|Company:||Medley Tomatoes, Inc.|
|Subject:||Federal Food, Drug and Cosmetic Act/Misbranded|
|Issuer:||Florida District Office|
|Issued:||Feb. 22, 2007||Closed:||
Department of Health and Human Services
Public Health Service
555 Winderley Pl., Ste 200
RETURN RECEIPT REQUESTED
February 22, 2007
Arnon Ziv, President
Medley Tomatoes, Inc.
7961 NW 76th Street
Medley, Florida 33166-7512
Dear Mr. Ziv:
The Food and Drug Administration conducted two inspections of your firm located at the above address on August 22 &23, 2006 and November 7, 9, 13-15, 2006. During the inspections, samples of some of your product labels were collected to determine compliance with the Federal Food, Drug, and Cosmetic Act (the Act) and its implementing regulations in Title 21, Code of Federal Regulations (21 CFR). You can find the Act and FDA regulations through links in FDA's homepage at www.fda.gov.
Based on our inspections and review of your labeling, we have found serious violations of Section 403 of the Act (21 U.S.C. § 343) and Title 21, Code of Federal Regulations, Sections 155 and 101 (21 CFR 155 and 101). Your significant violations were as follows:
Your Divine Celestio brand tomato paste in 28 ounce and 6 pound-10 ounce cans is misbranded within the meaning of Section 403(g)(1) of the Act (21 U.S.C. § 343(g)(1))because it purports to be or is represented as a food (tomato paste) for which a definition and standard of identity has been prescribed in 21 CFR 155.191, and it does not conform to the definition and standard. Specifically, your Divine Celestio brand tomato paste contains corn syrup, which is not authorized in 21 CFR 155.191 as one of the optional ingredients that may be used in tomato concentrates such as tomato paste.
Your Divine Celestio brand tomato paste in 28 ounce and 6 pound-10 ounce cans is misbranded within the meaning of section 403(i)(2) of the Act (21 U.S.C. § 343(i)(2)) because the ingredient statement on the product label fails to declare all of the ingredients in the product by their common or usual names, as required by 21 CFR 101.4. Your product contains corn syrup, salt, citric acid, tomato paste, and water. Your firm fails to list these ingredients on the product label, which includes only tomatoes as an ingredient.
Your Divine Celestio brand tomato paste in 28 ounce cans is misbranded within the meaning of section 403(q) of the Act (21 U.S.C. § 343(q)) in that the Nutrition Facts panel fails to declare trans fat as required by 21 CFR 101.9(c)(2)(ii). The regulation 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 this regulation. For additional information on trans fat labeling, go to http://www.cfsan.fda.gov/~dms/lab-cat.html#transfat .
We note that during the inspection you stated that some of your Divine Celestio brand tomato paste is manufactured for export to [redacted]. In order to export food products that other wise would be considered misbranded, you must satisfy the requirements in section 801(e)(1) of the Act (21 U.S.C. § 381) and 21 CFR 1.101. Specifically, you must have records demonstrating the following: (1) that the product meets the foreign purchaser's specifications, (2) the product does not conflict with the laws of the importing country, (3) the product is labeled on the outside of the shipping package that it is intended for export, and (4) that the product is not sold or offered for sale in the United States. During our inspection, you could provide no documentation to demonstrate your compliance with any of these requirements. Food that does not meet the requirements of section 801(e)(1) cannot legally be exported and is subject to enforcement action under the Act.
The above violations are not meant to be an all-inclusive list of deficiencies regarding your food product labels. It is your responsibility to ensure that all of your products are in compliance with applicable statutes and regulations. You should take prompt action to correct these violations. You should also review the labeling of all your products, take corrective action where appropriate, and establish procedures whereby such violations do not recur. Failure to promptly correct these violations may result in regulatory action without further notice, such as seizure of these misbranded products and/or injunction of your facility to prevent continued violation of the Act.
Please notify this office in writing within fifteen (15) working days from the date you receive this letter of the steps you have taken to correct violations. For corrections that you can not complete within the 15 working days, state the reason for the delay and your timeframe for completion. Please provide documentation of the corrections as they are made, including copies of any revised labels, and inform us of your plan for preventing similar violations in the future.
Please send your reply to the Food and Drug Administration, Attention: Brant M. Schroeder, Compliance Officer, 555 Winderley Place, Suite 200, Maitland, Florida, 32751. If you have any questions regarding any issue in this letter, please contact Mr. Schroeder at (407) 475-4763.
Emma R. Singleton
Director, Florida District