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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Middle East Bakery, Inc. 9/18/14

  

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

Public Health Service
Food and Drug Administration
 
New England District Office
One Montvale Avenue, 4th floor
Stoneham, MA 02180
Phone 781.587.7500
Fax 781.587.7556
 
WARNING LETTER
CMS # 433344   
 
UNITED PARCEL SERVICE
OVERNIGHT DELIVERY
 
September 18, 2014
 
Mr. Leopoldo Guggenheim
President and Co-Owner
Middle East Bakery, LLC
30 International Way
Lawrence, MA 01843
 
Dear Mr. Guggenheim:
 
On May 14, 15, 19, 21, 29, and June 6, 2014, the U.S. Food and Drug Administration (FDA) conducted an inspection of your firm’s bakery manufacturing operations at Middle East Bakery, Inc. 30 International Way, Lawrence, MA. During the inspection, FDA conducted a review of your labeling for two products you manufacture and found significant violations of the labeling regulations for foods, Title 21, Code of Federal Regulations, Part 101 (21 CFR 101). These violations cause your products, Market Basket brand Dairy-Free Gluten-Free Pancakes and liveGfree brand Blueberry Pancakes, manufactured at your facility to be misbranded within the meaning of section 403 of the Federal Food, Drug, and Cosmetic Act (the Act). You may find the ACT and FDA’s regulations through links in FDA’s homepage at www.fda.gov.
 
Furthermore, your firm failed on two occasions to report a Reportable Food to the Reportable Food Registry within twenty-four hours of determining that an article of food is a reportable food for which there is a reasonable probability that the use of, or exposure to, such article of food will cause serious adverse health consequences or death to humans or animals, as required by Section 417(d)(1) of the Act [21 U.S.C. § 350f(d)(1)].
 
Misbranding violations
 
1.  Your Market Basket Gluten-Free, Dairy-Free Pancakes are misbranded within the meaning of Section 403(a)(1) of the Act [21 U.S.C. § 343(a)(1)] in that the label is false or misleading because the product label specifically states that the product is “Dairy-Free”. For (b)(4) batches of this product (manufactured between July 15, 2013 and February 17, 2014), you used a formulation containing (b)(4) (milk). Therefore those batches of the product cannot be dairy-free.
 
Further, your liveGfree Blueberry Pancakes are misbranded within the meaning of Section 403(a)(1) of the Act [21 U.S.C. § 343(a)(1)] because it bears the claim “ALL NATURAL” but contains sodium acid pyrophosphate, which is a synthetic substance. FDA considers use of the term “natural” on a food label to be truthful and non-misleading when “nothing artificial or synthetic…has been included in, or has been added to, a food that would not normally be expected to be in the food.” [58 FR 2302, 2407, January 6, 1993
 
2.    Your Market Basket brand Dairy-Free Gluten-Free Pancakes and liveGfree brand Blueberry Pancakes 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 major food allergens present in the products, namely milk, 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)].

 

3.    Your Market Basket brand Dairy-Free Gluten-Free Pancakes and liveGfree brand Blueberry Pancakes 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 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. Specifically,

  • The products’ formulation sheets list (b)(4) and (b)(4) as ingredients; however, the finished product labels fail to declare (b)(4) or (b)(4) as ingredients. 
  • Your liveGfree brand Blueberry Pancakes declare “Natural Colors from Concentrated Fruit Juices (Elderberry, Watermelon, and Huito);” however, that is not the appropriate common or usual name for this ingredient, as required by 21 CFR 101.4.  
 
Reportable Food Registry
 
Furthermore, your firm failed on two occasions to report a Reportable Food to the Reportable Food Registry within twenty-four hours of determining that an article of food is a reportable food for which there is a reasonable probability that the use of, or exposure to, such article of food will cause serious adverse health consequences or death to humans or animals, as required by Section 417(d)(1) of the Act [21 U.S.C. § 350f(d)(1)]. Specifically,
 
  • You informed our investigator that you were notified of a consumer complaint of an allergic reaction to your Market Basket brand Dairy-Free Gluten-Free Pancakes on (b)(4), 2014, and that a review of your records revealed that your firm used an incorrect, milk-containing formulation to manufacture certain batches of this product. Therefore, you determined that the affected batches of this food contained undeclared milk on or about (b)(4), 2014, but you did not submit a report to the Reportable Food Registry about this product until May 16, 2014.
  • You informed our investigator that a review of your formulas on April 1, 2014 revealed that one batch of your liveGfree brand Blueberry Pancakes was manufactured using an incorrect, milk-containing formulation. Therefore, you determined that the affected batch of this food contained undeclared milk on or about April 1, 2014, but you did not submit a report to the Reportable Food Registry about this product until May 18, 2014. Moreover, you also informed our investigator that you were notified of a consumer complaint of an allergic reaction to this product on (b)(4), 2014.
 
The Reportable Food Registry was established by section 1005 of the Food and Drug Administration Amendments Act of 2007 (Pub. L.110-085) to provide a reliable mechanism to track patterns of adulteration in food in order to support efforts by FDA to target limited inspection resources to protect the public health. It requires a responsible party to file a report when there is a reasonable probability that the use of, or exposure to, an article of food will cause serious adverse health consequences or death to humans or animals. Such foods are “Reportable Foods.” The responsible party is the person who submits the registration under section 415(a) of the FD&C Act [21 U.S.C. 350fd] for a food facility that is required to register under section 415(a), at which such article of food is manufactured, processed, packed, or held. Failure to submit a required report about a reportable food is a prohibited act under Section 301(mm) of the Act [21 U.S.C. § 331(mm)].
 
We acknowledge receipt of your June 9, 2014 letter in response to the FDA 483 issued at the close of the recent inspection. However, your response does not adequately address product formulation controls or emergency and recall procedures. The corrective actions you describe do not provide assurances that future formulation changes will be achieved in a manner that prevents adulteration or misbranding. You do not address how you will handle future recalls, emergencies, or consumer complaints, or how you will ensure that your reporting duties are satisfied. Moreover, you did not include supporting documentation that would allow us to evaluate your corrective actions.
 
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 all applicable regulations, including the Current Good Manufacturing Practice regulation (21 CFR Part 110) and labeling regulations (21 CFR 101). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.
 
We may take further action if you do not promptly correct these violations. For instance, we may take further action to seize your product(s) and/or enjoin your firm from operating.
 
You should respond in writing within fifteen (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 product formulation procedures, recall, and emergency procedures. 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.
 
We also note the following labeling comments:
 
  • The liveGfree Blueberry Pancake ingredient list declares “tapioca, flour.” We note that flour is not an ingredient in this product but (b)(4) is an ingredient according to the production records. If this is a misprint, it needs to be corrected because flour refers to wheat flour [see 21 CFR 137.105] and this product does not declare wheat as an allergen and is labeled “GLUTEN FREE.”
  • Your firm's production records for both products lists (b)(4) as an ingredient; however, the labels declare potato flour. We question whether this is the appropriate name for this ingredient.
 
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 reinspection-related costs. A reinspection 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. Reinspection-related costs means all expenses, including administrative expenses incurred in connection with FDA's arranging, conducting, and evaluating the results of the reinspection and assessing and collecting the reinspection fees (21 U.S.C. 379j-31 (a)(2)(B)). For a domestic facility, FDA will assess and collect fees for reinspection-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 reinspection-related costs.
 
Please send your reply to the Food and Drug Administration, Attention: Pamela L. Ogonowski, Recall Coordinator, One Montvale Ave, Stoneham, MA 02180. If you have questions regarding any issues in this letter, please contact Pamela Ogonowski, Recall Coordinator at (781) 578-7449.
                                                                       
 
Sincerely,
/S/ 
Mutahar S. Shamsi
District Director
New England District

 

 
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