Abe Fortas

“ I submit that a much stronger showing is necessary than the expense and trouble of compliance and the risk of defiance. Actually, if the Court refused to permit this shotgun assault, experience and reasonably sophisticated common sense show that there would be orderly compliance without the disaster so dramatically predicted by the industry, reasonable adjustments by the agency in real hardship cases, and where extreme intransigence involving substantial violations occurred, enforcement actions in which legality of the regulation would be tested in specific, concrete situations. ”

“ We should confine ourselves-as our jurisprudence dictates-to actual, specific, particularized cases and controversies, in substance as well as in technical analysis. And we should repel these attacks, for we have no warrant and no reason to place these programs, essential to the public interest, and many others which this Court's action today will affect, at the peril of disruption by injunctive orders which can be issued by a single district judge. In short, the parties have an 'adequate remedy' to test the regulations ”

“ Somehow, the Court has concluded that the damage to petitioners if they have to engage in the required redesign and reprint of their labels and printed materials without threshold review outweighs the damage to the public of deferring during the tedious months and years of litigation a cure for the possible danger and asserted deceit of peddling plain medicine under fancy trademarks and for fancy prices which, rightly or wrongly, impelled the Congress to enact this legislation. ”

“ At least in cases where the claim is of erroneous action rather than the lack of jurisdiction or denial of procedural due process, a suit for injunctive or declaratory relief will not lie absent a clear demonstration that the type of review available under the statute would not be 'adequate,' that the controversies are otherwise 'ripe' for judicial decision, and that no public interest exists which offsets the private values which the litigation seeks to vindicate. ”

“ None is part of the warp and woof of an elaborate administrative pattern, intimately woven into the congressional design. None of them is apt to take different shape or to be modified by practical administrative action. ”

“ On the contrary, the clear intent was that the regulations, being to protect the consumer from unsafe, potentially harmful, and 'misbranded' foods, drugs, devices, and cosmetics, were to be subject to challenge only by way of defense to enforcement proceedings. It was Congress' judgment, after much controversy, that the special nature of the Act and its administration required this protection against delay and disruption. We should not arrogate to ourselves the power to override this judgment. ”

“ Where Congress has provided a method of review, the requisite showing to induce the courts otherwise to bring a governmental program to a halt may not be made by a mere showing of the impact of the regulation and the customary hardships of interim compliance. ”

“ Indeed, in respect of the access regulation the Commissioner may resort to a measure of self-help by withholding certification services, whereas if the FDA wishes to take action against a manufacturer who refuses to submit a 'color additive' to the agency on the ground that it is not ov ered, the agency must institute an independent proceeding in court which it can do only if the Attorney General agrees with its conclusions. ”

“ They are disruptive enough, regardless of the ultimate outcome. The Court's validation of this shotgun attack upon this vital law and its administration is not confined to these suits, these regulations, or these plaintiffs-or even this statute. It is a general hunting license; and I respectfully submit, a license for mischief because it authorizes aggression which is richly rewarded by delay in the subjection of private interests to programs which Congress believes to be required in the public interest. ”

“ As the Court states, by the regulations in No. 438 the Commissioner 'amplified the statutory definition' of color additives to include diluents and certain cosmetics and hair dyes. By provisions in the statute, 74 Stat. 399, 21 U.S.C. § 376 (a) (1) (A) , a product containing a 'color additive' shall be deemed 'adulterated' unless the color additive and its proposed use have been submitted to FDA, tested and listed in an FDA regulation as safe and unless the particular additive comes from a certified batch, or has been exempted from certification. ”

“ The Court also says that it is an adequate remedy for the manufacturer to defer challenge until after access is demanded and denied and further certification services by the agency are suspended. The suspension of certification services means a shutdown, at least pro tanto, but the Court says, with an optimism which is probably not shared by the industry, that 'prompt' challenge through administrative procedure and court review can then be had. ”

“ Storer utilized a procedure expressly made available by the statute. It sought review in the Court of Appeals where the Commission action was reviewed on the basis specified by statute, including the weight given to the agency findings and record. It did not commence a separate action, not provided for in the statute, in which the District Court's original jurisdiction was invoked. Storer, in brief, involves an action pursuant to the statute, and not in conflict with its plan as is true of the present cases. ”

“ It requires that manufacturers afford employees of the agency access to all manufacturing facilities, processes, and formulae involved in the manufacture of color additives and intermediates, and provides that the Commissioner of Food and Drugs 'may immediately suspend certification service' so long as access is denied. ”

“ The Administrative Procedure Act [1] and fundamental principles of our jurisprudence [2] insist that there must be some type of effective judicial review of final, substantive agency action which seriously affects personal or property rights. But, ' (a) ll constitutional questions aside, it is for Congress to determine how the rights which it creates shall be enforced. * * * In such a case the specification of one remedy normally excludes another.' Switchmen's Union of North America v. ”

“ The Court's opinion and the briefs cite only a single case in which such relief has been granted prior to the present cases, and that preceded enactment of the present statutory scheme. Morgan v. Nolan, 3 F.Supp. 143 (D.C.S.D.Ind.1933) , aff'd, 69 F.2d 471 (C.A.7th Cir. 1934) . The fact of the matter is that, except for the instances enumerated in §§ 701 (e) and (f) , the avenue for attack upon the statute and regulations has been by defense to specific enforcement actions by the agency. Congress has been well aware of this for more than a generation that the statute has been in effect. ”

“ It is sufficient, where only property rights are concerned, that there is at some stage an opportunity for a hearing and a judicial determination. Phillips v. Comissioner of Internal Revenue, 283 U.S. 589, 596-597, 51 S.Ct. ”

“ There is nothing here approaching the stringent showing that should be required before the courts will undertake to provide a remedy that Congress has not authorized but which, on the contrary, it has deliberately declined to afford. Those challenging the regulations have a remedy and there are no special reasons to relieve them of the necessity of deferring their challenge to the regulations uti l enforcement is undertaken. ”

“ In Ewing, the company's only recourse was to defend in the seizure actions, availing itself of consolidation of the multiple suits if it so desired. 339 U.S., at 602, 70 S.Ct., at 874. Despite the hardshp and destructive publicity of multiple seizures-a more serious variety of the kind of hardship which seems profoundly to affect the Court in the present cases-this Court refused to hold that the remedy of judicial review by defense in these actions was inadequate. ”