FDA WARNING_LETTER - Creation's Garden Natural Products, Inc.

The FDA issued a Warning Letter to Creation’s Garden Natural Products, Inc. on August 4, 2011, following a July 2011 review of their website, www.creationsgarden.com. The agency determined that several products, including Cardio Health, Prostate Factors, Glucosamine Chondrotin Complex with MSM, MSM with Vitamin C, Joint Maintenance beverage, Goji Berry Juice, and Mangosteen juice, are promoted with therapeutic claims that cause them to be unapproved new drugs under Section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act). Examples of these claims include reducing enlarged prostate, decreasing cholesterol, anti-inflammatory effects, joint repair, and even cancer treatment. Consequently, these products are considered "new drugs" under Section 201(p) as they are not generally recognized as safe and effective for their intended uses. Their introduction into interstate commerce without FDA-approved applications violates Sections 301(d) and 505(a) of the Act. Furthermore, the products are deemed misbranded under Section 502(f)(1) because adequate directions for layperson use cannot be provided for conditions not amenable to self-diagnosis, violating Section 301(a). The letter also noted the firm's misuse of the official FDA logo on its websites and letterhead, which is prohibited for private sector use and may violate federal law. Creation’s Garden must respond within 15 working days detailing corrective actions, with failure to comply potentially leading to enforcement actions like seizure or injunction.