| Public Health Service Food and Drug Administration |
| Chicago District 550 West Jackson Blvd., 15th Floor Chicago, Illinois 60661 Telephone: 312-353-5863 |
Department of Health and Human Services
September 22, 2011
WARNING LETTER
CHI-19-11
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
Mr. Donald W. Franko, Sr.
President
Florida Fruit Juices, Inc.
7001 West 62nd Street
Chicago, IL 60638
Dear Mr. Franko:
The United States Food and Drug Administration (FDA) inspected your firm, located at 7001 W 62nd Street, Chicago, IL 60661, between April 6, 2011 and April 29, 2011. We found that you have serious violations of the Food Labeling regulation, Title 21, Code of Federal Regulations, Part 101 (21 CFR Part 101). Based on your failure to comply with the requirements of 21 CFR Part 101, we have determined that your (b)(4) product, your (b)(4) artificially flavored Cherry Drink product, your (b)(4) Fruit Punch product, and your (b)(4) Fruit Punch product are misbranded within the meaning of Section 403 of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 343. You may find the Act and the Food Labeling regulations through links in the FDA's homepage at http://www.fda.gov./
Your significant violations of 21 CFR Part 101 include the following:
1. Your (b)(4) product is misbranded within the meaning of Section 403(r)(1)(A) of the Act [21 U.S.C. § 343(r)(1)(A)] because the label bears the claim "Fortified with vitamins" on the principal display panel, but the product does not meet the requirements for fortification. Under Section 403(r)(1)(A) of the Act, a claim that characterizes the level of any nutrient which is of the type required to be in the label or labeling of the food must be made in accordance with an FDA regulation that defines the term(s) used in the claim.
21 CFR 101.54(e)(ii) states that when a relative claim such as "fortified" is made on a label based on a nutrient that has been added to the food, fortification must be in accordance with the policy in 21 CFR 104.20(a). The policy on fortification in 21 CFR 104.20(a) states that FDA does not consider it appropriate to fortify sugars or snack foods, such as candies and carbonated beverages. Because your product is a sugary beverage consisting of water, sugar, and no juice, the fortification of your product with vitamins does not comply with the policy on fortification of foods in 21 CFR 104.20(a). Therefore, the "fortified" claim on your product label may not be made.
2. Your (b)(4) 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 described in 21 CFR 101.9.
Specifically,
• Calories are not expressed to the nearest 5-calorie increment as required by 21 CFR 101.9(c)(1) for statements up to and including 50 calories. Your product declares Total Calories as 37;
• Sodium is not expressed to the nearest 5 milligram increment as required by 21 CFR § 101.9(c)(4) for amounts from 5 to 140 milligrams. Your product declares Sodium as 87 mg;
• Your product label expresses a percent Daily Value for trans fat. However, because no daily reference value has been established for trans fat, no percent listing should be given, in accordance with 21 CFR 101.9(d)(7)(ii);
• The nutrition label does not meet the bolding requirements in 21 CFR 101.9(d)(1)(iv);
• The nutrients saturated fat and trans fat are not indented as required by 21 CFR 101.9(c)(2)(i) and (ii);
• The "Not a significant source of' statement lists the nutrients "saturated fat" and "trans fat," although both of those nutrients are declared on the nutrition label. Under 21 CFR 101.9(c)(2)(i) and (ii), these nutrients are only to be included in the "Not a significant source of' statement if a statement of their content is not declared on the nutrition label;
• In accordance with 21 CFR 172.804(d)(2), the statement "PHENYLKETONURICS: CONTAINS PHENYLALANINE" must appear in the labeling prominently and conspicuously as compared to other words, statements, designs or devices and in bold type and on clear contrasting background in order to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use. This phrase appears on your label in type that is not bold, and in a manner that is not prominent and conspicuous. Furthermore, this statement is placed inside the nutrition facts panel box, which is impermissible under 21 CFR 101.9(c). 21 CFR 101.9(c) states that no nutrients or food components other than those listed as either mandatory or voluntary may be included within the nutrition label.
3. Your (b)(4) artificially flavored Cherry Drink product is misbranded within the meaning of Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that your label fails to declare all of the ingredients used by your firm in the production of this product in accordance with 21 CFR 101.4(a)(1). According to the product formulation collected during the inspection, your product does not list the following ingredients: Sodium Hexamate (and its function) and Ascorbic Acid.
4. Your (b)(4) Fruit Punch, (b)(4) Fruit Punch and (b)(4) products are misbranded within the meaning of Section 403(k) of the Act [21 U.S.C. 343(k)] because the products bear or contain artificial flavoring or a chemical preservative but the product labels do not comply with the applicable regulations. Specifically,
• In accordance with 21 CFR 101.22(i)(2), when a food contains any artificial flavor which simulates, resembles or reinforces the characterizing flavor, the name of the characterizing flavor (or a descriptive generic term such as "fruit punch" [see 21 CFR 101.22(i)(3)(iii)] must be accompanied by the word(s) "artificial" "or artificially flavored" in letters not less than one-half the height of the letters in the name of the characterizing flavor or descriptive generic term. Your (b)(4) Fruit Punch and (b)(4) Fruit Punch product labels state "NATURALLY and ARTIFICIALLY FLAVORED BEVERAGE" in letters that are less than one-half the height of the phrase "fruit punch";
• In accordance with 21 CFR 101.22(i)(2), when a food contains any artificial flavor which simulates, resembles or reinforces the characterizing flavor, the name of the food on the principal display panel or panels of the label must be accompanied by the common or usual name(s) of the characterizing flavor in letters not less than one-half the height of the letters used in the name of the food. Furthermore, under 21 CFR 101.22(i)(2) the name of the characterizing flavor shall be accompanied by the word(s) "artificial" or "artificially flavored," in letters not less than one-half the height of the letters in the name of the characterizing flavor (e.g., "artificial vanilla," "artificially flavored strawberry," or "grape artificially flavored"). Your (b)(4) product label does not state a characterizing flavor that is accompanied by the word(s) "artificial" or "artificially flavored.";
• The ingredient statement for your (b)(4) product declares the presence of the chemical preservatives sodium benzoate and potassium sorbate, but fails to provide a separate description of the function of these ingredients as required. In accordance with 21 CFR 101.22(j), the label of a food to which a chemical preservative has been added shall bear a label declaration stating both the common or usual name of the ingredient and a separate description of its function, e.g. "preservative", "to retard spoilage", "a mold inhibitor", "to help protect flavor" or "to promote color retention".
5. Your (b)(4) artificially flavored Cherry Drink is misbranded within the meaning of Section 403(e)(2) [21 U.S.C. 343(e)(2)] in that the outer container for your product sold to individual customers does not provide a declaration of the net quantity of contents expressed in the terms of weight, measure, numerical count, or a combination of numerical count and weight or measure, as required under 21 CFR 101.105(a).
For additional information on food labeling requirements go to http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/
GuidanceDocuments/FoodLabelingNutrition/FoodLabelingGuide/default.htm.
The above is not intended to be an all-inclusive list of violations in your labeling or at your facility. It is your responsibility to ensure that your facility and all of your products are 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.
You should take prompt action to correct the violations described in this letter and establish and implement procedures which will prevent them from occurring in the future. Failure to take appropriate corrective action may result in FDA taking regulatory action, such as seizure or injunction, without further notice.
In addition to the above violations, we have the following comment:
• The percentage juice declaration for your (b)(4) Fruit Punch and (b)(4) products are not in easily legible boldface print or type in distinct contrast to other printed or graphic matter, as required by 21 CFR 101.30(e)(2).
You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific actions you are taking to correct the above violations. You should include in your response documentation such as copies of your product labels and/or other useful information that would assist us in evaluating 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 any remaining violations.
Please send your reply to the Food and Drug Administration, attention: Rosemary Sexton, Compliance Officer, at the address above. If you have any questions regarding any issues in this letter, please contact Ms. Sexton at 312-596-4225.
Sincerely,
/S/
Scott J. MacIntire
District Director
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