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FDA decision on coal tar

OKINCPG at aol.com OKINCPG at aol.com
Wed Feb 28 18:07:54 EST 2001

February 23, 2001


SAN FRANCISCO - A lawsuit against major shampoo manufacturers received a 
boost this week when the Food and Drug Administration (FDA) declared that 
coal tar, a common ingredient in many dandruff shampoos, is a carcinogen.  
Coal tar is found in many leading dandruff shampoo products including those 
sold by Neutrogena, American Home Products, Walgreens, and other defendants 
in the lawsuit.  

"Children and infants are most at risk to develop cancer from these 
shampoos." says Perry Gottesfeld, Executive Director of Occupational 
Knowledge International (OK International), who launched the suit.

In response to a petition filed by OK International, a nonprofit group 
involved in public health and environmental issues, the FDA declared, "there 
are animal and human occupational exposure data to show that coal tar is 
carcinogenic".  However, the FDA did not order that coal tar shampoos be 
taken off the shelf. 

A lawsuit filed by Gottesfeld against more than 20 manufacturers of coal tar 
shampoos and related products (Gottesfeld v. Alva-Amco) is before the courts 
under California's Proposition 65.  The multi-million dollar suit alleges 
that the companies knowingly violated California law by selling a product 
with a known carcinogen without the required warning label. 

Gottesfeld added, "the companies' refusal to label these products is 
irresponsible and illegal as warning labels are required on all consumer 
products which contain known carcinogens."  

"Consumers should carefully read the fine print on hair care products to see 
if coal tar is one of the ingredients", Gottesfeld said.

Coal tar is one of the first known human carcinogens.  Studies linking coal 
tar to cancer were first published in the 1880s.  

This mixture, and several of the constituent Polycyclic Aromatic Hydrocarbons 
(PAHs) in coal tar, were among the first to be listed under Proposition 65 as 
carcinogens.  Recent studies have demonstrated that PAHs can be readily 
absorbed from the use of these shampoo products and epidemiological studies 
demonstrate that it can cause skin and other cancers.  

Gottesfeld, who initiated the suit in 1997 was later joined by the California 
Attorney General's office.  "It is the public's right to know that a 
carcinogen is present in these products which is absorbed into the skin and 
is used on infants and toddlers to combat cradle cap." Gottesfeld said.

Gottesfeld says, "We believe that in light of  FDA's conclusion that coal tar 
is a carcinogen, these companies should voluntarily label these products and  
warn consumers not to use these shampoos on infants and children."

"We regret that FDA did not act more decisively in regulating coal tar 
shampoos, but consumer advocates have long known that there are major 
deficiencies in federal law which fail to protect the public from dangerous 
over-the-counter products."

Gottefeld also pointed out:

• Coal tar shampoo products were banned by Germany in 1995 and by the 
European Union in 1997 as a result of the genotoxic effects of these 

• One of the toxic components of coal tar -- Benzo[a]pyrene (BAP) is one of 
the most potent carcinogens known.  The concentration of BAP in a single 
application of some coal tar shampoos is 470,000 times greater than the 
amount in a cigarette and about 200 times greater than the amount in a 

                       -- 30 --

 For further information:  Perry Gottesfeld,  (415) 441-5199


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