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本帖最后由 StephenW 于 2011-2-3 18:25 编辑
回复 mtv982 的帖子
lingmaigui:"发表自己的、未经验证的、理论基础缺乏的观点进入新手聚集的版块是极为不恰当的。"
1.首先，我同意lingmaigui的观点,我想补充：没有证据.
2.我最 不同意"加吃灵芝，保持一年以上，双达标的可能性大，乙肝疫苗+灵芝双达标是真的，停了后复发的可能性小". 灵芝对乙肝是好是坏, 绝对没有任何科学或医学证据.
3. 灵芝不像其他的补充产品，如维生素或咖啡，灵芝有特殊的专利权, 非常昂贵.没有推荐剂量,"加吃灵芝，保持一年以上"将花费很多钱,受益一个商业财团.这个财团, 在香港赚了很多钱.他们还花了很多钱，要求中国的医生和教授做研究，以支持其灵芝产品, 但没有任何成功的结果.请阅读来自美国的FDA下面的信:
[美国FDA不批准灵芝进口]
.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
College Park, MD 20740
OCT 28 2004
Mr. Donald Chu
President & CEO
Tronex Company
One Tronex Centre
3 Lugar Road
Denville, New Jersey 07834
Dear Mr. Chu:
This is in response to your letter of September 21 I 2004 to the Foodand Drug
Administration (FDA) pursuant to 21 U.S.C. 343(r)(6) (section 403(r)(6)of the Federal
Food, Drug, and Cosmetic Act (the Act)). Your submission states thatTronex
Company is making the following claims, among others, for the productONCOZAC:
“ IF] or those combating serious illnesses. ”
“[IImprove the immune function of people suffering from serious illnesses,
alleviate the side effects caused by invasive treatments and assist
convalescence. ”
“ [Aldjunct health supplement complementary to conventional invasive
treatments which usually cause many side effects including decline ofimmune
function, reduction of red and white blood cell counts, oral ulcer,nausea,
vomiting and anorexia. ”
“[:E]nhance the host resistance to bacterial and fungal infectionsand abnormal
cell growth. ”
“[Clomplement the treatment effect of conventional invasive treatments.”
“[Ilmprove the health status and overall quality of life of peoplesuffering from
serious illnesses. ”
2 1 U. S.C. 343(r)(6) makes clear that a statement included in labelingunder the
authority of that section may not claim to diagnose, mitigate, treat,cure, or prevent a
specific disease or class of diseases. The statements that you aremaking for this
product, including the recommendations for uses before, during andafter invasive
treatments or surgery and curing convalescence after cancer treatment,suggest hat it is
Page 2 - Mr. Donald Chu
intended to treat, prevent, or mitigate disease. These claims do not meet the
requirements of 21 U. S.C. 343(r)(6). These claims suggest hat this products is
intended for use as a drug within the meaning of 21 U.S.C. 321(g)(l)(R),and that it is
subject to regulation under the drug provisions of the Act. If you intend to make
claims of this nature, you should contact FDA’s Center for Drug Evaluationand
Research (CDER), Office of Compliance, HFD3 10, Montrose Metro II,119 19
Rockville Pike, Rockville, Maryland 20855.
Please contact us if we may be of further assistance.
Sincerely yours,
Susan J. Walker, M.D.
Director
Division of Dietary Supplement Programs
Office of Nutritional Products, Labeling
and Dietary Supplements
Center for Food Safety
and Applied Nutrition
Copies:
FDA, Center for Drug Evaluation and Research, Office of Compliance,HFD310
FDA, Office of the Associate Commissioner for Regulatory Affairs, Officeof
Enforcement, HFC-200
FDA, New Jersey, Office of Compliance,HFR-CE340
Date : 21st September, 2004.
Dr. Robert Moore, Branch C&e&
Compliance and Enforcement Branch
Division of Dietary Supplement Program/ONPLDS
Center for Food Safety and Applied Nutrition
Food and Drug Administration I
HFS-810
200 c street, SW
Washington, DC 20204
Subject: 30-Days Notification Letter of Dietary Supplement’s Statement
Dear Dr. Moore,
As the authorized U.S. Agent and distributor for Principle, PurapharmInternational (H.K.)
Limited, with registered Company address at One Tronex Centre, 3 LugerRoti Denville, NJ
07834, notice is hereby given pursuantto the requirements of Section 403(r)(6) of the Federal
Food, Drug and Cosmetic Act (21 U.S.C. 343(r)(6)) of the intent ofus to marhetin the U.S. a
dietary supplement, brand-named as ONCOZAC, which contains 340mg gramsof Standardized
Ytmzhi (Coriolus Versicolor) Extract, equivalent to 3.4 grams of driednatural and wild Yunzhi
(Coriolus Versicolor). Accordingly, an original and two copies of thisnotifkation, the text of
Bottle Label and the Packing Insert are submitted for your reference.
I hereby also certify that, to the best of my knowledge, ail the informationsubmitted here is true
and accurate.
Please direct all correspondence to me and feel free to call me at(973)-627-3800 if you have any
question regarding this matter.
Cc: PuraPharm International (HK) Ltd.
Tronex Company
One Tronex Centre 3 Luger Road Denville, NJ 07834 U.S.A. Tel: 973 6273800 Fax: 973 625 7630
informationQtronexcompany.com
www.tronexcompany.com
Oncozac 300’s label (English)
OncozacTM is a new generation Yunzhi(CoriolusVersicolor)-derived adjunct remedy
with enhanced efficacy and consistency developed for those combatingserious
illnesses. Made from 100% wild Yunzhi,OncozacTM is produced with sophisticated
and proprietary production processes under strict GMP standards. Itcontains pure
Yunzhi extract, which consists ofhighly concentrated absorbable peptidoglucan
(APG) that can effectively improve/enhance bodily immune function.Every batch of
OncozacTM is tested with established hygienic, chemical and immunologicalassays to
warrant its safety, consistency and efficacy.
Ingredients: 100% Yunzhi extract(containing absorbable peptido
Dosge: 5 capsules, two times daily or as directed by physician
Packing: 300 capsules / bottle, net weight 102g.
Storage: Keep in a cool dry place. Avoid direct sunlight.
Supplement Fact
Serving size: 10 capsules
Each Cansule Contains
Y~hi (Coriolus Versicolor) extract
** Daily value not established
Other ingredients: Gelatin
% Dailv Value
34omg**
* These statements have not been evaluated by the Food & Drug Administration.This
product is not intended to diagnose, treat, cure or prevent any disease.
Oncozac insert (English)
Deserbtion:
Each capsule contains 340mg absorbable peptidoglucan (APG) - containingYunzhi
(Coriolus Versicolor) extract, which is equivalent to 3.4g naturaland wild Yunzhi.
OncozacTM is produced under proprietary production processes derivedfrom
extensive scientific researches. The efficacy, quality and consistencyof OncozacTM
are proven by established immunological hygienic and chemical tests.Evidences
indicate that OncozacTM can effectively improve the immune functionof people
suffering from serious illnesses, alleviate the side effects causedby invasive
treatments and assist convalescence.
Action:
OncozaP is a new generation Yunzhiextract which displays the following actions:
l
Invigorate the major immune cells such as T-lymphocytes, B-lymphocytes,
monocytes/macrophages, bone marrow cells and natural killer cells etc.,
l
Promote the production of antibodies, complements and various cytokinessuch as
interleukin (IL)-2, IL-6 and interferons, etc.,
l
Enhance the cytotoxic activity of lymphocytes,
l
Restore the compromised immune status caused by invasive treatments.
Indication and Usage:
Oncoza+ is an adjunct health supplement complementary to conventionalinvasive
treatments which usually cause many side effects including declineof immune
function, reduction of red and white blood cell counts, oral ulcer,nausea, vomiting
and anorexia. OncozacTM can reinforce the immune defense so as to enhancethe host
resistance to bacterial and mngal infections and abnormal cell growth.It can also
complement the treatment effect of conventional invasive treatments.Continuous
admit&ration of OncozacTM could improve the health status and overallquality of life
of people suffering from serious illnesses.
Dosape and Adminstration:
Take the capsules with plenty of water preferably before meals. Forbest effects,
OncozacTM should be taken regularly in accordance with the following
recommendations:
1) Before invasive treatments or surgery:
Take 5 capsules each time, 2 times daily starting from 7 days ‘beforethose
treatments or surgery, or under appropriate medical advice.
2) During and after invasive treatments or surgery:
Take 5 capsules each times, 2 times daily continuously for 6 monthsor under
appropriate medical advice.
3) Unable to undergo invasive treatments or operation:
Take 8 capsules each time, 2 times daily continuously for 6 months.Dosage could
be adjusted,according to the health conditions or appropriate medicaladvice.
4) Convalesce after cancer treatment:
Take 2-3 capsules each time, 2 times daily continuously during theconvalescent
period.
Adverse Reactions:
Adverse reactions to Yunzhi extractwere rarely found. Gastrointestinal discomfort
usually subsides after several administrations of OncozacTM or whenit is taken after
meals.
Drug Interactions:
Adverse drug interaction between Yunzhiextract and other drugs, has not been
reported. However, co-administration of immunosuppressants and OncozacTMis not
recommended.
Contraindications:
For those patients with a history of hypersensitivity to Yunzhiand other edible
mushrooms, please seek medical advice before usage.
Iwredient:
100% Yunzhi extract (containingabsorbable peptidoglucan APG)
Pa&a&w:
Each capsule contains 340mg highly concentrated Yunzhiextract supplied in either
100’s blister pack (10 capsules/blister) or 300’s bulk pack.
Storage:
Store in cool, dry place. Avoid direct sunlight.
A product of PuraPharm International (H.K.) Ltd.
Distributed by: Tronex Pharmaceutical Industries Denville NJ 07834USA
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楼主: mtv982
发表于 2011-2-3 14:38
