11
Reforming the Cosmetics and Personal-Care Products Industry
As you’ve seen, cosmetics and personal-care products present a minefield of potential dangers that the FDA has done criminally little to protect us against. These products are the single largest avoidable cause of disease in the U.S., and yet the information you’ve read here remains undisclosed by the industry and the FDA.
The products we use every day are plagued by a wide range of toxic ingredients; some are unintentional contaminants and others are purposeful additions. Our cumulative body burdens of chemicals keep growing. Clearly, we need to do something to put a stop to this. The question is, what?

There Are Safer Options

Aubrey Organics was one of the first manufacturers to abandon the use of the carcinogen DEA in its products. As Aubrey Hampton, director of that company, assured me back in 1996: “None of our products perform less effectively because they do not contain DEA. There are many alternative bases available without DEA that can be used by cosmetic manufacturers. The removal of DEA does not pose a manufacturing problem to the cosmetics industry.” By 1998, Neways International had also phased out the use of DEA, as well as subsequently pioneering a series of initiatives to phase out carcinogens and other toxic ingredients in its products. (Under recent new management, the company’s pledge of increased safety has become more aggressive. Neways has, with my collaboration, now eliminated all toxic ingredients in its new products.)
DEA isn’t an isolated example. For every single one of the toxic ingredients we’ve discussed in this book, there are safe alternatives available. Responsible companies have demonstrated how toxic ingredients can be economically removed from cosmetics and personal-care products, and their example provides a roadmap for what other manufacturers and distributors can accomplish if they place the interests of public health and safety ahead of a reliance on risky shortcuts to higher profitability.
Though most manufacturers have historically relied upon hormone-disruptive parabens as preservatives to keep their products from going bad, safe alternatives include chlorophenesin, phenoxyethanol, and caprylyl glycol. Grapefruit seed extract has also been claimed to be a safe alternative to parabens, but its preservative action is actually due to contamination by the highly toxic hormone disrupter triclosan, or sometimes by the less toxic benzethonium chloride. Pure grapefruit seed extract has no preservative action whatsoever.1
Phthalates are the most commonly used solvents, but cosmetic-grade petroleum distillate (or petroleum jelly) is just as effective. At high concentrations petroleum distillate can be an irritant, especially in mascara and other eye make-up products, but is generally highly purified and non-toxic and a great substitute for other solvents in conditioning, protective, and hairdressing creams.
Safe whitening ingredients—based on the synthetic peptide Melanostat, which suppresses tyrosinase, the enzyme responsible for the production of black pigment in skin cells—are becoming increasingly available. And there has been much promising research into safe, natural sunblocks (see chapter 8). Current safe sunblocks using zinc and titanium dioxide can even be made transparent using “encapsulated” ingredient formulas rather than untested nanoparticles.
For ingredients that frequently carry unsafe contaminants, there are often ways to remove those contaminants. Ethoxylate detergents, commonly used in shampoos and other cleansing products, can be largely purified of their hidden carcinogens, ethylene oxide and 1,4-dioxane, through a simple, inexpensive vacuum-stripping process. Steam-stripping is even more effective, particularly for ethylene oxide. (You can usually tell when ethoxylates in a particular product have been decontaminated, because they are labeled “ultra-purified.”)
Even purified, however, ethoxylates still contain low levels of these two carcinogens. Better to avoid ethoxylates entirely, and instead use organic ingredients such as coconut and babassu palm oils and their sulfates, which are very safe, effective detergent alternatives.
There are also ways to minimize the toxic effects of many ingredients. There are many safe herbal hair dyes readily available, but if you do use a toxic dye, preventing contact between the dye and your scalp by using a plastic cap, with holes through which hair strands can be pulled before they are painted or streaked with dye, will at least minimize contact.
If there are such reasonable safe alternatives available, why don’t more companies use them? The answer is twofold. The first part is economic; companies save a little, though not a lot, of money. Most unsafe ingredients are cheaper than their alternative—at least for now. The second part is plain irresponsibility. With no government agency standing watch over them, most manufacturers simply don’t take consumer health as seriously as they do corporate profitability.

Needed Reforms

Convincing companies to discontinue their use of toxic ingredients means making it more cost-effective to change than to continue as they are. One way to do this is through the power of the marketplace. If enough citizens boycott hazardous products in favor of safer ones, companies will be forced to alter their products to compete. And the first step toward making that a reality is re-establishing the consumer’s right to know.

RE-ESTABLISHING YOUR RIGHT TO KNOW

Being able to find out the identity of product ingredients and whether they are harmful to their user’s health should be a fundamental, inalienable right. But it is a right we are unlikely to get without some kind of government regulation.
Dr. Donald Kennedy, FDA Commissioner from 1977 to 1979 and one of the few if only activist and scholarly experts to ever hold that position, once stressed how “information strategy,” particularly the need for labeling of consumer products with explicit warnings of health risks, should be an integral function of regulation:
Regulation arises as a consequence of the generation of public costs by private activity. The best regulation is a clear signal that identifies these costs and allows members of the public to avoid them voluntarily. Sometimes the regulator has to do more, as when the costs are impossibly cryptic or public understanding is inadequate. In most cases, the regulator’s task is to provide information. This role puts the Food and Drug Administration in the middle of the health-education business [emphasis added].
Kennedy never had the reforming effect on his Agency that he sought, but his position remains a vigorous statement on the government’s responsibility to intervene, even if only by supplying information, to protect the public.2 His vision of the government’s role remains just as pertinent and essential in this century as when he made those remarks decades ago.
While the full and accurate labeling of product ingredients is a necessary first step, product labeling per se is still inadequate to protect consumer health. Products that contain hazardous or problematic ingredients need to be accompanied by “Red Flag” warnings that spotlight the health risks uncovered during laboratory testing, similar to the cancer warnings mandated to appear on packs and cartons of cigarettes. But product label warnings should not be used as a justification for the authorization of new carcinogens or for the continued use of carcinogenic products already on the market. It must be stressed that product label warning is no substitute for ingredient phase-out or a ban on products containing clearly harmful chemicals. Absolute prohibition should be placed on the introduction of new carcinogenic products and untested new technologies. Human health and safety should rank above economic and political concerns.
All of this is impossible while industry claims of confidentiality and trade secrecy still present a serious obstacle to our obtaining the information we need to know to issue such warnings. There is an urgent need for international rules that restrict claims of confidentiality by corporations trying to withhold information on ingredients and their toxic effects. Information on the carcinogenic and otherwise toxic risks of products must be automatically and fully released to the public. Right-to-know regulations should be extended to the overseas operations, particularly in lesser developed countries, of U.S. corporations and those of other major industrialized nations, encompassing not just testing practices, but environmental and human rights practices as well.
According to Horst Rechelbacher, CEO of Intelligent Nutrients
“Lowering safety and production standards and product quality to increase bottom-line profits, while knowingly and deceptively selling consumers inferior, defective, or unhealthy products, has long been a standard business strategy. Every day, substandard, defective, toxic, even dangerous products are knowingly released onto the market and sold to the public. At the same time and in the same way, we are also being denied a fundamental consumer right—the right to know exactly what we are being sold and are consuming, and what the effects of the things we are sold and consume can have on our bodies, our health, and on the environment. Today’s business and government have become so completely and often covertly enmeshed that the denial of these citizen and consumer rights now defines and affects every aspect of our lives.”
 
From Rechelbacher, Horst M. Minding Your Business: Profits That Restore the Planet. Earth Aware Editions: San Rafael, California, 2008.

MAKING COMPANIES PAY

Except for their operations in European Union countries, most of the global cosmetics and personal-care product industry has been essentially self-regulating (though that situation may be changing). Many nations still emulate the U.S. and rely on industry to ensure product safety, to determine the way cosmetics are labeled, and to decide the number of ingredients that are prohibited or restricted. There are no regulatory requirements for pre-market testing of ingredients and products. Nor, with few exceptions, are there any requirements for labeling products with cancer warnings or other dangers. Clearly, removing government from the equation does not work. Government regulation can be very useful not only in protecting our right to know, but in encouraging companies to adopt safer product standards—both by offering incentives for positive steps and threatening sanctions for violations of law.
Granting tax incentives for the development of safe alternatives to toxic-based, conventional technologies and ingredients, as well as tax penalties for failure to adopt available safe alternative technologies and ingredients, could encourage the active interest of mainstream industry in such initiatives—the surest way to stimulate belated reform of the mainstream cosmetic and personal-care product industry.
Consideration should also be given by state and federal government to using laws on white-collar crime—which are now applied largely just to crimes of economic motivation with adverse economic consequences—against crimes of economic motivation with adverse public health consequences, consistent with a major legislative initiative that I proposed nearly three decades ago.2 Penalties could be levied against industry managers, executives, and consultants who knowingly manipulate, distort, or suppress information on the environmental, occupational, and consumer hazards of their products and manufacturing processes. There is currently a double standard of justice in the U.S.; as Ralph Nader has repeatedly commented, “Jail for the crime in the streets, but bail for crime in the suites.”
More general reform of toxics use would have a positive impact as well. Following a well-organized political campaign by environmental groups and far-sighted industry representatives, the Commonwealth of Massachusetts unanimously passed the “Toxics Use Reduction Act” in 1989, which created the Massachusetts Toxics Use Reduction Program. The act is a specific form of pollution prevention that focuses on reducing the use of toxic chemicals by improving and redesigning industrial products and processes, and provides a useful model for state, national, and international legislation.
Thanks to this act, Massachusetts has reduced its generation of toxic wastes from 1989 to 1997 by 50 percent, by reducing toxics use by 20 percent; promoted reduction in the production and use of toxic chemicals; and enhanced and strengthened the enforcement of existing environmental laws, among other achievements.
Most recently, on August 14, 2008, Congress passed the Consumer Product Safety Modernization Act, the most comprehensive modernization of consumer product safety legislation in the last three decades. The act bans the sale of children’s products, such as games and toys, containing more than 0.1 percent of any phthalate. The act also requires the appointment of a Chronic Hazardous Advisory Panel within eighteen months of the act’s passing to consider and examine the following concerns:
• All potential health dangers, in isolation and in combination, for all consumer products intended for children under the age of twelve years.
• The health effects of exposure to phthalates from ingestion and skin contact.
• The likely levels of phthalate exposure in children, pregnant women, and others, based on products’ estimated normal use and also abuse.
• The cumulative effect of exposures to phthalates in children’s products, including personal-care products.
In addition, the legislation increases civil penalties, and possible criminal penalties, for companies that endanger consumers’ health. Large fines and even imprisonment may be imposed upon a company’s directors and officers, regardless of whether they are aware of the violation involved.
Most importantly, the Consumer Product Safety Modernization Act reflects explicit recognition of the FDA’s reckless abdication of responsibility for the regulation of toxic hormonal ingredients in cosmetics and personal-care products. The scope of this act is likely to be expanded to include a wide range of other toxic ingredients and offers an example of regulation on which we might base more comprehensive future regulation that protects consumers.
There are other successful models, both at home and abroad, we can look to in reforming our chemical safety policies as well, especially in terms of cosmetics and personal-care products—specifically, in California and in Europe.

California Pioneers U.S. Legislative Change

California often acts as a bellwether for the rest of the country, and in 2005 its state legislature enacted a Safe Cosmetics Act that requires cosmetic companies to disclose to a state agency any ingredients in their products that cause cancer or hormone disruption. Repeated failures in the U.S. Congress to enforce the FDA’s compliance with the Federal Food, Drug, and Cosmetic Act helped inspire California Assemblywoman Judy Chu to introduce landmark legislation, in 2004, that would have banned the use of phthalates and required disclosure of all carcinogenic, hormone-disruptive, and otherwise toxic ingredients in cosmetics and personal-care products, including their hidden use in perfumes and fragrances. Backed by a coalition of consumer, women’s, occupational, and church groups, but opposed by mainstream industry interests, the legislation failed to pass. But this shot across the bows of industry marked the beginning of nationwide initiatives to protect consumers from undisclosed dangerous ingredients in cosmetics and personal-care products.
A second attempt in the California Legislature in 2005, also vigorously opposed by the cosmetics industry, proved successful. The result was the California Safe Cosmetics Act, which Governor Arnold Schwarzenegger signed into law in 2007. It requires cosmetic companies to disclose to the State Department of Health Services any ingredients in their products that have been identified as causing cancer or hormone disruption. The department can then require the manufacturer to disclose these ingredients and their toxic effects on a Web site for public viewing. California state officials can also demand that products handled by salon employees meet minimum safety standards. Though the law does not require products to include warning labels for dangerous ingredients, the hope behind this legislation was that once companies were forced to publicly disclose product ingredients to the state, they would begin reformulating their product lines to remove questionable chemicals. Whether or not the law will achieve this goal remains to be seen.
The Safe Cosmetics Act was vigorously supported by activist groups, including Health Care Without Harm, a coalition of environment and health groups; the National Environmental Trust; and the San Francisco-based Breast Cancer Fund, founder of the Campaign for Safe Cosmetics (which demands that all U.S. and international companies marketing their products in the U.S. pledge to conform to the guidelines developed by the European Union). By January 2007, over 500 cosmetic and personal-care product manufacturers, but none of the major corporate players, had endorsed the Campaign for Safe Cosmetics’ “Compact for the Global Production of Safe Health and Beauty Products,” pledging to eliminate hazardous ingredients and replace them with safer alternatives. Additional support for the act came from public health and labor organizations, particularly those representing nail, hairdressing, and beauty salon workers, and the Screen Actors Guild.
California’s highly progressive initiative has motivated changes in other parts of the country as well. The act helped inspire the Oregon state legislature to pass a joint resolution in 2007 telling the U.S. Congress that it wants the federal government to mandate accurate labeling of all ingredients in cosmetics and personal-care products. The resolution also urged Congress to require the FDA to test the safety of all products used on the skin. In addition, thanks to efforts by the Campaign for Safe Cosmetics, a series of grassroots initiatives has taken hold in cities and small towns across the U.S. One of these initiatives occurred in the town of Belmont, Massachusetts, population 25,000, where in early 2008 the Sustainable Belmont committee embraced the precautionary principle as part of a program to educate local consumers on which harmful personal-care product ingredients to avoid and which companies are taking positive steps to make their products safer.

Europe’s Seventh Amendment

In beginning to reform our own policies, we would also do well to look to the legislative initiatives adopted in Europe, which have rewritten the rulebook for how cosmetic and personal-care product companies must operate in the twenty-first century in order to satisfy public concerns about health and safety.
The most important European initiative is the European Union’s Seventh Amendment, which went into effect in 2005 and attempts to ensure the safety of cosmetics and personal-care products sold in European Union countries.3 Three major classes of toxic ingredients are regulated by the amendment: carcinogens; mutagens (toxins that can cause genetic damage); and reproductive toxicants (or hormone disrupters). Ingredients are further broken down into three categories; those in Categories 1 and 2 (almost 1,000 total) are banned entirely, and those in Category 3 are permitted pending further investigation. The Seventh Amendment also requires the labeling of twenty-six additional fragrance ingredients that may cause allergic reactions, contact dermatitis, and asthma in sensitive users.
Driving these public policy reforms throughout Europe has been a groundswell of consumer demand for natural ingredients in personal-care products, coupled with a rejection of (most) synthetics as being unnecessary safety risks. Where most other countries (including our own) make consumer and environmental policy decisions based solely on a cost/benefit analysis of risk, European Union countries approach chemical safety with a directive to “do no harm,” even if an ingredient is only suspected of causing harm to human health. The European Union follows the “precautionary principle,” a moral and political principle based on the idea that harm need not be completely established for corrective action to be taken. The principle mandates that industry must provide unequivocal evidence that any new candidate products do not pose potential or recognized human or environmental risks. The principle further absolves citizens and regulatory agencies from the heavy burden of proving such a risk and allows the banning of suspect products in circumstances of scientific uncertainty. In addition, the raw data on which industry claims of safety are based must be fully disclosed and evaluated by an independent agency at industry’s expense.
This approach is essential to excluding bias and manipulation, of which there is a well-documented track record in the petrochemical and other industries. An illustrative example comes from a review of 161 studies in the National Library of Medicine files on four heavily regulated industrial chemicals—formaldehyde, perchloroethylene, atrazine, and alachlor. While only 14 percent of industry studies reported toxic or carcinogenic effects, such effects were disclosed in 71 percent of studies done by independent researchers.
Policies based on the precautionary principle are clearly preferable to our method, the deliberate acceptance of risks followed by often ineffectual attempts to “manage” effects. Ineffective management—reducing dangerous ingredients to levels claimed “acceptable” by self-interested industry or complicit regulatory agencies rather than banning them entirely—solves few real problems and creates many more.
The precautionary principle isn’t just relevant to the cosmetics and personal-care products industry. It’s also relevant in the case of genetically engineered food. Industry claims of safety regarding these foods are based on “trust us” assurances rather than published scientific data—claims that are called into question by the extensive scientific evidence on the veterinary and public health hazards (particularly increased risks of breast, colon, and prostate cancers) from consumption of genetically engineered (rBGH) milk.4

Problems with the Seventh Amendment

While important and well intentioned, the Seventh Amendment isn’t perfect. It’s marred by several problems and errors, such as:
• The well-known carcinogen formaldehyde is omitted from Categories 1 and 2 (which do include lead and mineral spirits), and instead is incorrectly listed in Category 3.
• Parabens are omitted from Categories 1 and 2.
• Dibutyl phthalate is listed in Category 1, but no other phthalates appear in any category.
• There are no hidden carcinogens, notably nitrosamine precursors, formaldehyde releasers, or ingredients that often carry contaminants, listed in any category.
In spite of these limitations, the Seventh Amendment has already had a profound impact on global cosmetic companies. Industry giants Revlon and L’Oreal reformulated their products in compliance with the amendment (and also in anticipation of California’s January 2007 law, which we’ll look at later in this chapter). Unfortunately, less responsible companies have opted to market new “green” products in Europe while continuing to supply U.S. and other markets with unsafe old products. This strategy is limited, however, by the fact that the EU has become the largest trading partner with every continent worldwide, except Australia.
The Seventh Amendment has also led to the ban of ingredients already on the market. In 2006, the EU announced a ban on twenty-two hair dye ingredients for which industry had not submitted any safety files.5 The Scientific Committee on Cosmetic Products, an advisory committee involved in the Seventh Amendment’s development, previously warned of epidemiological evidence that incriminated the long-term use of hair dyes in bladder cancer and called for carcinogenicity and mutagenicity testing of all dye ingredients.

More European Safety Regulations

The Seventh Amendment isn’t the only example of ground-breaking regulations being enacted in Europe. Less well recognized by cosmetic companies are new regulations on the manufacturer of industrial chemicals in the original twenty-five member states of the EU. These regulations are referred to as REACH—Registration, Evaluation, and Authorization of Chemicals.6 They passed their “first reading” in the European Parliament in 2004, were approved by the Environmental Committee of the Parliament in October 2006, and later were extended to the now twenty-seven-member bloc, including Romania and Bulgaria—a population larger than that of the U.S. Once REACH goes into effect, any new chemicals imported into Europe will need to be registered with a new European Chemicals Agency. Substances designated as toxic will be banned. Chemical registration is expected to begin by 2011. REACH’s regulations are designed to phase out the production and use of approximately 30,000 common toxic industrial chemicals, some of which are often used in cosmetics and personal-care products, and to stimulate the manufacture and use of safe alternatives. Not surprisingly, U.S. industries remain strongly opposed.
The new EU regulations have had an impact on other European countries as well. In 2005, Switzerland enacted a new law that matched EU regulations for industrial chemicals, pesticides, and cosmetics, but went even further in banning toxic ingredients. Sweden has also improved upon the EU regulations by banning persistent organic pollutants and other persistent chemicals like lead, and by requiring the phasing out of chlorinated paraffins, a large class of toxic ingredients that includes plasticizers and flame retardants. Swedish companies were given five years, until 2010, to test the estimated 2,500 chemicals used in quantities over 1,000 tons per year for such effects. By 2010, chemicals used in lesser amounts will also have to be tested.

Safety Regulations in Other Countries

In China, the first regulations on cosmetics and personal-care products were issued in 2002, banning approximately 400 ingredients. In an effort to become more competitive in the global market, particularly in the U.S., China extended its ban to a total of 1,100 ingredients in 2007 and also developed more stringent regulations approaching those of the EU—showing that China intends to establish itself as a major player in the global industry.
ASEAN, an organization of ten southeastern Asian countries (Indonesia, Laos, Philippines, Thailand, Vietnam, Brunei, Cambodia, Myanmar, Malaysia, and Singapore), in August 2006 announced its intent to create a unified regulatory system to harmonize ASEAN cosmetic regulations. This initiative, like China’s, is intended to attract major global players and investments, and allow ASEAN countries’ products to compete internationally.
In Japan, prior to April 1, 2003, cosmetics were regulated under the Pharmaceutical Affairs Law (PAL) by the Pharmaceutical and Safety Bureau, under the authority of the Ministry of Health, Labor and Welfare. Beginning in 2003, however, cosmetics were effectively deregulated and responsibility shifted from the ministry to industry.
Abolition of the PAL has thus effectively harmonized the Japanese and U.S. markets. However, there are important differences between Japanese law and our own. Importing companies are now required to notify the ministry that they intend to sell a product in Japan. The industry must also assure the safety of all product ingredients and keep files supporting safety data. While testing of cosmetics is no longer required, safety data must be made available on request. The majority of ingredients remain controlled by two “Negative Lists.” One list prohibits thirty ingredients, including formaldehyde. The other list sets restrictions on the use of many other ingredients, such as coal tar dyes, formaldehyde-releasing preservatives, and ultraviolet light absorbers. Words like “safe” and “no worries” are not allowed to appear on labels. Nor can superlatives (like “best in the world”) be used without solid proof for such claims. Similarly, words claiming superiority of products (such as “number one,” “available only from our company,” and “first in Japan”) are no longer allowed.
It’s not just Asian countries that are changing their policies. Canada’s Food and Drugs Act states that “no person shall sell a cosmetic product that has in it any substances that may injure the health of the user when the cosmetic is used according to its customary method.” To help manufacturers meet this requirement, Health Canada, the government department responsible for public health, developed a periodically updated “Cosmetic Ingredient Hotlist” of restricted and prohibited ingredients. The list identifies about 420 of these ingredients, but until recently the law did not require products containing these ingredients to include warnings on the label or even identify themselves as containing the ingredients.
Responding to mounting citizen protests, Health Canada reluctantly relented, and from January 2007 on, labeling requirements became law for all products except fragrances and perfumes. Health Canada now also requires that all ingredients be named by the worldwide standard Scientific International Nomenclature for Cosmetic Ingredients, in order to simplify the recognition of ingredient names by consumers. As a result of these actions, Canadian regulations now approach the high standards of the European Union. May our own soon follow.