Unilever United States, Inc. – FDA Warning Letter, Aug 31, 2010

The FDA issued a Warning Letter to Unilever, Inc. regarding its "Lipton Green Tea 100% Natural Naturally Decaffeinated" product. The FDA reviewed the product label and websites (www.lipton.com and www.liptont.com) in August 2010, determining the websites constitute labeling.

The product is in violation of the Federal Food, Drug, and Cosmetic Act due to two main issues:

1. **Unapproved New Drug:** The website www.liptont.com promotes the product with therapeutic claims, such as "total cholesterol was lowered by 8% after drinking 8 cups of green tea daily for 12 weeks," establishing it as a drug intended for disease treatment. Since it's not generally recognized as safe and effective for these uses, it's an unapproved "new drug" under section 201(p) of the Act, requiring prior FDA approval. Furthermore, it's misbranded under section 502(f)(1) because adequate directions for layperson use cannot be provided for conditions not amenable to self-diagnosis.

2. **Unauthorized Nutrient Content Claims:** The product's labeling includes unauthorized "antioxidant" nutrient content claims. Claims like "LIPTON Tea is made from tea leaves rich in naturally protective antioxidants" and "tea is a naturally rich source of antioxidants" violate 21 CFR 101.54