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Do cosmetic regulations have anything to do with your business? Maybe a little, maybe a lot. Some of you may package over-the-counter drugs that are used as cosmetic products. Some of you may package cosmetics as well as pharmaceuticals. Or some of you may just like to keep an eye on state regulations pertaining to any health and beauty aid, knowing that rules for cosmetics could perhaps influence rules for yours.

One bill to keep an eye on is Senate Bill 484, introduced by California Senator Migden to establish the California Safe Cosmetics Act of 2005. The bill has been passed by the California Senate Health Committee and has now moved on to the Senate’s Appropriations committee, scheduled for consideration in late August. If approved, the bill would require, starting January 1, 2007, manufacturers of any cosmetic products sold in California "to provide a list of its cosmetic products that are sold in the state and to identify by product any ingredient that contains a chemical identified as causing cancer or reproductive toxicity." The bill would authorize the Division of Environmental and Occupational Disease Control "to conduct an investigation of cosmetic products that contain chemicals identified as causing cancer or reproductive toxicity or other ingredients of concern to the division. The bill would authorize the division to require manufacturers of products subject to investigation to submit relevant health effects data and studies and other information as requested by the division."

Does FDA approval deeming a drug product safe and effective negate a cause for concern? Perhaps. But what if an ingredient that is used regularly in both cosmetics and topical pharmaceuticals shows up on the radar of the Division of Environmental and Occupational Disease Control?

Carl Geffken, chair of the Independent Cosmetic Manufacturers and Distributors' (ICMAD) Technical, Regulatory, Legislative Committee, gave the beauty industry a brief update on the bill and other California legislative activity during Cosmoprof North America in Las Vegas July 25, 2005. He encouraged cosmetic manufacturers to review the pending legislation and to be vocal about how their business may be affected.

Geffken said the bill is "not based on sound science." He said that the bill could require cosmetic manufacturers to identify certain products as having the "potential for ingredients to be linked to cancer," perhaps even on labeling. Dosage levels would need to be reported, too. "We are being slammed by nonscientific judgments... that are based on fear and speculation," he said.

The bill has been amended several times, one of which added a waiver for small businesses under $1 million in annual sales. "But who wants to stay under a million," he asked.

Given the size of the California market, this is an issue for any company marketing products in the United States. Geffken also argued that other state assemblies might be watching the fate of this bill, so these rules may spread beyond California.

Given the federal regulatory scrutiny that your products get, this bill may be moot for you. But I couldn’t help wonder about it this morning after using a skin care product that carried a Drug Facts panel on its carton. Just how far could this bill reach?

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