Chronic under-regulation

Readable Research | By Abby Ferla |
Feb. 1997

A report published in the Feb. 4 edition of the Journal of the American Pharmaceutical Association reveals that dyes for darkening gray hair contain lead that may leave a residue on the surfaces that they come into contact with. If the residue then gets on hands and is ingested – a particular risk in households with children – it can be easily absorbed into the blood stream. The report reveals that some hair dyes – particularly Grecian Formula 16 – have 10 times the lead concentration that is legally allowed in household paints. An article in Reuters says, “Studies show that lead exposure is particularly harmful to the developing brain and nervous system of fetuses and young children. The main effects of exposure include learning deficits and ‘disruptive behavior.’”5

The FDA tells the San Francisco Chronicle that it will investigate the study’s findings but that recommending recall at this stage would be “premature.”

Manufacturers tell the Chronicle that “lead acetate is a safe ingredient in hair dyes.”

Researchers advocate better labeling and laws that would prohibit the sale of hair dyes containing lead.

The Center for Environmental Health successfully sues to have a warning label put on Grecian Formula hair dyes. The AP writes, “FDA reports from 1978 found enough lead absorbed through the skin after use of Grecian Formula to trigger a mandatory customer warning under state law.”

Combe, Inc., manufacturer of the product, calls the lawsuit “bogus.”6

Sept. 1997

A bill to overhaul the FDA is introduced in Congress. According to the Chicago Tribune, one provision of the bill would be to “establish uniform, national labeling and warning requirements for cosmetics.” Proponents of cosmetics reform, including Sen. Ted Kennedy (D-Mass.) oppose the provision, because it would prohibit states from making their own regulations regarding cosmetics. Specifically, senators from California attempt to block the provision, because it would, as the Copley news Service reports, override California’s Proposition 65, which would require all companies in California to disclose information about known carcinogens and birth-defect causing chemicals in their products to the state.7 Sen. Dianne Feinstein (D-Calif.) says in a statement, “Proposition 65 has been very effective in eliminating carcinogens and reproductive toxins in foods, drugs, and cosmetics.”8 The bill passes but without the provision dealing with national standards and preemption of state regulation.


H. W. Mielk , M. D. Taylor, C. R. Gonzalez, M. K. Smith, P. V. Daniels, and A. V. Buckner, “Lead-Based Hair Coloring Products: Too Hazardous for Household Use,” Journal of the American Pharmaceutical Association 37.1 (1997): 85-89. Print.

Associated Press. “Excessive lead alleged in Grecian Formula,” Associated Press, February 7, 1997, accessed August 11, 2011,

Chicago Tribune, “Cosmetics Get 2nd Look.” Chicago Tribune, September 6, 1997, accessed August 11, 2011,

Stephen Green, “Boxer, Feinstein block FDA bill over toxin warnings,” Copley News Service, July 30, 1997, accessed August 11, 2011,

Send a letter to the editor