FDA WARNING_LETTER - Redco Foods, Inc.

The FDA issued a Warning Letter to Redco Foods, Inc. regarding their "Salada Naturally Decaffeinated Green Tea" product and its associated website, www.greentea.com. The FDA concluded that the green tea products violate the Federal Food, Drug, and Cosmetic Act.

The primary violation is that the website promotes the green tea products for conditions that cause them to be unapproved new drugs under section 201(g)(1)(B) of the Act. Examples of disease claims include inhibiting cancer, regulating cholesterol, warding off viruses, fungi, and food-borne bacteria, inhibiting dental plaque, lowering type 2 diabetes risk, curing digestive disorders, easing rheumatism, and reducing beta-amyloid buildup related to Alzheimer's disease. Since these products are not generally recognized as safe and effective for these uses, they are considered "new drugs" without prior FDA approval, violating section 505(a). Furthermore, they are misbranded under section 502(f)(1) because adequate directions for layperson use cannot be provided for these conditions.

Additionally, the products are misbranded under section 403(r)(1)(B) due to unauthorized health claims, specifically regarding the positive effect of green tea on cardiovascular disease risk factors.

Finally, the product label includes unauthorized nutrient content claims, violating section 403(r)(1)(A) and 403(r)(2)(A)(