FDA WARNING_LETTER - Pompeian, Inc.

The FDA issued a Warning Letter to Pompeian, Inc. after reviewing the label for "Pompeian Imported Extra Light Olive Oil" and the company's website, www.pompeian.com. The review concluded that the product is misbranded under the Federal Food, Drug, and Cosmetic Act (the Act) and 21 CFR Part 101, and is also promoted as an unapproved new drug. Labeling violations include the "Extra Light Olive Oil" claim, which fails to meet nutrient content claim requirements (21 CFR 101.56(b)(1)) because its fat content is not sufficiently reduced compared to a reference food, and lacks necessary qualifying language (21 CFR 101.56(e)). Additionally, the "high in 'good' monounsaturated fat" statement is an unauthorized nutrient content claim (403(r)(1)(A), 21 CFR 101.62) as "good monounsaturated fat" is undefined, and the "high" claim does not comply with 21 CFR 101.54(b) due to no established RDI/DRV. Website claims, such as "Olive oil is rich in antioxidants," are also misbranding violations (21 CFR 101.54(g)(4)) for failing to name specific antioxidant nutrients. Furthermore, therapeutic claims on the website, including "protects the heart," "lower inflammation," and "protects against cancers," cause the product to be an unapproved new drug (201(g)(1), 201(p), 505(a)). As a drug, it is misbranded (502(f)(1)) for lacking adequate directions for use. Pompeian must promptly correct these violations and respond within 15 days, detailing corrective actions to avoid further regulatory action.