| 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 ServicesJuly 7, 2011
WARNING LETTER
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
Refer to MIN 11 – 36
Oscar L. Murcia
Owner
El Guanaco Bakery & Café
849 East Seventh Street
St. Paul, Minnesota 55106
Dear Mr. Murcia:
The Food and Drug Administration (FDA) conducted several inspections of your facility located at 849 East Seventh Street, St. Paul, Minnesota, on January 19-20, 25, 2011, on February 1, 4, 2011, and most recently on March 3-4, 2011. During the inspections product labels were collected. Our review of your product labels reveals that your Empanada De Piña, Empanada De Leche, Pastel-D, Galleta De Naranja, and pan de feria bakery products are adulterated or misbranded within the meaning of sections 402 and 403, 21 U.S.C. §§ 342 and 343, of the Federal Food, Drug, and Cosmetic Act (the Act) and the implementing regulations contained within Title 21, Code of Federal Regulations, Part 101 (21 CFR 101). You may find the Act and the referenced CFR regulations through links on FDA’s internet home page at www.fda.gov.
The significant violations are as follows:
1. Your Empanada De Piña, Pastel-D, and Galleta De Naranja products are adulterated within the meaning of section 402(c) of the Act, 21 U.S.C. § 342(c), because the products bear or contain a color additive which is unsafe within the meaning of section 721(a) of the Act, 21 U.S.C. § 379e(a). Specifically, 21 CFR 74.705(d)(2) requires FD&C Yellow No. 5 to be declared as an ingredient when used in the manufacture of a food product. Your Empanada De Piña, Pastel-D, and Galleta De Naranja products are manufactured with Pine Apple [sic] Filling or (b)(4) ingredients, which contain FD&C Yellow No. 5; however, the finished product labels fail to declare the presence of FD&C Yellow No. 5 in the ingredient statements.
2. Your Empanada De Piña, Pastel-D, and Galleta De Naranja 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 artificial coloring. 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. For example:
• The statements of ingredients for your Empanada De Piña, Pastel-D and Galleta De Naranja products list “Pine Apple [sic] Filling” as an ingredient. This ingredient contains the artificial color additive Yellow 5, which is not declared on the finished product label.
• The Galleta De Naranja also uses (b)(4) in its manufacture; however (b)(4) is not listed as one of the ingredients. The ingredient statement for (b)(4) lists “FD&C Yellow 5 (102),” which is not declared on the finished product label for the Galleta De Naranja.
3. Your Galleta De Naranja and Empanada De Piña products are misbranded within the meaning of section 403(w) of the Act, 21 U.S.C. § 343(w) in that the labels for these products fail to declare completely or accurately the known major food allergens, egg, soy, and tree nuts, as specified by 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. “(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 Empanada De Piña product formulation reveals that egg wash is applied to the product prior to being baked; however, the product label fails to declare the presence of the major food allergen, egg. Your Galleta De Naranja product is made with margarine which contains soy lecithin and the major allergen soy is not declared.
Additionally, your pan de feria product label includes a “Contains” statement which does not properly identify the type of tree nut in the product, as required under section 403(w)(1)(A). Further guidance and information on food allergens can be accessed on FDA’s website at http://www.cfsan.fda.gov/~dms/wh-alrgy.html.
4. Your Empanada De Piña, Empanada De Leche, Pastel-D, Galleta De Naranja, and pan de feria products are misbranded within the meaning of section 403(i)(2), 21 U.S.C. § 343(i)(2), of the Act in that your labels fail to declare completely or accurately all of the ingredients used by your firm in the production of these baked goods in accordance with 21 CFR 101.4(b). For example:
• The Empanada De Piña, Empanada De Leche, Pastel-D, and Galleta De Naranja labels declare “shortning” [sic], however, the premium all-purpose shortening contains oil sub-ingredients which are not declared by their specific common or usual name in order of predominance in the food, 21 CFR 101.4(b)(14). The ingredient statement for the shortening reads: “PARTIALLY HYDROGENATED SOYBEAN AND COTTONSEED OILS.”
• The Empanada De Piña, Empanada De Leche, Pastel-D, and Galleta De Naranja labels declare “Baking Powder,” however, the product label for Double acting baking powder type II used in the manufacture of these products contains sub-ingredients which are not declared on the product label. The ingredient statement for the baking powder reads: “sodium bicarbonate, corn starch . . . aluminum sulfate, calcium sulfate, monocalcium phosphate….”
• Furthermore, several of your bakery products contain either margarine or pineapple filling. However, based on ingredient labels collected during the inspection, the margarine and pineapple filling contain sub-ingredients which are not declared on your product labels.
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. Under the second alternative, the component ingredients must be listed in descending order of predominance in the finished food.
• Your Galleta De Naranja product is further misbranded within the meaning of section 403(i)(2) because the label fails to bear the common or usual name of each ingredient as required by 21 CFR 101.4(a)(1). For example, your baked good is labeled to contain “Citric Orange….” The term “Citric Orange” is not an appropriate common or usual name.
5. Your Empanada De Piña, Empanada De Leche, Pastel-D, Galleta De Naranja and pan de feria are misbranded within the meaning of section 403(e)(2), 21 U.S.C. § 343(e)(2), because your labels do not provide the net quantity of contents completely or accurately in accordance with 21 CFR 101.105(b)(1) and 21 CFR 101.105(f). Any statements of weight shall be in terms of avoirdupois pound and ounce; however, your products declare the net weight in grams and units (i.e., 360 grams 6 units).
This letter is not meant to be an all-inclusive list of deficiencies that may exist in any of your product labeling. 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. It is your responsibility as top management to ensure that your establishment is in compliance with all requirements of Federal regulations.
We also note the following:
Your Empanada De Piña, Empanada De Leche, Pastel-D, and Galleta De Naranja product labels contain false and misleading statements. For example:
o Your Empanada De Piña product label includes the statement “Contains Wheat, Peanuts, Tree Nuts”; however, the formulation for your product reveals that there are no tree nuts or peanuts used in its manufacture.
o Your Empanada De Leche and Galleta De Naranja product labels include the statement “Contains Wheat, Milk, Peanuts, Tree Nuts”; however, the formulations for your products reveal that there is no milk, tree nuts, or peanuts used in their manufacture.
o Your Pastel-D product label includes the statement “Contains Wheat, Eggs, Milk”; however, the formulation for your product reveals that there are no eggs or milk used in its manufacture.
Your Empanada De Piña, Empanada De Leche, Pastel-D, Galleta De Naranja, and pan de feria product labels fail to bear any nutrition information as required by 21 CFR 101.9 and your firm has not filed for an exemption from the nutrition labeling requirements under section 403(q)(5)(D) of the Act, 21 U.S.C. § 343(q)(5)(D).
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.
Your Empanada De Piña, Empanada De Leche, Pastel-D, Galleta De Naranja and pan de feria product labels contain information in two languages but do not repeat all the required label information in both languages. In accordance with 21 CFR 101.15(c)(2), if a product label contains any representation in a foreign language or foreign characters, all words, statements, and other information required by or under authority of the Act to appear on the label must appear in the foreign language.
Your Empanada De Piña, Empanada De Leche, Pastel-D, and Galleta De Naranja labels declare “Vanilla” improperly on the ingredient statement. According to the ingredient label, it is actually “Artificial Vanilla Flavor.”
You should notify this office in writing within 15 working days of receipt of this letter of any steps you have taken or will take to correct the noted violations and to prevent their recurrence. If corrective actions cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed. Please include copies of any available documentation demonstrating that corrections have been made.
Your reply should be directed to Compliance Officer Jane E. Nelson at the address indicated on the letterhead.
Sincerely,
/s/
Gerald J. Berg
Director
Minneapolis District
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