FDA's New Agressive Policies on Websites and Skin Care

Recently, I have had several clients receive warning letters from the FDA regarding their websites or retail skin care products.

In regard to websites, the FDA makes various claims that the particular sites are making unsubstantiated claims regarding efficacy of products and services. In each cases, I strongly disagree with the FDA. In one instance, the website merely stated that a procedure "lessened the appearance of wrinkles". Those are appropriate words for an appropriate procedures.

In other website issues, the FDA is claiming that the procedure was not cleared for marketing of the respective procedure. This is ludicrous to me beause a physician can claim whatyever they want to - the FDA has no jurisdiction over them and their independent medical judgment. A physician can claim whatever they want, but they cannot claim that it is "FDA approved". This is a misnomer anyway as the FDA does not "approve" anything.

In regard to skin care, the FDA is cracking down on physicians that compound and offer prescription strength products in an over the counter format. They are also concerned with claims about claims made in skin care. In one example, the product merely claimed to "hydrate" the skin. The FDA had a problem with this?? The product contained hyaluronic acid which is agruably nature's best emollient since it binds to water and retains 1000 times its molecular weight in water. It is more than fair to say that it "hydrates" the skin.

In yet another skin care example, the FDA took exception to a clain that the product softened the appearance of wrinkles. What is wrong with that?? If they are going to start enforcing such language, there will be no marketing on any product. Cosmetics make far more medical claims every day in TV and print ads.

The point is that the FDA appears to be embarking on a course to strictly enforce its policies - to the point of over-stepping their bounds...