In April, the FDA sent a warning letter to Dr. Jacob Teitelbaum regarding claims made on his website. Dr. Teitelbaum is well-known in the CFS world for several reasons. His book, From Fatigued to Fantastic, is the top-selling book in Amazon’s category for CFS. Dr. Teitelbaum is medical director of the Fibromyalgia & Fatigue Centers, a chain of clinics that offers a six step treatment process for fibromyalgia and other illnesses. Finally, Dr. Teitelbaum is a frequent contributor to the Dr. Oz program, where he is described as overcoming CFS and fibromyalgia in 1975 and “has helped hundreds of thousands recover from these conditions.”
In its warning letter to Dr. Teitelbaum, the FDA cited multiple violations of federal law on the website where supplements were characterized as treatments for a variety of illnesses including breast cancer, heart disease, and arthritis. None of the cited violations related to CFS, but the FDA stated, “The unlawful disease treatment and prevention claims made on your website were too numerous to list in this letter.”
Under federal law, a product is a drug if it is “intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease.” 21 U.S.C. § 321(g)(1)(B). Drugs are regulated by the FDA, and cannot be marketed without prior approval by the FDA after submission of data demonstrating the drug is safe and effective. By claiming his products could treat or cure disease, Dr. Teitelbaum was claiming those products were drugs. Since he was selling those products without FDA approval, Dr. Teitelbaum was violating federal law.
Dietary supplements, in contrast, are regulated very differently from drugs. Supplements do not need to be proven safe and effective prior to marketing. A manufacturer can claim that a supplement addresses a nutrient deficiency or is linked to a body function (such as immunity) if there is research to support such a claim, but must explicitly state that the FDA has not evaluated the claim.
According to the Natural Products Insider, there is a “fine line between educational information on non-drug products and claims made in promotion of products for sale.” Physicians (or others) who offer information on the benefits of natural therapies cannot link that information to specific products that they sell. Natural Products Insider recommends keeping the treatment and research information “third party” and keeping product claims within legal bounds.
To me, this is a distinction without a difference. Under current law, it is illegal to market Product XYZ as a treatment for CFS but it is perfectly acceptable to market Product XYZ as a way to boost energy. The average consumer can read the second claim, and draw a short straight line back to CFS. It is relatively easy to write marketing copy in such a way that consumers fill in the blanks themselves, believing that a product is a treatment for CFS without the vendor ever having made that claim. In Dr. Teitelbaum’s case, the problem was not that he is selling “Eskimo 3 Fish Oil.” The problem is that he was selling “Eskimo 3 Fish Oil” while claiming it “can help treat hidden depression” (among other things). Change the language and go right back to selling to your heart’s content.
I know many CFS patients who take a wide range of supplements, and a number of them do detailed research on products before they buy. I know doctors who recommend a variety of natural and alternative remedies. I’ve experimented with many supplements and remedies myself. But it is important to remember that regulation of these products is very different from that of conventional treatments. I’ve seen ads for products that are barely different from the material that got Dr. Teitelbaum in trouble with the FDA. There is not a single treatment for CFS that has been approved by the FDA. CFS patients want to be well, or at least a little better if we can. Tell me a product will help my immune system, and I’ll wonder if it can help my CFS. You don’t have to stamp the word “treatment” on it for me to wonder if it is just that. Marketing through implication is ok under current federal law, but I don’t think this translates into extensive consumer protection in practice.