Multiple Carcinogens in Johnson & Johnson's Baby Shampoo

The Campaign for Safe Cosmetics must be congratulated for securing an agreement with Johnson & Johnson "for reducing or gradually phasing out trace amounts of potentially cancer-causing chemicals" from Baby Shampoo, "one of its signature products."
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The Campaign for Safe Cosmetics must be congratulated for securing a 11/15/11 agreement with Johnson & Johnson "for reducing or gradually phasing out trace amounts of potentially cancer-causing chemicals" from Baby Shampoo, "one of its signature products." However, this agreement is limited and restricted to the U.S. market.

There are three carcinogenic ingredients in Johnson & Johnson's Baby Shampoo, dioxane, formaldehyde and nitrosamine. Dioxane is a well-recognized carcinogenic contaminant in alcohol ethoxylates, a group of four ingrediens -- laureths, oleths, polyethylene glycol and polysorbates. The second ingredient, quaternium, is a precursor of two carcinogens, formaldehyde and nitrosamine. Johnson & Johnson has committed to "reducing or gradual phasing out" dioxane and formaldehyde in their U.S., but not in their international, products. A third carcinogen, not recognized by the Campaign for Safe Cosmetics, is nitrosamine, also of quaterniums, besides other precursors.

However limited, Johnson & Johnson's response is in sharp and disturbing contrast to the silence of the Food and Drug Administration (FDA). This federal agency has still failed to enforce the explicit requirements of the 1938 Federal Food Drug and Cosmetic Act. This directs the FDA to require that "the label of a cosmetic product shall bear a warning statement to prevent a health hazard that may be associated with the product."

The regulatory failure of the FDA extends to its failure to respond to the Cancer Prevention Coalition's extensively-documented 1996 Citizen Petition "Seeking A Cancer Warning On Cosmetic Products Containing (the carcinogen) Diethanolamine." FDA's regulatory failure extends still further to the Coalition's 2008 Petition, "Seeking A (ovarian) Cancer Warning On Talc Products Used By Premenopausal for Women's Genital Dusting." Both petitions, endorsed by leading cancer prevention experts, requested the FDA to ban or suspend approval of these products, which still pose an "imminent hazard," or minimally to require their labeling with a "caution" or other such warning. However, the FDA has still failed to respond.

Concerns on the cancer risks of talc, dioxane, formaldehyde, nitrosamine and ethylene oxide, besides other prohibited and restricted carcinogenic ingredients in cosmetics and personal care products, are not new. They were detailed in my 2001 "Unreasonable Risk: How To Avoid Cancer From Cosmetics and Personal Care Products," and 2009 "Healthy Beauty" books.

As published in the Feb. 25, 2011 Science Insider editorial, "Advancing Regulatory Science," FDA Commissioner Dr. Hamburg claimed that FDA's regulations must be based on "better predictive models -- functional genomics, proteomics, and metabolomics," rather than "high dose animal [carcinogenicity] studies -- unchanged for decades."

Dr. Hamburg's dismissal of standard carcinogenicity tests is bizarre. Their scientific validity has been endorsed by other federal regulatory agencies, the National Toxicology Program, the International Agency for Research on Cancer, besides the April 2010 President's Cancer Panel. Furthermore, as stipulated in the 1938 Federal Food Drug and Cosmetic Act, the FDA is charged with regulating food, drugs and cosmetics based on standard toxicology and carcinogenicity tests. Moreover, the FDA is not charged with, let alone capable of developing irrelevant "tests that incorporate the mechanistic underpinnings of disease."

As warned by Senator Edward Kennedy at the 1997 Senate Hearings on the FDA Reform Bill, "The cosmetics industry has borrowed a page from the playbook of the tobacco industry by putting profits ahead of public health." This warning remains current.

Samuel S. Epstein, M.D. is professor emeritus of Environmental and Occupational Medicine at the University of Illinois at Chicago School of Public Health; Chairman of the Cancer Prevention Coalition; and former President of the Rachel Carson Trust. His awards include the 1998 Right Livelihood Award and the 2005 Albert Schweitzer Golden Grand Medal for International Contributions to Cancer Prevention. He is the author of over 270 scientific articles and 20 books on the causes and prevention of cancer, including the Unreasonable Risk Book: How To Avoid Cancer from Cosmetics and Personal Care Products, The Neways Story (2001, Environmental Toxicology), the groundbreaking The Politics of Cancer (1979, Doubleday Books), Healthy Beauty (2010, BenBella Books), and National Cancer Institute And American Cancer Society: Criminal Indifference to Cancer Prevention and Conflicts of Interest (2011, Xlibris Publishing).

Samuel S. Epstein, M.D.
Chairman, Cancer Prevention Coalition
Professor emeritus Environmental & Occupational Medicine, University of Illinois at Chicago School of Public Health

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