| 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 Services
September 20, 2011
WARNING LETTER
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
Refer to MIN 11 -56
David Mess
President
Magic Mousse, Inc. dba Buttercream
18172 Minnetonka Boulevard
Deephaven, Minnesota 55391
Dear Mr. Mess:
We inspected your processing facility located at 682 Transfer Road, Saint Paul, Minnesota, on June 7-9 and 15, 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 cake products 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 they are 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 firm produces a variety of different cakes and other bakery products and distributes them in boxes which are labeled with a gold foil stick-on label which contains your firm's dba name, showroom street address, city, State, ZIP code and telephone number. You then add a hand-written label which includes the size of the cake, the name of the purchaser, the type of cake and the invoice number used for the sale of the cake. A copy of the invoice is also provided to the customer. It lists the products being supplied and the quantity of each. An ingredient statement is only provided upon request.
Your cakes and other bakery 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. Specifically, your Carrot Cake is manufactured using wheat flour, eggs, walnuts, and heavy cream; however, your label fails to declare the major food allergens wheat, egg, walnut, and milk.
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 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:
• 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 cakes and other bakery products are misbranded within the meaning of section 403(q) of the Act [21 U.S.C. § 343(q)] in that your retail product labels fail to provide nutrition information in accordance with 21 CFR 101.9. Specifically, your Carrot Cake product label does not bear any nutrition information.
Your firm may be eligible for certain exemptions from nutrition labeling requirements, such as the Small Business Nutrition Labeling Exemption. We recommend you review the nutrition labeling exemptions in 21 CFR 101.9(j)(18) [or see http://www.fda.gov/Food/LabelingNutrition/FoodLabelingGuidanceRegulatoryInformation/
SmallBusinessNutritionLabelingExemption/default.htm] for information on filing for an annual exemption. The application may be submitted online at: https://info1.cfsan.fda.gov/nle/client/login.cfm. We have no record of your firm having filed a Small Business Nutrition Labeling Exemption Notice.
Your cakes and other bakery products are misbranded within the meaning of section 403(i)(1) of the Act [21 U.S.C. § 343(i)(1)] in that the labels fail to bear the common or usual name of the food. Specifically, your Carrot Cake product label does not provide a statement of identity of the food in accordance with 21 CFR 101.3.
Your cakes and other bakery products are misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that they are fabricated from two or more ingredients, but the labels fail to bear the common or usual name of each ingredient. In accordance with 21 CFR 101.4(a)(1), ingredients required to be declared on the label or labeling of a food, including foods that comply with standards of identity, except those ingredients exempted by 101.100, shall be listed by common or usual name in descending order of predominance by weight on either the principal display panel or the information panel. Specifically, your Carrot Cake product label bears no declaration of ingredients. During our inspection you told our investigator that ingredient listings are maintained at your facility using two documents, but that this information is not included on the packaging or sent with the orders to wholesale or retail customers. You also stated that the listings are sent if the consumer requests ingredient information. This does not satisfy the requirement in 21 CFR 101.4 because the ingredients are not declared on the label or labeling of the product.
Your cakes and other bakery products are misbranded within the meaning of section 403(e)(2) of the Act [21 U.S.C. § 343(e)(2)] in that the labeling fails to bear an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count. Specifically, your Carrot Cake product label fails to bear a declaration of the net quantity of contents as required by 21 CFR 101.105.
We may take further action if you do not promptly correct these violations. For instance, we may take further action to seize your products and/or enjoin your firm from operating. 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 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.
This letter may not list all the violations at your facility. You are responsible for ensuring that your processing plant 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.
Further, this letter acknowledges receipt of Ms. Rachel Adam's letter of June 22, 2011, responding to the Form FDA-483, Inspectional Observations, issued on June 15, 2011, at the conclusion of our inspection of your production facility. The response has been made a part of the Minneapolis District's permanent file for your firm. The effectiveness of the corrections you have made or will be implementing will be evaluated during the next inspection.
Your reply should be directed to Compliance Officer Tyra S. Wisecup at the address indicated on the letterhead.
Sincerely,
/S/
Gerald J. Berg
Director
Minneapolis District
No comments:
Post a Comment