Don’t be tempted to make OTC claims on your cosmetics. My inbox has been full lately of miracle cures, blends, and products that will keep me safe from H1N1, colds and all the other flu bugs out there. Even if your essential oil blend or herbal extract is the next great cure for all that ails us DO NOT make any claims, don’t imply it and don’t use product testimony to do so either.
There is a clear distinction between cosmetics and over-the-counter drugs (OTC) that is not meant to be blurred. The FDA and the FTC sent Dr. Weil a warning letter this week regarding his product claims for “Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus; and Notice of Potential Illegal Marketing of Products to Prevent, Treat or Cure the H1N1 Virus”
The warning letter states, “The FDA has determined that your website offers a product for sale that is intended to diagnose, mitigate, prevent, treat or cure the H1N1 Flu Virus in people. This product has not been approved, cleared, or otherwise authorized by FDA for use in the diagnosis, mitigation, prevention, treatment, or cure of the H1N1 Flu Virus.”
It goes on to say, “In addition, FTC staff reminds you that the FTC Act, 15 U.S.C. § 41 et seq., requires that claims that a dietary supplement can prevent, treat, or cure human infection with the H1N1 virus, must be supported by well-controlled human clinical studies at the time the claims are made. More generally, it is against the law to make or exaggerate health claims, whether directly or indirectly, through the use of a product name, website name, metatags, or other means, without rigorous scientific evidence sufficient to substantiate the claims. Violations of the FTC Act may result in legal action in the form of a Federal District Court injunction or Administrative Order. An order also may require that you pay back money to consumers.”
I recently got an email from an essential oil supplier (not one of mine) stating, “Can a fragrance actually be considered healthy and holistic? Absolutely! The H1N1 virus has all of us concerned and many of our customers have come to us asking if we have any fragrance blends that have anti-bacterial properties. Well, we do!…This broad description of ANTISEPSIS includes anti viral, antifungal, anti-bacterial and general anti-microbial activity which is found in such oils as: Lemon, Thyme, Tea Tree, Garlic, Eucalyptus, Cinnamon, Pine, Lavender and Sandalwood…” Any company that uses this claim on their website, marketing or advertising can expect a similar letter from the FDA and FTC.
Dr. Weil has issued a response to the warning letter that you can read here. I commend Dr. Weil for this statement, “All Weil editorial content is reviewed for compliance with FDA /FTC guidelines. I directed the website team to remove the FDA/FTC-referenced content for review, and they have done so. I fully support the FDA/FTC task force in its efforts.” We all should be following his lead and checking all of our marketing material to insure that we are not crossing the line either.