miércoles, 16 de noviembre de 2016

FDA Law Blog - Our Question Has Been Answered; FTC (not FDA) Attempts to “Kill” OTC Homeopathic Products

Posted: 15 Nov 2016 07:45 PM PST
By Riëtte van Laack –
As we blogged previously, there have been activities both by FDA and the FTC foreboding a bleak future for homeopathic products. Both FDA and the FTC questioned the policies and standards applicable to homeopathic products. The FTC threatened to hold homeopathic products to the standard of modern science, i.e., substantiation by clinical studies, not by homeopathic proofing. The threat has become real.
On November, 15, 2016, the FTC issued an enforcement policy for homeopathic products. Essentially, the FTC has decided to hold homeopathic over-the-counter (OTC) products to the same standard as any other OTC products bearing a health-related claim, i.e., the products’ claims must be supported by modern scientific (not homeopathic) evidence. The Policy Statement applies only to OTC products intended for self-limiting disease conditions amenable to self diagnosis of symptoms and treatment. It does not apply to the practice of medicine and it also does not apply to prescription homeopathic products.
The FTC does not outright prohibit claims for homeopathic products that are not supported by scientific evidence. The Commission asserts that an effective disclaimer (e.g., a disclaimer clarifying that the product claims are based on theories of homeopathy not accepted by most modern medicine) that accompanies the efficacy claim may correct the misleading nature of the claim. At the same time, however, the FTC recognizes that there is an “inherent contradiction in asserting that a product is effective and also disclosing that there is no scientific evidence” for the claim and questions whether any disclaimer can be sufficient to prevent consumer deception. The FTC advises that companies develop evidence that their disclaimer is effective.
The FTC claims that the approach outlined in its Policy Statement is consistent with the First Amendment, and “neither limits consumer access to OTC homeopathic products nor conflicts with the FDA’s regulatory scheme.” However, the question remains whether an alternative but truthful disclaimer informing consumers of the facts pertaining to homeopathy, a practice that is recognized by inclusion in the Federal Food, Drug, and Cosmetic Act (FDC Act), would survive an FTC challenge based on First Amendment grounds. Maybe homeopathics are not dead yet?
For anyone interested in comments the FTC received and the Agency’s responses, the FTC staff has prepared a report discussing the comments and on the workshop, titled "Staff Report on the Homeopathic Medicine & Advertising Workshop."
It remains to be seen what if anything FDA will do regarding prescription homeopathic drug products and if the FTC’s new policy and potential resulting enforcements actions will be challenged.