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.
The stars where poorly aligned on June 15, 2009, when California finally issued its registration procedure and forms for the California Safe Cosmetics Act of 2005. At the same time, the US Food and Drug Administration (FDA) moved to an electronic-only filing system for drug registrations. These two changes have created significantly more work for the personal care industry—and with questionable benefits.
Registration in California
In October 2005, California governor Arnold Schwarzenegger signed the Safe Cosmetics Act (SB 484) into law; for a detailed review of this act, read the October 2005 and February 2006 “Regulatory Review” columns.1, 2
On Jan. 1, 2007, as a first part of the California Safe Cosmetics Program, the law required manufacturers of cosmetic products sold in California and subject to FDA regulation to provide the state with a list of products containing ingredients it deems to potentially cause cancer or reproductive toxicity. These ingredients include fragrance chemicals or those given trade secret status by the FDA. In accordance with this state Act, the definition of a manufacturer is the company named on the cosmetic product label; in contrast, ingredients are defined by federal regulation (FDA 21CFR700.3).
The law also declared the National Toxicology Report on Carcinogens, the International Agency for Research in Cancer, the US Environmental Protection Agency, and the National Toxicology Program’s Center for the Evaluation of Risks to Human Reproduction as the authoritative bodies responsible for classifying chemicals as carcinogens or as toxic to reproductive health. The law did not include the California Office of Environmental Hazard Health Assessment (OEHHA), which promulgates the California Proposition 65 list of chemicals deemed to cause cancer or reproductive toxicity. In addition, this law did not apply to companies whose sales were less than US$1 million, according to their tax returns.
While manufacturers were expected to report their products in 2007, they were unable to comply since they did not have the necessary forms or methods to submit; such means did not become available until June 15, 2009. Now that the forms are available, the deadline to submit is Oct. 15, 2009, and all manufacturers of products launched since Jan. 1, 2007, are expected to comply. Article 1 Section 9 of the US Constitution prohibits this, considering it ex post facto.