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Date: April 8, 2004
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
Suzanne Schmidt
Suzanne’s Natural Foods
6103 S. Connecticut
Joplin, Missouri 64804
Ref. No. CL-03-HFS-810-63
Dear Ms. Schmidt:
This is to advise you that the Food and Drug Administration (FDA)
has reviewed your web site at the Internet address
http://www.suzannes4u.com
and has determined that numerous products, including “Cor Cleanse,”
“SP-19 Glandular Blend (Goldenseal – Gentian Blend),” “Goldenseal,”
“Goldenseal Glycerite,” “Standardized Olive Leaf,” “Suprema Dophilus,”
“Evening Primrose Oil,” and “Hexane Free Black Currant Seed Oil GLA,”
being offered 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 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:
Cor Cleanse (Suzanne’s)
“Do you suffer from high cholesterol or heart disease? . . .”
“Cor Cleanse may just be the answer”
SP-19 Glandular Blend (Goldenseal – Gentian Blend) (Solaray)
“It is used in conjunction with the following: bronchitis,…cold
sores, common cold, sore throat, conjunctivitis, crohn’s disease,
gastritis, influenza, abnormal pap smear, parasites, urinary tract
infection, and vaginitis.”
Goldenseal (Suzanne’s)
“Primary Uses: Viral Infection, Sinus Infection, Gum Disease”
“Properties: Anti-Bacterial; Anti-Viral . . .”
“Goldenseal is indicated for acute manifestations of infection on
any mucosal tissue which includes the respiratory, digestive,
reproductive and urinary systems.”
“Goldenseal is famous for use in colds and flues [sic]. It should be
used in situations where traditional anibiotics [sic] are indicated
. . . . “
“It is arguably the best remedy for sinus infections . . . and gum
diseases . . . “
“It can help urinary tract infections, vaginal infections,
intestinal infections, prostate infections and topical infections on
the skin.”
Goldenseal Glycerite (Herb Pharm)
“Goldenseal is used to treat the following conditions: Canker sores;
Chronic candidiasis; Common cold/sore throat; Conjunctivitis/blepharitis;
Infection; Influenza; Parasites; Urinary tract infection; Vaginitis”
Olive Leaf Extract (Solaray)
“…aiding in the treatment of herpes and other viral conditions, flu
and colds, fungal infections, chronic fatigue and allergies.”
“It is very effective against many strains of virus, bacteria, and
fungus.”
Olive Leaf Extract (Natural Factors)
“. . . exerts powerful antiviral, antibacterial, antifungal and
antiparasitic activity. Anecdotal evidence shows it to be helpful
for many stubborn infections. It seems to work particularly well for
colds, flue [sic] and other respiratory infections.”
Standardized Olive Leaf (Suzanne’s)
“Helps with: human immunodefiency disease (HIV); herpesviruses
[sic]; influenza viruses; pneumonia; sore throat; sinusitis; skin
diseases (such as chronic infections or rashes); fungal or bacterial
infections”
Suprema Dophilus (Suzanne’s)
“. . . can lower cholesterol levels . . . .”
“Supplementation may prevent, or be helpful with, the following
conditions: Allergies (food); Atherosclerosis (heart disease);
Cancer (colon); Candidiasis (yeast infection); Canker Sores; . . .
Crohn's Disease; . . . Eczema; Immunodepression (immune function);
Infection (colds, flu, etc.); Irritable Bowel Syndrome (IBS);
Ulcerative Colitis”
Evening Primrose Oil (Suzanne’s)
“The anti-inflammatory properties of EPO have been studied in double
blind research with people suffering from rheumatoid arthritis.
Some, but not all, studies have reported that EPO supplementation
provides significant benefit to these people.”
“GLA, the primary active ingredient in EPO, has anti-cancer
activity…”
“Injecting GLA into tumors has caused regression of cancer…”
“Very preliminary evidence in people with cancer suggested ‘marked
subjective improvement.”
“EPO has been reported to lower cholesterol levels…”
“…diabetes, scleroderma, Sjogren’s syndrome, tardive dyskinesia, and
eczema. In preliminary research, supplementation with EPO has helped
people with these conditions.”
“…double blind evidence suggests that alcoholics may be deficient in
GLA and that alcohol withdrawal may be facilitated with EPO
supplementation.”
Hexane Free Black Currant Seed Oil GLA (Solaray)
“GLA, the primary active ingredient in Black Currant Seed Oil, has
anti-cancer activity[.] Injecting GLA into tumors has caused
regression of cancer in people. Evidence in people with cancer
suggested ‘marked subjective improvement.’”
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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