Inspections, Compliance, Enforcement, and Criminal Investigations
Juices Enterprises Inc. 11-Apr-08
Department of Health and Human Services
Public Health Service
New York District
April 11, 2008
RETURN RECEIPT REQUESTED
Juliet Mc Naughton
Juices Enterprises Inc.
1142 Nostrand Avenue
Brooklyn, New York 11225
Dear Ms. Naughton:
We inspected your juice processing facility, located at 142 Nostrand Avenue, Brooklyn, New York 11225 on November 13, 14, 15, 20 & 21, 2007. 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, and the Current Good Manufacturing Practice regulation for foods, Title 21, Code of Federal Regulations, part 110 (21 C.F.R. Parts 120 & 11.0). In accordance with 21 CFR 120.9, failure of a processor to have and implement a HACCP plan that complies with the requirements of 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). Additionally, failure of food facility to comply with the requirements of the Current Good Manufacturing Practice regulation, 21 CFR 110 renders food 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 your carrot juice, your pineapple juice and any other vegetable or fruit juices, whether sold as 100% juice, or used as ingredients in the manufacturing of juice beverages containing less than 100% juice, are adulterated in that they have been prepared packed, or held under insanitary conditions whereby they may have been rendered injurious to health. You may find the Act, the juice HACCP regulation, and the Juice HACCP Hazards and Controls Guidance through links in FDA's home page at www.fda,gov.
Your significant violations were as follows:
I. You must hold foods that can support the rapid growth of undesirable microorganisms, particularly those of public health significance, in a manner that prevents the food from becoming adulterated in order to comply with 21 CFR 110.80(b)(3). However, you failed to maintain your juice products, labeled as "KEEP REFRIGERATED" at refrigerated temperatures to prevent the rapid growth of Clostridium botulinum. Specifically, your carrot juice finished product labeled as "KEEP REFRIGERATED" was observed by our investigator to be stored un-refrigerated, in the production room for at least 24 hours. Moreover, our investigator observed that your firm is not equipped with adequate available refrigeration space for cooling and storing all your finished products at appropriate refrigerated temperatures.
II. You must develop, or have developed for you, a written hazard analysis to determine whether there are food hazards that are reasonably likely to occur for each type of juice that you process, and you must have and implement a written HACCP plan whenever that hazard analysis reveals one or more food safety hazards that are reasonably likely to occur, to comply with 21 C.F.R. Parts 120.7(a) and 120.8(a). However, your firm does not have a written hazard analysis or a written HACCP plan for your carrot juice, pineapple juice or any other 100% vegetable or fruit juices that you produce.
Furthermore, you must include in your hazard analysis and HACCP plan control measures that will consistently produce, at a minimum a 5 log reduction of the pertinent microorganism for at least as long as the shelf life of the product when stored under normal and moderate abuse conditions, to comply with 21 C.F.R. Part 120.24(a). The "pertinent microorganism" is defined as "the most resistant microorganism of public health significance that is likely to occur in the juice", 21 C.F.R. 120.24(a).
Moreover, as a result of several instances of botulism poisoning from refrigerated carrot juice the Agency recommends that a process be applied that will ensure that Clostridium botulinum growth and toxin production will not occur should the juice, as offered for sale by the processor, be kept un-refrigerated in distribution or by consumer. This guidance can be found at: http://www.cfsan.fda.gov/~dms/juicgu15.html
For acidic fruit juices, guidance on designating the pertinent microorganism can be found in the Juice HACCP Hazards and Controls Guidance. This guidance can be found at:http://www.cfsan.fda.gov/~dms/juicgul0.html
III. You must adequately monitor sanitation conditions and practices during juice processing with sufficient frequency to ensure, at a minimum, compliance with current good manufacturing practice requirements in 21 C.F.R Part 110 that are appropriate both to the plant and to the food being processed, to comply with 21 C.F.R. § 120,6 (h). Additionally, all of your juice and juice products must comply with 21 C.F.R. Part 110. However, you failed to do so as specified below:
1. You did not monitor all persons working in direct contact with food, food-contact surfaces, and food packing materials to ensure compliance with hygienic practices under 21 C.F.R. § 110.10(b)(5) and (8) as evidenced by the following:
• An employee was observed wearing torn gloves while filling glass bottles with carrot ginger drink;
• Employees were observed consuming foods and beverages in the production area during production of carrot ginger drink.
2. You did not monitor prevention of cross contamination from insanitary objects to food, food packaging material, and food contact surfaces, including utensils, gloves, and outer garments to ensure compliance with 21 CFR § 11.0.80(b)(5), as evidenced by the following:
• Unidentified individuals who were not employed in production activities were observed walking from the street directly into the production area during production of carrot ginger drink.
• During production of peanut punch drink (a beverage containing peanuts) an employee was observed using a towel to handle raw materials, clean equipment, and food contact surfaces and then storing the towel draped over a double compartment sink. The following day, during production of carrot ginger drink, the same towel was observed being removed from its draped position over the sink and being used on food contact surfaces.
3. You did not monitor pest control to ensure compliance with 21 C.F.R. § 1.10.35(c) as evidenced by flies that were observed in the production area on raw materials, food contact surfaces, and bottled carrot ginger drink that was not yet capped and sealed.
IV. You must maintain sanitation standard operating procedure records that, at a minimum, document the monitoring and corrections as set out in 21 C.F.R. § 120.6 (b), to comply with 21 C.F.R. § 120.6 (c). However, your firm did not maintain sanitation monitoring records for the processing of your juice beverages, documenting: safety of water that comes into contact with food or food contact surfaces, or is used in the manufacture of ice; condition and cleanliness of food contact surfaces, including utensils, gloves, and outer garments; prevention of cross contamination from insanitary objects to food, food packaging material, and other food contact surfaces, including utensils, gloves, and outer garments, and from raw product to cooked product; maintenance of hand washing, hand sanitizing, and toilet facilities; protection of food, food packaging material, and food contact surfaces from adulteration; proper labeling, storage, and use of toxic compounds; control of employee health conditions; and exclusion of pests.
In addition, your Carrot Juice, Carrot and Ginger Drink, Beet Carrot Juice, Irish [Sea] Moss, Ginger Beer Drink, Pineapple Twist Juice Drink, Double Trouble, Cashew Punch, Agony Peanut Punch, Original Roots, and Tan-pon-it Long Explosion Herbal Tonic products are misbranded under Section 403 of the Act, 21 U.S.C. § 343, due to violations of the labeling regulations under Part 101 of the
Code of Federal regulations as described below.
V. Your juice beverage products (Carrot Juice, Beet Carrot Juice, Carrot and Ginger Drink, Pineapple Twist Juice Drink, Cashew Punch, Agony, and Double Trouble) are misbranded under section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that these foods purport to be beverages containing fruit or vegetable juice and the labels fail to bear a percent juice declaration (21 C.F.R. § 101.30(b)(1)).
VI. Your products (Carrot Juice, Carrot and Ginger Drink, Beet Carrot Juice, Irish [Sea] Moss, Pineapple Twist Juice Drink, Double Trouble, Cashew Punch and Agony Peanut Punch are misbranded under section 403(q) of the Act [21 U.S.C. § 343(q)] because they fail to declare trans fat in their Nutrition Facts panels [21 C.F.R. § 101.9(c)(2)(ii)]. Regulations requiring the declaration of trans fat went into effect on January 1, 2006 [see 68 FR 41433]. You should review all of your product labels to ensure they comply with these regulations. For additional information on trans fat labeling, go to: http://www.cfsan.fda.gov/~dms/lab-cat.html#transfat. We also suggest that you review the "Nutrition Facts" labels of your products to assure that the format meets the requirements of 21 C.F.R, § 101.9(d) (e.g., the heading "Nutrition Facts" be set in a type size larger than all other print size in the nutrition label and be set the full width of the information provided in this label (21 C.F.R. § 101.9(d)(2)) and the name of each nutrient (other than vitamins or minerals) be immediately followed by the quantitative amount by weight for that nutrient (21 CFR 101.9(d)(7)(i)).
VII. The product "DOUBLE TROUBLE" is misbranded under section 403(i)(1) [21 U.S.C. § 343(i)(1)] in that its label fails to bear the common or usual name of the food or an appropriately descriptive term describing the food (21 C.F.R. § 101.3 (b)).
VIII. The products "ORIGINAL ROOTS herbal tonic" and "TAN-PON-IT Long EXPLOSION HERBAL TONIC" are misbranded under section 403(e)(1) [21 U.S.C. § 343(e)]in that the labels do not bear the place of business (address) of the manufacturer, packer, or distributor (21 C.F.R. § 101.5(a)).
This letter may not list all the deviations at your facility. You are responsible for ensuring that your firm operates in compliance with the juice HACCP regulation (21 CFR Part 120), the Current Good Manufacturing Practice regulation (21 CFR Part 110), and the food labeling regulations (21 CFR Part 101).
You should take prompt action to correct these violations and to establish procedures whereby such violations do not recur. Failure to do so may result in regulatory action without further notice. Such actions include seizure and injunction.
For your information when revising your product labels, please note the following:
• "IRISH (Sea) MOSS" - We are uncertain as to the nature of the ingredient "Icining Glass." All ingredients in a product must be listed by their common or usual name (21 CFR 101.4(a)(1)).
• "CASHEW PUNCH" - We are uncertain as to the nature of the ingredients identified as "Condensed Milk" and "Carnation Milk." If the "Condensed milk" ingredient is the canned milk product that is normally sweetened with sugar, the ingredient is likely a standardized food and should be labeled as such i.e., "sweetened condensed milk." Further, the ingredient statement should include all of the sub ingredients in sweetened condensed milk. (21 CFR 101.4(a) and 21 CFR 131.120).
Intervening material is not permitted in the ingredient statement under 21 CFR 101.2(e). For example, "Carnation" refers to a specific brand of "milk" and is therefore intervening in the ingredient statement of the "CASHEW PUNCH" label. In addition, words such as "Purified" (preceding water), and "fresh juiced" (preceding carrots, ginger or pineapple) should be removed from the ingredient statements of the labels as appropriate e.g., "Carrot Juice."
• As of March 6, 2008 there is no website at the address www.juicesenterpriseinc.com. Therefore unless this website is reestablished, under this or another name, the web address should be revised or removed.
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 deviations. 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, we expect that you will explain the reason for your delay and state when you will correct any remaining deviations.
Please send your reply to: the U.S. Food and Drug Administration, New York District, 158-15 Liberty Avenue, Jamaica, New York 11433, Attention: Anna Alexander, Compliance Officer, HFR-NE140. If you have questions regarding any issues in this letter, please contact Ms. Alexander at (718) 340-7000 ext. 5683.
Otto D. Vitillo