Inspections, Compliance, Enforcement, and Criminal Investigations
Mississippi Valley Canteen 01-Apr-03
Public Health Service
550 West Jackson Blvd., 15th Floor
Chicago, Illinois 60661
April 1, 2003
RETURN RECEIPT REQUESTED
Susan M. Wall, President
Mississippi Valley Canteen Service Co., Inc.
2513 Ellington Rd.
Quincy, IL 62305
Dear Ms. Wall:
The U.S. Food and Drug Administration (FDA) conducted inspections of your firm, Mississippi Valley Canteen Service Co., Inc., 2513 Ellington Road, Quincy, Illinois, on September 12, and 13, 2002, and October 29, 2002. Review of some of the labels for food products you prepare, label, and dispense in your vending machines find the foods to be misbranded under Sections 403(i)(2) and 403(e)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) in that their labels lack certain mandatory information,
You can find the Act and its applicable regulations through links on FDA's home page at www.fda.gov.
You prepare, label, and dispense a large number of different sandwiches and lunch products. Our review covered only a small randomly-selected, cross section of these products and the ingredients used in them. We found serious discrepancies in every label examined of these sandwiches and lunch products. The products are as follows:
1. Your products labeled and identified as "FISH & CHEESE" and "PASTA SALAD" are misbranded under Section 403(i)(2) of the Act in that they lack an ingredient statement to comply with Title 21, Code of Federal Regulations, Part 101.4 (21 CFR 101.4).
2. Your products labeled and identified as 'TUNA SALAD," "BBQ BEEF SANDWICH
PLATTER," and "BARED POTATO SUPREME" are misbranded under Section 403(i)(2) of the Act in that they fail to declare ingredients which themselves contain two or more ingredients, e.g., bread, tuna, BBQ sauce, and salad dressing. When such ingredients are listed by their established common or usual name, they must be followed by a parenthetical listing of all ingredients contained therein in descending order of predominance, in accordance with 101.4(b)(2)(i).
3. Your products are misbranded under Section 403(e)(1) of the Act in that the labels fail to specify conspicuously the name and place of business of the manufacturer, packer, or distributor in accordance with 21 CFR 101.5.
Concerning both deviations 1 and 2, the declaration of allergenic substances, which are found in all of the above-listed products, is of particular concern. FDA has received an increasing number of reports concerning consumers who have experienced adverse reactions following exposure to allergenic substances in foods. For sensitive individuals, the presence of allergens in food is potentially life threatening. Ingredients that are among the most commonly known to cause serious allergenic responses are milk, eggs, fish, crustacea, tree nuts, wheat, peanuts, soybeans, and derivatives of these products.
The above-listed violations are not intended to be all-inclusive. It is your responsibility to assure adherence to each requirement of the Act, and it's implementing regulations, including being vigilant that products you manufacture and distribute meet all of the applicable laws and regulations. We request that you take action to correct all violations. Failure to promptly correct these violations may result in regulatory action without further notice, including seizure and/or injunction.
Please provide this office, within 15 working days of receipt of this letter, a detailed response in writing that states the actions you plan to take, or have taken, to correct and prevent the objectionable conditions we have cited. Provide the specific time within which corrections will be completed, reasons why any corrective action cannot be completed, and documentation (e.g., modified label exhibits) to show that corrections have been made.
Please direct your reply to Paul A. Boehmer, Compliance Officer, 550 W. Jackson Blvd., 15th Floor, Chicago, IL 60661.
Arlyn H. Baumgarten