Inspections, Compliance, Enforcement, and Criminal Investigations
Grupo Gloria/Suiza Dairy
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|San Juan District|
466 Fernandez Juncos Avenue
San Juan, PR 00901·3223
TEL (787) 474-9500
FAX (787) 729-6658
August 31, 2006
RETURN RECEIPT REQUESTED
Mr. Jorge Rodriguez Rodriguez
Grupo Gloria/Suiza Dairy
Ave. Republica de Panama 2461
Urb. Santa Catalina
Lima 13, Peru
Dear Mr. Rodriguez:
This letter is in reference to the inspection of your facility located at Road number 467, kilometer 0.9 Sector Camaseyes, Aguadilla, Puerto Rico from March 3, 2006 to April 27, 2006, by investigators from the U.S. Food and Drug Administration (FDA). During the inspection, labels of your fruit juice beverages and fruit juice products were collected. Our review of these labels and other evidence collected by the investigators shows violations of the Federal Food, Drug, and Cosmetic Act (the Act) and Title 21, Code of Federal Regulations (CPR). You can find the Act and FDA regulations through links on FDA's home page at www.fda.gov.
1. Your Suiza Fruit Puro Light with Calcium Orange Juice Beverage, 64 fl. oz., is misbranded within the meaning of section 403(i)(1) of the Act [21 U.S.C. 343(i)(1)] in that the label fails to bear the common or usual name of the food. As stated in 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." This required term may 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.
Further, your product is misbranded within the meaning of section 403(r)(1)(A) [21 U.S.C. 343(r)(1)(A)] in that the label bears the nutrient content claim "light," but the use of this claim does not comply with the regulations prescribing requirements for the claim [see 21 CFR 101.13(j), 101.56]. Relative claims such as "light" compare the nutrient content of the food that bears the claim with the nutrient content of an appropriate reference food. According to your product label, orange juice is the reference food for the 'light" claim on Suiza Fruit Puro Light with Calcium Orange Juice Beverage. However, the reference food for "light" must be a similar food to the food bearing the claim (e.g., "regular" potato chips for a claim about "light" potato chips), as required by 21 CPR 101.13(j)(1)(i)(B). Your product is a diluted orange juice beverage (see 21 CFR 102.33(a)). Orange juice beverage is a different food than orange juice, which must be 100% juice (see 21 CFR 146.135). Therefore, the use of "light" on your product label does not comply with the requirements for this claim and misbrands the product.
The above-mentioned misbranding violation under section 403(i)(1) of the Act and 21 CFR 102.33(g)(1) was brought to your firm's attention during a meeting held at our District Office on August 10, 2005, as well as in a letter dated July 5, 2005 addressed to Mrs. Carmen Laura Marrero, President of Suiza Dairy Corporation.
2. Your Suiza Fruit Puro 100% Orange Juice From Concentrate, 64 fl. oz., is misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. 343(i)(2)] in that the label does not bear the common or usual name of each ingredient used in the food, as required by 21 CFR 146.145(f) and 101.4. The label for your product fails to list water as an ingredient.
3. Your Suiza Fruit Puro 100% Pineapple Juice From Concentrate, 64 fl. oz., is misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. 343(i)(2)] in that the label does not bear the common or usual name of each ingredient used in the food, as required by 21 CFR 146.185(a)(3) and 101.4. The label for your product fails to list water as an ingredient.
We acknowledge the receipt of your letter dated March 16, 2006, from Ms. Luz Damaris Rosario, Director, Quality Control Department, and the accompanying documents you submitted in response to FDA's July 5, 2005, letter concerning your product labeling and our meeting held in August 10, 2005. FDA has considered the issues raised in your letter, and this Warning Letter is intended to serve as a response to that letter as well as to state FDA's position on the inspectional findings above discussed.
You should take prompt action to correct these violations. Failure to correct the violations promptly may result in enforcement action without further notice, including seizure and/or injunction.
Please respond in writing within 15 working days from your receipt of this letter. Your response should outline the specific actions you are taking to correct these deviations. You should include in your response documentation for our evaluation of your corrective actions. If you cannot complete all corrections within 15 working days, we expect you to explain the reasons for your delay and state when you will correct any remaining deviations.
In addition to the violations described above, we have the following comments concerning the labeling of your products:
Your (b)(4) 100% Pure Orange Juice Pasteurized bears the claim "not from concentrate." Like any claim in food labeling, claims of this nature must be truthful and not misleading. The claim "not from concentrate" is false on this product label because PITUSA 100% Pure Orange Juice Pasteurized is processed in a manner such that it may contain concentrated orange juice to adjust acidity, as the product label states.
Your Suiza Fruit Puro Light Passion Fruit Juice Beverage and Suiza Fruit Puro Light with Calcium Orange Juice Beverage are labeled with quantitative statements giving the amounts of sugar, calories, and carbohydrates in the product as compared to those in the reference food for the "1/2 Sugar, Calories and Carbohydrates" relative claims on these products, as required by 21 CFR 101.60(b)(4)(ii)(B), 101.60(c)(5)(ii)(B), and 101.13(j)(2)(iv)(A). However, the nutrients to which these statements pertain are declared only in Spanish (e.g., Azucar [sugar], Calonas). In accordance with 21 CFR 101.15(c)(2) and (c)(3), if the label of a food contains statements both in English and Spanish, than an information required to be on the label must appear in both English and Spanish.
This letter is not intended to be an all inclusive review of your products and their labeling, and may not list all the deviations at your facility. You are responsible for ensuring that your business operations and all products marketed by your firm are in compliance with the Act and applicable regulations. You also have a responsibility to prevent violations of the Act and all applicable regulations.
Please send your reply to the U.S. Food and Drug Administration, San Juan District Office, 466 Fernandez Juncos Ave., San Juan, P.R. 00901-3223, Attention: Carlos A. Medina, Compliance Officer. If you have questions regarding any issue in this letter, please contact Mr. Medina at 787-474-9538 or at email@example.com.
Acting District Director
San Juan District
Letter from Ms. Luz Damaris Rosario,
Director Quality Control Department for Suiza Dairy Corporation.
Cc: Ms. Carmen Laura Marrero
Suiza Dairy Corporation
P.O. Box 363207
San Juan, PR 00936-3207
Mr. Juan Carlos Lozada, Project Manager
Diversified Food Manufacturing Corp.
P.O. Box 1977
Aguadilla, PR 00605