FDA Warning letter sent to Dr. Teitelbaum

[Guest guest]

--- [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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