Health Breakthroughs International, LLC – FDA Warning Letter, Jun 7, 2012

The FDA conducted an inspection of Health Breakthroughs International, LLC, from May 29 to June 7, 2012, and reviewed their websites (www.healthbreakthroughs.net and www.Odisease.com) in October 2012. The FDA determined that several products are promoted for conditions that classify them as drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 USC § 321(g)(l)(B)].

The products, including Amazing C, MPS-Gold 100, and Power Herbal Formula, are marketed with therapeutic claims for disease cure, mitigation, treatment, or prevention, such as "heal the small intestines," "protection against cold and flu," and "resolution of erectile disorders." The website www.Odisease.com also contains disease claims through personal testimonials. These products are considered "new drugs" under section 201(p) of the Act [21 U.S.C. § 321(p)] because they are not generally recognized as safe and effective for their claimed uses and lack prior FDA approval as required by section 505(a) [21 U.S.C. § 355(a)].

Additionally, even if not unapproved new drugs, the products Amazing C, MPS-GOLD 100