FDA WARNING_LETTER - Pom Wonderful - January 31, 2010

The FDA issued a Warning Letter to POM Wonderful following a January 2010 review of their websites, www.pomwonderful.com and www.pompills.com, which revealed serious violations of the Federal Food, Drug, and Cosmetic Act.

The primary violation is that POM Wonderful 100% Pomegranate Juice, POMx Pills, and POMx Liquid are promoted with therapeutic claims, causing them to be classified as unapproved new drugs under section 201(g)(1)(B) of the Act. Examples of these claims include reducing atherosclerosis, blood pressure, prostate cancer progression, and improving erectile function, often citing scientific studies and personal testimonials. Since these products are not generally recognized as safe and effective for these uses, they are considered new drugs requiring an approved New Drug Application (NDA) under section 505(a), which they lack.

Furthermore, these products are deemed misbranded drugs under section 502(f)(1) because they are intended for conditions not amenable to self-diagnosis and treatment, thus lacking adequate directions for layperson use.

POM Wonderful 100% Pomegranate Juice is also cited as a misbranded food under section 403(r)(1)(A) due to violative nutrient content claims. Claims like "[U]niquely high levels of powerful antioxidants" fail to declare specific antioxidant nutrients as required by 21 CFR 101.54(