden, President & CEO
Kraft Foods North America, Inc.
NF 301
Three Lakes Drive
Northfield, IL 60062
Dear Ms. Holden:
The Food and Drug Administration (FDA) recently conduct&dinspections of your
facilities located in Champaign, IL; New Ulm, MN; and Springfield, MO. These
inspections were conducted to determine your firm’s compliance with the Federal Food,
Drug, and Cosmetic Act (the Act) and implementing regulations contained in Title 21,
Code of Federal Regulations, Part 133 (2 1 CFR 133).
Our inspectional observations and a review of certain labeling collected during the
subject inspections found serious violations of Section 403 of the Federal Food, Drug,
and Cosmetic Act (the Act) and Title 21, Code of Federal Repulations, Section 133,
Subpart B - Requirements for Specific Standardized Cheeseand Related Products (2 1
CFR, Section 133, Subpart B).
Your firm’s ‘W-aft Singles American PasteurizedProcessCheeseFood,” ‘Waft
Singles Sharp Cheddar PasteurizedProcessCheeseFood,” and ‘Waft Singles
Swiss Pasteurized ProcessCheeseFood” products are misbranded within the
meaning of Section 403(g)( 1) of the Act in that they purport to be or are
represented as a food, namely pasteurized process cheesefood, for which a
definition and standard of identity has been prescribed in 21 CFR 133.173, and
the products do not conform to the definition and standard. Milk protein
concentrate is not listed in 9 133.173(d) as one of the optional dairy ingredients
that may be used in pasteurizedprocess cheesefood.

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Your firm’s ‘Waft Velveeta PasteurizedProcess Cheese Spread”product is
misbranded within the meaning of Section 403(g)( 1) of the Act in that it purports
to be or is representedas a food, namely pasteurized process cheesespread, for
which a definition and standard of identity has been prescribed in 21 CFR
133.179, and the product does not conform to the definition and standard. Milk
protein concentrate is not listed in 4 133.179(d) as one of the optional dairy
ingredients that may be used in pasteurized process cheesespread.
These products declare milk protein concentrate in their ingredients listings. Milk
protein concentrate (MPC) is not listed as an optional dairy ingredient in any of
the standardized cheeseproducts governed by a standard of identity, and therefore
standardized cheeseproducts are not permitted to contain MIT as an ingredient.
Further details of the inspections documenting these violations, and our observations,
follow below:
> On July 8,9, 10, 12, and 17,2002, we conducted an inspection of your facility
located in Champaign, IL. During the inspection, our Chicago District
investigator witnessed the use of dry milk protein concentrate during the
production of “Krafi Singles American PasteurizedProcess Cheese Food.”
Specifically, on July 9,2002, our investigator observed the addition of m
uring the manufacture of “IQ-aft Singles
eeseFood.” Our investigator collected labeling
for this finished product, which declares milk protein conc&trate in the
ingredients listing.
Product labels for ‘Waft Singles Sharp Cheddar Pasteurized Process Cheese
Food” and ‘Waft Singles Swiss PasteurizedProcessCheese Food,” both of which
declare milk protein concentrate in their ingredient listings, were also collected by
our investigator for review during the subject inspection.
> On July 30,3 1, and August 1,2,2002, we conducted an inspection of your
facility located in New Ulm, MN. During that inspection, our Minneapolis
District investigators witnessed the use of dry milk protein concentrate during the
production of “Kraft Singles American PasteurizedProcess CheeseFood.”
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Specifically, on July 30,2002, our investigators observed the addition ofduring the manufacture of ‘Waft Singles
American Pasteurized ProcessCheeseFood.” Our investigators collected labeling
for this finished product, which declares milk protein concentrate in its
ingredients listing.

 Page 3
> On August 26,27,28,29, and 30,2002, we conducted an inspection of your
facility located in Springfield, MO. During that inspection, our Kansas City
District investigators witnessed the use of dry milk protein concentrate during the
nroduction of ‘Waft Singles American PasteurizedProcess Cheese Food.”
Specifically, our investi&ors observed the combining of
with whey, and whey protein
mix. The wet mix was then added during the manuf;cture of
“&aft Singles American Pasteurized ProcessCheeseFood.” Our investigators
collected labeling for this finished product, which declares milk protein
concentrate in its ingredients listing.
Product labels for Kraft Velveeta PasteurizedProcessCheese Spread, which
declare milk protein concentrate in the ingredient list, were also collected by our
investigator for review during the subject inspection.
The use of milk protein concentrate in these products constitutes a violation of Section
403(g)(l) of the Act becausethe products are representedas foods for which standards of
identity have been prescribed by regulation and the use of milk protein concentrate in
these products does not conform to the standards.
The above is not intended to be an all-inclusive list of deficiencies at your facility. As a
food manufacturer, it is your responsibility to assurethat your overall operation and the
foods you distribute are in compliance with the law.
You should take prompt action to correct all of the violations noted in this letter. Failure
to promptly correct these violations may result in regulatory action without further notice,
such as seizure of these misbranded products and/or injunction of your facility to prevent
continued violation of the Act.
Please notify this office in writing, within 15 working days of receipt of this letter, of the
specific steps you will take to correct these violations, including an explanation of steps
that will be taken to prevent their recurrence. If corrective action cannot be completed
within 15 working days, state the reason for the delay and the date by which the
corrections will be completed. Please include copies of any available documentation
demonstrating that corrections have been made.
Your written reply should be sent to Patrick J. Brown, Compliance Officer, at the address
listed in the letterhead.
Sincerely,

Acting District Director