| Public Health Service Food and Drug Administration |
Los Angeles District |
Department of Health and Human Services
WARNING LETTER
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
W/L 36-11
Date: April 26, 2011
Mr. Gabriel Sanchez, President/Owner
La Placita Botanas Mexicanus, Inc.
10846 Central Avenue
South El Monte, CA 91733-3310
Dear Mr. Sanchez:
On October 18-26, 2010, and again on December 26, 2010 - January 3, 2011, the Food and Drug Administration (FDA) conducted two inspections of your snack food manufacturing facility located at 10846 Central Avenue, South El Monte, California. During these inspections our investigators collected samples of your product labeling. Our review of your product labels found that your Wheat Snack Duritos (3 oz.), Doraditas Potato Chips (2.5 oz.), and Anillos Michoacanos Con Chile (2.5 oz.) products are misbranded within the meaning of section 403 of the Federal Food, Drug and Cosmetic Act (the Act) [21 U.S.C. §343] and Title 21, Code of Federal Regulations (CFR) Part 101. Specifically,
1. The labels for your various snack food products are misbranded under section 403(q) of the Act [21 U.S.C. § 343(q)] because the nutrition information on their labels does not comply with the format and content requirements in FDA's regulations. Specifically, your Wheat Snack Duritos (3 oz.), Doraditas Potato Chips (2.5 oz.), and Anillos Michoacanos Con Chile (2.5 oz.) product labels fail to provide nutrition information in accordance with 21 CFR 101.9. The label stock for these products that was in use at the time of the inspections states "FOR NUTRITION INF. CALL ... " and does not provide any further nutritional information. Under 21 CFR 101.9(j)(13)(i)(A), there is an exemption to the nutrition labeling requirements for foods in small packages that have a total surface area available to bear labeling of less than 12 square inches, provided that the labels for these foods bear no nutrition claims or other nutrition information in any context on the label or in labeling or advertising. Your Wheat Snack Duritos (3 oz.), Doraditas Potato Chips (2.5 oz.), and Anillos Michoacanos Con Chile (2.5 oz.) packages measure 16.75 in. x 9 in., 10 in. x 8 in., and 6 in. x 9 in. respectively per side. These packages bear more than 12 square inches of total surface area available to bear labeling; therefore, your products do not qualify for the nutrition labeling exemption under 21 CFR 101.9(j)(13)(i)(A).
2. Your Wheat Snack Duritos (3 oz.) and Anillos Michoacanos Con Chile (2.5 oz.) products are misbranded under section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] because these foods are fabricated from two or more ingredients, but the labels do not list all ingredients found in the foods. For example:
• Your products that are labeled "con chile" contain a chili powder blend; however, the label for your Anillos Michoacanos Con Chile (2.5 oz.) product does not declare chili powder or spice in the ingredients statement in accordance with 21 CFR 101.4.
• Your Wheat Snack Duritos (3 oz.) and Anillos Michoacanos Con Chile (2.5 oz.) product labels fail to declare the sub-ingredients of the multi-ingredient food, baking powder. According to 21 CFR 101.4(b)(2), the requirement to list component ingredients (or "sub-ingredients") may be met by either parenthetically listing the component ingredients after the common or usual name of the multi-component ingredient, or by listing the component ingredients without listing the multi-component 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.
This letter may not list all the label violations at your facility. You are responsible for ensuring that your products are properly labeled, and that your processing plant operates in compliance with the Act, the Food Labeling regulation (21 CFR 101) and the Current Good Manufacturing Practice regulation (21 CFR 110). 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 seize your product(s) and/or enjoin your firm from further violating the Act.
We also have the following comments about your product labels:
• Your Wheat Snack Duritos (3 oz.) and Anillos Michoacanos Con Chile (2.5 oz.) product labels include the ingredient "Cotton Salad Oil." We question whether this ingredient is declared by an appropriate common or usual name under 21 CFR 101.4.
• Your Wheat Snack Duritos (3 oz.) and Anillos Michoacanos Con Chile (2.5 oz.) product labels improperly declare the ingredients "Yellow 5 and 6 Certificate." According to 21 CFR 101.22(k), a color additive subject to certification under 721 (c) of the act shall be declared by the name of the color additive listed in the applicable regulation in part 74 or part 82 of this chapter, except that it is not necessary to include the "FD&C" prefix of the term "No." in the declaration. The applicable regulations, 21 CFR 74.705 and 706, do not allow for these colors to be listed collectively and do not include "certificate" in the name of these colors.
• Your Wheat Snack Duritos (3 oz.), Doraditas Potato Chips (2.5 oz.), and Anillos Michoacanos Con Chile (2.5 oz.) product labels fails to declare oil ingredients in accordance with 21 CFR 101.4(b)(14). Your labels declare "Contains One or More Vegetable Oil, Corn Oil, Soybean Salad Oil, Cotton Salad Oil" and "Vegetable Oil (Contains One or More)(Corn, Soybean Salad Oil, Cotton)." According to 21 CFR 101.4(b)(14), oil ingredients not present in the product may be listed if they may sometimes be used in the product and shall be identified by words indicating that they may not be present, such as "or", "and/or", "contains one or more of the following:" e.g., "vegetable oil shortening (contains one or more of the following: cottonseed oil, palm oil, soybean oil)".
We also acknowledge that during the December 26, 2010 - January 3, 2011 inspection, your firm provided our investigators with two proposed new and revised labels for your (b)(4) products. A review of these labels also finds these products to be labeled incorrectly. We offer the following comments:
• Your (b)(4) label is a single-serving container; however it does not express the serving size in terms of a description of the individual container or package (e.g., can, box, package) in accordance with 21 CFR 101.9(b)(5)(iv).
• The number of servings per container in the Nutrition Facts panel of your (b)(4) product is incorrect. In accordance with 21 CFR 101.9(b)(8)(i), the number of servings shall be rounded to the nearest whole number except for the number of servings between 2 and 5 servings and random weight products. The number of servings between 2 and 5 servings shall be rounded to the nearest 0.5 serving. Rounding should be indicated by the use of the term about (e.g., about 2 servings, about 3.5 servings). Your serving size is listed as 1 oz (28g); however, the servings per container is listed as 1. Since your package contains 71 g (b)(4) and each serving is 28 g, your servings per container should be about 2.5 (71g/21g~2.5).
• We note that your (b)(4) and (b)(4) product labels include nutrition information in a tabular format. A firm may use a tabular or linear nutrition facts format if the product has a total surface area available to bear labeling of less than 12 square inches, or if the product has a total surface area available to bear labeling of 40 or less square inches and the package shape of size cannot accommodate a standard vertical column or tabular display on any label panel [21 CFR 101.9(j)(13)(i)(B)]. In addition, the tabular display format may be used if there is not sufficient continuous vertical space (i.e. approximately 3 in.) to accommodate the required components of the nutrition label up to and including the mandatory declaration of iron [21 CFR 101.9(d)(11)(iii)]. If your packaging fails to meet one of these conditions, you are not eligible to use the tabular display for nutrition information.
• Your (b)(4) and (b)(4) continue to bear ingredients that are improperly declared. As discussed previously in this letter:
o Baking powder is a multi-ingredient food for which sub-ingredients must be declared in accordance with 21 CFR 101.4(b)(2).
o The color additives "Yellow 5 and 6 Certificate" are not declared in accordance with 21 CFR 101.22(k).
o Vegetable oils are not declared in accordance with 21 CFR 101.4(b)(14).
We recommend that you revise these proposed labels based on the above comments and begin immediate use of the corrected product labels.
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 revised or proposed labels, 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.
If you have any questions relating to this letter you should contact Robert B. McNab, Compliance Officer, at (949) 608-4409. Your written reply should be addressed to:
Blake Bevill, Director, Compliance Branch
U.S. Food and Drug Administration
19701 Fairchild Rd.
Irvine, California 92612
Sincerely,
/S/
Alonza E. Cruse, Director
Los Angeles District
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