Inspections, Compliance, Enforcement, and Criminal Investigations
Sebastian Joe's Ice Cream Commissary 3/9/12
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
Minneapolis District Office
March 9, 2012
RETURN RECEIPT REQUESTED
Refer to MIN 12-27
Michael S. Pellizzer
Sebastian Joe's Ice Cream Commissary
4301 Nicollet Avenue South
Minneapolis, Minnesota 55409-2072
Dear Mr. Pellizzer:
An investigator from the Minneapolis District Office of the United States Food and Drug Administration (FDA) inspected your processing facility located at 4301 Nicollet Avenue South, Minneapolis, Minnesota, on October 5, 6 and 19, 2011. Our inspection found significant deviations from the food labeling regulations, Title 21, Code of Federal Regulations (21 CFR), Part 101. These violations cause the "Caramel Cashew" ice cream product distributed by your firm to be misbranded within the meaning of section 403 of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C § 343, in that it is not labeled with the mandatory information required by the Act. You may find the Act and FDA's regulations through links on FDA's home page at www.fda.gov.
Your significant violations include:
1. Your Caramel Cashew ice cream product is misbranded within the meaning of section 403(w) of the Act, 21 U.S.C. § 343(w), in that the product label fails to identify the major food allergens of milk, soybean, and egg as required by section 403(w)(1).
Section 201(qq) of the Act, 21 U.S.C. § 321(qq), defines "major food allergens" as milk, egg, fish, crustacean shellfish, tree nuts, wheat, peanuts, and soybeans; as well as any food ingredient containing protein derived from one of these foods, with the exception of highly refined oils. A food is misbranded if it is not a raw agricultural commodity and it is, or it contains, an ingredient bearing or containing a major food allergen, unless either:
• the word "contains," followed by the name of the food source from which the major food allergen is derived, is printed immediately after or is adjacent to the list of ingredients, section 403(w)(1)(A) of the Act, 21 U.S.C. § 343(w)(1)(A); or
• the common or usual name of the major food allergen in the list of ingredients is followed in parentheses by the name of the food source from which the major food allergen is derived (e.g., "Whey (Milk)"), except the name of the food source is not required when either the common or usual name of the ingredient uses the name of the food source or the name of the food source appears elsewhere in the ingredient list (unless the name of the food source that appears elsewhere in the ingredient list appears as part of the name of an ingredient that is not a major food allergen), section 403(a)(1)(B) of the Act, 21 U.S.C. § 343(w)(1)(B).
2. Your Caramel Cashew ice cream product is misbranded within the meaning of section 403(i)(2) of the Act, 21 U.S.C. § 343(i)(2), because it is fabricated from two or more ingredients but the labeling fails to bear a complete list of all of the ingredients by common or usual name in descending order of predominance by weight, as well as sub-ingredients, as required by 21 CFR 101.4, as follows:
• Your Caramel Cashew ice cream is made with ingredients, some of which are themselves comprised of multiple ingredients, including Sebastian Joe's Ice Cream Mix and Mini Caramel Cups. The Ice Cream Mix is manufactured with the following ingredients: cream, sugar, condensed skim milk, egg yolks, locust bean gum, guar gum and carrageenan. The Mini Caramel Cups are manufactured with these ingredients: sugar, coconut oil, corn syrup, sweetened condensed milk (milk, sugar), nonfat milk, whole milk, cocoa processed with alkali, heavy cream, butter (cream, salt), palm kernel oil, soy lecithin (an emulsifier), natural and artificial flavors, salt, vanillin (an artificial flavor), potassium sorbate (a preservative). However, neither these ingredients nor their sub-ingredients are listed on the label in accordance with 21 CFR 101.4(b)(2).
The requirement to list these component ingredients (or "sub-ingredients") may be met by either parenthetically listing the component ingredients after the common or usual name of the main ingredient, 21 CFR 101.4(b)(2)(i), or by listing the component ingredients without listing the ingredient itself, 21 CFR 101.4(b)(2)(ii). Under the first alternative, the component ingredients must be listed in descending order of predominance within the multi-component ingredient, and under the second alternative, the component ingredients must be listed in descending order of predominance in the finished food.
This letter is not meant to be an all-inclusive list of deficiencies that may exist in any of your product labeling. You are responsible for ensuring that your facility operates in compliance with the Act and the Food Labeling regulations (21 CFR Part 101). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations. You should take prompt action to correct all of the violations noted in this letter. Failure to promptly correct these deviations may result in regulatory action without further notice. Such actions include seizure and/ or injunction.
We acknowledge your firm's letter dated November 1, 2011, by Gregory V. Hefferan, General Manager-Production, in response to Form FDA-483, Inspectional Observations, issued at the conclusion of the most recent inspection of your firm. Your letter has been made a part of the Minneapolis District's permanent file for your firm. The implementation and effectiveness of your corrective actions will be evaluated during the next inspection.
Section 743 of the Act, 21 U.S.C. § 379j-31, authorizes FDA to assess and collect fees to cover FDA's costs for certain activities, including re-inspection-related costs. A re-inspection is one or more inspections conducted subsequent to an inspection that identified noncompliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Re-inspection- related costs means all expenses, including administrative expenses, incurred in connection with FDA's arranging, conducting, and evaluating the results of the re-inspection and assessing and collecting the re-inspection fees, 21 U.S.C. § 379j-31(a)(2)(B). For a domestic facility, FDA will assess and collect fees for re-inspection-related costs from the responsible party for the domestic facility. The inspection noted in this letter identified noncompliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any re-inspection-related costs.
We provide the following comments:
Your Caramel Cashew ice cream product declares the net quantity of content on the bottom of the container. In accordance with 21 CFR 101.105(a) and 21 CFR 101.105(e), the net quantity of content must be placed on the principal display panel and must appear in conspicuous and easily legible type in distinct contrast to other matter on the package, in accordance with 21 CFR 101.105(h). While a declaration of the net quantity embossed on a plastic surface is permissible when all label information is so formed on the surface of the container in accordance with 21 CFR 101.105(h) and 21 CFR 1.24(a)(6), the bottom of the ice cream container is not considered available label space for this product to declare the net quantity of contents.
The labeling for the sub-ingredient Mini Caramel Cups which is used to manufacture your Caramel Cashew ice cream declares the sub-ingredient "coconut oil." Coconut is a tree nut and as such is considered a major food allergen in accordance with section 201(qq) of the Act, 21 U.S.C. § 321(qq). If the coconut oil is not highly refined, it must be declared in accordance with the requirements of the Act, as amended by the Food Allergen Labeling and Consumer Protection Act.
The ingredient statement for the Mini Caramel Cups indicates that the sub-ingredient contains artificial flavors; however, the Caramel Cashew ice cream finished product label fails to declare the presence of artificial flavors in accordance with 21 CFR 135.110(f).
Please respond in writing within 15 working days from your receipt of this letter. Your response should outline the specific things you are doing to correct these violations. You should include in your response documentation, such as verification records and revised labeling, or other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, you should explain the reason for your delay and state when you will correct any remaining violations.
Your reply should be directed to Compliance Officer Tyra S. Wisecup at the address indicated on the letterhead.
Elizabeth A. Waltrip