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Cosmetic safety challenged

An advocacy group has complained to the U.S. Food and Drug Administration that most of the ingredients in personal care products like cosmetics and haircolors have not been evaluated for safety—not by FDA, not by the industry, "nor by any other publicly accountable institution."

The June 2004 petition by the group, the Environmental Working Group (EWG), also asks FDA to declare that the $35-billion cosmetics industry is operating without government oversight, and that as a result, consumers are routinely exposed to many substances used in cosmetics that are associated with serious health effects, including cancer.

So, the EWG wants FDA to take legal action against the many products that contain ingredients that have not been proven safe, and against products that are not properly labeled with their ingredients. The EWG says that millions of Americans are being exposed daily to personal care products that haven't been proven safe.

Are they right? Well, right about what? Not the implied conclusion that many of these products are unsafe, because the EWG doesn't quite say that. Like a joke lacking a punch line, the EWG's petition parades the horrors of unproven ingredients and toxic impurities and says that the group has identified "serious, probable safety violations." The EWG then says, "Overall, our investigation of product safety shows cause for concern, not alarm." (You understand the difference between concern and alarm, right? Concern is stroking your beard. Alarm is waving your arms and hollering, which I guess is more serious.) The EWG also says, "Much more study is needed to understand the contribution of exposures from personal care products to current human health trends."

On the other hand, when the EWG filed its petition, the Cosmetic, Toiletry and Fragrance Association (CTFA) issued a singularly unpersuasive response on behalf of industry, entitled "Cosmetics Are Safe." It recited the industry's voluntary steps and FDA's powers and controls over these products. It also described the role of the CTFA-funded, but independent, Cosmetic Ingredient Review Expert Panel, but said nothing about the specific charges about safety risks in the EWG petition. The trade group has issued several responses to assertions about specific chemicals in recent years, but as for the EWG petition, one has to hope they can do better than their conclusory, overly general response statement.

FDA, however, might already be persuaded that it needs to take more than mere cosmetic steps in response to the petition. In February, FDA responded to the EWG petition by writing a nasty letter to the head of the CTFA. (Even though not every maker of personal care products is a member of CTFA, FDA often communicates with an industry by using trade groups as stand-ins.)

FDA's letter was a classic shot-across-the-bow, telling the trade group that FDA was looking over the EWG petition and was aware of its very serious concerns, and that "FDA intends to consider taking compliance action, where appropriate, regarding cosmetic products that contain ingredients that we determine have not been shown to be safe...but that are not currently labeled with the warning statement, ('Warning—The safety of this product has not been determined') required under [regulation]." It also said it would work up a guidance document to help industry figure out what kinds of safety information are needed to establish safety.

Cosmetics and personal care products have always been like the poor relations in the FDA-regulated product family. Human and animal drugs and devices need preapproval before they can be marketed, and foods are subject to extensive labeling rules, manufacturing controls and food additive dictates. By comparison, the regulation of cosmetics is a sleepy realm. Mostly, FDA's law is set up to leave the industry to regulate itself, and you usually don't hear much about FDA-compliance squabbles with personal care product makers. Okay, there's the occasional imported eye shadow with an unapproved color ingredient, or if anti-aging wrinkle creams start making drug claims, FDA might write a batch of warning letters to marketers to get them to cool it. But generally, it's sleepy.

Mostly, FDA's law is set up to leave the industry to regulate itself, and you usually don't hear much about FDA-compliance squabbles with personal care product makers.

The law prohibits the marketing of cosmetics that are adulterated or misbranded. Cosmetics are defined to include what we'd usually think of as personal care products, too. Officially, they are "articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance," plus components of such articles. But not soap, oddly enough.

FDA doesn't preapprove these products before they hit the market (except for color additives), but if illegal products are marketed, FDA can take action against the companies responsible and their chief executives. FDA can enjoin the marketing of the product, seize illegal product, or criminally prosecute violating companies and their senior management. With these powers as a club, FDA can also induce a company to conduct a "voluntary" recall of product.

The law leaves up to the cosmetic marketers the job of proving the safety of their ingredients and products before they are marketed. Some ingredients are flat out prohibited from use. But for most products, even if the marketers don't substantiate their safety, the product can still be marketed as long as it bears a warning that says, "Warning—The safety of this product has not been determined." Have you ever seen that warning on a personal care product label? Few people have, because it's not used much, and that's one of the violations the EWG is asserting to be widespread.

Whether FDA's reaction to the EWG petition will signal a widespread change in the labels on personal care products or their ingredients should become clear in coming months. Then we'll know if FDA will pay attention to its long-lost cousin. And we might even learn if these products are really unsafe.

Eric F. Greenberg is principal attorney with Eric F. Greenberg, PC, with a practice concentrated in food and drug law, packaging law and commercial litigation. Visit his firm's website at www.ericfgreenbergpc.com. Contact him by e-mail at [email protected], or by phone at 312/977-4647.

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