Since its launch in late 2005, the US Food and Drug Administration's (FDA) voluntary cosmetic registration program (VCRP) has recorded more than 7,100 formula registrations, according to Cosmetic, Toiletry and Fragrance Association (CTFA) news, which is a promising sign that companies are willing to participate in the self-regulation of the industry.
The new Web-based filing system was designed for cosmetic firms to voluntarily submit cosmetic formulations electronically to allow the FDA to estimate the extent and use of cosmetic ingredients in the event that the agency needs to develop safety messages.
There are some important reasons why company participation is important, according to a recent article by David C. Steinberg.1
"One of the best defenses against new regulations, such as the recently passed California Law, is to show that cosmetic companies actively participate in the voluntary programs managed by the FDA," wrote Steinberg. "This shows that self-regulation works. If the process were to become mandatory, it could take quite some time before a product is on the market. Under this voluntary program, the FDA acknowledges a registration in two weeks."
He added that another reason to register is that the Cosmetic Ingredient Review (CIR) panel of the CTFA uses this data to determine its priority list. If the group reaches a conclusion of “insufficient data” for a particular ingredient because of a lack of data to support a "safe" conclusion, formulations incorporating the ingredient may be in serious jeopardy.
He explained that the FDA has indicated that, "a cosmetic containing an ingredient that the CIR has judged as presenting 'insufficient data' may be required to carry the 740.10 warning label that reads: 'WARNING the safety of this product has not been determined.'"
This warning is required for any cosmetic product or any ingredient in a cosmetic product that has not been found safe, and a CIR finding of insufficient data can trigger this warning. Steinberg commented, "Who would buy a cosmetic with this warning?" Thus, providing the necessary data through the VCRP is an important step.
1. DC Steinberg, 2005 Preservatives Use: Frequency Report and Registration, Cosm & Toil 121 7 65 (July 2006)