Re: FDA Warning letter sent to Dr. Teitelbaum

[Guest guest]

I wonder if they are targetting dr T to try and get his license revoked?

And how shocking to see its costs over $500 MILLION DOLLARS to approve

drugs/supplements?!?!:

" Current FDA regulations do not allow disease-related claims to be

made for natural products, unless the product has gone through the FDA

drug approval process, which can cost upward of $500 million, making

this impossible for most non-patentable natural options, "

[Guest guest]

Show he's doing something right if the FDA is after him!!

I was immensely helped by Dr. Teitlebaums protocal.

God Bless,

Sara

>

>

>

> --- [CO-CURE] NOT: MED: Fatigue supplements are actually

> misbranded drugs: FDA

> Date: Fri, 4 May 2012 20:37:40 -0500

> From: kelly <kellylatta66@...>

> Reply- kelly <kellylatta66@...>

> CO-CURE@...

>

>

>

> Fatigue supplements are actually misbranded drugs: FDA

> Chicago Tribune

> May 4, 2012

>

> A commercial website for people suffering from symptoms of chronic

> fatigue syndrome and fibromyalgia is rife with numerous illegal and

> misleading treatment claims, according to a recent warning letter sent

> to Dr. Teitelbaum by the U.S. Food and Drug Administration.

>

> Teitelbaum, the medical director of the national Fibromyalgia and

> Fatigue Centers and author of several books on the topic, including

> " From Fatigued to Fantastic! " also unlawfully used his Facebook

> account to promote his products for disease treatment and prevention,

> the FDA said in the three-page letter.

>

> More than a dozen of products on the Teitelbaum's website

> endfatigue.com are marketed with therapeutic claims – meaning they can

> prevent, cure or treat disease -- which classifies them as drugs, the

> FDA said. But the supplements have not been approved as drugs by the

> FDA and do not have Generally Recognized As Safe or GRAS status.

>

> The products are also promoted for treating conditions shouldn't be

> self diagnosed or treated by non-medical practitioners, the FDA said.

> As a result, they don't have adequate directions for use and are

> considered " misbranded. "

>

> The FDA found the section on Teitelbaum's website titled " Cures A-Z, "

> especially problematic because it listed a number of medical

> conditions with information on how to treat these conditions – along

> with products offered for sale through the website.

>

> For example, it recommended " Eskimo 3 Fish Oil " as a treatment for

> Alzheimer's Disease and claimed the product could " help treat any

> hidden depression which may be present. "

>

> On the web page titled, " Breast Cancer, " under the heading,

> " TREATMENT, " it recommended Coenzyme Q10 and claimed that " [E]arly

> experience showed these nutrients may decrease breast cancer growth. "

> The Website also recommended specific supplements to treat colds and

> flu, hypertension, Parkinson's Disease, heart disease and reduce

> cholesterol.

>

> And in one example of a Facebook post, Teitelbaum wrote that he looked

> at a new study " showing that an herbal can beat the pants off a pain

> medication when managing arthritis, " according to the warning letter.

> In that post, he included a link titled, " Herbal Beats Pain Medication

> in New Arthritis Study, " which links to his website, endfatigue.com.

> " The webpage accessible through that link includes the claim described

> above for your Healthy Knees and Joints product, " the FDA said.

>

> The FDA's surveillance of false or misleading claims on Facebook is of

> great interest to the supplement industry. One important lesson for

> manufacturers is " the continued tendency for the FDA to consider

> social media as a source for illegal claims, when linked to products

> for sale, " wrote the Natural Products Insider. " There is no safe haven

> in Facebook or Twitter. "

>

> In a statement, Teitelbaum characterized himself as a " patient

> advocate reporting on thousands of scientific studies. " His goal is to

> " help people become aware of the pros and cons of new research on both

> natural health products and prescription treatment options. "

>

> Teitelbaum said he recognized the need for the regulations but was

> " surprised " by FDA's letter. The " Cures A-Z " section is no longer on

> the site; Teitelbaum said he is working with the agency to address

> concerns.

>

> " Current FDA regulations do not allow disease-related claims to be

> made for natural products, unless the product has gone through the FDA

> drug approval process, which can cost upward of $500 million, making

> this impossible for most non-patentable natural options, " he said.

>

> " This often creates a difficult line between what is considered simply

> reporting on a research study result versus what is considered making

> a promotional product claim to treat a disease, even if the report is

> based on solid research. "

>

> Teitelbaum vowed to keep advocating " for consumer access to truthful,

> reliable, information about the thousands of studies demonstrating the

> health benefits of natural dietary supplements and herbal products,

> while ensuring the language on the web site complies with FDA

> regulations. "

>

> Still, after reading the warning letter, you could almost hear a

> collective sigh by agency staff. " The unlawful disease treatment and

> prevention claims made on your website were too numerous to list in

> this letter, " wrote Bonnin, District Director of the FDA's

> Baltimore District Office.

>

> The FDA listed the following dietary supplements as being marketed as

> unapproved drugs but also noted the list was only a fraction of the

> violations.

> Corvalen (D-Ribose)

> Coenzyme Q10

> Jigsaw Magnesium w/ SRT

> BMR Complex (Thyroid Glandular)

> Energy Revitalization System

> Acetyl-L-Carnitine

> Chol-less

> Thymic Protein

> Alpha Lipoic acid

> Black Cohosh

> Healthy Knees and Joints

> Eskimo 3 Fish Oil

> Copyright © 2012, Chicago Tribune

>

>

http://www.chicagotribune.com/features/tribu/julieshealth/chi-fatigue-supplement\

s-illegal-drugs-fda-20120504,0,5706746.story

>

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