Cosmetics Registration in California and the FDA's Electronic-only Drug Registration

By: David C. Steinberg, Steinberg & Associates

Posted: September 29, 2009, from the October 2009 issue of Cosmetics & Toiletries.

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In addition, the definition of a cosmetic was changed by California lawmakers to include drugs that make cosmetic claims. This author is now wondering if drugs making cosmetic claims are thus regulated as cosmetics in California. To this end, will these products no longer require FDA OTC monographs, and can they use any UV filter they desire?

Instead of carefully reviewing existing lists of chemicals published by various organizations, California included all of them without considering the fact that the vast majority of these chemicals have never been used in cosmetics and may or may not cause cancer or reproductive toxicity. Those directed to come up with a list of ingredients simply aggregated a large list, which is likely to scare consumers.

In fact, California has relied on a study by the Environmental Working Group stating that 54 cosmetic products contain ingredients that the CIR has deemed as unsafe. This is the same group that gave titanium dioxide its safest rating, when according to the International Agency for Research on Cancer, this ingredient is found to cause cancer. How much money will be wasted to locate these “unsafe” products? California should save its money; these 54 products are not sold in the United States, much less in California.

As an aside, California is in such a poor fiscal position that the office administering this program has mandated closings for three Fridays each month until 2010—yet it is willing to bleed precious dollars on something of zero value. There is nothing in this law that will make cosmetics safe. Cosmetics are already required by federal law to be safe but California is attempting to make them safer than safe, which makes little sense. While the governor should not have signed such a bill, it was also the media’s responsibility to expose the silliness of such legislation.

Electronic-only Drug Registering
Effective June 1, 2009, the FDA no longer accepts drug establishment registrations or drug listing information in paper form unless a waiver is granted. The same forms are required; however, they now are only accepted electronically.