One of the most difficult problems of a democracy is to strike the balance between over-regulation and under-regulation. The former stifles productivity, free enterprise and innovation. The latter may give rise to safety problems, price gouging and other problems.

One of the best examples of under-regulation involves cosmetics. Unlike drugs, the FDA exercises virtually no regulatory power over cosmetics. That's surprising, as a typical American, according to estimates, uses around a dozen cosmetics, containing hundreds of chemicals, on their skin, in their hair, in their mouth and about every other place. We now know cosmetics applied to the skin are absorbed into the body, where they may have all kinds of toxic effects.
Unsafe cosmetics have the potential to do the same kind of harm as unsafe drugs.

If you want to manufacture cosmetics, you can put them on the market without any testing or any assurance they will be safe. The FDA, which regulates cosmetics, has no authority to require testing for safety, efficacy or anything else. I once did an undercover investigation of cosmetics. With hidden cameras, my producer and I posed as buyers for a cosmetics company in Philadelphia, The World of Breh. We went to New York City to contract for the manufacturer of some of our products. We asked one manufacturer if he could put certain vitamins and other ingredients into our products. His reply - "I'll put as much as you want in, up to the point it starts to stink." When it comes to cosmetics, anything goes and anything goes into them.

The FDA doesn't control what goes onto the market. If cosmetics prove to be dangerous or mislabeled, it can step in and take the offending cosmetics off the market, but, of course, by then you may be injured or even dead. One of the few regulatory protections is that if a cosmetic company uses an untested product, it has to inform the consumer of that on the label. There are a couple of problems even with that weak regulatory measure, according to Stacy Malkan, a spokesman for the Campaign for Safe Cosmetics. First of all, in recent years, critics claim it has not been enforced, and one group, the Environmental Working Group, said they've never been able to find a product with that warning. I've never seen one either. I have no reason to believe that such untested products aren't on the market. But there's another problem. There are no standards for what kind of test is required. In other words, even if that labeling requirement were enforced, it would take little or no imagination to evade it.

This all suggests that if you want even a modicum of protection, you better buy from a retailer you trust, who stocks products of name-brand manufacturer you can also trust, or at least trust more than a no-name, a fly-by-nighter, or some other company of unproven reputation.

There's another strange thing about the cosmetics market and cosmetic safety. I've covered this issue for over 30 years, and it seems there is one wave of criticism after another, followed by one wave of regulatory inaction and neglect after another. But you never know when the wave of criticism will finally have impact. Maybe now is the time.

The latest wave of criticism comes from the Environmental Working Group, the above-mentioned Campaign for Safe Cosmetics, the Breast Cancer Fund, and an investigative journalist who has just authored a book with information on this subject. The journalist is David Steinman, author of Safe Trip to Eden, which discusses this contaminant. He is also the author of the highly regarded book Diet for a Poisoned Planet (2007) and is the publisher of Healthy Living, a health magazine.
Here is the hazard most recently identified by this group of cosmetics critics - 1,4-Dioxane, a petroleum-derived contaminant considered a probably human carcinogen by the EPA. The group of critics report, "A hidden cancer-causing petrochemical has been found in dozens of children's bath products and adults' personal care products, in some cases at levels that are more than twice the U.S. Food and Drug Administration's lenient recommended maximum."

In announcing the findings about 1,4-Dioxane, Jeanne Rizzo, R.N. executive director of the Breast Cancer Fund, said, "Regrettably, 1,4-Dioxane contamination is just the tip of the iceberg. Because the FDA does not require cosmetics products to be approved as safe before they are sold, companies can put unlimited amounts of toxic chemicals in cosmetics."

Steinman said parents should be outraged that companies are willing to spend a significant amount of money on entertainment licensing agreements that entice children but won't spend pennies to remove contaminants such as 1,4-Dioxane. He continued, "Consumers who have young children, as I do, have the right to expect the highest purity in children's products. I call on American consumers to say no to dangerous petrochemicals in their children's cosmetic and personal care products."

The FDA has monitored 1,4-dioxane levels since 1979, and has worked with the industry to lower levels on a voluntary basis. The FDA recommends that any product should not have more than 10 parts per million (ppm) of this contaminant. However, Steinman reports that 15 percent of products tested had more than that amount.
The 10 ppm limit doesn't take into account that babies may be getting this contaminant from bubble bath, body wash, baby shampoo and other products. Hence, the 10-ppm limit may be ineffective in preventing overexposure. Of course, that makes the assumption that less than 10 ppm is actually safe.
Among the adult products tested with the most 1,4-dioxane levels were Clairol Herbal Essences Rainforest Flowers Shampoo, 23 ppm and Olay Complete Body Wash with Vitamins (normal skin), 23, ppm. Among the children's products with the most of this contaminant were Hello Kitty Bubble Bath (Kid Care), 12 ppm, and Johnson's Kids Shampoo Watermelon Explosion (Johnson & Johnson), 10 ppm.

In his book, Steinman says there's no excuse for 1,4-dioxane to be found in these products and the FDA knows it. He writes, "The tragedy is that the problem could have been averted with a few cents' worth of vacuum stripping, and not enough companies took the measures to eliminate these questionably safe cosmetic ingredients. The laboratory that was used is widely regarded as one of the best. I'm willing to acknowledge that not every product will contain 1,4-dioxane as a contaminant, but the results I obtained were compelling because they were consistent and because they simply confirmed what high-level FDA officials had earlier conceded: less than optimal manufacturing is leaving residues of a potential cancer-causing petrochemical."