DEPARTMENT OF HEALTH & HUMAN SERVICES
August 7, 2012
Mr. James Chong
Chairman and Owner
Double Deuce Jamaica Ltd.
7 Kentucky Avenue
Paterson, NJ 07503
Dear Mr. Chong:
The Food and Drug Administration (FDA) conducted an inspection of your facility at Yallahs Industrial Estate, Poorman’s Corner, Yallahs, St. Thomas, Jamaica, on February 3 – 4, 2012. During the inspection, labeling of your Premium Jamaican Ackee in Brine was collected for review. FDA has reviewed the labeling for this product and, based on our review, we have concluded that this product is in violation of section 403 of the Federal Food, Drug and Cosmetic Act (the Act) (21 U.S.C. § 343), and the food labeling regulations in Title 21, Code of Federal Regulations, Part 101 (21 CFR 101). You may find these regulations through links in FDA’s home page at www.fda.gov.
Your labeling deficiencies are as follows:
Your Premium Jamaican Ackee in Brine product is misbranded within the meaning of section 403(q) of the Act [21 U.S.C. § 343(q)] in that the nutrition facts information is not in an appropriate format as defined in 21 CFR 101.9. For example:
Trans fat is not declared [21 CFR 101.9(c)(2)(ii)].
The serving size declaration is not expressed in common household measure [21 CFR 101.9(b)(5)] and is not based on the correct reference amount customarily consumed (RACC). For fruits, the RACC is 140 grams [21 CFR 101.12(b)]. The suggested household measure for small pieces of fruit is “cups” [21 CFR 101.12(b)].
We note that “per 100 g” is not considered a household measure in the United States. US regulations do allow another column of figures to be used to declare the nutrient and food component information per 100 grams in addition to the information provided per serving size based on the RACC [21 CFR 101.9(b)(10)(i)].
Nutrition information is based on the edible portion. If the brine is typically consumed, the nutrition information should include the canning medium. We would not object to a second column declaring the nutrition information for an alternate version of the product (drained or undrained as appropriate), provided that it was properly identified.
Calories are not expressed to the nearest 10 calorie increment [21 CFR 101.9(c)(1)].
Sodium and potassium are not expressed to the nearest 10 mg increment [21 CFR 101.9(c)(4) and (5)]
The percent daily values of vitamin A, vitamin C, calcium, and iron per serving are not declared [21 CFR 101.9(c)(8)].
Your Premium Jamaican Ackee in Brine product is misbranded within the meaning of section 403(f) because the label contains information in two languages but does not repeat all the required label information in both languages. In accordance with 21 CFR 101.15(c), if a product label contains any representation in a foreign language or foreign characters, all words, statements, and other information required by or under authority of the Act to appear on the label must appear in the foreign language. Specifically, the ingredient statement should be stated in French, in addition to English.
The net quantity of contents for this product is expressed in terms of weight; therefore, the term “net weight” must be used when stating the quantity [21 CFR 101.105(j)(3)]. In conformance with the above, the term “net weight” should also be stated in French.
The above violations are not meant to be an all-inclusive list of violations that exist in connection with your products and labeling. It is your responsibility to ensure that the products you market are in compliance with the Act and regulations.
Please notify this office, in writing, within thirty (30) business days of the receipt of this letter, as to the specific steps you have taken to correct the violations noted above and to ensure that similar violations do not occur. Include any documentation necessary to show that correction has been achieved. If you cannot complete corrective actions within thirty business days, state the reason for the delay and the time within which the corrections will be completed.
Your response should be directed to Carrie Lawlor, U.S. Food and Drug Administration, Center for Food Safety and Applied Nutrition, Office of Compliance, Division of Enforcement, 5100 Paint Branch Parkway (HFS-608), College Park, Maryland 20740. If you have any questions regarding any issues in this letter, please contact Ms. Lawlor at (240) 402-0315 or via e-mail at firstname.lastname@example.org.
Jennifer A. Thomas
Division of Enforcement
Office of Compliance
Center for Food Safety
and Applied Nutrition