[Diabetes-talk] Fwd: FDA tells companies to stop the illegalmarketing of treatments for diabetes

[Bill Lewis]

Hello Mike,  Thanks for passing this letter to us, but I want to call your 
attention to some facts about what this letter is really about.  Read on 
carefully!

In the letter near the bottom, notice that they openly state that they have 
had no data showing injury or death as a result of these OTC products. 
Doesn't that say something to you?

The government, in case you have not heard already, is trying to find a way 
of driving the alternative medicine market out of business, leaving us only 
with Obama Care.

Remember back, Mike, to 1993 when Hillary Clinton tried to ram her Hillary 
Care down our throats?  It came to light that her blue ribbon committee that 
wrote her health care plan did not actually exist.  Her claims about the 
plan's benefits were conspicuously wrong.  And in the plan, she had a 
section that prohibited patients from paying for medical care privately, for 
penalty of prison and/or huge fines, which included the doctors who 
cooperated in an effort to provide private care.  Remember?

This letter from the government--once again, looking at the person signing 
the letter and her official rank and department and you will see that she is 
one of the parties that Obama set up with immunity and with instruction to 
bad-mouth the alternative med industry out of business.  True, there are 
some companies and products on the OTC market that are scams, but there are 
many others that are legitimate.  The OTC vitamin market, the basic herb 
markets, and others.  So, Mike, be careful.  Read any government, or 
otherwise, pronouncements very very carefully and pay attention to the 
wording.

Contact me if you still are uncertain about this government-issued letter. 
I personally am skeptical about herbs and such, but I sure as heck am not 
going to let this particular government turn our country into a banana 
republic or our health care system into a sshameful excuse for health care 
that is affordable and effective.

Your friend -- yes, you are my friend; because I ain't going to let nobody 
tell me how to pick my friends!

Bill Lewis
<billlewis31 at cox.net>




-----Original Message----- 
From: Mike Freeman
Sent: Tuesday, July 23, 2013 10:16 AM
To: Diabetes Talk for the Blind
Subject: [Diabetes-talk] Fwd: FDA tells companies to stop the 
illegalmarketing of treatments for diabetes




Begin forwarded message:

> From: FDA NEWS FOR HEALTHCARE PROFESSIONALS 
> <NewsHealthCareProfs at fda.hhs.gov>
> Date: July 23, 2013, 7:12:10 PDT
> To: FDA NEWS FOR HEALTHCARE PROFESSIONALS 
> <NewsHealthCareProfs at fda.hhs.gov>
> Subject: FDA tells companies to stop the illegal marketing of treatments 
> for diabetes
>
> Dear Colleagues,
>
> The U.S. Food and Drug Administration is taking action to remove from the 
> market illegal products, including some labeled as dietary supplements, 
> that claim to mitigate, treat, cure or prevent diabetes and related 
> complications. The agency recently issued letters warning 15 companies 
> that the sale of their illegally marketed diabetes products violates 
> federal law. The letters were sent to foreign and domestic companies whose 
> products were sold online and in retail stores.
> The FDA is advising consumers not to use these or similar products because 
> they may contain harmful ingredients or may be otherwise unsafe, or may 
> improperly be marketed as over-the-counter products when they should be 
> marketed as prescription products. Using these products could cause 
> consumers to delay seeking proper medical treatment for their diabetes. 
> FDA-approved diabetes treatments, prescribed by a licensed health care 
> professional and shown to be safe and effective, are readily available for 
> people with diabetes.
> “Diabetes is a serious chronic condition that should be properly managed 
> using safe and effective FDA-approved treatments,” said FDA Commissioner 
> Margaret A. Hamburg, M.D. “Consumers who buy violative products that claim 
> to be treatments are not only putting themselves at risk but also may not 
> be seeking necessary medical attention, which could affect their diabetes 
> management.”
> Nearly 26 million Americans have diabetes, a disease in which blood 
> glucose or blood sugar levels are high, resulting from the body’s 
> inability to produce sufficient amounts of insulin or to effectively 
> utilize its own insulin. There is a greater risk for serious health 
> complications, such as heart disease, blindness, kidney failure, and 
> lower-extremity amputations, if diabetes is not managed appropriately.
> “The FDA is committed to protecting consumers from the dangers of these 
> illegally sold products,” said Howard Sklamberg, director of the Office of 
> Compliance in the FDA’s Center for Drug Evaluation and Research. “We will 
> continue to take aggressive action against firms that sell illegal 
> products claiming to treat diabetes.”
> Many of the illegally sold products that are the subject to this action 
> include claims such as “prevents and treats diabetes,” and “can replace 
> medicine in the treatment of diabetes.” In addition, some of the products 
> may cause harm because the products contain undeclared active drug 
> ingredients or may not have been manufactured and handled according to FDA 
> quality standards.
> These illegally sold products include:
> Products sold as “natural” treatments for diabetes, but containing 
> undeclared active pharmaceutical ingredients in unknown quantities that 
> could cause harm or complicate medical conditions;
> Dietary supplements and ayurvedic products (medicine of the healing arts 
> that originated in India) with claims to treat, cure, and/or prevent 
> diabetes;
> Unapproved drugs sold over-the-counter, including some homeopathic 
> products, intended to treat complications associated with diabetes, which 
> include relieving symptoms caused by nerve damage in the arms and legs 
> (also called peripheral neuropathy); and
> Prescription drugs for diabetes sold by online pharmacies without a 
> prescription.
>
> The FDA has requested a written response from these companies within 15 
> business days stating how the companies will correct the violations. 
> Failure to promptly correct the violations may result in legal action, 
> including product seizure, injunction, and/or criminal prosecution.
> To date, the FDA is not aware of any reports of injury or illness 
> associated with the illegally sold products but is taking action to 
> protect the public health from potential harm related to these violative 
> products. The FDA asks health care professionals and consumers to report 
> any adverse reactions to FDA’s MedWatch program either by:
> completing and submitting the report online at 
> www.fda.gov/medwatch/report.htm2; or
> downloading and completing the form3, then submitting it via fax at 
> 1-800-FDA-0178.
>
> For more information:
> Warning Letters4
> Cyber Letters5
> Illegally Sold Diabetes Products6
> Consumer Update7
>
> We thank you for your continued support of our mission.
>
> Best regards,
>
> Helene
>
> Helene D. Clayton-Jeter, OD
> Cardiovascular and Endocrine Liaison Program
> Office of Health and Constituent Affairs
> Office of External Affairs
> Office of the Commissioner
> U.S. Food and Drug Administration
> 10903 New Hampshire Avenue
> Bldg 32, Room 5341
> Silver Spring, MD  20993
> Phone:  301-796-8452
> BB:  240-753-3939
> Fax:  301-847-8623
> Email:  helene.clayton-jeter at fda.hhs.gov
> Diabetes Information
> Cardiovascular Information
>
>
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> AND PROTECTED FORM DISCLOSURE UNDER LAW. If you are not the addressee, or 
> a person authorized to deliver the document to the addressee, you are 
> hereby notified that any review disclosure, dissemination, copy or other 
> action based on the content of this communication is not authorized. If 
> you have received this document in error, please immediately notify us by 
> e-mail or telephone.
>
>
>
>
>
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