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Warning Letter from FDA to Dr. Mercola
Source
Bee's Note: Isn't this ridiculous???
5100 Paint Branch Pkwy
College Park, MD 20740-3835
February 16, 2005
WARNING LETTER
VIA CERTIFIED MAIL, RETURN RECEIPT REQUESTED
Joseph Mercola
Optimal Wellness Center
1443 W. Schaumburg, Ste 250
Schaumburg, IL 60194
Ref. No. CL-04-HFS-810-134
Dear Dr Mercola:
This is to advise you that the Food and Drug Administration
(FDA) has reviewed your web site at the Internet address http://www.mercola.com and has determined
that the products Living Fuel Rx™,
Tropical Traditions Virgin Coconut Oil, and Chlorella 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
these products are drugs because they are intended for use in the cure,
mitigation, treatment, or prevention of diseases. The marketing of these
products with these claims violates the Act.
Examples of some of the claims observed on your web site include:
Living Fuel Rx™
"In today's society people are simply not meeting their
nutritional needs. We see evidence of this with the rampant illnesses including
cancer, cardiovascular disease, diabetes, autoimmune diseases, etc. Living Fuel
Rx is an exceptional countermeasure to this lifestyle, meeting all of your
nutritional needs."
Tropical Traditions Virgin Coconut Oil
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"Reduce the risk of heart disease"
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"Lower your cholesterol"
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"Improve conditions in those with diabetes and chronic
fatigue"
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"Improve Crohn's, IBS [Irritable Bowel Syndrome], and
other digestive disorders"
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"Prevent other disease and routine illness with its
powerful antibacterial, antiviral and antifungal agents"
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"A Delicious Way
to Prevent Disease ..."
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"[V]irgin coconut oil is rich
in lauric acid, a proven antiviral, antibacterial and antifungal agent that is
very beneficial in attacking viruses, bacteria, and other pathogens ...."
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"Coconut oil also raises metabolic rate .... A faster
metabolic rate stimulates increased production of needed insulin and increases
absorption of glucose into cells, thus helping both Type I and Type II
diabetics."
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"For those with Crohn's and IBS, the
anti-inflammatory and healing effects of coconut oil have been shown to play a
role in soothing inflammation and healing injury in the digestive tract."
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"The fatty acids in coconut oil can kill herpes and
Epstein Barr viruses .... They kill Candida and giardia.
They kill a variety of other infectious organisms, any of which could cause
chronic fatigue."
Chlorella
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"Normalize your blood sugar and blood pressure"
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"Fight cancer"
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"One of the ways to fight cancer is the use of agents
to stimulate macrophage production and activity. Interferon is a natural
secretion of the body that is thought to be a stimulator of macrophages and tumor
necrosis factor (TNF). Chlorella stimulates the activity of T-cells and
macrophages by increasing interferon levels thus enhancing the immune system's
ability to combat foreign invaders whether they are bacteria, viruses,
chemicals, or foreign proteins."
Your products are not generally recognized as safe and effective for the
above referenced conditions and therefore, these products are also "new
drugs" under section 201(p) of the Act [21 USC 321(p)]. New drugs may not
be legally marketed in the US
without prior approval from FDA as described in section 505(a) of the Act [21
USC 355(a)]. FDA approves new drugs on the basis of scientific data submitted
by a drug sponsor to demonstrate that the drugs are 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 are removed from the promotional materials
and the products otherwise comply with all applicable provisions of the Act and
FDA regulations.
With regard to your Living Fuel Rx™ product, which your
website describes as an "optimized superfood meal
replacement," please note that products represented for use as a meal
replacement do not meet the definition of a dietary supplement in section
201(ff) of the Act [21 USC 321(ff)] and may not be marketed as such.
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 requirements 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.
In addition, only products that are intended for ingestion may be lawfully
marketed as dietary supplements. Topical products and products intended to
enter 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 Kenneth.Taylor@CFSAN.FDA.GOV,
or you may respond in writing to:
Kenneth M. P. Taylor, PhD
Chemist, Food and Drug Administration
Division of Dietary Supplement Programs
5100 Paint Branch Pkwy.
College Park, MD 20740-3835
If you have any questions concerning this letter, please contact Dr Taylor at 301-436-1439.
Sincerely,
/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
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