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

[Sandi Ryan]

Yea, FDA!  It's about time!

Sandi

----- Original Message ----- 
From: "Mike Freeman" <k7uij at panix.com>
To: "Diabetes Talk for the Blind" <diabetes-talk at nfbnet.org>
Sent: Tuesday, July 23, 2013 10:16 AM
Subject: [Diabetes-talk] Fwd: FDA tells companies to stop the 
illegalmarketing of treatments for diabetes


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>
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> 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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