Inspections, Compliance, Enforcement, and Criminal Investigations
George Weston Bakeries, Inc. 09-Nov-01
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration
300 S. Riverside Plaza, Suite 550 South
Chicaao. Illinois 60606
November 9, 2001
RETURN RECEIPT REQUESTED
Mr. Gary J. Prince, President
George Weston Bakeries, Inc.
1724 5th Street
Bay Shore, New York 11706
Dear Mr. Prince:
On June 20, 2001, an investigator from the Chicago District Office of the Food and Drug Administration (FDA) collected a sample of Entenmann?s Light Fat Free Cinnamon Twist Danish (11.5 OZ), manufactured at Bestfoods Baking Company, located at 300 North Avenue in Northlake, IL, a company for which you are President. The sample was submitted to our Southeast Regional Lab in Atlanta, Georgia, for analysis related to your labeling on this product. Food products are subject to labeling requirements in the Federal Food, Drug, and Cosmetic Act (the Act), and regulations defined in Title 21, Code of Federal Regulations(21 CFR).
Based on the results of the analysis, this product is misbranded within the meaning of Section 403(r)(l) (A) of the Act, in that the label bears the nutrient content claim "Fat Free." The product fails to qualify for the claim, as definedin21 CFR Part 101.62(b)(i), since it contains more than 0.5 grams of total fat per serving. The analytical results indicate that the sample contains 0.702 grams of total fat per serving (check analysis -0.772 g fat/serving).
The above violations concern certain new labeling requirements and are not meant to be an all-inclusive list of deficiencies on your labels. Other label violations can subject the food to legal action. It is your responsibility to assure compliance with regulations, as required under the Nutrition and Education Act of 1990 (NLEA). You should take prompt action to correct these labeling deviations. Failure to promptly correct these violations may result in regulatory action by the agency without further notice.
These actions may include seizure and/or injunction.
You should notify this office in writing within 15 working days of receipt of this letter of the specific steps that you have taken to correct the noted violations, along with a copy of the revised label. 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 should be directed to James T. Karpus, Compliance Officer, at the address noted above.
Raymond V. Mlecko