CLAIROL

345 PARK AVENUE
NEW YORK,N. Y. 10022

CONNER M. FAY " J
VICE PRESIDENT Gumer .
CORPORATE RELATIONS

October 8, 1980

 

Mr. Josh Lederberg
President

The Rockefeller University
1230 York Avenue

New York, NY 10021

Dear Josh:

I thought you would be interested to know Clairol and six other hair

coloring companies have won an agreement from the Food and Drug Administration
to remand its regulation requiring a warning label for hair dyes containing
4~MMPD,

The agreement came as a result of a lawsuit filed in Federal District
Court. Its significance rests chiefly in the fact that FDA has now agreed
to take into account the level of risk, if any, presented by hair dyes
containing 4-MMPD.

FDA's original decision to require label warnings failed to take into
account the level of risk. In connection with, any further rulemaking which
might be undertaken, FDA has now agreed to "propose the utilization of |
scientifically accepted procedures of risk assessment and to raise the
issue as to whether, in view of those procedures, hair dyes containing
4-MMPD present a generally recognized level of insignificant risk to human
health.”

This represents an important change in the thinking of the FDA concerning
risk. I have attached a copy of the court order and CTFA press release.

Sincerely,

Crow

/gmp
Enclosures