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Posted April 17, 2012

FDA Warns Seller of Diabetes Supplement Marketed with Rx Claims

The FDA has posted a Warning Letter (dated April 4, 2012) to Leaner Living regarding the marketing of its Glycosolve product. Although sold as a supplement, Glycosolve is being promoted for use in the cure, mitigation, treatment, or prevention of diseases such as diabetes and elevated cholesterol, making the product an unapproved drug.

The FDA cited many examples of impermissible claims including:
-- "Most EFFECTIVE diabetes supplement ever made" 
-- Pharmaceutical grade blood sugar control! -Several studies have shown that berberine HCL [an ingredient in your product] was just as or more effective than the prescription drug Metformin." 
-- "Lower Cholesterol WITHOUT side effects - In many studies ... berberine ... was shown to lower patient's cholesterol with similar results of STATINS (prescription cholesterol drugs). Diabetics were able to lower their LDL (bad cholesterol) by 21% with NO SIDE EFFECTS!"  

The product is being promoted on websites owned by the company including www.leanerliving.com, www.berberinehcl.com, http://banabaleaf.org/, and www.glycosolve.com.

Leaner Living was given 15 working days to respond to the FDA.

ConsumerLab.com is not aware of well-controlled studies supporting the therapeutic claims made for Glycosolve or the ingredient berberine. See ConsumerLab's Product Review of Cholesterol-Lowering Supplements. Also see the answer to the question, Which supplements can help lower or control my blood sugar? for more information.

For more details regarding the FDA's warning letter, use the link below.