We are surrounded today by endless products that claim to cause weight loss, grow hair, make your skin look younger..and even the necessity to cleanse your colon for optimal health. Between TV and the internet (and soon to be cell phones), these ‘miracle’ products are everywhere we turn. When I see these many ads, I am reminded of old Sears and Roebuck catalogs and other century old publications where more primitive variations of what we see today were originally sold. In the old days, many of these (I didn’t say all) products were given the term ‘snake oil’. Today better sounding names of cosmeceuticals and supplements are used which sounds a whole lot more hopeful and likely to work.
While I am not the biggest fan of governmental regulations, they do play a major role in determining the validity of many of these product claims. If you look carefully at the small print on most of these product claims, they state that the statements and claims in the ad have not been evaluated by the FDA. This suggests that the manufacturers place some value on this regulatory agency.
Since safety and effectiveness of a product seems to be best determined by their FDA approval status, what does that really mean? A little bit of the history into how products are classified is in order. Products are classified into either drugs or cosmetics by the 1938 Food, Drug, and Cosmetic Act. If it treats a disease it is viewed as a drug, if it enhances appearance it is a cosmetic. Drugs must meet rigid safety and efficacy criteria. Cosmetics, nutriceuticals and supplements do not. The latter can be marketed and sold as long as they include a disclaimer.
The problem with many of these products today is that they are becoming very sophisticated and many may have some weak drug-like effects. The entire marketing campaign of some of these products certainly gives the illusion that they are drugs by the way they are packaged to the white coats of the people in the ad. Heavy use of testimonials and phrases similar to ‘a leading research institute study shows that ‘ are common. Some of what is touted is most certainly right on the border of a drug claim.
Does this mean that what isn’t classified as a drug or doesn’t have FDA approval has no value. No, but it does make it virtually impossible to evaluate the potential effectiveness of any claim of a non-drug product. The message is be skeptical and dubious of most product claims. The vast majority are probably safe, it is just a question of do they have any effect.
FDA approved products go through years of rigorous testing and review before getting approval. And it is a very expensive process. But if the manufacturer has confidence that it really will do what it purports, the market rewards will likely be worth it at the end. It is likely that something that seems to be a miracle really is a jar, tube or pill of hope. As I tell my Indianapolis plastic surgery practice patients, as long as you know that is what you are buying, then you won’t be disappointed.
Dr. Barry Eppley
Indianapolis, Indiana