Dr Pepper Snapple Group – FDA Warning Letter, Jul 31, 2010

The FDA issued a Warning Letter to Dr Pepper Snapple Group regarding their Canada Dry Sparkling Green Tea Ginger Ale, based on a July 2010 review of the product label and website. The product is deemed misbranded under section 403(r)(1)(A) of the Federal Food, Drug, and Cosmetic Act due to unauthorized nutrient content claims.

Specifically, the claim "ENHANCED WITH 200 mg OF ANTIOXIDANTS FROM GREEN TEA & VITAMIN C**" is problematic. "Enhanced" is considered an unauthorized synonym for a "more" nutrient content claim. Even if authorized, the product fails to meet "more" claim requirements because carbonated beverages are not appropriate for fortification per 21 CFR 104.20(a), and the label lacks a reference food identity and percentage difference as required by 21 CFR 101.13(j)(2).

Furthermore, the "antioxidant" claim violates 21 CFR 101.54(g). While Vitamin C is a recognized antioxidant, accounting for 60mg of the claimed 200mg, the remaining 140mg from green tea or green tea flavonoids are not recognized as nutrients with antioxidant activity under 21 CFR 101.54(g)(2).

The FDA requires prompt corrective action within 15 days, including a detailed plan and documentation,