- The Washington Times - Saturday, August 14, 2004

Q: Are my personal care products harmful? Should I stop using them?

A: You should continue to use cosmetics and other personal care products if they are part of the routine you are comfortable with.”

Would you believe? That Q&A; appears in a report warning soap, shampoo, toothpaste and the like might contain cancer-causing ingredients or reproductive toxins.

So, why the fuss? Because government fails to evaluate the safety of ingredients in personal care products and industry has a poor record of voluntary scientific reviews, charges the Environmental Working Group in its report “Skin Deep”(available on www.ewg.org and contains rankings of known and probable risks of ingredients in 7,500 products). “Few individual ingredients pose excessive risks, but most people use many products in the course of a day, so it well may be that these risks are adding up,” cautions EWG.

The environmentalists have petitioned the Food and Drug Administration “to assess the safety of scores of products that may be adulterated and to declare as misbranded hundreds of products containing ingredients the industry’s own self-policing safety panel has found lack sufficient data to be considered safe.”

EWG not only is subdued, but is unclear about what alleged problems may exist and what regulatory actions might correct them, according to government and industry spokespeople For one thing, Linda Katz, director of the FDA Office of Cosmetics and Colors, explained, some ingredients described in “Skin Deep” fall under her office, which deals strictly with cosmetics, while other personal care products are regulated by the FDA office that oversees over-the-counter drugs or by the U.S. Consumer Product Safety Commission.

Dr. Katz also emphasized a point actually recognized by EWG: FDA has no legal authority to mandate or conduct premarket safety studies for cosmetic ingredients — except for color additives. Instead, manufacturers have the duty to test their products, and “cosmetics that lack safety substantiation are considered misbranded and must bear the warning, ‘Safety of these products has not been determined,’ ” she said.

Enter here the Cosmetic Ingredient Review, or CIR, a self-regulation panel established in 1976 as a joint effort between the Cosmetic, Toiletry and Fragrance Association (which pays all costs), the FDA and the Consumer Federation of America. The panel has seven voting members representing physicians and scientists who must meet government conflict-of-interest standards plus three nonvoting members representing FDA, CFA and CTFA. The panel issues reports about individual substances based on staff research plus public discussion.

Has the CIR dealt with only 11 percent of 10,500 chemical ingredients in personal care products, as EWG charges? Gerald McEwen, CTFA vice president for science research, replied nowhere near 10,500 ingredients are subject to review. Calling this a “misunderstanding,” he said, “The International Cosmetic Ingredient Dictionary and Handbook has a large number of chemicals that have a name that can be used for labeling. These are ingredients offered for sale, but not necessarily used. Probably around 2,000 are used.”

Of the 2,000, Mr. McEwen said, “it is hard to know how many are reviewed for safety. You can have a family of ingredients and test one or two of them and determine which would be close relatives or alike. So you may not test those, but from a scientific standpoint, may be able to say, yes, that is safe or no, that is not safe.”

Remember, Mr. McEwen emphasized. “The law says the manufacturer is responsible… to know all ingredients are safe or has to put a warning on the label saying the safety of this product has not been determined.”

Are any such warnings out there? “No,” Mr. McEwen answered. “Why would a company put a product that requires a warning label on the market?”

That brings us back to the claim manufacturers use ingredients judged potential hazards by the CIR, and EWG’s request for recalls or seizures of those items. Mr. McEwen answered: The panel might say an ingredient is unsafe at a particular dose or for a particular use, and a manufacturer could use that ingredient at a different dose or for a different purpose. To illustrate: HC Blue No. 1 was judged cancer-causing in hair dyes, but not in other personal care products. In contrast, pyrocatechol could be safe in hair dyes but carcinogenic in other products. Altogether, the CIR panel saw certain risks attached to eight chemicals.

The FDA, meanwhile, has banned certain uses of nine additional chemicals: bithionol, mercury compounds, vinyl chloride, halogenated salicyanilides, zirconium complexes in aerosol cosmetics, chloroform, methylene chloride, chlorofluorocarbon propellants and hexachlorophene.

In the end, what’s a consumer to believe? “Cosmetics are safe,” said FDA’s Dr. Katz. “That is an important message.” She added, “For the most part, cosmetic ingredients have been out there for years. At this point, if there is a problem the agency finds out — from complaints or reports of adverse events…. It may take a while for us to get the information, but we do go in, and we will inspect and make sure manufacturers have done what they are supposed to do.”

Goody L. Solomon is executive editor of Food Nutrition Health News Service.

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