FDA WARNING_LETTER - Royal Domains

The FDA issued a Warning Letter to Royal Domains regarding their "Nature's Pearl Premium Muscadine Grape Seed" dietary supplement, based on a December 2011 website review. The product is deemed an unapproved new drug under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) due to therapeutic claims on www.itsnaturespearl.com. Claims like "inhibiting the growth of 7 different cancers," "anti-inflammatory as well as anticancer properties," and addressing "type 2 diabetes and insulin resistance," along with testimonials for arthritis and blood pressure, establish drug intent. The product is not generally recognized as safe and effective for these uses, making it a "new drug" under section 201(p) and illegally marketed without FDA approval (section 505(a)). It is also misbranded under section 502(f)(1) because adequate directions for layperson use cannot be provided for such conditions.

Furthermore, the product is a misbranded dietary supplement under section 403 of the Act. The website falsely claims "Nature's Pearl has been certified by the FDA" and "in Full Compliance under FDA 21 CFR 111," which is misleading as FDA does not certify dietary supplements. The product also bears an unauthorized nutrient content claim, "Nature's Pearl Contains The Highest Level's [sic] of Natural Antioxid