FDA Hassles Dr. Mercola

October 31, 2006

http://www.thenhf.com/fda_48.htm

Just Another Reason to Support the Passage of H.R. 4282,

the Health Freedom Protection Act

Posted April 19, 2006

Department of Health and Human Services

Public Health Service

Food and Drug Administration

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

" Reduce the risk of heart disease "

" Lower your cholesterol "

" Improve conditions in those with diabetes and chronic fatigue "

" Improve Crohn's, IBS [irritable Bowel Syndrome], and other

digestive disorders "

" Prevent other disease and routine illness with its powerful

antibacterial, antiviral and antifungal agents "

" A Delicious Way to Prevent Disease … "

" [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 …. "

" 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. "

" 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. "

" 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

" Normalize your blood sugar and blood pressure "

" Fight cancer "

" 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. This document is

available on the Internet at

http://vm.cfsan.fda.gov/~lrd/fr000106.html (codified at 21 CFR 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 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, 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,

Division of Dietary Supplement Programs

Office of Nutritional Products, Labeling and Dietary Supplements

Center for Food Safety and Applied Nutrition

November 1, 2006

Thank God we have the FDA to get rid of these " Quacks " . Dr. Mercola

is obviously hooked up with the various food distributors throughout the

world and making millions of dollars with these untested claims.

The big question here is: What reputable drug company has tested Extra

Virgin Olive Oil as a drug and found it safe? Obviously, anyone using

such foods to keep themselves free of disease is stealing profits from

the pharmaceutical companies. As you probably are well aware, these

companies are spending billions of dollars a year in an all out effort

to keep the population pain free and happy. While some may have led

you to believe that these companies are making huge profits at your

expense, the experts who work for them will set you straight if you

inquire. Additionally, of course, everything that they say is carefully

scrutinized by the FDA. The fact is that the drug companies are only

interested in you and your family's welfare which is why that have put

these wonderful ads on TV to help keep you informed... an informed

public makes wise decisions.

Please help us stamp out these false hopes and help our unsuspecting

general population realize that safe, proven drugs (FDA qualified !!!)

are the only answer. You may be asking, " What can I do to save our

nation from these quacks like Mercola? " First, make sure that your

medicine cabinet is well stocked with proven drugs like Ritlin, Advil/

Motrin (no prescription is even required for you to benefit from these)

and the new non-prescription " Simply Sleep " from the makers of

Tylenol, Statins (any brand will do), and Viagra. We all want to be

pain and worry free, happy, highly sexual, and be assured a good

night's sleep while doing it. At the same time, you will keep your

doctor worry free by assuring him that your tests will come within the

values that our caring pharmaceutical companies have set for you.

Finally, by doing this you will not only be happy for these obvious

reasons, but at the same time, you will be helping keep the money

where it belongs... and money is power.

Thank you for your cooperation on this important issue... and please

copy this into an email and forward this to everyone that you care for

and love. While you are at it, send a copy to the FDA with your

signature. They will be proud to hear from you.

November 1, 2006

, Jim Clark

<huuman60 wrote:

>

> Thank God we have the FDA to get rid of these " Quacks " . Dr.

Mercola is obviously hooked up with the various food distributors

throughout the world and making millions of dollars with these

untested claims.

>

> The big question here is: What reputable drug company has tested

Extra Virgin Olive Oil as a drug and found it safe?

Hi Jim!

Perhaps you should have examined the article more closely before expressing an

opinion. Mercola has never promoted or will ever promote the benefits of extra

virgin olive oil (that's apparently now where the profits lie) Apparently one of

those which they are questioning is in regards to the perceived benefits of

virgin coconut oils and his heart healthy claims for this specific oil. I am

includig for your review a snip of the original as confirmation. The FDA appears

to be questioning the

following health claims ....

Quote from FDA:

" Tropical Traditions Virgin Coconut Oil "