409 F.Supp. 473 (D.D.C. 1976), Civ. A. 75-1250, Consumers Union of United States, Inc. v. Department of Health, Ed. and Welfare

Docket Nº:Civ. A. 75-1250
Citation:409 F.Supp. 473
Party Name:Consumers Union of United States, Inc. v. Department of Health, Ed. and Welfare
Case Date:March 12, 1976
Court:United States District Courts, District of Columbia

Page 473

409 F.Supp. 473 (D.D.C. 1976)





The Cosmetic, Toiletry and Fragrance Association Inc., Intervenor-Defendant.

Civ. A. No. 75--1250.

United States District Court, District of Columbia.

March 12, 1976

Page 474

Nancy H. Chasen, Washington, D.C., for plaintiff.

Peter C. Schaumber, Asst. U.S. Atty., Kenneth Baumgartner, Associate Chief Counsel for Enforcement Food and Drug Administration, Washington, D.C., for defendants.

Eugene I. Lambert, Covington & Burling, Washington, D.C., for intervenor-defendant.


JOHN LEWIS SMITH, Jr., District Judge.

This case involves a relatively narrow legal question: Were the meetings held on April 9 and September 17, 1975 between Food and Drug Administration (FDA) officials and representatives of the Cosmetic, Toiletry and Fragrance Association, Inc. (CTFA, Intervenor) advisory committee meetings within the meaning of the Federal Advisory Committee Act (FACA, Act), 5 U.S.C. App. I? If so, they were invalidly held since under FACA the meetings should have been open to the public and the 'advising' group authorized through administrative approval and chartering. Id. ss 9, 10(a). If the sessions were not advisory committee meetings, they were valid private meetings similar to numerous agency-industry or agency-consumer gatherings taking place daily at FDA. The matter is before the Court on defendants' Motions to Dismiss or, in the Alternative, for Summary Judgment and Plaintiff Consumers Union's Cross Motion for Summary Judgment.

The FDA has considered the desirability of labeling and of testing cosmetic ingredients since 1960. The initiative in these areas has moved back and forth from agency to industry, with industry representatives (acting at times to forestall pending legislation) proposing certain voluntary programs and FDA calling for refinements and clarifications in procedures. There now exist procedures for voluntary registration of cosmetic product establishments, for voluntary filing of cosmetic product ingredients, and for voluntary filing of cosmetic product experiences. 21 C.F.R. pts. 710, 720, 730 (1975); see 37 Fed.Reg. 23344 (1972); 36 Fed.Reg. 16934 (1971) (CTFA petitions for procedures). Regulations requiring cosmetic labeling have also been issued iby FDA. 21 C.F.R. pt. 701 (1975).

In the area of testing cosmetic ingredients, FDA-CTFA efforts have increased

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in the past two years. 1 Speaking at CTFA's annual meeting on February 27, 1974, FDA Commissioner Schmidt discussed the need for establishment of an ingredient review program. Another FDA official, Dr. Mark Novitch, stated: 'Certainly, this kind of approach (i.e., cosmetic ingredient safety substantiation paralleling the drug review process) is something you should consider and we will consider in our common effort to increase our mutual assurance and the public's confidence in the safety of our cosmetic products.' (Emphasis in original.) 2 CTFA had been developing a safety review program since 1972, and planning and consultation moved forward rapidly. After three exploratory meetings between FDA and CTFA representatives in 1974 and two briefing meetings in early 1975, CTFA requested a meeting with FDA to discuss CTFA's draft proposal. This meeting was held on April 9, 1975, and detailed minutes were kept for the session. Plaintiff's counsel subsequently requested permission to attend or participate in future FDA-CTFA meetings on the ingredient review proposal, invoking the Federal Advisory Committee Act. Commissioner Schmidt denied the request on grounds that these were private, CTFA-initiated meetings. Following the filing of this lawsuit, a second meeting was held on September 17, 1975 to discuss CTFA's revised proposal. Minutes were also kept for this meeting.

Resolution of the issues in this case requires a careful examination of FACA and its administrative and judicial construction. The Federal Advisory Committee Act was aimed at eliminating useless advisory committees, strengthening...

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