| Public Health Service Food and Drug Administration |
| Minneapolis District Office Central Region 250 Marquette Avenue, Suite 600 Minneapolis, MN 55401 Telephone: (612) 334-4100 FAX: (612) 334-4142 |
Department of Health and Human ServicesJune 24, 2011
WARNING LETTER
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
Refer to MIN 11 – 33
Richard T. Koenings
Owner
Buddy Squirrel LLC
Quality Candy
1801 E. Bolivar Avenue
St. Francis, Wisconsin 53235-5312
Dear Mr. Koenings:
The Food and Drug Administration (FDA) conducted an inspection of your food manufacturing facility on February 24-25, 2011. During the inspection our investigator obtained the labeling of several of your products, including Marshmallow Eggs-Milk (bulk), Chocolate Covered Marshmallow Eggs (retail 5 oz. package), Vanilla Caramels-Dark, and Cheezzzy Cheese Corn (retail). We reviewed these labels for conformance to the labeling requirements of the Federal Food, Drug, and Cosmetic Act (the Act) and the implementing regulations, Title 21, Code of Federal Regulations, Part 101 (21 CFR 101). Our review found that the labeling of these products causes your foods to be misbranded within the meaning of section 403(w), 403(q), and 403(i) of the Act, 21 U.S.C. §§ 343(w), 343(q), and 343(i). You can find the Act and the referenced regulations through links on FDA’s internet homepage at www.fda.gov.
Your Marshmallow Eggs-Milk (bulk) and Vanilla Caramels-Dark 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 the presence of soybean, a major food allergen present in the product, as required by section 403(w)(1) of the Act.
Section 201(qq) of the Act, 21 U.S.C. § 321(qq), defines as “major food allergens” milk, egg, fish, Crustacean shellfish, tree nuts, wheat, peanuts, and soybeans, as well as any food ingredient that contains 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 that bears or contains 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 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., “flour (wheat)”), except that 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 Chocolate Covered Marshmallow Eggs (retail 5 oz. package) is misbranded within the meaning of section 403(i)(1) in that the label fails to bear an adequate common or usual name of the food. In accordance with 21 CFR 101.3, the principal display panel (PDP) of a food in package form shall bear as one of its principal features a statement of identity of the commodity and such statement of identity shall be in terms of the name specified in or required by any applicable Federal law or regulation, or in the absence thereof, the common or usual name of the food, or in the absence thereof, an appropriately descriptive term, or when the nature of the food is obvious, a fanciful name commonly used by the public for such food. You apply stickers to the back of your Chocolate Covered Marshmallow Egg packages that read either “Dark Marshmallow Eggs” or “Milk Marshmallow Eggs” and our investigators determined that you use semi-sweet chocolate or milk chocolate accordingly in the manufacture of these products. The statement of identity on the principal display panel (PDP) of the package fails to identify the products as either dark chocolate or milk chocolate. We also note that “chocolate” and “milk chocolate” are standardized foods under 21 CFR 163.111 and 130 and these names should only be used if the food complies with the applicable standard.
Additionally, your Vanilla Caramels-Dark are misbranded within the meaning of section 403(i)(2) of the Act, 21 U.S.C. § 343(i)(2), in that it is fabricated from two or more ingredients, but the labeling fails to bear a complete list of all the ingredients by common or usual name in descending order of predominance by weight as well as all sub-ingredients, as required by 21 CFR 101.4, because your label for Vanilla Caramels-Dark declares evaporated milk and cream powder as ingredients. However, you fail to list the specific sub-ingredients of these ingredients.
The requirement to list component ingredients (or “sub-ingredients”) may be met by either parenthetically listing the component ingredients after the common or usual name of the multi-component ingredient, or by listing the component ingredients without listing the multi-component 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, 21 CFR 101.4(b)(2).
Your Cheezzzy Cheese Corn (retail) is misbranded within the meaning of section 403(q) of the Act, 21 U.S.C. § 343(q) in that the product label fails to provide an accurate serving size. In accordance with 21 CFR 101.9(b)(2)(iii), the serving size for non-discrete bulk products shall be the amount in household measure that most closely approximates the reference amount for the product category. The Reference Amount Customarily Consumed (RACC) for snacks such as popcorn is 30 g (21 CFR 101.12(B), Table 2). Your label incorrectly lists the serving size as “3/4 Cup (14 g).” The nutrition values and servings per container information provided on the label of your product must be based on this serving size.
The above violations are not meant to be an all inclusive list of deficiencies on your labels. It is your responsibility to ensure that all of your products are labeled and processed in compliance with the laws and regulations enforced by FDA. You should take prompt action to correct these deviations and prevent their future recurrence. Failure to make prompt corrections could result in regulatory action without further notice. Possible actions include seizure and/or injunction.
We have the following comments about your product labels:
1. We note that if your Marshmallow Eggs-Milk retail packages fail to declare soybean, they are also misbranded under section 403(w) of the Act.
2. We note that the PDP of your Marshmallow Eggs product (retail) bears the name and place of business of your firm. However, 21 CFR 101.2(d) states that all information required to appear on the PDP or information panel under this section must appear on the same panel unless there is insufficient space. Therefore, the name and place of business, nutrition facts information and ingredient statement must appear on the information panel in one place without other intervening material in accordance with 21 CFR 101.2(e).
You should 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 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.
Please send your reply to Tyra Wisecup, Compliance Officer, at the address in the letterhead. If you have any questions, please contact Ms. Wisecup at (612) 758-7114.
Sincerely,
/s/
Gerald J. Berg
Director
Minneapolis District
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