Small Claims

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.

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3 Responses to Small Claims

  1. Sue Jackson says:

    Excellent post, Jennie.

    Frankly, I am glad to hear Dr. T got his wrist slapped just because I cringe everytime I hear or read one of his outrageous claims wrt CFS. He often uses “chronic fatigue” and CFS interchangeably and claims to be able to cure people.

    I also feel that people need to be extremely careful when gtreating themselves with so-called natural products because of the lack of any regulatory oversight. My back ground is in chemical engineering, so I am very much aware that “natural” products can be just as potentially harmful and dangerous as prescription drugs – in fact, more so because there has been no FDA approval process and natural products may have multiple active ingredients with multiple effects (both intended and unintended). Lots of research is smart before trying anything new – including looking for side effects, interactions with other supplements and meds, and fully investigating all ingredients – and then proceed cautiously. And of course, always tell your doctor about all supplements as well as meds.


    Live with CFS

  2. Lester says:

    In the fall of 2005 I went to the Fibro and Fatigue Center near Philadelphia. I was treated by a Dr. Nurse-Bey who, icdulned in the thousands of dollars in supplements, treatments and prescriptions (that insurance did not cover) prescribed thyroid medicine for then-normal thyroid. I kept going back because I was feeling worse rather than better, and was beginning to lose my hair at an alarming rate. At my final appt with her, she increased my thyroid dosage for a third time. Although I filled the prescription, I was terrified to take it because on the web I had learned that high thyroid levels could cause the hair loss and other symptoms I was experiencing. I had also examined my copy of the lab results and seen that the thyroid levels she was trying to get me to reach were way above the normal range listed by the lab. Instead I went to my regular doctor who hit the roof. I then saw an endocrinologist who confirmed the extremely negative reaction of my GP, and added that taking thyroid meds that I did not need could have given me a heart attack.I have searched in the years since for websites that might give me information on the experience of other people who were treated by the FFC. What I have read here has confirmed my own experience how I wish I had seen it before I went.You are very fortunate that you were not able to continue treatment at the FFC. You may have saved your hair and your life.

  3. Pingback: High Thyroid Levels – The Causes and Treatment of Hyperthyroisism | MYHEALTHCAREBLOG.NET

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