FDA WARNING_LETTER - Zooscape.com - August 31, 2010

The FDA issued a Warning Letter to Cary Heather, CEO of Zooscape.com, after reviewing their website in August 2010. The agency determined that three products—TerraVita Ginkgo Biloba Leaf Powder, TerraVita Dog Grass Root 450 mg, and Webber Naturals Omega-3 Super Concentrate—are promoted with therapeutic claims that classify them as drugs under section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. § 321(g)(1)]. These claims, including treating Alzheimer's, depression, jaundice, gout, eczema, urinary infections, kidney stones, rheumatism, and lowering cholesterol and heart attack risk, establish the products' intent for disease treatment or prevention. Consequently, marketing these products with such claims violates the Act. Furthermore, the products are not generally recognized as safe and effective for their referenced uses, making them "new drugs" under section 201(p) of the Act [21 U.S.C. § 321(p)]. New drugs require prior FDA approval, based on scientific data demonstrating safety and effectiveness, as per section 505(a) of the Act [21 U.S.C. § 355(a)]. The FDA mandates prompt corrective action, requiring a written response within fifteen working days detailing specific steps taken and providing documentation. Failure to comply may lead to regulatory actions like seizure or injunction.