Warner-Lambert Company

Text (OCR of the scan at left; may contain errors)

IN THE MATTER OF WARNER-LAMBERT COMPANY Docket 8891. Order, Mar. 19m Denial of respondent' s petition to reopen proceedings to receive evidence of ex parte communications and of FDA findings concerning Listerine, and to withdraw final order pending consideration of such evidence. Appearances For the Commission: Wallace S. Snyder and William S. Busker. For the respondent: Mudge, Rose, Guthrie Alexander New York City and LaIT Sharp, Bergson, Barkland, Margolis Adler Washington, D.

Respondent has petitioned the Commission to reopen the proceeding for the purpose of receiving " evidence of ex parte communications and of FDA findings concerning Listerine, and to withdraw (the) final order pending consideration of such evidence. First, respondent contends that the Commission staff, through written memoranda dealing with the Commission s over-the-counter drug program, has "single(edJ out Listerine by name, (andj made improper and damaging ex parte arguments to the Commission" while the above-styled matter was pending. This contention is plainly without merit. The Commission has based its determinations and order in this proceeding solely upon the record compiled in Dkt. 8891. See Encyclopaedia Britannica, Inc. (Order Denying Motion To Reopen Record And Proceedings) (March 2, 1976' ). We have examined the memoranda 2 attached to respondent' s Petition, as well as the portions of the memoranda which were excised prior to FOIA release. The only mention of Listerine occurs in a few statements that a proceeding exists with respect to respondent the Listerine case which is now before the Commission " There are no arguments, as respondent contends, of the appropriateness of corrective advertising as a remedy in the Listerine proceeding. The references to Listerine are not ex parte communications since they are not statements "with respect to the merits " Rules of Practice Section 4. Secondly, respondent contends that the record should be reopened since an FDA advisory panel, after issuance of the Commission opinion and order found that combination products containing the 1 R ported in thig Volume , The memoranda. with one exception, COJ\Sist of reports to the Commis ion or the Chairman as to the gtatus of the Commission s Over-the-Counter Drug program. The exception is " report to the Director of the Bureau of Consumer Protection from the Division of National Advertising- "nd was a whoJI)" intra-Bureau communication. , 620 FEDERAL TRADE COMMISSIO" DECISIONS Order 87 F.T.C.

active ingredients of Listerine may be efficacious for the symptomatic relief of colds and coughs and that until further test data can be developed, may continue to label and to sell the products as in the past for the conditions indicated* * * " (footnote omitted). We also find this contention to be without merit.

In the decision in this proceeding, the Commission concluded, on the basis of the preponderance of the evidence in the record before us, that the use of Listerine, as directed, wil not prevent or cure colds or sore throats or ameliorate cold symptoms. Here the report that the respondent references in its Petition is a draft report by the FDA' review panel for over-the-counter cough and cold remedies. The report has not been adopted and thus there is no "finding," as respondent contends. The draft report has been placed on the public record for comment. See CCH Food, Drug & Cosmetic Law Reporter Para. 41 571 l4I F.R. 38312J. Moreover Category III " the category in which respondent claims its product's ingredients fall, is designated by FDA for drugs requiring additional study. Accordingly, It is ordered That the aforesaid petition be, and it hereby is, denied. MUTl:AL CONSTRUCTIOK CO.. INC., ET AL. 621 621 Complaint