Co-Cure: Food and Drug Administration sends warning letter to Teitelbaum

[Guest guest]

forwarded from Co-Cure...........

Subject: RES,NOT: Food and Drug Administration sends warning letter to

TeitelbaumSource: Chicago TribuneDate: May 4, 2012Author: DwardorffURL:

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

s-illegal-drugs-fda-20120504,0,5706746.storyRef:

http://www.chicagotribune.com/features/tribu/julieshealth/Fatigue supplements

are actually misbranded drugs:

FDA------------------------------------------------------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--------© 2012, Chicago Tribune

--------------------------------------------- Send posts to

CO-CURE@... Unsubscribe at

http://www.co-cure.org/unsub.htm

---------------------------------------------Co-Cure's purpose is to provide

information from across the spectrum ofopinion concerning medical, research and

political aspects of ME/CFS and/orFMS. We take no position on the validity of

any specific scientific orpolitical opinion expressed in Co-Cure posts, and we

urge readers toresearch the various opinions available before assuming any

oneinterpretation is definitive. The Co-Cure website & lt;www.co-cure.org & gt; has

alink to our complete archive of posts as well as articles of centralimportance

to the issues of our community.

---------------------------------------------