FDA WARNING_LETTER - San Mar Manufacturing Corporation - May 12, 2008

The FDA inspected San Mar Manufacturing Corporation's fruit juice beverage facility from April 28 to May 12, 2008, to assess compliance with the Federal Food, Drug, and Cosmetic Act. The inspection revealed that "Cool River Fruit Punch" and "Cool River Grape" juice products are misbranded.

Specifically, the labels bear the claim "Sugar Free," while the Nutrition Facts Panels state the products contain 2 grams and 10 grams of sugars, respectively, per serving. This violates 21 CFR § 101.60(c)(1)(i), which requires "sugar free" products to contain less than 0.5g of sugars per serving. The definition of "sugars" includes naturally occurring sugars. Therefore, the "Sugar Free" claim is false and misleading under sections 403(a)(1) and 403(r)(1)(A) of the Act.

Additional labeling issues include: not all required information appearing in both Spanish and English when both languages are used on the label (21 CFR 101.15(c)(1)); the "Phenyketonurics: Contains Phenylalanine" statement being obscured on the Cool River Fruit Punch label; and artificial flavors needing to be declared in accordance with 21 CFR 101.22(i)(2) and (3).

San Mar must take prompt action to