The opinion of the court was delivered by: SAND
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 "about the liquid protein diets now so popular. These diets are being promoted in the news media and in books as a new way of reducing "without drugs'. One in particular has been popularly advertised as the "last chance diet' ". Press Release at 1.
Commissioner Kennedy's press release went on to state:
"What I have just said reflects not only our own views, but also the information provided by the Center for Disease Control and advice given us by leading experts in obesity and obesity control. Dr. Harold Sours, an epidemiologist with the Center for Disease Control, is here this afternoon and can answer questions about his data. Two other experts, Dr. George Blackburn of Harvard and Dr. Theodore Von Itallie of Columbia, are also with us today. Both are conducting careful studies on the uses of very low calorie diets in extremely obese people. They are finding that very low calorie diets may have some value in treating extremely fat people under very close medical supervision. Dr. Blackburn and Dr. Von Itallie are here to answer your questions about their research and about their views."
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 "our investigations and CDC's are not complete. We need to take stronger actions later on if evidence of harm continues". 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:
"This proposal would establish label warning requirements for protein supplements that may be used in weight reduction or weight maintenance programs. The Food and Drug Administration is proposing these requirements on the basis of evidence that, without proper medical supervision, very low calorie diets consisting primarily of protein may cause serious medical problems, including death. The purposes of this proposal are to ensure that consumers are alerted to the potential health hazards associated with consumption of protein supplements for purposes of weight control and to inform consumers that the advice of a physician should be sought before using these products for weight control.
The agency is asking for the submission of any additional data relating to the safety of these products, and is also inviting comment with respect to whether the agency should take any other action concerning these products, including removing them from the market."
. . . . The Commissioner believes that large quantities of these products are being sold nationwide and that a significant number of consumers are using these products for weight control or maintenance. Diets consisting primarily of protein have been, and continue to be, widely promoted. One such diet is the subject of a best-selling book.
An Ad hoc advisory group consisting of five clinicians internationally recognized for their studies on obesity and weight control measures met with FDA representatives on October 20, 1977 to review the safety for consumer use of the various liquid and dry preparations composed primarily of protein or protein hydrolysates. A copy of a memorandum of the meeting has been placed on file with the Hearing Clerk, F.D.A.
The advisory group reviewed and discussed several cases of illnesses and deaths which involved individuals who were apparently utilizing these protein products as their primary sources of nourishment. . . . ."
. . . . "Members of the advisory group expressed concern that promotion of these protein products did not adequately inform consumers of potential health hazards associated with protein diets, and they concluded that these protein products should not be used without careful supervision by specially trained medical personnel. The advisory group pointed out that use of very low calorie protein diets is particularly hazardous for individuals who are taking diuretics, antihypertensive drugs, oral hypoglycemic agents, insulin, adrenergic medications, corticosteroids, thyroid preparations, digitalis, or other prescribed medications and that very low calorie protein diets should not ordinarily be used with significant renal, hepatic, or cerebrovascular disease; by patients with cardiovascular disorders; by psychiatric patients with suicidal tendencies; or by infants, children, or pregnant or lactating women.
The Commissioner has considered the evidence discussed by the advisory group and is concerned that many individuals are using these protein products for weight control without any awareness of the possible consequences. The Commissioner, therefore, believes that consumers should be alerted to the potential health hazards associated with use of these products and should be informed of ...