National Nutritional Foods Ass'n v. Califano, 77 CIV 6083 (LBS).
Decision Date | 29 August 1978 |
Docket Number | No. 77 CIV 6083 (LBS).,77 CIV 6083 (LBS). |
Citation | 457 F. Supp. 275 |
Parties | The NATIONAL NUTRITIONAL FOODS ASSOCIATION and Protein Products Association, Plaintiffs, v. Joseph A. CALIFANO, Jr., Secretary of Health, Education and Welfare, Donald M. Kennedy, Commissioner of Food and Drugs, and Allan L. Forbes, M.D., Acting Associate Director for Nutrition and Consumer Sciences, Bureau of Foods, Defendants. |
Court | U.S. District Court — Southern District of New York |
Jacob Laufer, Bass, Ullman & Lustigman, New York City, for plaintiffs.
Robert B. Fiske, Jr., U. S. Atty., Peter R. Paden, Asst. U. S. Atty., New York City, Edward M. Basile, Asst. Chief Council for Enforcement, Food and Drug Division, Rockville, Md. of counsel, for defendants.
In this action, plaintiffs, two trade associations representing manufacturers, wholesalers and retailers of various food products (including protein supplements) raise a number of objections to the rulemaking procedures employed by the United States Food and Drug Administration ("FDA") related to "special dietary protein products" and seek declaratory, injunctive and other relief.
In the late summer of 1977, the FDA began receiving reports of deaths which might have been related to the use of special dietary protein products. At that time, these products were being used by many dieters and were attracting considerable public attention. Concerned by the reports, Dr. Allan L. Forbes, Acting Associate Director for Nutrition and Consumer Sciences, Bureau of Foods, FDA, a defendant herein, decided to investigate the safety of these products. He learned that a conference on obesity was scheduled to take place on October 20-22, 1977, at the National Institutes of Health in Bethesda, Maryland, and that the conference would be attended by a number of experts knowledgeable in this field.
On October 18, 1977, Dr. Forbes communicated with five clinicians attending the conference and two days later, met with them at the offices of the Federation of American Societies of Experimental Biology in Bethesda, Maryland. No special preparation for this meeting was requested or performed; some working papers were submitted by one conferee, Dr. George Blackburn, and a detailed memorandum of the comments and discussions was made.
On November 9, 1977, defendant Donald M. Kennedy, Commissioner of Food and Drugs, held a press conference and issued a press release, which is annexed as an exhibit to the complaint herein. He declared at that time that the FDA was aware of sixteen reported deaths and a number of severe illnesses possibly associated with the use of special dietary protein products, and expressed concern . Press Release at 1.
Commissioner Kennedy's press release went on to state:
Dr. Blackburn and Dr. Von Itallie were two of the experts in attendance at the October 20, 1977 meeting at the offices of the American Societies of Experimental Biology.
The release outlined the investigation being conducted by the FDA "in addition to consulting with outside experts and working with the Center for Disease Control" ("CDC"). It described a "mandatory warning label" that the FDA was developing and urged immediate voluntary compliance by manufacturers. The release stated that . Press Release at 3.
On December 2, 1977, there appeared in the Federal Register an announcement signed by the defendant Commissioner which proposed certain "Food labeling warning statements for all protein supplement products". 42 F.R. 61285-61287.
The proposal included the following pertinent statements:
On December 15, 1977, this suit was commenced asserting three claims: (a) that the October 20, 1977 meeting constituted a violation of the Federal Advisory Committee Act ("FACA"), 5 U.S.C. App. I (1976); (b) that the FDA violated the Administrative Procedure Act, 5 U.S.C. section 551 et seq. (1976), and its own regulations by failing to make available to the public the documentary materials upon which it relied in promulgating the challenged regulation; and (c) that the FDA is attempting to promulgate the warning label regulation without the public hearing required by the Federal Food, Drug and Cosmetic Act, 21 U.S.C. section 301 et seq. (1976) "FDCA" and is doing so by failing to proceed under the proper section of the Act, which requires such a hearing.
With respect to their first claim, plaintiffs seek a...
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Nat'l Res. Def. Council v. Zinke
...Foods Ass'n v. Califano, trade associations challenged an FDA advisory committee regarding protein supplements. 457 F. Supp. 275, 276-77 (S.D.N.Y. 1978) (Sand, J.). The district court granted dismissal partially because plaintiffs' claims had become mooted. Id.at 281. On appeal, Judge Frien......