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.
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:
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."
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
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
The memorandum concluded by saying:
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:
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 Drug Act. The notice stated that the Commissioner was also considering "whether the risk to human health presented by these products is so great that he should seek to remove some or all of them from the market, instead of requiring warnings." He sought scientific comment on the merits and legal comment "on the most appropriate statutory basis for a partial or total ban." Comments were required by
Shortly after plaintiffs began this action on December 15, 1977, they moved for a preliminary injunction to stay implementation of the proposed regulations which they deemed illegal in the absence of the hearing required by §§ 403(j) and 701(e) and as a result of use of an unlawful advisory committee; they also sought access to documents underlying the FDA's proposal. On January 4, 1978, they petitioned the FDA for release of the documents and for an announcement that a trial-type hearing would be held before the rules would become effective. The FDA agreed to release most of the underlying data and stipulated that a final rule would not be issued until after an interim announcement and further opportunity for comment.
The FDA thereupon moved for summary judgment. It contended that, as apparently is not denied, the issue with respect to the documents had been mooted, and that there was no basis for issuing an injunction under FACA, particularly in light of FDA's agreement that the ad hoc advisory group would not be reconvened and would not serve any further formal role in the promulgation of the protein supplement regulations. It urged finally that it was justified in proceeding under § 403(a) and that plaintiffs had not exhausted their administrative remedies on that score, particularly because of the pendency of the pertinent portion of plaintiffs' petition of January 4, 1978. This last reason was removed when, on March 20, 1979, the FDA refused to rule on that portion of the petition, stating that:
which was expected to be issued "in the next few weeks." On August 29, 1978, with no TFR yet issued, Judge Sand filed his opinion and order dismissing the complaint.
After plaintiffs had appealed to this court, the long awaited TFR appeared on December 29, 1978, 43 F.R. 60883. Basically the warning requirements remained unchanged. The bulk of the TFR was devoted to discussing the significance of the evidence of the adverse consequences of uncontrolled use of protein supplements to relieve obesity. The conclusions were:
To no one's surprise the FDA ruled that it could properly proceed under § 403(a), 43 F.R. 60888, and that it had not violated FACA, 43 F.R. 60889. Further comments would be received until February 27, 1979; the proposed effective date of a final rule would be 60 days after publication in the Federal Register. At this writing no final rule has yet been issued.
We deal first with appellants' claim that the FDA should be enjoined from proceeding further with the rulemaking unless it agrees to follow the procedure prescribed in § 701(e) of the Act for the issuance of a regulation under § 403(j).
Myers v. Bethlehem Shipbuilding Corp., 303 U.S. 41, 58 S.Ct. 459, 82 L.Ed. 638 (1938), decided before enactment of the APA, established a general approach of nonintervention by courts prior to final agency action. This principle, designed to avoid delay of administrative procedures, was codified in the Administrative Procedure Act, 5 U.S.C. § 704, which provides judicial review for "[a]gency action made reviewable by statute and final agency action for which there is no other adequate remedy in a court . . .." Leedom v. Kyne, 358 U.S. 184, 79 S.Ct. 180, 3 L.Ed.2d 210 (1958), gave birth to a narrow exception to this, expanded in McCulloch v. Sociedad Nacional de Marineros, 372 U.S. 10, 83 S.Ct. 671, 9 L.Ed.2d 547 (1963), in cases where the proposed agency action was plainly beyond its powers or, even when the impropriety of the action was not so plain, the very conduct of the proceeding would adversely affect important national interests. See Empresa Hondurena de Vapores, S.A. v. McLeod, 300 F.2d 222, 228-29 (2 Cir. 1962), vacated as governed by McCulloch, 372 U.S. at 22, 83 S.Ct. 671. We applied the Myers principle in Pepsico, Inc. v. FTC, 472 F.2d 179 (2 Cir. 1972), cert. denied, 414 U.S. 876, 94 S.Ct. 44, 38 L.Ed.2d 122 (1973), and Sterling Drug, Inc. v. Weinberger, 509 F.2d 1236
While appellants have much to say about Abbott Laboratories v. Gardner, 387 U.S. 136, 87 S.Ct. 1507, 18 L.Ed.2d 681 (1967), see also Gardner v. Toilet Goods Ass'n, 387 U.S. 167, 87 S.Ct. 1526, 18 L.Ed.2d 704 (1967), these decisions are inapposite. There the agency had completed its rulemaking activity; the question was whether parties adversely affected could immediately attack the assertedly invalid regulations or must either comply with them or await enforcement activity, both courses involving large cost and expense. In such cases, as said by Justice Harlan, "the impact of the regulations upon the petitioner is sufficiently direct and immediate as to render the issue appropriate for [immediate judicial] review," 387 U.S. at 152, 87 S.Ct. at 1517. The limited scope of those two decisions was illustrated by the contrary result reached in the third of the trilogy, Toilet Goods Ass'n v. Gardner, 387 U.S. 158, 87 S.Ct. 1520, 18 L.Ed.2d 697 (1967). We have
Abbott Laboratories and its progeny have no application here. When the case was decided by the district court, no TFR had even been formulated. At the time of argument before us no final order had yet been issued. If the case is governed by § 701(e), as appellants assert, the FDA must still issue final regulations before the right to demand a public hearing arises. Appellants' concern is that the final order will in fact be final in the sense that it will not contain the provisions, which § 701(e) would mandate if applicable, for a delay of thirty days during which appellants could obtain an automatic stay by filing objections which request a public hearing. Unless a stay is granted by the FDA, they will thus be forced to seek one in an action in a district court, see National Nutritional Foods Association v. Food and Drug Administration, supra, 504 F.2d at 771-74, which no one denies they can initiate under Abbott Laboratories. For us to relieve them of this before the agency has even acted, would be the very course which is condemned by Myers unless within the Leedom exception. Nothing in Abbott or the cases following it would justify our doing this.
Appellants contend that the meeting of October 20, 1977, was of an advisory committee as defined in FACA, 5 U.S.C. App. I, Pub.L. No. 92-463, 86 Stat. 770 (1972) and did not comply with the Act and the FDA's regulations thereunder, 21 C.F.R. §§ 14.1 et seq., in several respects. The FDA gave no notice of the meeting as required by 21 C.F.R. § 14.20 and § 10(a)(2) of the Act. No advisory committee charter was filed as required by § 9(c). The meeting was not open to the public, nor were interested persons given any opportunity to appear before the committee or file statements with it, as required by § 10(a)(1) and (3). Most important, appellants claim that appointment of a group composed solely of physicians, understandably leaning in favor of medical supervision of the use of protein supplements to conquer obesity, did not comply with § 5(b)(2) and (3), made applicable to agencies by § 5(c), which require that membership of an advisory committee "be fairly balanced in terms of the points of view represented and the functions to be performed" and that suitable provision be made to assure that advice and recommendations "will not be inappropriately influenced . . . by any special interest." The FDA's principal answer is that the group convened on October 20 was not an advisory committee within the meaning of FACA. The district court avoided deciding this on the basis that, in view of FDA's undertaking not to reconvene the committee, there was no need for an injunction, and that the issue was not appropriate for declaratory relief.
Section 3(2) of the Act provides, so far as here pertinent, that "The term `advisory committee' means any committee, board, commission, council, conference, panel, task force, or other similar group, or any subcommittee, or other subgroup thereof" established or utilized by an agency "in the interest of obtaining advice or recommendations" for the agency. The Senate report, No. 92-1098, 92d Cong. 2d Sess., reprinted in the Source Book on FACA, 95th Cong. 2d Sess., p. 158, said of a substantially identical provision in the Senate bill, differing in that it used the words "established or organized":
Although the source of the definition seems to have seen the Bureau of the Budget Circular No. A 63, dealing with inter-agency committees, which spoke of "any formally constituted committee, board, commission, council, conference, panel, task force or other similar group, or any subcommittee
As against these indications of coverage sufficiently broad to include the October 20 meeting, a joint memorandum of the OMB, to which § 7 of the Act confides special responsibilities, and the Department of Justice, 38 F.R. 2306 (1973), contained an explanation, quoted in Nader v. Baroody, 396 F.Supp. 1231, 1233 n.4 (D.D.C.1975), that would exclude it. However, the joint memorandum was rescinded by OMB's Advisory Committee Management Guidance Circular of March 27, 1974, 39 F.R. 12389, which offered no help on the definitional problem. The FDA's regulations, § 14.1(5), add this:
Subparagraph (i), if valid, would exclude the October 20 meeting—except for the important fact that the group did advise the agency.
In the long run the Government's argument that the October 20 meeting was not within FACA rests mainly on what it conceives to be common sense. An agency dealing with technical matters ought to be able to get the advice of highly qualified technicians in the private sector before it even initiates proceedings or takes other action, and to get this speedily and informally. Yet the OMB guidelines require that before creating a new advisory committee, an agency must first consult with the OMB secretariat and, if the OMB concurs, a process that may be time consuming, must publish in the Federal Register a certification of need and a description of the nature and purpose of the committee at least 15 days (unless that period is shortened by the OMB secretariat) before the filing of the committee's charter, 39 F.R. 12389, which under § 9(c) of the Act, is a precondition to the committee's meeting. Congress, the Government argues, could not have intended to place such obstacles in the way of what proved to be a one-time meeting, even though there may have been an intention to hold more, especially in a case like this where the Commissioner was "considering whether the risk to human health presented by these products is so great that he should seek to remove some or all of them from the market, instead of requiring warnings." 42 F.R. 61286.
The two most relevant reported decisions are Food Chemical News, Inc. v. Davis, 378 F.Supp. 1048 (D.D.C.1974), holding that two separate "informal" meetings with consumer and distilled spirits industry representatives with respect to the drafting of proposed regulations of the Bureau of Alcohol, Tobacco and Firearms of the Treasury Department were meetings of advisory committees,
The question of remedy remains. So far as we are aware, no court has held that a violation of FACA would invalidate a regulation adopted under otherwise appropriate procedures, simply because it stemmed from the advisory committee's recommendations, or even that pending rulemaking must be aborted and a fresh start made. We perceive no sound basis for doing so. Applicable rulemaking procedures afford ample opportunity to correct infirmities resulting from improper advisory committee action prior to the proposal. In this we are in accord with Center for Auto Safety, Inc. v. Temann, 414 F.Supp. 215, 226 (D.D.C.1976), remanded on other grounds, 188 U.S.App. D.C. 426, 580 F.2d 689 (1978). We likewise cannot fault the district judge for concluding that, in light of the Government's agreement not to reconvene this particular group, there was no need for an injunction. Whether it was proper to deny declaratory relief is a closer question. The judge justified this on the ground that the FDA was acting on a good faith belief that the advisory group was not within FACA and that the calling, of the meeting was "a largely fortuitous result of the fact that a group of experts was convening nearby at the precise time when the FDA, alarmed by the reports it was receiving of deaths possibly attributable to protein supplement diets, was seeking expert guidance under considerable time pressures." 457 F.Supp. at 280. Given the wide discretion afforded district judges by the Declaratory Judgment Act, 28 U.S.C. § 2201, see Public Service Comm'n v. Wycoff Co., 344 U.S. 237, 241, 243-44, 73 S.Ct. 236, 97 L.Ed. 291 (1952), we cannot say that this was an abuse. In any event this opinion gives appellants substantially the same relief as a declaratory order.