Inspections, Compliance, Enforcement, and Criminal Investigations
Kerber, Inc. 5/30/13
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
900 U.S. Customhouse
2nd and Chestnut Streets
Philadelphia, PA 19106
RETURN RECEIPT REQUESTED
May 30, 2013
Thomas L. Kerber Sr., Co-Owner and President
1856 Guffey Road
North Huntington, PA 15642
Dear Mr. Kerber:
The U.S. Food and Drug Administration (FDA) inspected your facility, located at 1856 Guffey Road, North Huntington, PA from February 6, 2013 to February 14, 2013. During the inspection our investigator reviewed labeling for your Muddy Sneakers, Chocolate Freckles, Mint Chocolate Chip, Cherry Chocolate Chip, Butter Pecan, Cherries Jubilee, Peanut Heaven, and Strawberry ice cream products and your Jungle Juice Orange Drink product. Your products are in violation of the Federal Food, Drug, and Cosmetic Act (the Act) in that they are misbranded within the meaning of sections 403 of the Act [21 U.S.C. § 343] and the implementing regulations contained within Title 21, Code of Federal Regulations, Parts 74 and 101 (21 CFR 74 and 101). You may find the Act and the CFR through links on FDA’s home page at www.fda.gov.
Your significant labeling violations are as follows:
1. Your Cherry Chocolate Chip, Chocolate Freckles, and Mint Chocolate Chip ice cream products are misbranded within the meaning of section 403(w) of the Act [21 U.S.C. § 343(w)] in that the labels fail to declare all major food allergens present in the products, as required by section 403(w)(1) of the Act.
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 certain exceptions, e.g., highly refined oils derived from a major food allergen. A food is misbranded under section 403(w) of the Act if it is not a raw agricultural commodity and it is, or it contains, an ingredient that bears or contains, a major food allergen, unless either:
i. 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
ii. 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(w)(1)(B) of the Act [21 U.S.C. § 343(w)(1)(B)].
Your Cherry Chocolate Chip, Chocolate Freckles, and Mint Chocolate Chip ice cream products are manufactured using Semi-Sweet Chocolate Chips, which contains soy; however, the labels for the Cherry Chocolate Chip, Chocolate Freckles, and Mint Chocolate Chip ice cream products fail to declare soy.
Further guidance and information on food allergens can be accessed on FDA’s website at http://www.fda.gov/Food/IngredientsPackagingLabeling/FoodAllergens/default.htm.
2. Your Cherry Chocolate Chip ice cream product is misbranded within meaning of section 403(i)(2) [21 U.S.C. § 343(i)(2)] in that it is fabricated from two or more ingredients and each ingredient is not declared on the label, as required by 21 CFR 101.4. The Cherry Chocolate Chip ice cream product includes Semi-Sweet Chocolate Chips and Maraschino Cherries as ingredients but fails to list the sub-ingredients of theses ingredient in the finished product label.
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, or by listing the component ingredients without listing the ingredient itself. 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.
Additionally, your Jungle Juice Orange Drink product is misbranded within the meaning of section 403(i)(2) [21 U.S.C. § 343(i)(2)] in that the food purports to be a beverage containing fruit juice, but fails to bear a statement of the total percentage of such fruit contained in the food in accordance with 21 CFR 101.30.
3. Your Cherries Jubilee and Strawberry ice cream products are misbranded within the meaning of section 403(k) of the Act [21 U.S.C. 343(k)] because the products bear or contain an artificial flavoring, coloring, or chemical preservative. In accordance with 21 CFR 101.22(k), the label of a food to which any coloring has been added shall declare the coloring in the statement of ingredients. Specifically,
- Your Cherries Jubilee ice cream product is manufactured with the ingredient, Maraschino Cherries, containing the certified color additive FD&C Red No.40; however, the product does not bear a label identifying the presence of this color additive.
- Your Strawberry ice cream product is manufactured with the ingredient, Strawberry Flavoring, containing the certified color additives FD&C Red No. 40 and FD&C Blue No. 1; however, the product label does not identify the presence of these color additives by their listed names or appropriate abbreviations.
Under 21 CFR 101.22(k)(1), certified colors must be declared by the name of the color additive listed in the applicable regulation in part 74 or part 82 of this chapter. The common or usual name may be abbreviated to omit the "FD&C" prefix and the term "No." (e.g., Yellow 5).
You should take prompt action to correct the violations described above. Failure to do so may result in regulatory action without further notice. Such action may include, but is not limited to, seizure or injunction.
Further, 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 acknowledge your response in which you submitted revised labels for some of your ice cream products. The above violations were not addressed with your corrected labels.
We also have the following comments regarding your product labels:
- Your Muddy Sneakers, Cherry Chocolate Chip, and Butter Pecan ice cream products do not bear nutrition labeling in the form of a Nutrition Facts panel, which is required under 21 CFR 101.9. If your firm has fewer than 10 employees and the product has annual sales of fewer than 10,000 total units, your firm may be exempt from nutrition labeling.
- We note that the labels you submitted include a document that states: “General Note All ice creams are made in a facility that also uses Soy Lecithin, Peanuts, and Food Coloring. Flavors may contain these ingredients: Food Coloring and Soy Lecithin (an emulsifier). Non-Flavor Ingredients may include: FD&C Yellow #5, FD&C Yellow #6, FD&C Red #40, FD&C Red #5, FD&C Red #3, FD&C Blue #1, Modified Food Starch (Corn), Peanut Traces, Tree Nuts.” It is not clear to us how this “sticker” is to be used, but we advise your firm that some of your flavor ingredients (excluding allergens) may be incidental additives under 21 CFR 101.100(a)(3), and we offer the following information about advisory statements:
FDA requires foods that contain a major food allergen to declare the presence of that allergen on food labels. FDA does not address the use of advisory labeling, including the presence of unintentional ingredients in food products resulting from the food manufacturing process. Use of such statements is voluntary and at the discretion of the manufacturer, provided that they are not false or misleading. FDA would expect firms to adhere to good manufacturing practices designed to prevent or reduce the possibility of major food allergens accidentally becoming incorporated into foods not formulated to contain those food allergens as ingredients. For more information, please see http://www.fda.gov/Food/IngredientsPackagingLabeling/FoodAllergens/default.htm.
Please notify this office in writing within fifteen (15) working days from your receipt of this letter of the specific things that you are doing to correct the violations described above. Include in your response documentation to show that correction has been achieved. If you cannot complete all corrections before you respond, state the reason for the delay and when you will complete the corrections.
This letter may not list all the violations in your product labeling or at your facility. You are responsible for ensuring that your firm operates in compliance with the Federal Food, Drug, and Cosmetic Act and all applicable regulations. You are also responsible for ensuring that all of your products and their labeling are in compliance with the laws and regulations enforced by FDA. In addition to consulting the Act and Title 21 of the CFR, further guidance and information on food allergens can be accessed on FDA’s website at: http://www.fda.gov/Food/IngredientsPackagingLabeling/FoodAllergens/default.htm.
Your response should be sent to Yvette Johnson, Compliance Officer at the address noted above. If you have any questions with regard to this letter, Ms. Johnson can be reached at 215-717-3077 or Yvette.Johnson @ fda.hhs.gov.