FDA WARNING_LETTER - Leaner Living - March 31, 2012

The FDA issued a Warning Letter to Leaner Living, specifically addressing their "Glycosolve" product, after reviewing their websites (www.leanerliving.com, www.berberinehcl.com, http://banabaleaf.org/, and www.glycosolve.com) in March 2012. The FDA determined that "Glycosolve" is promoted for conditions that classify it as a drug under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)], due to therapeutic claims indicating intent for cure, mitigation, treatment, or prevention of disease.

Violations include claims such as "Most EFFECTIVE diabetes supplement ever made," "Pharmaceutical grade blood sugar control!", comparisons to prescription drugs like Metformin and Statins for lowering blood sugar and cholesterol, and testimonials from individuals claiming to have used Glycosolve as an alternative to prescribed medications for pre-diabetes and high cholesterol. These claims establish the product as a "new drug" under section 201(p) of the Act [21 U.S.C. § 321(p)], which requires prior FDA approval based on scientific data demonstrating safety and effectiveness, an approval Glycosolve lacks.

Furthermore, the product is deemed misbranded under section 502(f)(1) of the