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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Interstate Brands Corporation 27-Sep-01

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration
Chicago District
300 S. Riverside Plaza, Suite 550 South
Chicago, Illinois 60606
Telephone: 312-353-5863

September 27, 2001
WARNING LETTER
CHI-53-01
CERTIFIED MAIL
RETURN RECEIPT REQUESTED

Mr. Charles Sullivan
Chief Executive Officer
Interstate Brands Corporation
12 E. Armour Blvd.
Kansas City, MO 64111

Dear Mr. Sullivan:

On June 19, 2001, an investigator from the Food and Drug Administration (FDA) collected a sample of "Hostess® ** Low Fat CUP CAKES **3.25 OZ. **" from your plant located at 9555 W. Soreng Ave., Schiller Park, Illinois. The sample was analyzed by our Southeast Regional Laboratory in Atlanta, Georgia, and found the level of Total Fat to be 187% (check analysis 163%) and Saturated Fat to be 241% (check analysis 211 %) of the label declared amounts of 1.5g and 0.5g respectively, per serving [1 Cake (46g)].

The cup cakes are misbranded within the meaning of Section 403(a)(l ) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the label declared levels of Total Fat 1.5g and Saturated Fat 0.5g are false and misleading.

You should take prompt action to correct these violations. Failure to promptly correct these violations may result in regulatory action without further notice, such as seizure and/or injunction.

You should notify this office in writing within 15 working days of receipt of this letter, of the specific steps you have taken to correct the noted violations. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed.

Your reply relating to these concerns should be directed to the Food and Drug Administration, attention Paul Boehmer, Compliance Officer.

Sincerely,
Raymond V. Mlecko
District Director