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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