Inspections, Compliance, Enforcement, and Criminal Investigations
Blossom Valley Foods Inc 11/27/13
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
San Francisco District
1431 Harbor Bay Parkway
Alameda, CA 94502-7070
Telephone: 510-337-6700FAX: 510-337-6701
United Parcel Service
Delivery Signature Requested
November 27, 2013
Robert M. Wagner, President
Blossom Valley Foods, Inc.
20 Casey Street
Gilroy, CA 95020
Ref: FEI 2910359
Dear Mr. Wagner:
The Food and Drug Administration (FDA) conducted an inspection of your food processing facility, located at 20 Casey Street, Gilroy, California, from June 4 through 13, 2013. The inspection determined that your firm is engaged in the processing of acidified foods but has not filed scheduled processes with FDA for all of your acidified foods as required. You have significant deviations from the requirements of the Acidified Food regulations described in Title 21, Code of Federal Regulations (CFR), Part 108, Emergency Permit Control (21 CFR Part 108), and Part 114, Acidified Foods (21 CFR 114). These conditions cause the acidified foods processed and stored at your facility to be 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)] because these food products have been prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth or rendered injurious to health. In addition, FDA collected and reviewed samples of the labeling of your dietary supplement products during the inspection of your facility. Based on our review of your product labels, we have determined that your Noni Juice product, 32 oz., is promoted for conditions that cause it to be a drug within the meaning of section 201(g)(1)(B) of the Act [21 U.S.C. § 321(g)(1)(B)]. The therapeutic claims on your label establish that the product is a drug because it is intended for use in the cure, mitigation, treatment, or prevention of disease. You can find the Act and its associated regulations on the internet through links on the FDA web page at www.fda.gov.
We received your written response to the Form FDA 483 on August 9, 2013. After reviewing your response we continue to have concerns with the following significant observations:
1. As a commercial processor engaged in the processing of acidified foods, you must, not later than 60 days after registration and prior to the packing of a new product, provide FDA information as to the scheduled processes including, as necessary, conditions for heat processing and control of pH, salt, sugar, and preservative levels, and source and date of the establishment of the process, for each acidified food in each container size, as required by 21 CFR 108.25(c)(2). However, our inspection found that your firm failed to file a scheduled process with FDA for the acidified food products that you manufacture, including your Crying Tongue Hot Sauce product.
According to your undated written response, received on August 8, 2013, you plan to submit your scheduled processes for your acidified food products to FDA. Your response also indicates that this will take a while because the products may have to be recreated in order to obtain the process information required for filing. We recommend working with your Process Authority to ensure that the appropriate process information is included in your process filing forms. Please note that you must file processes prior to packing any new products. In addition, please indicate a date by which your firm will file your scheduled processes with FDA in your response to this letter.
Scheduled process information for acidified or low-acid canned foods must be submitted on Form FDA 2541a (Processing Filing for all Processing Methods Except Low Acid Aseptic). More information on filing can be found in the publication “Instructions for Establishment Registration and Processing Filing for Acidified and Low-Acid Canned Foods,” available at: http://www.fda.gov/food/guidanceregulation/foodfacilityregistration/%20acidifiedlacfregistration/default.htm
2. Your firm failed to ensure acidified foods are manufactured in accordance with the scheduled process as required by 21 CFR 114.80(a)(1). Specifically, your Crying Tongue Hot Sauce in 10 oz. glass jars produced on February 1, 2013 (date code 11103231B) was processed with filling temperatures of (b)(4) and (b)(4) and not filled at the minimum (b)(4) as stated in your scheduled process (dated May 11, 2011 from the State of California). In addition, your Batch Record for the Crying Tongue Hot Sauce indicates the process of heating all ingredients to (b)(4) and holding for (b)(4), whereas your scheduled process indicates the minimum temperature of (b)(4) for a minimum of (b)(4).
According to your written response, you have re-instituted the adherence to all scheduled processes. You indicate that any product that does not meet the stated scheduled process will be treated as a process deviation and samples will be sent to an independent laboratory for micro testing. Please note that according to 21 CFR 114.89, after a process deviation, the product must be either: (a) fully reprocessed by a process established by a competent process authority; (b) thermally processed as a low-acid food under part 113; or (c) set aside for further evaluation by a process authority as to any potential public health significance. Further, a record must be made of the procedures used in the evaluation and the results.
Unapproved New Drug
As stated above, your Noni Juice product, 32 oz., is promoted for conditions that cause it to be a drug within the meaning of section 201(g)(1)(B) of the Act [21 U.S.C. § 321(g)(1)(B)]. The therapeutic claims on your label establish that the product is a drug because it is intended for use in the cure, mitigation, treatment, or prevention of disease. An example of the claims that provide evidence that your product is intended for use as a drug include:
- “Noni Juice daily can help prevent certain diseases…”
Your Noni Juice Dietary Supplement product, 32 oz., is not generally recognized as safe and effective for the above referenced use and, therefore, the product is a “new drug” under section 201(p) of the Act [21 U.S.C. § 321(p)]. New drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from FDA, as described in section 505(a) of the Act [21 U.S.C. § 355(a)]; see also section 301(d) of the Act [21 U.S.C. § 331(d)]. FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate that the drug is safe and effective.
The above items are not intended to be an all-inclusive list of the objectionable conditions and/or practices in your facility. It is your responsibility to ensure that your establishment and your food products comply with the Act and its implementing regulations. You should take prompt action to correct all violations noted above. Failure to do so may result in regulatory action being initiated by the FDA without further notice. These actions include, but are not limited to seizure and/or injunction and/or issuance of an Order of Need to obtain and hold a Temporary Emergency Permit.
We also have the following additional comments concerning your response and your firm’s labels:
In your firm’s August 9, 2013 response, you included an updated juice HACCP plan titled “Juice Concentrates – (Kettle Pasteurization).” Your “(b)(4) Pasteurization” critical control point lists a critical limit of (b)(4) but fails to list the amount of time you hold the juice at temperatures equal to or greater than (b)(4). An adequate critical limit for pasteurization includes both time and temperature parameters. According to your monitoring records and information you provided our investigators during the inspection, you typically process juice at (b)(4) for (b)(4) which produces a shelf-stable product. If you use a single thermal processing step to produce a shelf-stable juice, or a thermal concentration process that includes all of the ingredients of a juice, you are not required to include control measures in your HACCP plan for achieving the 5-log pathogen reduction. However, under 21 CFR 120.24(a)(2), you must include a copy of the thermal process or the concentration process in your written hazard analysis and you must establish controls in your HACCP plan for any chemical and physical hazards identified in your hazard analysis.
Under section 201(ff)(2)(B) of the FFDCA (21 U.S.C. 321(ff)(2)(B)), the term “dietary supplement” means a product that, among other requirements, “is not represented for use as a conventional food or as a sole item of a meal or the diet.” However, your 32 oz. Noni Juice Dietary Supplement product includes nutrition information in the form of a “Nutrition Facts” panel. We note your 8 oz. Noni Juice Dietary Supplement product lists the nutrition information in the form of a "Supplement Facts".
Even when the label of a liquid product characterizes it as a dietary supplement, the product may not in fact be a dietary supplement. Liquid products can be represented as conventional foods as a result of factors such as their packaging, the volume in which they are intended to be consumed, their product or brand name, and statements about the product in labeling or advertising. In addition, the name of a product can represent the product as a conventional food.
In your written response to the FDA 483, you indicate that the Noni Juice products will no longer be labeled as “liquid dietary supplements” and that label will be re-printed. We recommend that you remove the disease claim from the product label prior to the upcoming re-print.
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 reinspection-related costs. A reinspection 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. Reinspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the reinspection and assessing and collecting the reinspection fees (21 U.S.C. 379j-31(a)(2)(B)). For a domestic facility, FDA will assess and collect fees for reinspection-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 reinspection-related costs.
Please notify this office in writing within 15 working days of receipt of this letter, of the specific steps you have taken to correct the noted violations and to prevent recurrence. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed.
Your response should be sent to:
Lawton W. Lum
Director, Compliance Branch
U.S. Food and Drug Administration
San Francisco District
1431 Harbor Bay Parkway
Alameda, CA 94502
Please reference the CMS number 411857 in your response.
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.
Kathleen M. Lewis, J.D.
San Francisco District Office