Green Tea Antioxidant Claims Trigger FDA Warning Letters as Agency Focuses More on FOPs

Last October, we wrote about FDA's intention to adopt a more aggressive approach to regulating "Front-of-Package" (FOP) food labels. On March 3, 2010, FDA wrote an open letter to the food industry outlining its focus on developing "practical, science-based" criteria for FOP labeling as well as its plans to review FOP labels to determine compliance with existing regulations. At the time, the Agency issued 17 Warning Letters asserting that FOP statements for various products were misleading because they were unauthorized or unsubstantiated health or nutrient claims or were supplemented by or linked to claims or health information on company websites or in other materials that created an mistaken impression about the product or its potential health benefits. A Warning Letter issued on August 30, 2010 to Dr Pepper Snapple Group and directed at FOP statements regarding antioxidants suggests that FDA is continuing its aggressive approach to regulating FOP statements as well as statements on company websites to which consumers are referred by the product labels (For example, see a warning about dietary supplements focused on a company website here). The principal display panel of Dr Pepper Snapple Group's "Sparkling Green Tea Ginger Ale" label contained the claim, "ENHANCED WITH 200 mg OF ANTIOXIDANTS FROM GREEN TEA & VITAMIN C" with the double asterisk referring to the statement, "**Each 8oz serving contains 200mg of antioxidants from Green Tea Flavonoids and Vitamin C." The warning letter suggests that this claim is misleading for the following reasons: The use of the term "enhanced" suggests that the Ginger Ale is fortified with antioxidants – i.e., that it contains at least 10 percent more of the Reference Daily Intake or Daily Reference Value for antioxidants. However, "the FDA does not consider it appropriate to fortify snack foods such as carbonated beverages." The Nutrition Facts on the back label of the bottle indicate that Vitamin C only accounts for 60mg of the 200mg of antioxidants identified. This implies that the remaining 140mg of antioxidants come from "green tea" or "green tea flavonoids;" however, "green tea" is not a recognized source of antioxidants by the FDA. These "Green Tea" letters are yet another example of FDA's renewed focus on food labeling as a part of its broader food safety agenda. They illustrate that FDA's regulatory approach to food labeling focuses not only on the individual label statements, but what those statements imply about the product's nutrient content when examined in conjunction with the Nutrition Facts on the back panel and the package as a whole. Moreover, as FDA increases its focus on regulating product-related internet and social media content, online content that supplements or explains FOP or package label statements will receive greater scrutiny. For companies, this trend underscores the importance of coordinating the development and review of FOP and other labeling with any supplemental online marketing. Consistent with FDA's practice, Dr Pepper Snapple Group had 15 days to respond to FDA with its plan to correct current violations and prevent future violations. Failure to correct the violations may result in regulatory actions without further notice, such as seizure or injunction. – Vernessa Pollard and Daniel Stuart

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