DEPARTMENT OF HEALTH & HUMAN SERVICES
June 12, 2012
Mr. Justin S. Uy
President and Founder
Profood International Corporation
No 12 Res. Roxas Street
6000 Cebu City
Dear Mr. Uy:
The Food and Drug Administration (FDA) conducted an inspection of your facility on November 17 – 18, 2011. During the inspection, labels of your Mango Juice Nectar and Four Seasons Juice Nectar products were collected for review. FDA has reviewed the labeling for these products, and based on our review, we have concluded that these products are in violation of the Federal Food, Drug and Cosmetic Act (the Act), 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 juice nectar products are misbranded within the meaning of section 403(a)(1) of the Act [21 U.S.C. § 343(a)(1)] in that the labeling is false or misleading with respect to the percentage juice declaration. While your Mango Juice Nectar and Four Seasons Juice Nectar product labels declare the percentage juice content to be 37% and 25% respectively, your labels also contain the statement “Our Juice Nectar is made 100% from the finest Quality Mangoes in the world!” This statement is false or misleading because the statement may be perceived by the consumer to mean that the product contains 100% juice. Under 21 CFR 101.30(1), a beverage required to bear a percentage juice declaration on its label that contains less than 100 percent juice, cannot bear any other percentage declaration that describes the juice content of the beverage in its label or in its labeling.
Your juice nectar products are 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:
- Your product labels fail to declare the calories from fat as required [21 CFR 101.9(c)(l )(ii)].
- Your Mango Juice Nectar product label fails to declare the percent daily value of calcium and iron as required [21 CFR 101.9(c)(8)(ii)].
- Your Nutrition Facts panel declares “carbohydrate,” but does not declare it in the required manner. Title 21 CFR 101.9(c)(6) requires the declaration of total carbohydrate to be titled "Carbohydrate, total" or "Total carbohydrate.” Under 21 CFR 101.9(c)(6) and 21 CFR 101.9(j)(13)(ii)(B), there is no provision for the abbreviation of “carbohydrate” as the nutrient title.
- The required footnote is missing on your Mango Juice Nectar product [21 CFR 101.9(d)(9)].
- There is no provision for the declaration "Per 8.4 fl oz (250 ml)" to be used in place of "Serving Size." [21 CFR 101.9(d)(3)(i)].
- The Nutrition Facts panels on your Four Seasons Juice Nectar and Mango Juice Nectar products do not meet the font requirements in 21 CFR 101.9(d)(l)(iii). The ''Nutrition Facts" heading must appear in a type size no smaller than 13 point, and a minimum type size of 6 point and 8 point are required for the other information in the nutrition label.
- "Sugars" on your Mango Juice Nectar product must be indented [21 CFR 101.9(c)(6)(ii)].
Your Four Seasons Juice Nectar product is misbranded within the meaning of section 403(f) of the Act [21 U.S.C. § 343(f)] in that the product label contains information in two languages but does not repeat all the required label information in both languages. As required by 21 CFR 101.15(c)(2), 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. Your Four Seasons Juice Nectar product label contains representation in an additional language besides French and English, but does not contain nutrition labeling or the name and address of the manufacturer, packer or distributor in the additional language.
In addition, we note that your Four Seasons Juice Nectar juice product contains artificial flavor. If this artificial flavor simulates, resembles or reinforces the characterizing flavor, the name of the food must be in accordance with 21 CFR 101.22(i)(2).
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) working 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 corrective actions cannot be completed within thirty working 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 email@example.com.
Jennifer A. Thomas
Division of Enforcement
Office of Compliance
Center for Food Safety and Applied Nutrition