I do not have any hands-on knowledge of this but did do a search and it
appears to still be "experimental" as there are no valid studies that
support this therapy but mostly anecdotal reports. This is a bit dated, but
this appears to still be the stand of the FDA.

Sorry that I wasn't more helpful.  I will post the question to NPF medical
Director.  More soon. . .

   [image: Department of Health and Human Services' logo] Department of
Health and Human Services

Public Health Service
Food and Drug Administration


College Park, Maryland 20740

November 3, 2004
WARNING LETTER
VIA CERTIFIED MAIL, RETURN RECEIPT REQUESTED

Tenzing Kunga
Traditional Tibetan Healing, Inc.
13 Harrison Street
Somerville, Massachusetts 02143

Ref. No. CL-03-HFS-810-74

Dear Tenzing Kunga:

This is to advise you that the Food and Drug Administration (FDA) has
reviewed your web site at the Internet address www.tibetanherbs.com and has
determined that the products "Parkinson's Support", "Liver Support", and
"Sleep Support" are promoted for conditions that causes the product to be
drugs under section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act
(the Act) [21 USC 321(g)(1)]. The therapeutic claims on your web site
establish that the products are drugs because they are intended for use in
the cure, mitigation, treatment, or prevention of disease. The marketing of
these products with these claims violates the Act.

Examples of some of the claims observed on your web site include:

*Parkinson's Support*

"The formula is highly effective in correcting Parkinson's, getting at its
root cause within the body."

*Liver Support*

"The formula is used to correct all types of liver disorders . . . [and]
headaches."

"It can also be taken to reduce cholesterol and aids in healing hepatitis
A, B and C."

*Sleep Support*

"The primary benefit of this formula is to balance insomnia. . . ."

Furthermore, FDA has no information that your products are generally
recognized as safe and effective for the above referenced conditions and
therefore, the products may also be "new drugs" under section 201(p) of the
Act [21 USC 321(p)]. New drugs may not be legally marketed in the U.S.
without prior approval from FDA as described in section 505(a) of the Act
[21 USC 355(a)]. FDA approves a new drug on the basis of scientific data
submitted by a drug sponsor to demonstrate that the drug is safe and
effective.

FDA is aware that Internet distributors may not know that the products they
offer are regulated as drugs or that these drugs are not in compliance with
the law. Many of these products may be legally marketed as dietary
supplements if claims about diagnosis, cure, mitigation, treatment, or
prevention of disease are removed from the promotional materials and the
products otherwise comply with all applicable provisions of the Act and FDA
regulations.

Under the Act, as amended by the Dietary Supplement Health and Education
Act, dietary supplements may be legally marketed with truthful and
non-misleading claims to affect the structure or function of the body
(structure/function claims), if certain conditions are met. However, claims
that dietary supplements are intended to prevent, diagnose, mitigate,
treat, or cure disease (disease claims), excepting health claims authorized
for use by FDA, cause the products to be drugs. The intended use of a
product may be established through product labels and labeling, catalogs,
brochures, audio and videotapes, Internet sites, or other circumstances
surrounding the distribution of the product. FDA has published a final rule
intended to clarify the distinction between structure/function claims and
disease claims. This document is available on the Internet at
vm.cfsan.fda.gov/~lrd/fr000106.html<http://vm.cfsan.fda.gov/%7Elrd/fr000106.html>(codified
at 21 CFR 101.93(g)).

In addition, only products that are intended for ingestion may be lawfully
marketed as dietary supplements. Topical products and products intended to
enter into the body directly through the skin or mucosal tissues, such as
transdermal or sublingual products, are not dietary supplements. For these
products, both disease and structure/function claims may cause them to be
new drugs. Certain over-the-counter drugs are not new drugs and may be
legally marketed without prior approval from FDA. Additional information is
available in Title 21 of the Code of Federal Regulations (21 CFR) Parts 310
and 330-358, which contain FDA's regulations on over-the-counter drugs.

This letter is not intended to be an all-inclusive review of your web site
and products your firm markets. It is your responsibility to ensure that
all products marketed by your firm comply with the Act and its implementing
regulations.

If you need additional information or have questions concerning any
products distributed through your web site, please contact FDA. You may
reach FDA electronically (e-mail) at [log in to unmask], or you may respond
in writing to Linda J. Webb, Compliance Officer, Food and Drug
Administration, Division of Dietary Supplement Programs, 5100 Paint Branch
Parkway, College Park, Maryland 20740-3835. If you have any questions
concerning this letter, please contact Ms. Webb at (301) 436-2375.

Sincerely yours,
/s/
Susan J. Walker, MD
Director,
Division of Dietary Supplement Programs
Office of Nutritional Products, Labeling and Dietary Supplements
Center for Food Safety and Applied Nutrition

This page was posted on January 27, 2005.


On Sun, Apr 22, 2012 at 4:14 PM, Ginny Koroly <[log in to unmask]> wrote:

> HI  i have a question.  Many people in my support group are taking Tibetan
> Natural Healing with varying degrees of good will.  One man hasn't taken
> sinemet for 6 months.  I took it and had trouble for 2 weeks till I finally
> felt better.  They say I didn't take it right and keep up with the sinemit
> and gradually ween off sinemet.  Any one know about this stuff?
>
>
>
> -----Original Message-----
> From: Kevin Lockette <[log in to unmask]>
> To: PARKINSN <[log in to unmask]>
> Sent: Thu, Apr 19, 2012 2:00 am
> Subject: New blog/forum for people with PD
>
>
> Hey Gang,
>
> I just started a new blog for people with Parkinson's Disease with a focus
> on mobility and ADL's.   My posts are Q & A format based on questions from
> many support group presentations and the forum will encourage people to
> post their own questions as well.  Please feel free to pass on to folks
> with PD.   http://parkinsonsphysicaltherapist.wordpress.com
>
> Much aloha,
>
> --
> Kevin Lockette PT
> www.ultimatecaregiversguide.com
> www.ohanapacificrehab.com
> www.parkinsonsmoveit.com
> Kailua Clinic 808 262-1118
> Honolulu Clinic 808 593- 2610
> Cell Phone 808 228-0340
>
>
> SPECIAL NOTE:  This communication is intended solely for the individual or
> the entity to which it is addressed and may contain information that is
> privileged, confidential, and/or prohibited from disclosure.  If the reader
> of this communication is not the intended recipient, you are hereby
> notified that any dissemination, distribution, or copying of this
> communication is strictly prohibited.  If you have received this
> communication in error, please notify us immediately at the above telephone
> number provided and return the original message to us at the above address
> via the U.S. Postal Service.  Your cooperation is greatly appreciated.
> Thank you.
>
> ----------------------------------------------------------------------
> To sign-off Parkinsn send a message to: mailto:
> [log in to unmask]
> In the body of the message put: signoff parkinsn
>
>
>
> ----------------------------------------------------------------------
> To sign-off Parkinsn send a message to: mailto:
> [log in to unmask]
> In the body of the message put: signoff parkinsn
>



-- 
Kevin Lockette PT
www.ultimatecaregiversguide.com
www.ohanapacificrehab.com
www.parkinsonsmoveit.com
Kailua Clinic 808 262-1118
Honolulu Clinic 808 593- 2610
Cell Phone 808 228-0340


SPECIAL NOTE:  This communication is intended solely for the individual or
the entity to which it is addressed and may contain information that is
privileged, confidential, and/or prohibited from disclosure.  If the reader
of this communication is not the intended recipient, you are hereby
notified that any dissemination, distribution, or copying of this
communication is strictly prohibited.  If you have received this
communication in error, please notify us immediately at the above telephone
number provided and return the original message to us at the above address
via the U.S. Postal Service.  Your cooperation is greatly appreciated.
Thank you.

----------------------------------------------------------------------
To sign-off Parkinsn send a message to: mailto:[log in to unmask]
In the body of the message put: signoff parkinsn