U.S. flag An official website of the United States government
  1. Home
  2. Inspections, Compliance, Enforcement, and Criminal Investigations
  3. Compliance Actions and Activities
  4. Warning Letters
  5. Helados La Tapatia, Inc - 10/24/2014
  1. Compliance Actions and Activities

WARNING LETTER

Helados La Tapatia, Inc Oct 24, 2014

Helados La Tapatia, Inc - 10/24/2014


Recipient:
Helados La Tapatia, Inc


United States

Issuing Office:
San Francisco District Office

United States


  

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

Public Health Service
Food and Drug Administration
 
San Francisco District
Pacific Region
1431 Harbor Bay Parkway
 Alameda, CA 94502-7070
 
Telephone:    510-337-6700
FAX:    510-337-6701

 

WARNING LETTER
 
Via UPS
Delivery Signature Requested
                                                     
October 24, 2014
 
Mr. Emilio Sandoval, Owner/President
Helados La Tapatia, Inc.
1418 G Street
Fresno, CA 93706
 
Ref: FEI 3005151826
 
Dear Mr. Sandoval:
 
The U.S. Food and Drug Administration (FDA) inspected your facility, located at 1418 G Street, Fresno, CA from March 3rd to March 19th, 2014. During the inspection, our investigators collected and reviewed labeling for many of your ice cream and frozen treat products. Our review of the labeling for your Strawberry Ice Cream (1.75 QT) and Mango Ice Cream (1.75 QT) products revealed that they are adulterated within the meaning of section 402(c) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 342(c)] and misbranded within the meaning of section 403 of the Act [21 U.S.C. § 343]. Our review of your Natural Creamy Fruit Bar All Natural Esquimal product and your Natural Creamy Fruit Bar All Natural Cookies “n” Cream product revealed that they are also misbranded within the meaning of section 403 of the Act.   You can find the Act and the implementing regulations contained within Title 21, Code of Federal Regulations, Parts 74 and 101 (21 CFR 74 and 101) through links on FDA’s home page at www.fda.gov.
 
Your significant violations are as follows:
 
1.    Your Strawberry Ice Cream (1.75 qt) and Mango Ice Cream (1.75 qt) products are adulterated within the meaning of section 402(c) of the Act [21 U.S.C. 342(c)] because they contain color additives which are unsafe within the meaning of section 721(a) of the Act. For example:
 
  • Your Strawberry Ice Cream (1.75 qt) label declares “red color” which is a non-permitted color additive.
  • Your Mango Ice Cream (1.75 qt)” label declares “yellow food colorings.”
 
The submitted copies of the labeling for the “Yellow Color- CL-164” ingredient declare “FD&C Yellow # 5.” FD&C Yellow No. 5 is specifically required to be declared on food product labels under 21 CFR 74.705(d)(2).
 
2.    Your Natural Creamy Fruit Bar All Natural Esquimal (3 OZ), Natural Creamy Fruit Bar All Natural Cookies “N” Cream (3 OZ), and Strawberry Ice Cream (1.75 QT), and Mango Ice Cream 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 or chemical preservative but do not bear labeling stating that fact. Specifically,
 
    • Your Strawberry Ice Cream (1.75 QT) fails to declare the “Red Color” in the product statement of ingredients. 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.
    • Your Mango Ice Cream (1.75 QT) fails to declare FD&C Yellow No. 5 and FD&C Red No. 40 by their listed names or appropriate abbreviations as required under 21 CFR 101.22(k)(1).
    • Your Natural Creamy Fruit Bar All Natural Cookies “N” Cream (3 OZ), Natural Creamy Fruit Bar All Natural Esquimal (3 OZ), and Strawberry Ice Cream (1.75 QT) products contain a chemical preservative, calcium sorbate, however they fail to bear labeling stating that fact in accordance with 21 CFR 101.22(j). This substance is listed under 21 CFR 182, sub-part D-Chemical Preservatives.
 
In accordance with 21 CFR 101.22(j), the label of a food to which a chemical preservative(s) is added shall bear a label declaration stating both the common or usual name of the ingredient(s) and a separate description of its function; e.g. “preservative,” “to retard spoilage,” “a mold inhibitor,” “to help protect flavor,” or “to promote color retention.
 
3.    Your Natural Creamy Fruit Bar All Natural Esquimal (3 OZ), Natural Creamy Fruit Bar All Natural Cookies “N” Cream (3 OZ), and Strawberry Ice Cream (1.75 QT) products are misbranded within the meaning of section 403(a)(1) of the Act [21 U.S.C. § 343(a)(1)] in that the labeling is false and misleading. For example:
 
  • Your Natural Creamy Fruit Bar All Natural Esquimal (3 OZ) and Natural Creamy Fruit Bar All Natural Cookies “N” Cream (3 OZ) product labels declare “Natural” and “All Natural” in the statement of identity. However, according to your formulation sheets and declaration of ingredients, these products contain chemical preservatives (calcium sorbate) and other synthetic ingredients (polysorbate 40), and the Natural Creamy Fruit Bar All Natural Esquimal also contains artificial colors (Yellow 5 and Red 40). The use of these substances in your products render your use of the term “natural” false and misleading. 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].  
  • Your Strawberry Ice Cream (1.75 QT) product label declares “Natural Fresh Coconut” as an ingredient. However, according to your formulation sheet, “Natural Fresh Coconut” is not an ingredient in this product.
  • Your Natural Creamy Fruit Bar All Natural Esquimal (3 OZ) and Natural Creamy Fruit Bar All Natural Cookies “N” Cream (3 OZ) products statement of identity includes “fruit;” however, there is not any fruit in these bars.
 
4.    Your Natural Creamy Fruit Bar All Natural Cookies “N” Cream (3 OZ) product is misbranded within the meaning of section 403(w) of the Act, 21 U.S.C. § 343(w), in that the finished product label fails to declare the major food allergens; Wheat and Soy, as required by section 403(w)(1) of the Act. 
 
Section 201(qq) of the Act, 21 U.S.C. § 321(qq), defines a major food allergen as 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 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 is 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, 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, your Natural Creamy Fruit Bar All Natural Cookies “N” Cream (3 OZ) product is manufactured using cookies, which contain “wheat” and “soy.”
 
5.    Your Natural Creamy Fruit Bar All Natural Cookies “N” Cream (3 OZ), Natural Creamy Fruit Bar All Natural Esquimal (3 OZ), and Strawberry Ice Cream (1.75 QT) products are misbranded within meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that each product is fabricated from two or more ingredients and each ingredient is not declared on the label, as required by 21 CFR 101.4. For example:
 
  • Your Natural Creamy Fruit Bar All Natural Cookies “N” Cream (3 OZ) product is manufactured using chocolate cookies; however, you fail to list all the sub-ingredients on your finished product label.
 
According to 21 CFR 101.4(b)(2), 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; and under the second alternative, the component ingredients must be listed in descending order of predominance in the finished food.
 
  • Your Natural Creamy Fruit Bar All Natural Esquimal (3 OZ)product is manufactured using “oil;” however, you fail to declare “oil” on your finished product label as required by 21 CFR 101.4(a).
  • Your Natural Creamy Fruit Bar All Natural Esquimal (3 OZ) product declares “fresh condensed skim milk;” however, the term “fresh” is not part of the common or usual name of any milk product.
  • Your Strawberry Ice Cream (1.75 QT) product is manufactured using “strawberry” and “water;” however, you fail to declare “strawberry” and “water” on your finished product label as required by 21 CFR 101.4(a).
  • Your Strawberry Ice Cream (1.75 QT) product label declares “corn sweeteners.” However, this is not an appropriate common or usual name for any sweetener nor is there a collective term for sweeteners in 21 CFR 101.4(b)(3).
 
6.    Your Strawberry Ice Cream (1.75 QT) product is misbranded within the meaning of Section 403(q) of the Act [21 U.S.C. § 343(q)] in that the nutrition facts information is not in an appropriate format. For example, the product label fails to trans-fat as required by 21 CFR 101.9(c)(2)(ii).
 
7.    Your Strawberry Ice Cream (1.75 QT) product is misbranded within meaning of section 403(g) of the Act [21 U.S.C. § 343(g)]. The product appears to be represented as a food for which a definition and standard of identity have been prescribed by regulations as provided by section 401 and the food does not appear to conform to such definition and standard in accordance with 21 CFR 135.110. Specifically, according to the product formulation the product is made with water; however, ice cream is a standardized food and does not provide for the addition of water.
 
8.    Your Natural Creamy Fruit Bar All Natural Esquimal (3 OZ) Strawberry Ice Cream (1.75 QT) products are misbranded within the meaning of 403(f) of the Act [21 U.S.C. §343(f)] because they contain information in a foreign language but does not repeat all the required label information in both languages. For example, the statement of identity must be declared in both, Spanish and English as required by 21 CFR 101.15(c)(2). Specifically, the term “Esquimal” is Spanish for Eskimo and the word “fresa” on the Principal Display Panel is Spanish for Strawberry.
 
9.    Your Natural Creamy Fruit Bar All Natural Esquimal (3 OZ) and Natural Creamy Fruit Bar All Natural Cookies “N” Cream (3 OZ) products are misbranded within the meaning of 403(i)(1) of the Act [21 U.S.C. §343(i)(1)] because the labels fail to declare the common or usual name of the food. Specifically, “Natural Creamy Fruit Bars” is not an appropriate common or usual name for a product that does not contain any fruit [21 CFR 101.3(b)].
 
(b)(4)
 
This letter is not intended to be an all-inclusive list of violations in connection with your products. You are responsible for ensuring that your firm operates in compliance with the Act and its implementing regulations. You are also responsible for ensuring that all of your products and their labeling are in compliance with the laws and regulations enforced by FDA.  
 
You should take prompt action to correct the violations described above. Failure to correct these violations may result in enforcement action without further notice. Such action may include, but is not limited to, seizure and/or injunction.
 
We also have the following comments:
 
  • Our review of your Certificates of Analysis for environmental samples analyzed by a private laboratory indicated that at least two of your environmental samples collected on November 24, 2013 and December 11, 2013 resulted in presumptive positives for Listeria monocytogenes in your processing environment.  Moreover, on March 5, 2014, FDA collected one environmental sample consisting of 50 swabs from various food contact and non-food contact surfaces in your processing room. Twenty-one (21) of the 50 environmental swabs tested positive for L. monocytogenes. Of the swabs that tested positive, 11 were collected directly from food contact surfaces, and the remaining 10 were collected from non-food contact surfaces. The positive environmental swabs are indicators of insanitary conditions in your facility and demonstrate the failure of cleaning and sanitation operations which may allow for contamination of foods with filth or pathogens. When Listeria monocytogenes or Listeria spp. is recovered from environmental samples, you should take prompt corrective actions to address insanitary conditions in your facility that may cause contamination of food, and ensure that production procedures do not contribute contamination from any source.
  • We also note that the amount of calcium declared for the Cookies "n" Cream (3 oz.) and Strawberry Ice Cream products is 8%. We question whether or not the Esquimal product's declaration of 0% is an error considering the similarities of these products.
 
Please notify this office in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific actions that you are taking to correct these violations and to prevent similar violations from occurring in the future. You should include in your response documentation and any 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 the delay and state when you will correct any remaining violations.
 
Further, 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 re-inspection-related costs.  A re-inspection 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.  Re-inspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the re-inspection and assessing and collecting the re-inspection fees, [21 U.S.C. § 379j-31(a)(2)(B)].  For a domestic facility, FDA will assess and collect fees for re-inspection-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 re-inspection-related costs.
 
Please send your reply to the attention:
           
            Lawton W. Lum
            Director, Compliance Branch
            U.S. Food and Drug Administration
            San Francisco District
            1431 Harbor Bay Parkway
            Alameda, CA 94502
 
 
If you have any questions regarding any issue in this letter, please contact Brandon Bridgman, Compliance Officer at 510-337-6794, or by fax at (510) 337-6703.
 
 
Sincerely,
/S/
 
Kathleen Lewis, JD
District Director