Mercola warned by Department of Health and Human Services

[Guest guest]

I haven't been keeping up with Mercola's newsletter so don't know if

he mentioned this...

http://www.casewatch.org/fdawarning/prod/2005/mercola.shtml

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

ph 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 .@...,

or you may respond in writing to M. P. , 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 at

301-436-1439.

Sincerely,

/s/

J. , MD

Director,

Division of Dietary Supplement Programs

Office of Nutritional Products, Labeling and Dietary Supplements

Center for Food Safety and Applied Nutrition

This page was revised on October 5, 2005.

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