Cosmetics and the FDA
If you hear that dangerous levels of lead in lipstick, you might think, "well, good, I'm off the hook, I don't wear lipstick", or, "I don't wear Merry Berry Cherry Blush lipstick". But lead is contained not only in brands of shiny red lip gloss. And the concern is not only about lead. The US government doesn't oversee chemicals in "cosmetics". Cosmetics includes not only make-up -- lipstick and eyeshadow, but soap, shampoo, mouthwash, suntan lotion, wart remover, towelettes, tooth whitening strips, baby oil, etc.. As Proctor & Gamble likes to brag: "Three billion times a day P&G brands touch the lives of people around the world".
The FDA does prohibit "misbranded" or "adulterated" products in "interstate commerce", which amounts to exceedingly mundane, or exceedingly basic oversight. The containers, for instance, cannot be "so made, formed, or filled as to be misleading". The cosmetics themselves cannot "consist in whole or in part of any filthy putrid, or decomposed substance". Granted, it's comforting to know that in America, you'll probably be spared the 6:30AM surprise of patting shaving cream with lumps of decomposed rat tails onto your cheeks. But with the federal bar low, industry gets a lot of latitude for formulating its products as it sees fit. While the average hand soap fails to impress us as potentially dangerous, there are quite a few products marketed in the US that contain disturbing levels of the same carcinogens or reproductive hazards that are banned in Japan, Australia and the EU.
There are regulations in place in the US, but people who assume that the regulatory environment of the 1970's and 1980's is still keeping unsafe chemicals off the market be surprised at the current state of affairs. For instance in the EPA's Toxic Substances Control Act (TSCA), provides regulations for chemicals in the environment. Apparently TSCA is weak enough that some people deride it as the "Toxic Substances Conversation Act". 60,000 chemicals were grandfathered in when the act was first put in place. At the 25th anniversary of the organization, Lynn Goldman, a professor at John's Hopkins University, said she realized just how flawed regulation might be when, "someone from the chemical industry got up to salute TSCA and said ""This is the perfect stature. I wish every law could be like TSCA"".
EU: Competitiveness = Safety?
In Europe, cosmetics are regulated by the European Commission/ Directorate General Enterprise and Industry, which oversees both the competitiveness and safety of EU products. The fact that both goals, competitiveness and safety, are combined in the same organization, underlines the idea that one does not cancel the other out. The health of the industry is ostensibly tied to the safety of the chemicals. As well, the EU Health and Consumer Protection Directorate regulates chemicals in cosmetics. To date, about over 1000 chemicals, carcinogens, mutagens, and reproductive toxicants (CMRs), which are prohibited in European cosmetics. The Health and Consumer Protection Directorate also removes imported products containing banned chemicals or chemicals in excess of allowable levels. It recently pulled several brands of nail polish with dibutyl-phthalate, and body-care products with hydroquinone and N-Nitrosodiethanolamine.
The changes in European regulatory climate relative to the US can be seen in recent actions on cosmetics, as well as plastics, persistent organic pollutants (POPS), and in the the REACH (Registration, Evaluation,Authorization and restriction of CHemical substances) directive on chemical reporting.
The general difference between the EU approach and the American approach is that in the US companies tend to reason that exposures to toxicants are small, therefore harmless.The EU looks at the inherent hazardous properties of the chemical. Considering that these chemicals interact with humans and the environment from the time they're manufactured to the time they're disposed of, taking steps to understand how citizens are exposed to what chemicals and to regulate or even ban toxic chemicals seems important.
EU v. US: How Companies Manage
Because of the different regulations in the EU, many cosmetics are formulated differently for European and American markets. This doesn't necessarily alarm US citizens, who no doubt believe that because the US is a "litigous society", companies are motivated to keep products safe. Mark Shapiro writes in "Exposed, The Toxic Chemistry of Everyday Products and What's at Stake for American Power" that this notion that the federal government oversees products and therefore insures our safety is false.
P&G, for instance, says it abides by the EU guidelines, submits required toxicity data, and formulates its European products according to European market standards. But while P&G is submitting toxicity data to the EU, it spends $600K to lobby against the same safety guidelines being proposed by the Safe Cosmetics Act in California. P&G protested that the act would create "an unreasonable and unnecessary burden". P&G is also a significant corporate sponsor of tort reform efforts in the US, including campaign donations Republican judges attentive to "business-friendly" legal reform.
Mark Shapiro describes how chemical regulation in the United States has lagged since it's heyday in the 1970's and 1980's, especially in past decade. By contrast, he says, the EU has stepped up chemical regulation and product safety standards.
Shapiro notes that US company opposition to chemical regulation emphasizes the economic cost necessary to comply with the rules, and that US lobbyists even accuse the EU of welfare economics. However European agencies stress they're not sacrificing profit at the alter of environmental socialism, not even close. The EU currently manufactures more chemicals for the world market than the U.S., and Shapiro argues that they are taking a proactive stance on manufacturing standards that's threatening to leave the U.S. in the dust, even as the U.S. loses deals insisting that business profits trump consumer safety.
Shapiro's book covers accounts of cosmetic regulation, as well as endocrine disruptors - especially phthalates, GMO's, persistant organic pollutants (POPs) (like DDT, Aldrin, Dieldrin, Endrin, Chlordane, Heptachlor, Hexachlorobenzene, Mirex, Toxaphene, Polychlorinated Biphenyls, Dioxins, and Furans), and the EU Restriction of Hazardous Substances Directive (RoHS) that regulates substances in electronic equipment (like lead, Mercury, Cadmium, Hexavalent chromium, Polybrominated biphenyls (PBB), and Polybrominated diphenyl ether (PBDE)). In his telling, the U.S. consistently undermines efforts to regulate the chemicals.
Shapiro's point that European leadership is at the forefront of environmental considerations across the globe might seem optimistic. A couple of years ago Acronym Required wrote about an incident involving the inclusion of an Ampicillin gene in genetically modified seeds that were erroneously sold and planted for four years in the EU and the US. Both European and US regulatory agencies failed to respond to the error, as we described in "Transgenic Crops - Strife Across the Pond". It might seem that between government agencies and business interests, assessments of chemical toxicity would be the same on both sides of the Atlantic, but that assumption is false.
Events in recent legislation in San Francisco and California concerning phthalates in children's toys illustrate the influence the EU might have on the US. One reason consistently given by both state and city legislators for enacting the legislation was that Europe had already banned phthalates. It works both ways. Although the San Francisco law originally sought to ban bisphenol-A, this chemical was quickly dropped from the bill when the city and state seemed to be influenced by lobbyists who pointed out that bisphenol-A regulation in Europe is limited.
Shapiro makes a convincing case in an interesting book, that the EU's more aggressive stance on chemicals will benefit its economy, as well as citizens within and outside the EU.
Acronym Required wrote about REACH, and Mark Shapiro's article in Harper's a couple months ago . We also wrote about REACH back in 2005. We've written frequently on bisphenol-A and phthalates, the environment, and government regulation.
The Environmental Working Group has a database of 25,000 health care products available in the US with estimates of potential risks. Many health care products, whether high end, organic, or cheap drugstore brands, contain chemicals known or suspected to cause cancer or affect reproductive health. The database compares ingredient lists on the labels to databases of chemical toxicants, then rates the products on a 1-10 score. Imperfect, but interesting.