Document npZ6KR9v1VjpqerqKzvwoQy8X

iugust 1978 Dr, Donald Kennedy Commissioner Food and Drug Administration 200 C Street, S.W. Room 6815 Washington, DC 2020^ * Dear Dr. Kennedy: The strong likelihood that talc is carcinogenic was the subject of a letter from Dr. Marshall E. Deutsch to the New England Journal of Medicine on February 16, 1978 (page *i05), A more recent letter to the same journal by Drs. W.R. Moorehead and T.O. Oei (June 15* 1978, pp. 1365-66) states that: (a) talc is still used by U.S. drug companies both in the manufacturing process and as a filler in certain tablets; > j ' (b) a major drug firm "has not used talc in. any of the new drugs that it has developed in the last five years because it recognizes the possible danger of talc;" (c) FDA regulations discourage its replacement -in older drugs because the new formulation without talc would have to be resubmitted and approved by the FDA-- and this procedure would take a long time. If there is good reason to believe-- even if the evidence is not conclusive-- that talc is carcinogenic, prudence would dictate that its use be eliminated promptly in FDA-regulate-d products such as drugs and cosmetics. It would be greatly appreciated if you would let us know what steps FDA Is taking to achieve this objective. Sincerely, 9 ! Sidney M. Wfelfe, M.D. Health R esearch G roup =>2000 P Street. N.W., Washington, D.C.,20036 . o r m s7.-5.m-m PLAINTIFFS EXHIBIT WCD-166 WCD 001569