| 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 |
Department of Health and Human Services
WARNING LETTER
2010-DT-18
September 8, 2010
VIA UPS
Jack D. Pauley, President
39002 Webb Court
Westland, Michigan 48185-7606
Mr. Pauley:
The U.S. Food & Drug Administration (FDA) inspected your juice processing facility, located at 39002 Webb Court, Westland, Michigan 48185 on March 18-19, 23, and April 5, 2010. 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 Part 120). In accordance with 21 CFR 120.9, failure of a processor to have and implement a HACCP plan that complies with the requirements of 21 CFR Part 120, 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 concentrated “juice” products are adulterated in that they have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health. In addition, during the inspection of your facility, FDA collected labels of your (b)(4) Natural Apple Juice Blend Concentrate, (b)(4) Passion Fruit Juice Blend Concentrate, (b)(4) White Grape Juice Blend Concentrate (b)(4) Pineapple Juice Concentrate, Penguin Juice Co. Orange Juice Concentrate, and Penguin Juice Co. Prune Juice Concentrate products. We have reviewed the labels in conjunction with other evidence collected during the inspection, and have determined that your products are adulterated within the meaning of section 402 of the Act [21 U.S.C. § 342], and are misbranded within the meaning of section 403 of the Act [21 U.S.C. § 343] and FDA’s implementing regulations under 21 CFR Part 101.
You may find the Act, FDA’s juice HACCP regulations and guidance, and labeling regulations on FDA’s home page at www.fda.gov.
In addition, we have reviewed your response letter dated May 3, 2010. In your response, you indicated that you are having a private contractor review your HACCP plan and that you are working on addressing and correcting other violations. However, you need to provide specific information and documentation of the corrections that you are making.
Your significant violations are as follows:
1. You must have and implement a written HACCP plan to control any food safety hazards that are reasonably likely to occur, as required by 21 CFR 120.8(a). Your HACCP plan lists a critical limit, “(b)(4)” at the “Pasteurization 5 Log reduction” critical control point.
However, during the inspection, the FDA investigator observed that you are not implementing a pasteurization step listed in your HACCP plan for “100% Juice Concentrates” and “100% Juice Blend Concentrates” to control the food safety hazard of pathogens. Specifically, it was observed that no pasteurization step was performed for “100% Juice Blend Concentrates,” Clear Raspberry flavor.
Additionally, you also reported to the investigator that your “100% Juice Blend Concentrates” are typically heated to (b)(4), and this does not meet the critical limit, “(b)(4)” listed in your HACCP plan at the “Pasteurization 5 Log reduction” critical control point to control the food safety hazard of pathogens.
We note that although your HACCP plan for “100% Juice Concentrates” and “100% Juice Blend Concentrates” includes the critical control point, “Pasteurization 5 Log reduction,” your HACCP plan does not specifically list pathogens as the hazard to be controlled at this critical control point.
2. You must apply a 5-log pathogen reduction measure and perform final product packaging in a single production facility, as required by 21 CFR 120.24(c). However, you are not performing a 5-log pathogen reduction measure for your “100% Juice concentrates’ and “100% Juice Blend Concentrates” in the same facility in which you perform final product packaging to control the occurrence of the most resistant microorganism of public health concern that is likely in these products.
3. You must maintain sanitation standard operating procedure records that, at a minimum, document the monitoring and corrections, as required by 21 CFR 120.6(c). However, your firm did not maintain sanitation standard operating procedure records for safety of the water that comes into contact with the food or food contact surfaces, the condition and cleanliness of food contact surfaces, including utensils, gloves, and outer garments; prevention of cross contamination from insanitary objects to foods, food packaging material, and other food contact surfaces; maintenance of hand washing, hand sanitizing, and toilet facilities; the protection of food, food packaging material, and food contact surfaces from adulteration with contaminants; proper labeling, storage, and use of toxic compounds; control of employee health conditions; and the exclusion of pests.
4. Your written hazard analysis must identify the food hazards that are reasonably likely to occur for the juice concentrates you process, and identify control measures that you can apply to control those hazards, as required by 21 CFR 120.7(a). A food hazard is defined in 21 CFR 120.3(g) as “any biological, chemical, or physical agent that is reasonably likely to cause illness or injury in the absence of its control.” However, your firm’s hazard analysis does not identify the hazard of undeclared allergens and undeclared food intolerance ingredients due to cross contact from equipment shared with your products that contain milk ingredients and your products that contain food intolerance ingredients, such as sulfites and Yellow #5. Additionally, there were no specific control measures identified in either your SSOPs[OGC1] or HACCP plan to address this hazard.
5. Your HACCP plan must, at a minimum, list all food hazards that are reasonably likely to occur, and include appropriate critical control points, establish critical limits, and identify monitoring procedures and record keeping to ensure control of these food safety hazards, as required by 21 CFR 120.8(b). However, your HACCP plan for “100% Juice Concentrates” and “100% Juice Blend Concentrates” does not list the food hazard of undeclared food intolerant substances, such as sulfites and FD&C Yellow # 5, for your juice products that contain these ingredients.
6. 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 comply with 21 CFR 120.8(b)(4). However, your HACCP plan for “100% Juice Concentrates” and “100% Juice Blend Concentrates” lists a monitoring procedure, “(b)(4),” and frequency, “(b)(4),” at the “Pasteurization 5 Log reduction” critical control point that is not adequate to ensure that the critical limit, “(b)(4)” is met, to control the food hazard of pathogens.
7. The corrective actions described in your HACCP plan must include steps to be taken and assign responsibility for taking those steps to ensure that no products enter commerce that is either injurious to health or is otherwise adulterated as a result of the deviation, and that the cause of the deviation is corrected, as required by 21 CFR 120.10(a) and 120.8(b)(5). However, your HACCP plan for “100% Juice Concentrates” and “100% Juice Blend Concentrates” lists corrective actions, “control sample on file” at the “Pasteurization 5 Log reduction” critical control point that does not ensure these corrective outcomes.
8. Your (b)(4) Natural Apple Juice Blend Concentrate, (b)(4) Passion Fruit Juice Blend Concentrate, and (b)(4) White Grape Juice Blend Concentrate products are adulterated within the meaning of section 402(b)(1) of the Act [21 U.S.C. 342(b)(1)] because a valuable constituent, namely juice solids, has been in part omitted or abstracted from these products. Specifically, your product labels state “Contains 100% Flavored Juice Blend When Reconstituted to the Mixing Ratio”; however, you have omitted the necessary amount of juice solids to result in such a product when prepared according to package directions. We used the minimum Brix levels listed in 21 CFR 101.30(h)(1) to calculate the percentage of juice from concentrate found in your products when reconstituted according to package directions. Our calculations indicate that your (b)(4) Natural Apple Juice Blend Concentrate, (b)(4) Passion Fruit Juice Blend Concentrate, and (b)(4) White Grape Juice Blend Concentrate products contain approximately 89%, 91% and 89% juice, respectively. when prepared according to package directions.
9. Your (b)(4) Natural Apple Juice Blend Concentrate, (b)(4) White Grape Juice Blend Concentrate, and (b)(4) Passion Fruit Juice Blend Concentrate products are misbranded within the meaning of 403(a)(1) of the Act [21 U.S.C. § [OGC2] 343(a)(1)] in that the labels contain false or misleading statements. For example, these product labels state “From a Pasteurized Quality Product.” This may lead a consumer to believe that your product has been pasteurized or otherwise treated to achieve a 5-log pathogen reduction. However, based on our investigation, your product is neither pasteurized nor treated to achieve a 5-log pathogen reduction.
10. Your (b)(4) Pineapple Juice Concentrate, Penguin Juice Co. Orange Juice Concentrate, and Penguin Juice Co. Prune Juice Concentrate products are misbranded within the meaning of section 403(g)(1) of the Act [21 U.S.C. § 343(g)(1)] in that they purport to be foods for which definitions and standards of identity have been prescribed by regulation but they fail to conform to such definitions and standards. For example:
• Your (b)(4) Pineapple Juice Concentrate purports to make pineapple juice when reconstituted but it includes ingredients that are not permitted by the standard for pineapple juice (21 CFR 146.185), namely calcium lactate, natural and artificial flavors, potassium sorbate, sodium benzoate, and sodium metabisulphite.
• Your Penguin Juice Co. Orange Juice Concentrate purports to make 100% orange juice when reconstituted but it includes ingredients that are not permitted by the standards for orange juice concentrate (including frozen concentrated orange juice [21 CFR 146.146], reduced acid frozen concentrated orange juice [21 CFR 146.148], canned concentrated orange juice [21 CFR 146.150], and concentrated orange juice for manufacturing [21 CFR 146.153]), namely citric acid, malic acid, ascorbic acid, sodium benzoate and potassium sorbate.
• Your Penguin Juice Co. Prune Juice Concentrate purports to make prune juice when reconstituted but it includes ingredients that are not permitted by the standard for canned prune juice (21 CFR 146.187), namely malic acid, sodium benzoate, and potassium sorbate. In addition, the label fails to bear the statement “a water extract of dried prunes” as required by the standard.
11. Your (b)(4) Natural Apple Juice Blend Concentrate, (b)(4) White Grape Juice Blend Concentrate, Penguin Juice Co. Prune Juice Concentrate, (b)(4) Passion Fruit Juice Blend Concentrate, (b)(4) Pineapple Juice Concentrate, and Penguin Juice Co. Orange Juice Concentrate products are misbranded within the meaning of 403(i) of the Act [21 U.S.C. § 343(i)]. Specifically:
• Your (b)(4) Natural Apple Juice Blend Concentrate, (b)(4) White Grape Juice Blend Concentrate, (b)(4) Passion Fruit Juice Blend Concentrate, Penguin Juice Co. Orange Juice Concentrate, (b)(4) Pineapple Juice Concentrate, and Penguin Juice Co. Prune Juice Concentrate products do not contain accurate declarations of the percentage of juice in the products, as required by 21 CFR 101.30(b). For example:
o The labels of your (b)(4) Juice Natural Apple Juice Blend Concentrate, (b)(4) White Grape Juice Blend Concentrate, and (b)(4) Passion Fruit Juice Blend Concentrate products declare “Contains 100% Flavored Juice Blend When Reconstituted to the Mixing Ratio”; however these products do not contain 100% juice when prepared according to the package directions. We calculated the total percentage of juice in your products using your firm’s product formulation sheets and the information you provided to our investigator regarding the firm’s substitution of all juice volumes in formulations containing white grape concentrate with a 50-50 blend of apple and pear concentrate because the white grape concentrate was no longer used. Based upon our calculations, your (b)(4) Natural Apple Juice Blend Concentrate, (b)(4) White Grape Juice Blend Concentrate, and (b)(4) Passion Fruit Juice Blend Concentrate products actually contain approximately 89%, 89% and 91% juice respectively when reconstituted according the package directions. Therefore, the label declaration of 100% juice blend is not accurate.
o The labels of your Penguin Juice Co. Orange Juice Concentrate, (b)(4) Pineapple Juice Concentrate, and Penguin Juice Co. Prune Juice Concentrate products do not contain declarations of percentage of juice in the product.
• Your (b)(4) Natural Apple Juice Blend Concentrate, (b)(4) White Grape Juice Blend Concentrate, and (b)(4) Passion Fruit Juice Blend Concentrate products fail to bear accurate common or usual names. As required by 21 CFR 102.33(a), for a carbonated or noncarbonated beverage that contains less than 100 percent and more than 0 percent fruit or vegetable juice, the common or usual name shall be a descriptive name that meets the requirements of 21 CFR 102.5(a) and, if the common or usual name uses the word "juice," shall include a qualifying term such as "beverage," "cocktail," or "drink" appropriate to advise the consumer that the product is less than 100 percent juice (e.g., "diluted apple juice beverage" or "apple juice drink"). Based on your formulas, your products contain less than 100% juice, when reconstituted according to your label instructions. However, your products are labeled as “juice blend concentrate” and fail to include a qualifying term appropriate to advise the consumer that the product is less than 100 percent juice.
• Your (b)(4) Natural Apple Juice Blend Concentrate, (b)(4) White Grape Juice Blend Concentrate, and (b)(4) Passion Fruit Juice Blend Concentrate products fail to adequately feature the statement of identity on the principal display panel (PDP). The label must present the statement of identity in bold face type on the PDP in a size reasonably related to the most prominent printed material on the panel, as required by 21 CFR 101.3(d). However, your product labels present the flavor of the drink (“Natural Apple”) in type size that is approximately twice the size of the type size in which the statement of identity (“Juice Blend Concentrate & Vitamin C Added”) is presented.
• Your (b)(4) Passion Fruit Juice Blend Concentrate product fails to accurately declare the characterizing flavor of this product. As required by 21 CFR 101.22(i)(1)(ii), if the food is commonly expected to contain a characterizing food ingredient (e.g. passion fruit) and the food contains no such ingredient, then the food shall be labeled either with the flavor of the product from which the flavor is derived or as “artificially flavored.” Additionally, 21 CFR 102.33(d)(1) requires that in a diluted multiple-juice beverage where one or more, but not all, of the juices are named on the label other than in the ingredient statement, and where the named juice is not the predominant juice, the common or usual name for the product shall indicate that the named juice is present as a flavor or flavoring. Your (b)(4) Passion Fruit Juice Blend Concentrate contains strawberry, orange, and raspberry flavors, but does not contain any passion fruit flavor. Therefore, your flavor must be declared as artificial and your product name must indicate that the named juice is present as a flavor or flavoring (e.g., “Passion Fruit, artificially flavored, juice drink”).
• Your (b)(4) Natural Apple Juice Blend Concentrate, (b)(4) White Grape Juice Blend Concentrate, and (b)(4) Passion Fruit Juice Blend Concentrate products fail to properly declare the common or usual name of several ingredients. The combined declaration of the juice ingredients as “Juice Concentrates (Pear, Apple, and/or White Grape)” in these products is not consistent with the requirements of 21 CFR 101.4 which requires that each individual ingredient be declared by common or usual name in descending order of predominance. In addition, several ingredients appear to be omitted from your declaration of ingredients. Your formulation sheet for the (b)(4) Natural Apple Juice Blend Concentrate product indicates that malic acid and vitamin solution is used; however these ingredients are not declared on your label. Your formulation sheet for the (b)(4) White Grape Juice Blend Concentrate Juice product indicates that vitamin solution is used; however this ingredient is not declared on your label. Your formulation sheet for the (b)(4) Passion Fruit Juice Blend Concentrate product indicates that orange emulsion and vitamin solution are added; however, these ingredients are not declared on your label. Also, there is no exemption for the use of “and/or” labeling with juice ingredients. The actual juice ingredient used in the product must be declared on the label.
You should take prompt action to correct the violations cited in this letter. Failure to correct these violations may result in enforcement action being initiated by the Food and Drug Administration without further notice. The Act provides for the seizure of violative products, the assessment of civil money penalties, and for enjoining the manufacturer and/or distributor of violative products.
For your information, a FDA Guidance for Industry that may be helpful to your firm is entitled "Guidance on Bulk Transport of Juice Concentrates and Certain Shelf Stable Juices.” A copy of the guidance was provided to you during your inspection and this guidance is also available on FDA's website at www.fda.gov.
This letter does not list all of the violations observed at your facility. You are responsible for ensuring that your firm operates in compliance with the Act, and FDA’s implementing regulations, including the juice HACCP regulation (21 CFR Part 120), food labeling regulations (21 CFR Part 101), and the Current Good Manufacturing Practice regulation for foods (21 CFR Part 110). [OGC3]
Please respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific things that you are doing to correct these violations. You may wish to include in your response documentation such as your HACCP plan, copies of your Sanitation Standard Operating Procedure, or other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, please explain the reason for your delay and state when you will correct any remaining violations.
Additional Comments:
We note that your (b)(4) Natural Apple Juice Blend Concentrate, (b)(4) White Grape Juice Blend Concentrate, and (b)(4) Passion Fruit Juice Blend Concentrate products bear the statement, “Vitamin C Added.” This is a relative claim as defined by 21 CFR 101.13(j). Under 21 CFR 101.54(e)(1), a product may use a relative claim using the term “added” to describe the level of vitamins provided that the food contains at least 10 percent or more of the recommended daily intake (RDI) for vitamins per recommended amount customarily consumed (RACC) than an appropriate reference food, the fortification is in accordance with FDA’s policy on fortification of foods (21 CFR 104.20), the identity of the reference food and the percentage (or fraction) that the nutrient is greater relative to the RDI are declared in immediate proximity to the most prominent such claim, and quantitative information comparing the level of the nutrient in the product per labeled serving with that of the reference food that it replaces is declared adjacent to the most prominent claim or to the nutrition label. However, your product does not provide the identity of the reference food; the percentage (or fraction) that the nutrient is greater relative to the RDI; or quantitative information comparing the level of the nutrients in the product per labeled serving with that of the reference food.
We also note that your (b)(4) Natural Apple Juice Blend Concentrate, (b)(4) White Grape Juice Blend Concentrate, and (b)(4) Passion Fruit Juice Blend Concentrate labels state “100% Vitamin C” which appears to be an incomplete nutrient content claim. Your statement fails to describe the percentage of vitamin C in relation to the RDI for the vitamin in a serving of the product [21 CFR 101.13(q)(3)]. For example, a complete nutrient content claim may read, “100% of the daily value of Vitamin C per serving.”
Your reply should be sent to the Food and Drug Administration, Attention: Tina M. Pawlowski, Ph.D., Compliance Officer, at the above address. If you have questions regarding any issue in this letter, please contact Compliance Officer Pawlowski at (313) 393-8217.
Sincerely,
/S/
Joann M. Givens
Detroit District Director
Detroit District Office
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