CFS Practitioner Warning Letter
GLEN BURNIE, MD—FDA has sent a warning letter to Jacob Teitelbaum, MD, and www.EndFatigue.com, after the agency's review of the website revealed treatment claims for various natural ingredients and products, with the claims linked to products available for sale on the website. FDA warned the use of these therapeutic claims renders the connected products drugs.
The agency took issue with the Cures A-Z section of the website for its listing of several medical conditions including information on how to treat these conditions with products offered for sale through the website. Conditions cited include Alzheimer's disease, breast cancer, diabetic neuropathy, cold and flu, infections, high cholesterol, hypertension and Parkinson's disease. Among the offending ingredients/products were: Corvalen (D-Ribose), Coenzyme Q10, Jigsaw Magnesium w/ SRT', 'BMR Complex (Thyroid Glandular), Energy Revitalization System, Acetyl-L-Carnitine, Chol-less, Thymic Protein, Alpha Lipoic acid, Black Cohosh, Healthy Knees and Joints, and Eskimo 3 Fish Oil. FDA noted not only are the products rendered drugs because they are not generally recognized as safe for the conditions mentioned in Cures A-Z, but also they are misbranded because the conditions for which they are recommended "are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners," according to the letter. Note: The Cures A-Z section is no longer present on the site, but there is a Health A-Z section housing information on various conditions.
Also an issue for FDA were therapeutic advice postings on Teitelbaum's Facebook page, which promoted to products available on his website.
In response to the letter, Teitelbaum issued the following statement:
"As a patient advocate reporting on thousands of scientific studies, Dr. Teitelbaum’s goal is to help people become aware of the pros and cons of new research on both natural health products and prescription treatment options. Current FDA regulations do not allow disease-related claims to be made for natural products, unless the product has gone through the FDA drug approval process, which can cost upwards of $500 million, making this impossible for most non-patentable natural options.
This often creates a difficult line between what is considered simply reporting on a research study result vs. what is considered making a promotional product claim to treat a disease, even if the report is based on solid research.
Dr. Teitelbaum recognizes the need for the regulations, although he was surprised by FDA’s letter. We have already contacted the FDA and are making the needed changes to our web site to address FDA’s concerns. We will continue to advocate for consumer access to truthful, reliable information about the thousands of studies demonstrating health benefits of natural dietary supplements and herbal products, while ensuring the language on the web site complies with FDA regulations. We are moving quickly to be sure this process is completed as soon as possible."
INSIDER's Take: This letter and situation is a classic example of the fine line between educational information on non-drug products and claims made in promotion of products for sale, as Teitelbaum noted in his response. The key to recognizing and heeding this fine line is to keep the research and "treatment" information third-party, relative to products for sale. This isn't an easy task for active physicians, who might be in the toughest spot of all marketers.
The other significant takeaway for industry is the continued tendency of FDA's considering social media a source for illegal claims, when linked to products for sale. There is no safe haven in Facebook or Twitter.
Teitelbaum's Cures A-Z is a deep resource of information on the health benefits of various natural and alternative therapies, and is very convenient in mobile app form. However, linking the information to his products renders the information as claims, which in this case end up being treatment or drug claims. Does this mean doctors can't offer valuable research and benefit information to clients and consumers? Does this mean they can't use their knowledge to offer their clients and consumers products they can personally back in terms of quality and origin—a big concern for physicians is which natural products are high quality and efficacious enough to recommend to patients. No, doctors can do both those things, but they simply can't link the two enterprises. Well, simply it isn't, but the challenge for Teitelbaum and other physicians is to find a way to do both without connecting one to the other: keep information third-party and offer products with claims that are legal for natural products.
For more information, check out the "Claim Substantiation and Compliance" seminar, May 9, from 9am to 11am, during SupplySide MarketPlace trade show in the Javitz Center, NYC. Speakers will include David Barnes, Ph.D., Director of Research, Standard Process, and Justin J. Prochnow, Esq., Shareholder, Greenberg Traurig LLP.