Department of Health and Human Services
Public Health Service
Food and Drug Administration
San Juan District
466 Fernández Juncos
San Juan, Puerto Rico 00901-3223
SEP 27, 2012
Return Receipt Requested
Mr. Eluith Velez
Altura Food, Inc.
P. O. Box 1367
Ciales, Puerto Rico 00638
Dear Mr. Velez:
The United States Food and Drug Administration (FDA) conducted inspections of your pasteurized fruit juice beverages manufacturing facility located at Road #149, Km 15.5, Bo Jaguas, Ciales, Puerto Rico 00638 on March 28 and 29, April 17, 18 and 25, and June 28-29, 2012. FDA collected product labels during the inspection. Further review of your labels found that your AFI Fruit Punch and the V-100 Apple Carrot, Cranberry, and Orange Juice products that you manufacture for your customers are misbranded within the meaning of section 403 of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 343] and the implementing regulations contained within Title 21, Code of Federal Regulations, Part 101 (21 CFR Part 101). You can find the Act and FDA’s regulations through links on FDA’s home page at http://www.fda.gov .
1. The V100 Orange Juice product is misbranded within the meaning of section 403(g)(1) of the Act [21 U.S.C. § 343(g)(1)] in that it is represented as a food for which definitions and standards of identity have been prescribed by regulation but it fails to conform to such definitions and standards. This product is represented as orange juice from concentrate, but it includes ascorbic acid which is not permitted by the standard in 21 CFR 146.145.
FDA has not objected to the fortification of standardized juices provided that the statement of identity reveals that the product has been fortified and the standardized juice meets the requirements of the standard except for the fortification ingredient(s). For more information, see Compliance Policy Guide (CGP) Sec. 505.700 at http://www.fda.gov/ICECI/ComplianceManuals/CompliancePolicyGuidanceManual/ucm074434.htm .
2. Your AFI Fruit Punch and the V100 Apple Carrot, V100 Cranberry, and V100 Orange Juice products are misbranded within the meaning of 403(i)(1) of the Act [21 U.S.C. § 343(i)] in that they do not bear adequate common or usual names. Specifically:
- As required by 21 CFR 102.33(a), for a carbonated or noncarbonated beverage that contains less than 100 percent and more than 0 percent fruit or vegetable juice, the common or usual name shall be a descriptive name that meets the requirements of 21 CFR 102.5(a) and, if the common or usual name uses the word "juice," shall include a qualifying term such as "beverage," "cocktail," or "drink" appropriate to advise the consumer that the product is less than 100 percent juice (e.g., "diluted apple juice beverage" or "apple juice drink"). Based on the label, the V100 Cranberry Juice product contains 27% juice; however, it is labeled as “Cranberry Juice.”
- Based on your manufacturing records and label declaration, the V100 Cranberry Juice product contains predominantly apple juice. However, the name for this product fails to comply with either 21 CFR 102.33(c) or 102.33(d) as follows:
o As required by 21 CFR 102.33(c), if a diluted multiple-juice beverage or blend of single-strength juices contains a juice that is named or implied on the label or labeling other than in the ingredient statement (represented juice), and also contains a juice other than the named or implied juice (nonrepresented juice), then the common or usual name for the product shall indicate that the represented juice is not the only juice present (e.g., "Apple blend; apple juice in a blend of two other fruit juices."). Based on your manufacturing records and label declaration, the V100 Cranberry Juice product contains apple juice; however, the name for this product fails to indicate that cranberry juice is not the only juice present.
o As required by 21 CFR 102.33(d), in a diluted multiple-juice beverage or blend of single-strength juices where one or more, but not all, of the juices are named on the label other than in the ingredient statement, and where the named juice is not the predominant juice, the common or usual name for the product shall indicate that the named juice is present as a flavor or flavoring (e.g., "Raspcranberry"; raspberry and cranberry flavored juice drink); or include the amount of the named juice, declared in a 5- percent range (e.g., Raspcranberry; raspberry and cranberry juice beverage, 10- to 15-percent cranberry juice and 3- to 8-percent raspberry juice). The 5-percent range, when used, shall be declared in the manner set forth in 102.5(b)(2). The V100 Cranberry Juice product is manufactured with predominantly apple juice; however, the label fails to state that the named juice (i.e. cranberry juice) is present as a flavor or flavoring.
- As required by 21 CFR 102.33(g)(1), if one or more juices in a juice beverage is made from concentrate, the name of the juice must include a term indicating that fact, such as "from concentrate," or "reconstituted." Such term must be included in the name of each individual juice or it may be stated once adjacent to the product name so that it applies to all the juices, (e.g., "cherry juice (from concentrate) in a blend of two other juices" or "cherry juice in a blend of 2 other juices (from concentrate)"). The term shall be in a type size no less than one-half the height of the letters in the name of the juice. Your AFI Fruit Punch is made from several juices from concentrate; however, your product name does not include a term indicating that fact. The V100 Apple Carrot, V100 Cranberry and V100 Orange Juice product labels bear the term “from concentrate;” however, it is not adjacent to the product name or at least one-half the height of the letters in the name of the juice.
3. Your AFI Fruit Punch and the V100 Apple Mango, V100 Apple Carrot, and V100 Orange Juice products are misbranded within the meaning of 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that they are fabricated from two or more ingredients, but do not bear the common or usual name of each such ingredient, and they are foods purporting to be beverages containing vegetable or fruit juice, but do not bear an appropriate statement of the total percentage of such fruit or vegetable juice contained in the food. Specifically:
- As required by 21 CFR 101.4(a), ingredients required to be declared on the label or labeling of a food shall be listed by common or usual name in descending order of predominance by weight. Our investigator observed that the V100 Apple Mango product is made with malic acid and gum acacia solution; however these ingredients are not declared on the label. Also, the V100 Cranberry Juice label bears the ingredient name “HFCS.” This is not appropriate common or usual name for high fructose corn syrup.
- As required by 21 CFR 101.30(b)(3), if a beverage contains 100 percent juice and also contains non-juice ingredients that do not result in a diminution of the juice soluble solids or, in the case of expressed juice, in a change in the volume, when the 100 percent juice declaration appears on a panel of the label that does not also bear the ingredient statement, it must be accompanied by the phrase "with added ___," the blank filled in with a term such as "ingredient(s)," "preservative," or "sweetener," as appropriate (e.g., "100% juice with added sweetener"), except that when the presence of the non-juice ingredient(s) is declared as a part of the statement of identity of the product, this phrase need not accompany the 100 percent juice declaration. Your AFI Fruit Punch, V100 Apple Carrot, and V100 Orange Juice products contain other ingredients such as natural flavors, ascorbic acid, and colors; however, your percent juice declarations on your principal display panels fail to bear this information.
4. Your AFI Fruit Punch and the V100 Apple Carrot, V100 Cranberry, and V100 Orange Juice products are misbranded within the meaning of section 403(r)(1)(A) of the Act [21 U.S.C. § 343(r)(1)(A)] in that the labels bear nutrient content claims, but the products do not meet the requirements to bear the claims. Under section 403(r)(1)(A) of the Act, a claim that characterizes the level of a nutrient which is of the type required to be in the labeling of the food must be made in accordance with a regulation authorizing the use of such a claim. Characterizing the level of a nutrient in food labeling without complying with the specific requirements pertaining to nutrient content claims for that nutrient misbrands the product under section 403(r)(1)(A) of the Act.
Specifically, your AFI Fruit Punch and V100 Cranberry, V100 Apple Carrot, and V100 Orange Juice products are misbranded because their labels bear the nutrient content claims “no sugar added” or “sin azucar añadida [no sugar added]” but do not meet the requirements for a “sugar content” nutrient content claim. As set forth in 21 CFR 101.60(c)(2)(v), the term “no sugar added” may be used in the labeling of a product that does not meet the requirements for a “low” or “reduced calorie” food only if the product bears a statement that the food is not “low calorie” or “calorie reduced” and directs consumers’ attention to the nutrition panel for further information on sugar and calorie content. These products do not meet the requirements for a “low calorie” or “calorie reduced” food because they have a reference amount customarily consumed (RACC) greater than 2 tablespoons and provide more than 40 calories per RACC (21 CFR 101.60(b)(2)(i)(A)). However, the product labels do not state that fact and direct the consumers’ attention to the nutrition panel for further information as required by 21 CFR 101.60(c)(2)(v).
In addition, the V100 Cranberry product label bears the claim “sin azucar añadida [no sugar added].” This claim may only be used if no amount of sugars, as defined in 21 CFR 101.9(c)(6)(ii), or any other ingredient that contains sugars that functionally substitute for added sugars is added during processing or packaging. However, based upon the information on the product label, this product contains “HFCS” (high fructose corn syrup), which is a sweetener and functions as a sugar. Therefore, the claim “sin azucar añadida” misbrands this product under section 403(r)(1)(A) of the Act.
5. Your AFI Fruit Punch and V100 Cranberry and V100 Apple Carrot Juice products are misbranded within the meaning of section 403(a)(1) of the Act [21 U.S.C. § 343(a)(1)] in that the labels bear information that is false or misleading. Specifically,
- The V100 Cranberry Juice label bears the statement “Unsweetened;” however, based upon the information on the product label, this product is made with sucralose and HFCS (high fructose corn syrup) which both function as sweeteners. Therefore, this statement is false.
- The Nutrition Facts label on the V100 Apple Carrot Juice product label declares “0g” for both Total Carbohydrates and Sugar. However, during the inspection we learned that you obtained a nutritional data report for this product that indicates that the product contains 27 g of Total Carbohydrates per serving. In addition, the basic nature of apple and carrot juice includes the presence of “sugars,” which is further documented in the USDA National Nutrient Database. Therefore, your declaration of both Total Carbohydrates and Sugar as “0g” is false.
- The label of the AFI Fruit Punch product lists apple, passion fruit, and grape juice concentrate in the ingredients statement. However, the vignette on the label shows additional fruits such as banana, pineapple, pear, orange, and strawberry. Neither these fruits nor their juices are ingredients in this product. Consequently, the label is misleading.
We also note that your AFI Fruit Punch label states “120% Vitamin C” which appears to be an incomplete nutrient content claim. Your statement fails to describe the percentage of vitamin C in relation to the Recommended Daily Intake (RDI) for the vitamin in a serving of the product [21 CFR 101.13(q)(3)]. For example, a complete nutrient content claim may read, “120% of the daily value of Vitamin C per serving.”
In addition to the labeling violations cited above, we also note that there were observations related to Juice Hazard Analysis Critical Control Point (HACCP) and Current Good Manufacturing Practices (CGMP) Regulations included in the Form FDA 483, List of Inspectional Observations provided to your firm and discussed with you during the inspection. In your response to the Form FDA-483, received on May 16, 2012, you promised to correct these issues. The effectiveness of your implemented corrective actions will be verified during our next scheduled inspection.
U. S. Food and Drug Administration, HFS-681
5600 Fishers Lane
Rockville, MD 20857
When completed, the form may be faxed to (301) 210-0247 or mailed to the address above. FDA will process registrations submitted by mail or fax and provide a facility's registration number using the same method used to submit the registration to FDA.
Further, Section 743 of the Act, 21 U.S.C. § 379j-31, authorizes FDA to assess and collect fees to cover FDA's costs for certain activities, including re-inspection-related costs. A re-inspection is one or more inspections conducted subsequent to an inspection that identified noncompliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Re-inspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA's arranging, conducting, and evaluating the results of the re-inspection and assessing and collecting the re-inspection fees, 21 U.S.C. § 379j-31(a)(2)(B). For a domestic facility, FDA will assess and collect fees for re-inspection-related costs from the responsible party for the domestic facility. The inspection noted in this letter identified noncompliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any re-inspection-related costs.
This letter may not list all the violations related to your products or their labeling. You are reminded that it is your responsibility for ensuring that your firm operates in compliance with the Act, FDA’s regulations for Food Labeling [21 CFR Part 101] and all other applicable laws and regulations. Please take prompt action to correct these violations and to implement procedures whereby such violations do not recur. Failure to do so may result in regulatory action without further notice, including seizure and injunction.
Please respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific steps you are taking to correct the violations cited above. You should include in your response evidence such as documents and/or procedures implemented, copies of the revised labels for the products that your firm manufactures and distributes, or other information that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, this agency expects that you will explain the reason for your delay and state when you will correct any remaining violations.
Your written reply to these concerns should be directed to the Food and Drug Administration, attention: Mrs. Maridalia Torres, District Director, at 466 Fernández Juncos Avenue, San Juan, Puerto Rico 00901-3223. If you have any questions regarding any issue in this letter, please contact Mrs. Marilyn Santiago, Compliance Officer, at (787) 474-9535.
San Juan District