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U.S. Department of Health and Human Services

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Enforcement Actions

Shatila Food Products, Inc. 3/6/13

  

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 Detroit District
300 River Place
Suite 5900
Detroit, MI 48207
Telephone: 313-393-8100
FAX: 313-393-8139 

 

WARNING LETTER
2013-DET-08
 
March 6, 2013
 
VIA UPS
 
Riad S. Shatila, President/Owner
Shatila Food Products, Inc.
8505 W. Warren Avenue
Dearborn, MI 48126
 
 
Dear Mr. Shatila:
 
The U.S. Food and Drug Administration (FDA) inspected your manufacturing facility located at 8505 W. Warren Ave., Dearborn, MI 48126 from December 3, 2012 through December 28, 2012. A review of your product labels revealed violations that cause several of your products to be misbranded within the meaning of section 403 [21 U.S.C. § 343] of the Federal Food, Drug, and Cosmetic Act (the Act) and the implementing regulations under Title 21, Code of Federal Regulations, Part 101 (21 CFR 101). You may find the Act and FDA’s regulations through links on FDA’s home page at www.fda.gov.
 
The labeling violations are as follows: 

1.    Your “Premium Mediterranean Pastries” products and various-sized “Premium Mediterranean Pastries” Holiday Tin 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 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, as “major food allergens.” 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 ingredient [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)].
 
Specifically, the application of your “Mixed Pastries” label to the various-sized “Premium Mediterranean Pastries” Holiday Tin products commencing December 4, 2012, does not adequately address this violation, in that the “Mixed Pastries” product label fails to properly declare almonds, cashews, pine nuts, pistachios, and walnuts in the ingredient statement. Additionally, the “Gourmet Mixed Pastries” product labels do not properly declare cashews, pine nuts, pistachio nuts, and walnuts. Each individual tree nut must be listed in descending order of predominance by weight for the product as a whole and may not be designated using a “may contain” statement in the ingredient statement.
 
2.    Your “Premium Mediterranean Pastries” products, and various-sized “Premium Mediterranean Pastries” Holiday Tin products are misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)], because they are fabricated from two or more ingredients but the labels fail to bear the common or usual name of each ingredient. Specifically, the various-sized “Premium Mediterranean Pastries” Holiday Tin products labels do not properly declare the presence of almonds, cashews, pine nuts, pistachios, and walnuts in the ingredient statement. The “Gourmet Mixed Pastries” products do not properly declare cashews, pine nuts, pistachio nuts, and walnuts in the ingredient statement.
 
The Food and Drug Administration does not object to ingredient labeling designed for more than one product, provided other requirements of the Act and regulations are met and such labeling is not false or misleading. Title 21 CFR 101.100(a)(1) permits such labeling “in terms which are as informative as practical and which are not misleading.” In cases where such labeling is necessary, ingredients common to all products should be listed first in the ingredient declaration followed by a listing of ingredients not common to all, including specific indications of which ingredients are actually present in designated products. The ingredient declaration must enable the consumer to tell exactly what is in the specific food product.
 
In addition, the “Gourmet Mixed Pastries” product labels fail to adequately declare the wheat flour ingredient in that the parenthetical listing of the wheat flour sub-ingredients does not include all of the sub-ingredients of wheat flour, but rather merely states the enrichment ingredients of the wheat flour. The requirement to list component ingredients (or “sub-ingredients”) may be met by either parenthetically listing all of 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.
 
In addition, both the “Premium Mediterranean Pastries” product labels and various-sized “Premium Mediterranean Pastries” Holiday Tin product labels declare the ingredient(s) “vegetable gums,” which should be identified by the common or usual name.
 
3.    Your “Premium Mediterranean Pastries” products, and various-sized “Premium Mediterranean Pastries” Holiday Tin products are misbranded within the meaning of section 403(q) of the Act [21 U.S.C. § 343(q)]. Specifically:
 
  • Your “Premium Mediterranean Pastries” products, and various-sized “Premium Mediterranean Pastries” Holiday Tin product labels do not include nutrition facts information as defined in 21 CFR 101.9. 
The application of your “Mixed Pastries” label to the various-sized “Premium Mediterranean Pastries” Holiday Tin products commencing December 4, 2012 does not adequately address this violation, in that the “Mixed Pastries” product label also fails to include nutrition facts information.
 
  • Your “Gourmet Mixed Pastries” product label does not declare Trans-fat content in accordance with 21 CFR 101.9(c)(2)(ii).
 

4.    Your various-sized “Premium Mediterranean Pastries” Holiday Tin products are misbranded within the meaning of section 403(e)(2) of the Act [21 U.S.C. § 343(e)(2)] in that the labels fail to bear a statement of the net quantity of contents as required under 21 CFR 101.105(a). The application of your “Mixed Pastries” label to these products commencing December 4, 2012 does not adequately address this violation, in that the “Mixed Pastries” product label also fails to bear a statement of the net quantity of contents.

We also offer the following comments regarding your product label:
  • Required information such as the product name, name and place of business and ingredient statement should not be placed on the bottom of the tin as it is in the “Mixed Pastries” products.
 
The above violations are not meant to be an all-inclusive list of deficiencies in your product labeling. It is your responsibility to assure all your products are in compliance with all applicable federal regulations enforced by FDA. You should take prompt action to correct these violations noted in this letter and you should establish procedures to ensure such violations do not recur. Failure to promptly do so may result in regulatory action being initiated by the FDA without further notice, including seizure and/or injunction.
 
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 acknowledge your response to the Form FDA 483, List of Inspectional Observations issued by the investigator during the inspection. This response was received into our District on January 18, 2013. Our review of this response finds that it pertains to the Form FDA 483, List of Inspectional Observations but does not address the labeling concerns relayed during the inspection and noted in this document. 
 
Further response to this document should be sent to Tina M. Pawlowski, Ph.D., Compliance Officer at the address noted above. If you have any questions with regard to this letter, Dr. Pawlowski can be reached at 313-393-8217.
 
 
Sincerely,
/S/ 
Art O. Czabaniuk
Acting District Director
Detroit District Office