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

Tue Jul 23 15:30:34 UTC 2013

It amazes me how many diabetics attempt to *treat* themselves, not
working with a doctor, and in many cases, not an endo.

Type 1, type 2, despite how well-managed or lack of management, any
diabetic should, and must, seek medical attention which includes any
specialist. It boggles my mind how many diabetics don't follow this
regimin, which is actually quite simple.

Then less people may seek treatments and drugs that are not safe.

Bridgit

-----Original Message-----
From: Diabetes-talk [mailto:diabetes-talk-bounces at nfbnet.org] On Behalf
Of Mike Freeman
Sent: Tuesday, July 23, 2013 10:17 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
>  
>  
> THIS MESSAGE IS INTENDED ONLY FOR THE USE OF THE PARTY TO WHOM IT IS 
> ADDRESSED AND MAY CONTAIN INFORMATION THAT IS PRIVILEGED,
CONFIDENTIAL, 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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