FDA WARNING_LETTER - Florida Bottling, Inc.

On July 8, 2010, the FDA issued a Warning Letter to Florida Bottling, Inc. following an inspection of their Miami facility and a review of their websites (www.lakewoodjuices.com and www.floridabottling.com). The FDA determined that the firm's Fresh Pressed Blueberry Blend, Pure Aloe, Pure Pomegranate (organic), and Tart Cherry juice products were in violation of the Federal Food, Drug and Cosmetic Act.

The primary violation was that the products were promoted with therapeutic claims on labels and websites, causing them to be unapproved new drugs under section 201(g)(1) of the Act. Examples of these claims included "reduces infections" for Blueberry Blend, "fight artherosclerosis" and "inhibit the growth of cancer cells" for Pure Pomegranate, "Reduce Swelling in Joints" and "Healing Bums and Wounds" for Pure Aloe, and "Reduce the Pain of Arthritis, Gout" for Tart Cherry. Since these products are not generally recognized as safe and effective for these uses, they are considered "new drugs" requiring prior FDA approval, which they lacked. Additionally, they were deemed misbranded under section 502(f)(1) for failing to bear adequate directions for use by a layperson.

Further violations included unauthorized health claims (e.g., "Heart Healthy," "Reduction of risk factors related to Cancer, Heart Disease, Stroke