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Home > Archive > Politics and Medicine > October 2006 > Mercola Gets Another Warning Letter
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Mercola Gets Another Warning Letter
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| Nana Weedkiller 2006-10-17, 4:28 pm |
| September 21, 2006
WARNING LETTER
CHI-7-06
CERTIFIED MAIL
RETURN RECEIPT REOUESTED
Joseph M. Mercola, D.O.
Optimal Wellness Center
1443 West Schaumburg Road, Suite 250
Schaumburg, IL 60194
Dear Dr. Mercola:
The Food and Drug Administration (FDA) conducted an inspection at your
facility at the above address on April 24, 2006. During that inspection, the
investigator collected various product labels including, but not limited to,
the following products: Vibrant Health Research Chlorella XP, Fresh Shores
Extra Virgin Coconut Oil, Momentum Health ProductsT Vitamin K2 T, and
Momentum Health ProductsT Cardio EssentialsT Nattokinase NSK-SD. In
addition, we reviewed labeling on your website at http://www.mercola.com. A
review of this labeling found that the products listed above are promoted
for conditions that cause these products to be drugs under section
201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21
U.S.C.321 (g)(1)(13)]. These claims on your labeling, including your
website, 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. You can find
the Act and FDA's regulations through links on FDA's Internet home page,
http://www.fda.gov.
Examples of disease claims observed in your products' labeling, including
your website and product labels, include:
Vibrant Health Research Chlorella XP
a.. "In Japan, interest in chlorella has focused largely on . . . its
ability to neutralize or remove poisonous substances from the body."
b.. "Eliminating processed foods with whole foods like chlorella will help
to virtually eliminate your risk of developing cancer in the future."
Further, the main Chlorella XP page of your website (http://www
..mercola.com/forms/chlorella.htm) links to a page captioned "Chlorella
Scientific Research" where several publications reporting on human and
animal studies of chlorella products are cited. Under each citation is an
abstract of the publication. Many of the publications cited and summarized
on this page concern therapeutic uses of chlorella. When scientific
publications are used commercially by the seller of a product to promote the
product to consumers, such publications may become evidence of the product's
intended use. For example, under 21 CFR 101.93(g)(2)(iv)(C), a citation of a
publication or reference in the labeling of a product is considered a claim
about disease treatment or prevention if the citation refers to a disease
use, and if, in the context of the labeling as a whole, the citation implies
that the product is useful for treatment br prevention of a disease.
The following are examples of reference citations on your website that are
used to promote Vibrant Health Research Chlorella XP for treatment or
prevention of various diseases:
a.. "Nutritional supplementation with Chlorella pyrenoidosa for patients
with fibromyalgia syndrome: a pilot study." Merchant RE; Carmack, CA; Wise
CM. Phytother Res 2000 May; 14(3):167-73. The abstract of the study on your
website states, in part: "Any amelioration of symptoms was validated and
quantified . . . at clinic visits on days 0, 30 and 60 of the diet therapy.
.. . . After two months the average pain decrease was 22%."
b.. "Effect of dried, powdered Chlorella vulgaris on experimental
atherosclerosis and alimentary hypercholesterolemia in cholesterol-fed
rabbits." Sano T; Tanaka Y. Artery 1987;14(2) :76-84.
c.. "Effect of hot water extract of Chlorella vulgaris on cytokine
expression patterns in mice with murine acquired immunodeficiency syndrome
after infection with Listeria monocytogenes." Hasegawa T, Kimura Y,
Hiromatsu, K, et al. Immunopharmacology. 1997 Jan;35(3):273-82.
d.. "Augmentation of antitumor resistance by a strain of unicellular green
algae, Chlorella vulgaris." Tanaka K; Konishi F; Himeno K, et al. Cancer
Immunol Immunother 1984;17(2):90-4.
e.. "Oral administration of Chlorella vulgaris augments concomitant
antitumor immunity." Tanaka K; Tomita Y; Tsuruta M, et al. Immunopharmacol
Immunotoxicol 1990;12(2):277-91.
f.. "Oral administration of a unicellular green algae, Chlorella vulgaris,
prevents stress-induced ulcer." Tanaka K, Yamada A, Noda K, et al. Planta
Med 1997 Oct;63(5):465-6.
Fresh Shores Extra Virein Coconut Oil
a.. "Coconut oil is . . . uniquely rich in lauric acid, which is converted
to the same disease-fighting substance--monolaurin--that nursing babies
derive from lauric acid in mother's milk. Research has demonstrated coconut
oil's anti-microbial, anti-viral and anti-parasitical properties . . .."
b.. "Pure Virgin Coconut Oil: The Healthy Fat That ... Banishes Infection,
And Heads Off Heart Disease"
c.. "The numerous health benefits of coconut oil are finally again
reaching the mainstream. Benefits like:
Reducing your risk of heart disease . . .
Reducing your risk of cancer and degenerative diseases . . .
Preventing infections due to harmful bacteria, viruses, yeasts and other
microorganisms . . ."
d.. "[H]elps you prevent heart disease, lower cholesterol...."
e.. "[L]auric acid is the predominant type of MCFA [medium-chain fatty
acid] found in coconut oil . ... [A] great volume of research has been done
establishing the ability of lauric acid to fight dangerous micro-organisms .
.. . like viruses, bacteria, yeasts, fungi, parasites and molds . . . .
Numerous studies have indicated that many viruses are inactivated by
medium-chain fats-viruses like influenza, measles, HIV, herpes and
cytomegalovirus."
Momentum Health ProductT Vitamin K2T
a.. "Recent research supporting vitamin K's usefulness against
osteoporosis and heart disease is now becoming too abundant to overlook .
.... I now offer the most potent disease fighting form of this vitamin
available-Vitamin K2-in supplemental form."
b.. "[S]cientists are even looking at vitamin K to be the future of
treating certain kinds of cancer and Alzheimer's disease."
c.. "Research shows that vitamin K regulates calcium and keeps it in the
bones and out of arteries-stopping heart attacks and osteoporosis at the
same time."
d.. "Health Advantages of Vitamin K2
a.. . . .[P]revents Osteoporosis
b.. " Prevention of atherosclerosis
c.. " Inhibits cancer cell growth"
a.. Momentum Health ProductsT Cardio EssentisT Nattokinase NSK-SD
"CardioEssentials is a much safer and effective option than aspirin and
other pharmaceutical agents to treating heart disease."
b.. "With the discovery of nattokinase, we no have a safe,
scientifically-proven and natural way for millions to combat hardened
arteries, heart attack, stroke, angina, dementia and senility."
c.. "While modern medicine has come up with several clot-busting
drugs--they come at a very high price. Among them, tissue plasminogen
activactors [sic] (t-PAs) lead the pack. Every year, stroke and heart attack
victims are administered t-PAs such as actiase, urokinase and streptokinase.
While these treatments do save between 300,000-500,000 lives annually, one
dose of urokinase cost approximately $1,500. Comparatively, CardioEssentials
is ridiculously cheap.
d.. "Prevents heart attacks, strokes, and blood clots"
e.. "Lowers blood pressure"
f.. "Minimizes joint pain in osteoarthritis and rheumatoid arthritis"
g.. "Decreases cholesterol"
h.. "CardioEssentials contains a truly revolutionary and powerful enzyme
called nattokinase that has produced monumental success for dissolving blood
clots!"
i.. (under heading "Product and Dosage Information for CardioEssentials")
"Therapeutic dose (e.g., person under medical supervision w/high blood
pressure, risk factors for coronary artery disease, high risk for blood
clots, DVT). 4,000 fibrin units per day.
Ischemic strokes (e.g., person at risk for ischemic, "dry" stroke, or who
is recovering from a stroke, transient ischemic attack, RND {reversible
ischemic neurologic deficit], etc. 6,000 fibrin units per day.
These claims cause your products to be drugs, as drug, as defined in Section
201(g)(1)(B) of the Act [21 U.S.C. 321(g)(1)(B)]. Because these products are
not generally recognized as safe and effective when used as labeled, they
are also new drugs as defined in Section 201(p) of the Act [21 U.S.C.
321(p)]. New drugs may not be legally marketed in the United States without
prior approval from FDA as described in Section 505(a) of the Act [21 U.S.C.
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.
These products are also misbranded within the meaning of Section 502(f)(1)
of the Act, in that the labeling for these drugs fails to bear adequate
directions for use [21 U.S.C. 352(f)(1)].
Please note that similar therapeutic claims on you web site were brought to
your attention in a letter from FDA's Center for Food Safety and Applied
Nutrition dated February 16, 2005. In that letter, we notified you hat
claims for several of your firm's products, including chlorella and coconut
oil products, caused those products to be unapproved new drugs within the
meaning of the Act. A copy of the February 16, 2005, letter, which also
provides additional information elated to the Dietary Supplement Health
Education Act, is enclosed for your reference.
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.
Failure to promptly correct these violations may result in enforcement
action without further notice. Enforcement action may include seizure of
violative products and/or injunction against the manufacturers and
distributors of violative products.
Please advise this office in writing, within 15 working days of receipt of
this letter, as to the specific steps you have taken or will be taking o
correct these violations, including the steps taken to assure that similar
violations do not recur. Include any documentation necessary to show that
correction has been achieved. If you cannot complete all corrections before
you respond, we expect that yo will explain the reason for your delay and
state when you will correct any remaining deviations.
Your reply should be sent to the Food and Drug Administration, Attention:
Patrick J. Brown, Compliance Officer, 550 W. Jackson Blvd , 15th Floor,
Chicago, Illinois 60661-5716.
Sincerely,
/S/
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| PeterB 2006-10-17, 4:28 pm |
|
Nana Weedkiller wrote:
<Read it above>
Yes, Nana, we realize that FDA is in the business of distorting the
truth about natural medicine, and that it's not legal to even place
brochures with sceintifically documented disease-benefit information
*next* to dietary supplements containing those beneficial ingredients.
Other than that, was there something meaningful you wanted to say?
PeterB
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| Max C. 2006-10-17, 4:28 pm |
|
PeterB wrote:
> Nana Weedkiller wrote:
> <Read it above>
>
> Yes, Nana, we realize that FDA is in the business of distorting the
> truth about natural medicine, and that it's not legal to even place
> brochures with sceintifically documented disease-benefit information
> *next* to dietary supplements containing those beneficial ingredients.
> Other than that, was there something meaningful you wanted to say?
>
> PeterB
There could be a silver lining to this. It's my understanding that Dr.
Mercola has been working with law makers to revamp some of the laws
that the FDA is attempting to use to stop legit businesses from selling
supplements or foods and using scientific research to promote their
products. This could actually be beneficial in the face of those
changes. The letter certainly reads like there's a vendetta.
Max.
| |
| PeterB 2006-10-17, 4:28 pm |
|
Max C. wrote:
> PeterB wrote:
>
> There could be a silver lining to this. It's my understanding that Dr.
> Mercola has been working with law makers to revamp some of the laws
> that the FDA is attempting to use to stop legit businesses from selling
> supplements or foods and using scientific research to promote their
> products. This could actually be beneficial in the face of those
> changes. The letter certainly reads like there's a vendetta.
>
> Max.
If I'm not mistaken, both he and LEF have areas on their websites
supporting The Health Freedom Protection Act (HR4282), which I know
you're familiar with. It's a very important piece of legislation whose
passage upholds our First amendment right to relevant disclosure of
nutritional science relating to supplements and/or whole foods.
PeterB
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| Mark Probert 2006-10-17, 9:34 pm |
| PeterB wrote:
> Nana Weedkiller wrote:
> <Read it above>
>
> Yes, Nana, we realize that FDA is in the business of distorting the
> truth about natural medicine, and that it's not legal to even place
> brochures with sceintifically documented disease-benefit information
> *next* to dietary supplements containing those beneficial ingredients.
If there really is scientific proof, why do they not submit the proof to
the FDA when they get these warning letters? What are they afraid of?
> Other than that, was there something meaningful you wanted to say?
Nana post is far more meaningful than yours.
| |
| Mark Probert 2006-10-17, 9:34 pm |
| Max C. wrote:
> PeterB wrote:
>
> There could be a silver lining to this. It's my understanding that Dr.
> Mercola has been working with law makers to revamp some of the laws
> that the FDA is attempting to use to stop legit businesses from selling
> supplements or foods and using scientific research to promote their
> products. This could actually be beneficial in the face of those
> changes. The letter certainly reads like there's a vendetta.
If Mercola were to be successful in those efforts, his biggest selling
point of his products, i.e., "I am the victim of a conspiracy" would be
washed away.
| |
| PeterB 2006-10-18, 8:33 am |
|
Mark Probert wrote:
> PeterB wrote:
>
> If there really is scientific proof, why do they not submit the proof to
> the FDA when they get these warning letters? What are they afraid of?
Because, Markey, FDA does not evaluate scientific support for dietary
supplements. How many years have you been posting here?
>
> Nana post is far more meaningful than yours.
Said the good little pharmonkey about his Weedeating friend.
| |
| Mark Probert 2006-10-18, 8:33 am |
| PeterB wrote:
> Mark Probert wrote:
>
> Because, Markey, FDA does not evaluate scientific support for dietary
> supplements. How many years have you been posting here?
If it is a dietary supplement, as you claim, then there should be no
health claims made as that is the law.
The only conclusion I can reach is that you support criminal activity.
>
>
> Said the good little pharmonkey about his Weedeating friend.
>
| |
| Max C. 2006-10-18, 4:34 pm |
|
Mark Probert wrote:
> PeterB wrote:
>
> If it is a dietary supplement, as you claim, then there should be no
> health claims made as that is the law.
>
> The only conclusion I can reach is that you support criminal activity.
Of course that's the only conclusion *you* can reach. It's a law that
strongly favors drug companies. Just because something is law does not
mean that the law is just. Would you support segregation if you lived
back in those days?
"An unjust law is itself a species of violence. Arrest for its breach
is more so."
Mohandas Gandhi
"An unjust law is a code that is out of harmony with the moral law. To
put it in the terms of Saint Thomas Aquinas, an unjust law is a human
law that is not rooted in eternal and natural law."
Martin Luther King
And for those of you who think the FDA is above corruption, how about
reading up on current events?
http://www.nytimes.com/2006/10/17/w...d-crawford.html
"Lester M. Crawford, the former head of the Food and Drug
Administration, pleaded guilty this afternoon to lying and
conflict-of-interest charges in connection with stock he and his wife
owned in companies regulated by the F.D.A."
The corruption goes all the way to the top.
Max.
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| PeterB 2006-10-18, 4:34 pm |
|
Mark Probert wrote:
> PeterB wrote:
>
> If it is a dietary supplement, as you claim, then there should be no
> health claims made as that is the law.
You first questioned why the supplement maker does not provide FDA with
the scientific data, now you say it doesn't matter that FDA doesn't
evaluate such evidence, it's the law and we should live with it. It's
amazing how many ways can you display your ignorance in a single
thread, but that's nothing new for a pharmonkey like yourself. My
point is that the public should not lay down and permit a drug-pimping
FDA to control the flow of scientific information to the public. Laws
are made to be changed, and HR4282 will accomplish that unless your
sponsors are able to bribe the legislature, which is certainly a real
possibility.
[vbcol=seagreen]
> The only conclusion I can reach is that you support criminal activity.
>
| |
| Max C. 2006-10-18, 4:34 pm |
|
Mark Probert wrote:
> Max C. wrote:
>
> If Mercola were to be successful in those efforts, his biggest selling
> point of his products, i.e., "I am the victim of a conspiracy" would be
> washed away.
I have never purchased a product from Mercola for any reason even close
to that. I purchased them because they worked and he had them at a
reasonable price.
Max.
| |
| Jan Drew 2006-10-18, 4:34 pm |
|
"Max C." <maxc246@gmail.com> wrote in message
news:1161178802.116962.309210@k70g2000cwa.googlegroups.com...
>
> Mark Probert wrote:
>
> Of course that's the only conclusion *you* can reach. It's a law that
> strongly favors drug companies. Just because something is law does not
> mean that the law is just. Would you support segregation if you lived
> back in those days?
>
> "An unjust law is itself a species of violence. Arrest for its breach
> is more so."
> Mohandas Gandhi
>
> "An unjust law is a code that is out of harmony with the moral law. To
> put it in the terms of Saint Thomas Aquinas, an unjust law is a human
> law that is not rooted in eternal and natural law."
> Martin Luther King
>
> And for those of you who think the FDA is above corruption, how about
> reading up on current events?
>
> http://www.nytimes.com/2006/10/17/w...d-crawford.html
> "Lester M. Crawford, the former head of the Food and Drug
> Administration, pleaded guilty this afternoon to lying and
> conflict-of-interest charges in connection with stock he and his wife
> owned in companies regulated by the F.D.A."
>
> The corruption goes all the way to the top.
>
> Max.
>
Shhhh, Max.
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| Mark Probert 2006-10-18, 4:34 pm |
| Max C. wrote:
> Mark Probert wrote:
>
> I have never purchased a product from Mercola for any reason even close
> to that. I purchased them because they worked and he had them at a
> reasonable price.
Then you are one of his smarter customers.
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