National Nutritional Foods Ass'n v. Califano, 907

• Decision Date: 27 June 1979
• Docket Number: D,No. 907,907
• Citation: 603 F.2d 327
• Parties: CA 79-2519 The NATIONAL NUTRITIONAL FOODS ASSOCIATION and Protein Products Association, Plaintiffs-Appellants, 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-Appellees. ocket 78-6171.
• Court: U.S. Court of Appeals — Second Circuit

Page 327

603 F.2d 327

CA 79-2519 The NATIONAL NUTRITIONAL FOODS ASSOCIATION and Protein Products Association, Plaintiffs-Appellants, 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-Appellees.

No. 907, Docket 78-6171.

United States Court of Appeals, Second Circuit.

Argued May 30, 1979.

Decided June 27, 1979.

Jacob Laufer, New York City (Bass, Ullman & Lustigman, New York City, Milton A. Bass, Steven R. Trost and Joan Licht Mantel, New York City, of counsel), for plaintiffs-appellants.

Peter R. Paden, Asst. U. S. Atty., New York City (Robert B. Fiske, Jr., U. S. Atty., S.D.N.Y., Peter C. Salerno, Asst. U. S. Atty. and Richard M. Cooper, Chief Counsel, Rockville, Md., and Edward M. Basile, Associate Chief Counsel for Enforcement, Food and Drug Administration, Washington, D.C., of counsel), for defendants-appellees.

Before MOORE, FRIENDLY and FEINBERG, Circuit Judges.

FRIENDLY, Circuit Judge:

This is an appeal from an order of the District Court for the Southern District of New York, 457 F.Supp. 275 (1978), in an action by two trade associations whose members manufacture and sell protein supplements against the Secretary of Health, Education and Welfare, the Commissioner of Food and Drugs, and the FDA's Acting Associate Director for Nutrition and Consumer Sciences, Bureau of Foods. Federal jurisdiction rests on 28 U.S.C. §§ 1331 and 1337. The action concerns FDA rulemaking designed to require warnings for protein supplements and other preparations that may be used as the sole or primary source of calories in order to lose weight. Plaintiffs' complaints are that the FDA is proceeding under § 403(a) of the Food, Drug and Cosmetics Act, which calls only for notice and comment procedure, rather than under § 403(j), which, by virtue of § 701(e), would entitle plaintiffs to a "hearing" of the traditional type, and that the FDA relied on the advice of a committee not constituted in compliance with the Federal Advisory Committee Act (FACA), 5 U.S.C. App. I, Pub.L. No. 92-463, 86 Stat. 770 (1972). In a considered opinion Judge Sand denied relief without reaching the merits on either issue. Although we affirm, we believe a more detailed statement of the facts (some subsequent to the district court's opinion) and a more elaborate discussion of the law will be useful.

I.

According to plaintiffs' assertions, which we will recount to place the issues in setting but without implication as to their correctness, one way or the other, there is more to the controversy than a reading of the proposed regulations, 42 F.R. 61285 (1977), or the Tentative Final Rule (TFR), 43 F.R. 60883 (1978), reveals. The story as told in their brief, based on an affidavit of David Blechman, president of plaintiff Protein Products Association, and of Twin Laboratories, Inc., a seller of liquid protein products, and other materials before the district court, is as follows:

Liquid protein products have been available for direct retail sale to the consuming public for at least 12 years. Within the last five years new medical research has suggested the usefulness of a modified fasting diet, supplemented by protein, vitamins and minerals, in alleviating obesity. Prominent in this "Protein Sparing Modified Fast" (PSMF) research was Dr. George L. Blackburn of the Harvard University Medical School, who is Director of the Center for Nutritional Research in Boston.

At first the use of liquid proteins as an aid in the management of obesity was limited to experimental research and to sales through physicians. Some of these formed the American Society of Bariatric Physicians (ASBP); physician demand for the product was met promptly by a company known as Control Drugs, Inc. Rivalry developed between Twin Laboratories and Control Drugs over the former's efforts to invade the physician market and to continue to make the product directly available to the public at retail outlets.

The controversy was heated by the publication in late 1976 of "The Last Chance Diet" by Robert Linn, a doctor of osteopathy, which popularized the use of liquid protein products for diet control. The ASBP attacked the new widespread and uncontrolled use of PSMF programs and urged its members to help with the problem, through such means as writing letters to newspapers. However, the ASBP continued to advocate physician monitored programs using products manufactured by Control Drugs.

Primary responsibility in the FDA for products such as those manufactured and sold by plaintiffs lay in Dr. Allan Forbes, Acting Associate Director for Nutrition and Consumer Sciences in the Bureau of Foods. In the spring of 1977 he and Dr. Blackburn had various conversations about Dr. Linn's book and the consequent popularity of liquid food protein products, including Dr. Blackburn's attempts to dissuade Dr. Linn from publishing. In a letter to Dr. Forbes dated May 25, 1977, Dr. Blackburn suggested that the Bureau of Foods might become involved. During the summer of 1977, the FDA received a report of a death believed to be associated with the use of liquid protein products in dieting; a second death was reported in September. At a conference of FDA officials held on or before October 3, 1977, it was decided, among other things, "to obtain the advice of experts in the field of obesity research among whom are Dr. George L. Blackburn, Dr. Theodore B. Van Itallie, and Dr. Sanford A. Miller." Mr. Blechman averred that, at a symposium of the ASBP on October 7, Dr. Blackburn stopped at Twin Laboratories' booth, pointed to the display of products freely available in retail outlets, and said "We are going to get rid of this." ¹

Later in October, Dr. Forbes learned that a conference on obesity was scheduled to take place on October 20-22, 1977, at the National Institutes of Health in Bethesda, Md., near the FDA's headquarters. Between October 18 and 20 he communicated with five clinicians who were attending the conference ² and arranged for them to meet with him and six other FDA officials on the afternoon of October 20 at the Federation of American Societies for Experimental Biology, also in Bethesda. No special preparation for the meeting was requested, but Dr. Blackburn submitted some working papers. An official of FDA later prepared a detailed memorandum of the meeting.

The memorandum recites that the "ultimate purpose for the meeting" was to assist the FDA in selecting the best course of action "for regulating the production and promotion of (protein products used for weight reduction) and/or informing the public of their hazard potential." It described the five physicians as an "ad hoc advisory group." Dr. Forbes announced the FDA's intent "to take appropriate actions to alert the public on the safe use of protein products for weight control purposes and to recommend interim cautionary label statements to manufacturers and distributors prior to formal rule-making relative to labeling." Eleven case histories terminating in death were examined "because of a possible link with adherence to a modified fast regimen." Although "(t)he cause-and-effect relationships with regard to these deaths have not yet been established . . . there is sufficient information to indicate that protein products for weight reduction require prudent use." This is followed by nine points on which all members of the ad hoc group agreed; the gist of these was that certain types of persons should not use protein products as part of a PSMF at all and that such products are not suitable for use in the absence of careful supervision by medical personnel trained in their use. The group recommended that protein products used in weight reduction programs be required to carry a label reading:

Do not use for weight reduction or maintenance without medical supervision. Do not use without medical advice if you are taking prescribed medications. Not for use by infants, children, or pregnant or nursing women.

The memorandum concluded by saying:

The members of the ad hoc advisory group have graciously agreed to provide further assistance to FDA as the need may arise.

On November 9, 1977 the Commissioner of Food and Drugs held a press conference and issued a press release on the subject of protein supplements used to fight obesity. He declared the FDA was aware of 16 reported deaths and a number of severe illnesses possibly associated with the use of such products and expressed special concern about "the liquid protein diets now so popular", which were being promoted in the news media and in books such as Dr. Linn's. He said that his statements reflected not only the views of the FDA but also "the information provided by the Center for Disease Control and advice given us by leading experts in obesity and obesity control", two of whom, Drs. Blackburn and Van Itallie, see note 2, were present and could answer questions.

As should have been expected, this publicity resulted in a drastic decline in the sale of protein products for use in weight reduction. On December 2, 1977, the FDA gave notice of a proposed rule, 42 F.R. 61285, whereby protein supplements intended for use in weight reduction or maintenance programs would be required to bear the following warning:

WARNING. Very low calorie protein diets may cause serious illness or death. DO NOT USE FOR WEIGHT REDUCTION OR MAINTENANCE WITHOUT MEDICAL SUPERVISION. Do not use for any purpose without medical advice if you are taking medication. Not for use by infants, children, or pregnant or nursing women. ³

The notice relied heavily on the October 20 meeting with the ad hoc advisory group, which was described in detail, and the memorandum of the meeting was placed on file with the Hearing Clerk. The authority cited for the proposed rulemaking was §§ 201(n), 402(a), 403(a), 505 and 701(a) of the Food and...