Thursday, March 29, 2012

A New One: "Cosmeceuticals"

As we dig through sites to bring information to light here, I stumbled across the term cosmeceuticals. On Wiki, we find this: Cosmeceuticals refers to the combination of cosmetics and pharmaceuticals. Cosmeceuticals are cosmetic products with biologically active ingredients purporting to have medical or drug-like benefits.
What's troubling to me is the seemingly industry focused grafting of two words - cosmetics and pharmaceuticals - to suggest that an over the counter product would have medical like properties. It's not just troubling to me or others. A Bloomberg article notes this: 
The industry calls them “cosmeceuticals,” a term that doesn’t exist in regulation,Michael Landa, director of the Food and Drug Administration’s Center for Food Safety and Applied Nutrition, said in testimony prepared for a House subcommittee hearing. The claims companies make that the products contain active ingredients may classify them as drugs, he said.
Retinol and peptides weren’t listed as ingredients in any cosmetics before 2005, Landa said in his written remarks to the House Energy and Commerce health subcommittee. Retinol is now registered in 200 items, while peptides are listed in 1,200 product statements voluntarily submitted to the FDA, he said.
The report referenced in that article is titled  “EXAMINING THE CURRENT STATE OF COSMETICS." Here is what is known:
Cosmetics are not not required to submit safety substantiation data to the Agency, nor to make it available to the Agency.  Under the  FD&C Act, cosmetic products and ingredients (with the exception of color additives) are not subject to FDA premarket approval or premarket notification.    
This class of products  presents new regulatory challenges in a number of ways, including how such products should be regulated and with what requirements such products should comply.  Many products in this category are advertised as containing “active ingredients,” which, by virtue of the ingredients  themselves or the claims made for the product, may cause the product to be classified under the FD&C Act as a drug.  

What is known about the industry? There are eight billion personal care products on the market.  According to the report,  estimates of annual U.S. sales of these products range from $54 to over $60 billion.
The report is seeking approval for new fees and a registry, and the grand total of the fees generated by the registry would be less than $20 million. In other words, they are seeking to throw a needle into a hurricane in an effort to address safety in a multi billion dollar industry that is creating a medical benefits-sounding term. My money is on the FDA failing consumers in this area.