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April 8, 2004
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
Qing Zhu Zhao
Maxnature.com
10748 La Jara Street
Cerritos, California 90703
Ref. No. CL-03-HFS-810-61
Dear Sir or Madam:
This is to advise you that the Food and Drug Administration
(FDA) has reviewed your web site at the Internet address
http://www.maxnature.com
and has determined that the products “Jiang Dan Gu Chun Wan,” “
Zhi Qi Guan Wan,” “Wu Ling San Wan,” “Xue Fu Zhu Yu Wan,” “Huo
Xue Tong Mai Wan,” “Chai Hu Long Gu Mu Wan” and “Long Dan Xie
Gan Wan” being offered are promoted for conditions that cause
these products 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
continued marketing of these products with these claims violates
the Act and may subject you or the products to regulatory action
without further notice.
Examples of some of the claims observed on your web site
include:
Jiang Dan Gu Chun Wan (Pian) Guang Ci Tang Series Chinese Herbs
“Indication:…It is highly effective for treating hyperlipemia
[sic], diabetes, arteriosclerosis and coronary heart disease and
has the positive effects of preventing the apoplectic seizure
and other cardio-cerebral angiopathy.”
Zhi Qi Guan Wan (Pian) Guan Ci Tang Serial Chinese Herbs
“Indication:…It is used for …dyspnea with shortness of breath,
…acute and chronic tracheitis, and for patients in bronchial
asthma.”
Wu Ling San Wan (Pian) Guang Ci Tang Serial Chinese Herbs
“Indication:…strangury…or strangury with hematuria…. It is
usually used to treat cystitis, urethriris,….kidney stone and
syndrome of strangury.”
Xue Fu Zhu Yu Wan (Pian) Guang Ci Tang Serial Chinese Herbs
“Indication: … relieve pain. It is used for chest pain,
headache... coronary heart disease, angina pectoris,
hypertension ….”
Huo Xue Tong Mai Wan (Pian) Serial Chinese Herb from Guang Ci
Tang
“Indication: … relieve pain. It is used for…coronary heart
disease … angina pectoris hypertension …headache …and arrhythmia
caused by cardiac disease.”
Chai Hu Long Gu Mu Li Wan (Pian) Guang Ci Tang Serial Patent
Chinese Herbs
“Indication:…It is used for…dysuria, hypertension, cerebral
hemorrhage and schizophrenia.”
Long Dan Xie Gan Wan (Pian) Guang Ci Tang Serial Chinese Herbs
“Indication:…Dizziness due to…tinnitus and otalgia… dysuria….”
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 or as cosmetics if
therapeutic claims 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 (DSHEA), 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
http://vm.cfsan.fda.gov/~lrd/fr000106.html (codified at 21
C.F.R. 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 may market. It is your
responsibility to ensure that all products marketed by your firm
are in compliance 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 APope@CFSAN.FDA.GOV,
or you may respond in writing to Angela F. Pope, Compliance
Officer, Food and Drug Administration, Division of Compliance
and Enforcement,
5100 Paint Branch Parkway, College Park, Maryland 20740-3835. If
you have any questions concerning any issue in this letter,
please contact Ms. Pope at (301) 436-2375.
Sincerely yours,
/s/
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
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