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Recalls & Warnings
ConsumerLab.com is keeping you informed with current product recalls and warnings.
Posted April 17, 2012
FDA Warns Seller of Diabetes Supplement Marketed with Rx Claims
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.
Report a Problem
If you have experienced an unexpected and adverse reaction to a dietary supplement, nutritional product, or generic drug, we would like to hear about it, as we may investigate the problem. Please select from one of these options:
Dietary Supplement or Nutritional Product Problem Report
If you believe that a dietary supplement (e.g., vitamin, mineral, or herbal supplement) or other nutritional product has caused an unexpected, adverse reaction, we would like to know about it. We are collecting and organizing this information and may publish it. We might test the product in the future. You may also want to report the problem to the U.S. FDA through their Safety Reporting Portal at https://www.safetyreporting.hhs.gov.
Please complete the form below as accurately as possible. You may need to check the label on the product.
Thank you for submitting your report.
Generic Drug Problem Report
If you believe that a generic drug has not acted like the original drug, we would like to know about it. We are collecting and organizing this information and may publish it. We might test the product in the future. You may also want to report the problem to the U.S. FDA through their MedWatch program at the FDA MedWatch website.
Please complete the form below as accurately as possible. You may need to check the label on the drug.
Thank you for submitting your report.
