The Food and Drug Administration wrote:
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."
"Normalize your blood sugar and blood pressure"
"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.