FDA Orders Dr. Joseph Mercola to Stop Illegal Claims
Stephen Barrett, M.D.
Joseph Mercola, D.O., who practices in Schaumburg, Illinois, also operates one of the Internet's largest and most popular health information sites. Mercola states that his site has over 50,000 pages and is visited by "millions of people each day" [1] and his three-times-a-week electronic newsletter has over 850,000 subscribers [2]. In 2004, Medical Economics reported that his practice employed 50 people and that he employed 15 people to run his newsletter, including three editors [3]. Many of his articles make unsubstantiated claims and clash with those of leading medical and public health organizations. For example, he opposes immunization [4] and fluoridation [5], claims that amalgam fillings are toxic [6], and makes many unsubstantiated recommendations for dietary supplements. Much of his support comes from chiropractors who promote his newsletter from their Web sites. Two of his books have hit the #2 sales rank on Amazon Books shortly after his newsletter plugged them for the first time.
FDA Warnings
In 2005, the FDA ordered Mercola and his Optimal Wellness Center to stop making illegal claims for products sold through his Web site [7]. The claims to which the FDA objected involved three products:
- Living Fuel Rx, claimed to offer an "exceptional countermeasure" against cancer, cardiovascular disease, diabetes, autoimmune diseases, etc.
- Tropical Traditions Virgin Coconut Oil, claimed to reduce the risk of heart disease and has beneficial effects against Crohn's disease, irritable bowel syndrome, and many infectious agents
- Chlorella, claimed to fight cancer and normalize blood pressure.
In 2006, the FDA send Mercola and his center a second warning that was based on product labels collected during an inspection at his facility and on claims made on the Optimum Wellness Center Web site [8]. This time the claims to which the FDA objected involve four products:
- Vibrant Health Research Chlorella XP, claimed to "help to virtually eliminate your risk of developing cancer in the future."
- Fresh Shores Extra Virgin Coconut Oil, claimed to reduce the risk of heart disease, cancer, and degenerative diseases.
- Momentum Health Products Vitamin K2, possibly useful in treating certain kinds of cancer and Alzheimer's disease.
- Momentum Health Products Cardio Essentials Nattokinase NSK-SD, claimed to be "a much safer and effective option than aspirin and other pharmaceutical agents to treating heart disease."
The warning letters explained that the use of such claims in the marketing of these products violates the Federal Food Drug and Cosmetic Act, which bans unapproved claims for products that are intended for curing, mitigating, treating, or preventing of diseases. (Intended use can be established through product labels, catalogs, brochures, tapes, Web sites, or other circumstances surrounding the distribution of the product.)
References
- Mercola JM. Health website rankings: Mercola.com is now world's #1. Optimal Wellness Center Web site, accessed Oct 12, 2006.
- Mercola JM. E-mail message to Dr. Stephen Barrett, Oct 12, 2006.
- Joseph Mercola: The physician as entrepreneur. Medical Economics, August 20, 2004, p 37.
- Buttram H. Vaccine safety and benefits not scientifically proven. Optimal Wellness Center Web site, Jan 15, 2003.
- Mercola JM. Is fluoride as safe as you are told. Optimal Wellness Center Web site, Feb 2, 6, and 9, 2002.
- Mercola JM. The experts get it wrong about mercury again! Optimal Wellness Center Web site, Dec 9, 2004.
- Walker SJ. Warning letter to Joseph Mercola, D.O., Feb 16, 2005.
- MacIntire SJ. Warning letter to Joseph Mercola, D.O., September 21, 2006.
This article was revised on October 12, 2006.