Inspections, Compliance, Enforcement, and Criminal Investigations
Aunt Kitty's Foods, Inc. 12/24/08
Department of Health and Human Services
|Public Health Service
Food and Drug Administration
Waterview Corporate Center
10 Waterview Blvd., 3rd floor
Parsippany, NJ 07054
Telephone (973) 331-4905
RETURN RECEIPT REQUESTED
December 24, 2008
File # 09-NWJ-02
Hanover Foods Corporation
1550 York Street
Hanover, PA, 17331
Dear Mr. Warehime:
The Food and Drug Administration (FDA) conducted an inspection of your subsidiary company, Aunt Kitty's Foods, Inc., located at 270 North Mill Road, Vineland, New Jersey, from July 28 to August 1, 2008. At the close of the inspection, we collected samples of (b)(4) Brand Red Clam Italian Style Pasta Sauce (15 lot number VM 61100733331 NOV 2010, manufactured by Aunt Kitty's Foods, Inc., to determine compliance with the Federal Food, Drug, and Cosmetic Act (the Act) and with FDA's food labeling requirements (21 CFR Part 101 - Food Labeling). You can find the Act and the food labeling regulations through links on FDA's website at http://www.fda.gov. FDA analyzed a (b)(4) sample of the brand Red Clam Italian Style Pasta Sauce (15 oz) that you manufacture and that is distributed by (b)(4), Inc. to determine whether the information on the Nutrition Facts panel accurately reflects the nutrient content of the product. The label states that one serving (125 g) of this product contains 15% of the daily value (DV) of Vitamin C per serving (i.e., 9 mg/serving). The analyzed content of your red clam sauce was found to contain 50.2% (4.52 mg) (original analysis) and 38.8% (3.94 mg) (check analysis) of the amount of Vitamin C declared on the label.
A product is misbranded unless the nutrient content for a naturally occurring, indigenous nutrient is at least equal to eighty percent of the value for that nutrient declared on the label. 21 CFR §§ 101.9(g)(3) and (4)(ii). If the nutrient content falls below' such a level, it must not be by a factor greater than the variability generally recognized for the analytical method used in that food at the level involved. See 21 CFR § 101.9(g)(4)(ii). Eighty percent of the declared value for Vitamin C on your product is 7.2 mg Vitamin C. The samples were analyzed for Vitamin C content by AOAC Official Method 967.22,
Microfluoromctric Determination. Standard Reference Material was analyzed by the same method and results fell within the expected range for Vitamin C in the Reference Material. The variability generally recognized for the analytical method used in these circumstances is between 2.6% and 9.7%. Thus, assuming a variability of approximately 10%, the high end of the range, your product is required to contain at least 6.48 mg Vitamin C per serving (80% of the label value, or 7.2 mg/serving, - 10% variability, or 6.72 mg/serving). However, the amount of Vitamin C in your product fell below this amount. Thus, your product contains less than eighty percent of the value for Vitamin C declared on the label, and by a factor that is greater than the variability generally recognized for the analytical method used. Therefore, your product is misbranded under section 403(a)(1) of the Act [21 U.S.C. § 343(a)(I)] in that the label is false or misleading.
Please be advised that a similar Warning Letter, 07-NWJ-07, was issued on February 1 2007, for another product that you manufacture (b)(4) brand White Clam Italian Style Pasta Sauce, regarding the amount of iron contained in that product.
You should take prompt action to correct this deviation, and any other deviations that may exist at your firm. Failure to promptly correct the above referenced deviation may result in regulatory action without additional notice, such as seizure or injunction.
Furthermore, we note that your (b)(4) brand Red Clam Italian Style Pasta Sauce declares "clams and clam juice" in its ingredient statement. These are two separate ingredients that must be listed individually in descending order of predominance by weight as specified by 21 CFR § 101.4(a)(I).
You should notify this office in writing, within 15 working days of receipt of this letter, of the corrective actions you plan to make, including an explanation and timeline for each step to be taken to prevent the recurrence of similar deviations. If corrective action cannot be completed within 15 working days, please state the reason for the delay.
Your reply should be sent to The Food and Drug Administration, New Jersey District Office, 10 Waterview Boulevard, 3rd Floor, Parsippany, New Jersey 07054, Attention Joseph F. McGinnis, Compliance Officer. If you have any additional questions, please contact Mr. McGinnis at 973-33-4905.
New Jersey District