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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Leaner Living 4/4/12

  

Department of Health and Human Services' logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 Central Region
Baltimore District Office
6000 Metro Drive, Suite 101
Baltimore, MD 21215
Telephone: (410) 779-5455
FAX: (410) 779-5707 

WARNING LETTER
CMS#239834

April 4, 2012

Certified Mail
Return Receipt Requested

Leaner Living
Attn: Spencer Nadolsky, D.O.
540 Lanier Crescent
Portsmouth, VA 23707

Dear Dr. Nadolsky:

This is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your websites at www.leanerliving.com, www.berberinehcl.com, http://banabaleaf.org/, and www.glycosolve.com in March 2012 and has determined that your "Glycosolve" product is promoted for conditions that cause the product to be 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)]. The therapeutic claims on your websites establish that this product is a drug because it is intended for use in the cure, mitigation, treatment, or prevention of disease. The marketing of your product with these claims violates the Act. You can find the Act and its implementing regulations through links at FDA's home page at http://www.fda.gov.

Examples of the claims observed on your www.leanerliving.com website include:

From your webpage for "Glycosolve":

• "Most EFFECTIVE diabetes supplement ever made"

• "Imagine being able to eat a meal without worrying if the carbohydrates were ... sitting in your blood, wreaking havoc on your arteries. This dream is possible by decreasing insulin resistance with the most powerful glucose support supplement on the market:
GLYCOSOLVE .... "

• "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!"

• "While ridding of high blood sugars and cholesterol, the studies [involving berberine] also showed a 36% decrease of triglycerides! Triglycerides are another marker for cardiovascular disease and metabolic syndrome."

• "Those with some level of insulin resistance (Type 2 Diabetes) will appreciate the effects from GLYCOSOLVE more than anybody!"

This webpage also contains claims in the form of personal testimonials:

• "I used to suffer from pre-diabetes so my doctor put me on Metformin. . . . I looked for an alternative and found Glycosolve. Now my fasting blood sugar is in the 80's .... "

• "When my doctor told me I would have to start taking statins for my cholesterol, I scrambled to find an alternative. I ... found Glycosolve. My bad cholesterol dropped 30 points!"

From a video entitled, "Berberine," which can be found through your website www.leanerliving.com by clicking on the "Glycosolve" webpage, and on You Tube at http:/ /www.youtube.com/watch?v=owwhkbLjhhO:

• "Pharmaceutical-like Blood Sugar Control"

• "Lower Cholesterol WITHOUT side-effects"

From the webpage entitled, "FAQ" and the link titled, "Glycosolve Questions":

• "The components in Glycosolve have been shown to decrease cholesterol and blood pressure."

Examples of the claims observed on your www.berberinehcl.com website (and www.glycosolve.com website which redirects to www.berberinehcl.com) include:

• "Lower blood sugar, cholesterol ... and blood pressure, with only one supplement"
• "Behold the power of Glycosolve - by Leaner Living - which contains two of the most potent as well as safest compounds known for normalizing blood sugar and dropping cholesterol - Berberine HCl and Banaba.

o Improves Insulin Sensitivity"

• "Improves Cholesterol Levels"

• "Berberine HCl has recently been shown to decrease hemoglobin AlC (measures longterm glycemic control)from an average of 9.5% ... to 7.5% in one study, and from 7.5% to 6.6% in another study .... This change was comparable to the strong pharmaceutical drug Metformin!"

• "In the same studies, patients with dyslipidemia and Type 2 Diabetes lowered serum cholesterol, triglycerides, and LDL-c by 18%, 35.9% and 21% respectively. Not only that, but it was also shown to decrease blood pressure . ... "

Examples of the claims observed on your http://banabaleaf.org website include:

• "I decided to formulate a banaba leaf product to help with patient's blood sugar problems who couldn't take medications .... I figured supplements could never be as powerful as the medications I prescribe. Boy, WAS I WRONG!"

Your product is not generally recognized as safe and effective for the above referenced uses and, therefore, the product is a "new drug" under section 201(p) of the Act [21 U.S.C. § 321(p)]. A new drug may not be legally marketed in the U.S. without prior approval from FDA as described in section 505(a) of the Act [21 U.S. C. § 355(a)]. FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate that the drug is safe and effective.

Furthermore, your product is misbranded within the meaning of section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)] in that the labeling for this product fails to bear adequate directions for use. Because this product is intended for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners, adequate directions cannot be written for it so that a layperson can use it safely for their intended uses. The introduction of a misbranded drug into interstate commerce is a violation of section 301(a) of the Act [21 U.S.C. § 331(a)].

This letter is not meant to be an all-inclusive list of violations that exist in connection with your products. It is your responsibility to ensure that your products and their labeling comply with the Act and its implementing regulations. We advise you to review your website, product labels, and other labeling and promotional materials for your products to ensure that the claims you make for your products do not cause them to violate the Act. You should take prompt action to correct the violations described above and prevent their future recurrence. Failure to promptly correct these violations may result in legal action, such as seizure and/or injunction, without further notice.

Please notify this office in writing within fifteen (15) working days from your receipt of this letter as to the specific steps you have taken to correct the violations noted above and to assure that similar violations do not occur. Your response should include any documentation necessary to show that correction has been achieved. If you cannot complete all corrections within fifteen working days, please explain the reason for the delay and state the date by which the corrections will be completed.

Please send your reply to the U.S. Food and Drug Administration, Attention: Ernest F. Bizjak, Compliance Officer at the address above. If you have questions regarding any issues in this letter, please contact Mr. Bizjak at (410) 779-5715.

Sincerely yours,

/s/

Evelyn Bonnin
District Director
Baltimore District Office