| 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 Services
August 18, 2011
WARNING LETTER
CERTIFIED MAIL
RETURN RECEIPT REQUESTED Refer to MIN 11 – 46
Timothy P. Kezman
President
King Juice Company, Inc.
851 W. Grange Avenue
Milwaukee, Wisconsin 53221-4425
Dear Mr. Kezman:
We inspected your juice processing facility located at 851 W. Grange Avenue, Milwaukee, Wisconsin, on April 7 and 11-13, 2011. We found that you have serious violations of the juice Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 120 (21 CFR 120). In accordance with 21 CFR 120.9, failure of a processor of juice products to have and implement a HACCP plan that complies with 21 CFR 120, or otherwise operate in accordance with the requirements of this Part, renders the juice products adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 342(a)(4). Accordingly, your juice products, including Apple Juice, Orange Juice, Grape Juice, Pineapple Juice, Fruit Punch, Pear Juice, and Cranberry Juice, are adulterated in that they have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health.
We have reviewed your labels in conjunction with other evidence collected during the inspection, and have determined that your Calypso Classics brand 100% Pure Orange Juice, (b)(4) Ginseng Green Tea, and Calypso Natural Lemonade products are also misbranded within the meaning of section 403 of the Act, 21 U.S.C. § 343, and FDA’s implementing regulations under 21 CFR 101.
You may find the Act, labeling regulations, the juice HACCP regulation and the Juice HACCP Hazards and Controls Guidance through links on FDA’s home page at www.fda.gov.
Your significant juice HACCP violations were as follows:
- Your HACCP plan must, at a minimum, list the procedures and frequency with which they are to be performed, that will be used to monitor each of the critical control points to ensure compliance with the critical limits, to comply with 21 CFR 120.8(b)(4). However, your HACCP plan for Cold-Filled (b)(4) Juice Products does not list the procedures for monitoring at the critical control point “Pasteurize” to ensure compliance with the critical limits specified in your HACCP plan. Specifically, for refrigerated fill, you must list the procedures to monitor time between product leaving the heating section and entering the regeneration/cooling section. In addition, you must list the procedures to monitor the holding time of your pasteurization process.
Comments on Hot Fill Products:
Since your company uses a (b)(4) processing step to produce shelf-stable juices, you are not required to include control measures in your HACCP plan to achieve a 5-log reduction for these products. However, under 21 CFR 120.24(a)(2), you are required to include a copy of their thermal process in the hazard analysis. Additionally, 21 CFR 120.24(a) requires validation of the thermal process. Your firm should validate your thermal process for hot fill products initially and annually thereafter.
- Your HACCP plan must, at a minimum, list all food hazards that are reasonably likely to occur, to comply with 21 CFR 120.8(b)(1). Specifically, your HACCP plan for Hot Filled 100% Fruit Juices, packaged in glass, does not list the physical hazard of glass fragments. Once you have identified this hazard, you must include control measures in your HACCP plan for the periodic monitoring of processing lines for evidence of glass breakage. You may refer to the Juice HACCP Controls Guidance, First Edition, for information to control this food safety hazard.
Your significant labeling violations were as follows:
- Your Calypso Classics brand 100% Pure Orange Juice, (b)(4) Ginseng Green Tea and Calypso Natural Lemonade products 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 required by 21 CFR 101.4 as follows:
- The product label of your Calypso Classics brand 100% Pure Orange Juice declares “a Blend of Floridian and Brazilian Concentrate;” however, that is not the common or usual name of the ingredient.
- The product label for your (b)(4) Ginseng Green Tea lists “Cane Sugar And/Or Corn Based Sweetener” as ingredients. “Corn Based Sweetener” is not the common or usual name of the ingredient. Additionally, the regulations do not allow for the use of terms such as “and/or” in your ingredient statement. The ingredient statement should be an accurate list of only the ingredients that are used in the product’s manufacture.
Furthermore, our regulations do not provide for the use of modifiers. Therefore, the terms “Triple Filtered,” “Pure,” and “Filtered” are considered intervening material, 21 CFR 101.2(e).
- Your Calypso Classics brand 100% Pure Orange Juice, (b)(4) Ginseng Green Tea and Calypso Natural Lemonade products are 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 as defined in 21 CFR 101.9. For example:
- 100% Pure Orange Juice
o The Total Calorie content is not rounded to the nearest 10-calorie increment, 21 CFR 101.9(c)(1).
o The Calories From Fat content is not declared as required by 21 CFR 101.9(c)(1)(ii).
o The Trans fat content is not declared as required by 21 CFR 101.9(c)(2)(ii).
o The Dietary Fiber content is not declared as required by 21 CFR 101.9(c)(6)(i).
- (b)(4) Ginseng Green Tea
o The Calories From Fat content is not declared as required by 21 CFR 101.9(c)(1)(ii).
o The Trans fat content is not declared as required by 21 CFR 101.9(c)(2)(ii).
o The Saturated Fat content is not declared as required by 21 CFR 101.9(c)(2)(i).
o The Cholesterol content is not declared as required by 21 CFR 101.9(c)(3).
o The Dietary Fiber content is not declared as required by 21 CFR 101.9(c)(6)(i).
o The Vitamins and Minerals are not declared as required by 21 CFR 101.9(c)(8)(iii).
- Natural Lemonade
o The Calories From Fat content is not declared as required by 21 CFR 101.9(c)(1)(ii).
o The Trans fat content is not declared as required by 21 CFR 101.9(c)(2)(ii).
o The Dietary Fiber content is not declared as required by 21 CFR 101.9(c)(6)(i).
We recognize that you may be attempting to use the simplified format to declare the nutrition information and that when using the format Trans Fat can be omitted; however, because you voluntarily declare sugar, your “Not a significant source of ____” statement must now include all nutrients that are not present in a significant amount that are required under 21 CFR 101.9 to be declared in the Nutrition Facts panel.
We also note the following comments about your product labels:
- Your Calypso Classics brand 100% Pure Orange Juice does not properly declare the statement of identity. Although you declare “From Concentrate” on the side of your label, the proper statement of identity should be “Orange Juice From Concentrate” with the words “From Concentrate” in letters no less than one-half the height of the letters in the words “orange juice,” 21 CFR 146.145(c). Additionally, your percent juice declaration should also be declared near the top of the Nutrition Facts panel, 21 CFR 101.30(e).
- Your Calypso Classics brand 100% Pure Orange Juice, (b)(4) Ginseng Green Tea and Calypso Natural Lemonade products do not declare net weight in accordance with 21 CFR 101.105.
o Calypso Classics brand 100% Pure Orange Juice declares a net weight of “32 FL OZ (946 mL).” However, the proper declaration would be “32 FL OZ (1 QT) 946mL,” 21 CFR 101.105(m)(3).
o (b)(4) Ginseng Green Tea declares a net weight of “16 oz (473 mL)” but it fails to declare that the ounces are fluid ounces, 21 CFR101.105(j)(3).
o Calypso Natural Lemonade declares a net weight of “20 oz (591 mL).” The net weight should also be declared with the largest whole unit (pint) with any remainder in terms of fluid ounces or common or decimal fractions of the pint, 21 CFR 101.105(j)(1).
We may take further action if you do not promptly correct these violations. For instance, we may take further action to seize your products and/or enjoin your firm from operating.
Please 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 deviations. You may wish to include in your response documentation such as your revised HACCP plans or other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, we expect that you will explain the reason for your delay and state when you will correct any remaining deviations.
This letter may not list all the deviations at your facility. You are responsible for ensuring that your processing plant operates in compliance with the Act and the Good Manufacturing Practice regulations, 21 CFR 110. You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.
Please send your reply to the Food and Drug Administration, Attention: Tyra S. Wisecup, Compliance Officer, at the address in the letterhead. If you have questions regarding any issue in this letter, please contact her at (612) 758-7114.
Sincerely,
/S/
Gerald J. Berg
Director
Minneapolis District
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