Inspections, Compliance, Enforcement, and Criminal Investigations
Sunshine Packing & Noodle Co., Inc 28-Sep-05
Department of Health and Human Services
| Public Health Service |
Food and Drug Administration
|555 Winderley PI., Ste. 200 |
Maitland, FL 32751
RETURN RECEIPT REQUESTED
September 28, 2005
Bill H. Chen, President
Sunshine Packing & Noodle Co., Inc.
57 Cantee Street
Jacksonville, FL 32204-1701
Dear Mr. Chen:
The Food and Drug Administration (FDA) conducted an inspection of your facility located at the above address on February 16-18, 2005. During the inspection, we collected samples of your "IPP Lo Cal Grape Jelly" product for lab analysis (Florida District received the results from this lab analysis on June 10, 2005) and label review to determine your firm's compliance with the Federal Food, Drug, and Cosmetic Act (the Act) and its implementing regulations in Title 21, Code of Federal Regulations, Part 101 (21 CFR 101). You can find the Act and FDA regulations through links on FDA's home page at www.fda.gov.
Our lab analysis and review of your product label found your "IPP Lo Cal Grape Jelly" product to be misbranded within the meaning of section 403(a)(1) of the Act [21 USC 343(a)(1)] because the labeling is false or misleading in that the amounts of total calories and total carbohydrates are significantly higher than the values declared for these nutrients on the label I[21 CFR 101.9(g)(5) and (6)]. Your label declares that the product provides 20 calories and 6g of total carbohydrate per serving, the serving being the entire one ounce packet of IPP Lo Cal Grape Jelly product. However, our analysis found the calories to be 3,71% (74 .2 calories) (original analysis) and 432% (86.3 calories) and 393% (78.6 calories) (check analyses) of the value on the label, and the total carbohydrates to be 358% (21.5 g) (original analysis) and 327% (19.6 g) (check analysis) of the value on the label.
The product is also misbranded under section 403(r)(1)(A) of the Act in that the label bears the term "Lo Cal," which is synonymous with the nutrient content claim "Low Calorie," but is not qualified to make this claim. The term "low calorie" has been defined by regulation in 21 CFR 101.60(b)(2)(i)(B) and may be used to describe a food that has 40 calories or less per Reference Amount Customarily Consumed (RACC) and per 50g when a food has a RACC of 30 g or less, or of two tablespoons or less. Based on the laboratory analysis of this product, the product does not comply with these requirements.
Furthermore, your "IPP Lo Cal Grape Jelly" product is misbranded within the meaning of section 403(q)(1) of the Act [21 USC 343(q)(1)] because the nutrition information is not provided in one of the formats required by 21 CFR 101.9. We also note that the serving size for this single serving container is not properly declared as specified by 21 CFR 101.9(b); for example, a description of the individual container or package must be used for declaring the serving size for single serving containers, e.g., "1 package" [21 CFR 101.9(b)(5)(iv)].
This letter may not list all the deviations at your facility. We note that your firm also received an FDA-483 form during the inspection, which cited numerous accounts of insanitary conditions at your firm. You are responsible for ensuring that your processing plant operates in compliance with the Act and all applicable regulations. You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations. We may, without further notice, take 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.
In addition, we note the following additional labeling issues. When the named firm on a package is not the manufacturer, terms such as "Manufactured foe' or "Distributed by" must be used to qualify the firm's connection to the product (e.g ., Distributed by RECIPE FOODS, INC., TAMPA, FL), as required by 21 CFR 101.5(c). We also note that the net quantity of contents statement is not presented in the lower 30% of the principal display panel as required by 21 CFR 101.105(f).
Please respond in writing within fifteen (15) working days from receipt of this letter. Your response should outline the specific things you are doing to correct and prevent the recurrence of these deviations. You may wish to include documents in your response that support 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 the remaining deviations.
Please send your reply to the Food and Drug Administration, Attention: Diane J. Englund, Compliance Officer, 555 Winderley Place, Suite 200, Maitland, Florida, 32751. If you have any questions regarding any issue in this letter, please contact Ms. Englund at (407) 475-4741.
Emma R. Singleton
Director, Florida District