Inspections, Compliance, Enforcement, and Criminal Investigations
San Mar Manufacturing Corporation 10-Sep-08
Department of Health and Human Services
Public Health Service
San Juan District
September 10, 2008
RETURN RECEIPT REQUESTED
Mr. Otoniel Sanchez
San Mar Manufacturing Corporation
P.O. Box 4007
Guaynabo, P.R. 00970-4007
Dear Mr. Sanchez:
The Food and Drug Administration (FDA) inspected San Mar Manufacturing Corporation's (San Mar's) fruit juice beverage manufacturing facility, located at number 19 Street M1118, section 23, Fomento Industrial Park, Catano, Puerto Rico 00962, from April 28, 2008 to May 12, 2008. The inspection was conducted to assess your compliance with the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. §§ 301 et seq., and applicable implementing regulations found in Title 21 of the Code of Federal Regulations (CFR).
During the inspection, we collected labels for your "Cool River Fruit Punch" and "Cool River Grape" juice products. Our review of the labels and other evidence collected during the inspection found violations of the Act and FDA's implementing regulations. You may find the Act and FDA regulations in the CFR through links in FDA's website at http://www.fda.gov.
The violations we noted are as follows:
San Mar's Cool River Fruit Punch beverage in 64 oz. containers and its Cool River Grape beverage in 16 oz. containers are misbranded within the meaning of sections 403(a)(1) and 403(r)(1)(A) of the Act [21 U.S.C. §§ 343(a)(1) and 343(r)(1)(A)] because their labels bear the claim "Sugar Free." The Nutrition Facts Panels for the Cool River Fruit Punch and Cool River Grape beverages state that the products contain 2 grams and 10 grams of sugars, respectively, per labeled serving. Under FDA's regulations at 21 CFR § 101.60(c)(1)(i), a food may not be labeled with a nutrient content claim using the term "sugar free" unless the product "contains less than 0.5g of sugars, as defined in 21 CFR 101.9(c)(6)(ii), per reference amount customarily consume and per labeled serving." The definition of "sugars" in § 101.9(c)(6)(ii) is not limited to added sugars, but also includes naturally occurring sugars like the fructose in fruit juice and fruit pulp. Your Cool River Fruit Punch and Cool River Grape beverages are therefore misbranded because the "Sugar Free" claim on their labels is false and misleading under § 403(a)(1) of the Act.
These products are also misbranded under § 403(r)(1)(A) of the Act, because they do not comply with the requirements to bear the nutrient content claim "sugar free."
At the inspection closing meeting, you stated that San Mar would provide a written response to FDA's observations of labeling violations. FDA has received no further communications from San Mar to date. You should take prompt action to correct these violations. Failure to do so may result in regulatory action without further notice. Such action may include, but is not limited to, seizure and injunction.
The above violations concern certain labeling requirements and are not meant to be an all-inclusive list of deficiencies in your products and their labeling. Other violations can also subject your products to legal action. It is your responsibility to assure that all of your products are in compliance with all applicable statutes and regulations enforced by FDA. You may find it useful to visit our website at http://www.cfsan.fda.gov when reviewing your labels.
Please notify this office in writing, within fifteen (15) working days from your receipt of this letter, of the specific things that you are doing to correct the violations described above and to prevent similar violations. You should include in your response documentation of your corrective actions, such as revised labels, revised procedures, 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 the delay and state when you will correct any remaining violations.
In addition, please note the following regarding your product labeling:
• The product labels we reviewed bear information in both Spanish and English, but not all information required to be on the label appears in both languages. Under 21 CFR 101.15(c)(2), your products may be labeled solely in Spanish if they are distributed solely in Puerto Rico. However, in accordance with 21 CFR 101.15(c)(1), if the products' labels also contain information in English, all of the required label information must appear in both Spanish and English.
• Part of the required statement "Phenyketonurics: Contains Phenylalanine" is obscured by the vignettes of grapes on the label of the Cool River Fruit Punch. You should revise the label so that the entire required statement is clearly visible.
• The label of Cool River Fruit Punch declares artificial flavors in the ingredient list. Any artificial flavoring must be declared on the product's label in accordance with the requirements of 21 CFR 101.22(i)(2) and (3).
Please send your reply to the Food and Drug Administration, Attention: Mr. Carlos A. Medina, Compliance Officer, at 466 Fernandez Juncos Avenue, San Juan, Puerto Rico 00901-3223. If you have any questions regarding any issue in this letter, please contact Mr. Medina at 787-474-9538 or firstname.lastname@example.org.
San Juan District Director