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April 8, 2004
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
Janet Dillon
American Health & Herbs
1313 Main Street
Philomath, Oregon 97370
Ref. No. CL-03-HFS-810-90
Dear Ms. Dillon:
This is to advise you that the Food and Drug Administration (FDA)
has reviewed your web site at the Internet address
http://www.healthherbs.com
and has determined that the products “Maitake Mushroom,” “Memory
Formula #2,” “Mistletoe (European),” “Kidney/Bladder,” “Omega 3
Flaxs Seed Oil – High Lignan,” and “Fringe Tree” are promoted for
conditions that cause the 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 these 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:
Maitake Mushroom
“For strengthening the immune system to fight disease and heal.”
Memory Formula #2
“Helps with Meniere’s Syndrome . Use for …disorders which may result
in memory loss, such as Alzheimer’s.”
Mistletoe (European)
“Lowers blood pressure ...” “Helps with arteriosclerosis and
tumors.”
Kidney/Bladder
“[H]elp fight infection of the kidneys and bladder.”
Omega 3 Flax Seed Oil – High Lignan
“Reduces symptoms of … allergy/asthma …beneficial against cancer and
diabetes.”
Fringe Tree
“[G]radually dissolves gallstones and prevents their formation. Also
for jaundice and other liver disorders.”
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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