FDA WARNING_LETTER - H & L Worldwide Inc.

On May 20, 2008, the FDA issued a Warning Letter to H&L Worldwide Inc. after reviewing their website, www.vitasprings.com. The FDA determined that several products, including "Best Curcumin with Bioperine," "Curcumin," "Breast Health - Breast Support Formula," "Comprehensive Prostate Formula," "Coral Calcium," "Grape Seed Extract," "Organic Flaxseed Oil," "Immune Ace," "IP-6 Inositol Hexaphosphate," "Lycozyme," "Lycozyme Extra Strength," and "Shark Cartilage," were promoted with therapeutic claims that classify them as unapproved new drugs under section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)].

The claims, such as "fighting heart disease and cancer," "aid in the prevention of breast cancer," and "effective cancer treatment," establish the products' intent for use in the cure, mitigation, treatment, or prevention of disease. Since these products are not generally recognized as safe and effective for these conditions, they are considered "new drugs" under section 201(p) of the Act [21 U.S.C. § 321(p)] and require prior FDA approval for legal marketing, which they lack.

Furthermore, these products are deemed misbranded under