RUSSELL, Circuit Judge:
This appeal turns on a construction of the Federal Food, Drug, and Cosmetic Act of 1938, as amended in 1962.1 21 U.S.C. § 301 et seq. This statute requires premarketing approval and clearance of any “new drug” by the Secretary of Health, Education and Welfare.2 The term “new drug” is defined as one “not generally recognized, among experts qualified by scientific training and experience to evaluate the safety and effectiveness of drugs, as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling thereof * * 3 From a denial of a pre-marketing approval or a withdrawal of a previously given approval, an appeal, originally to the District Court, now to the Circuit Court of Appeals, is authorized.4 Drugs, which do not fit the definition of a “new drug” do not require FDA clearance for marketing. There is no provision in the Act for administrative determination whether a particular drug is a “new drug” nor for any right of appeal from any such determination. The FDA sometimes offers to render “informal advice” as to whether it considers a product a “new drug” but it uniformly designates such opinion “advice”.5 Accordingly, the responsibility for determining whether its [366] product is a “new drug” requiring premarketing clearance by FDA, rests on the manufacturer, who must act at its peril.6 If it makes an incorrect determination and seeks to market without FDA clearance a drug meeting the definition of a “new drug”, it lays itself open to drastic judicial procedures that may be invoked by FDA, i. e.: The product may be seized in an in rem action instituted by the Government;7 its sale may be enjoined in an action begun by the Government;8 in addition, the manufacturer may be subjected to criminal action.9 All these remedies must be prosecuted in the District Court and the role of the Secretary is that of plaintiff or prosecutor. The Act thus establishes two forums for the regulation of drugs: One is administrative and deals with the procedures for securing pre-marketing clearances for the statutorily defined “new drug”, with right of appeal from a denial of approval, or withdrawal of a previous approval, to the District Court, later changed to the Court of Appeals; the other is judicial and is intended to make effective and give strength to the requirement that “new drugs” be cleared as safe before marketing by providing the Government with certain potent judicial remedies, available exclusively in the District Court.
Under the 1938 Act, a new drug was one “not generally recognized, among experts * * * as safe for use.” The Amendments added “effectiveness” as well as “safety” to the definition. Simply stated, the change effected by the Amendments was that, whereas prior to the 1962 Amendments a drug which was generally recognized as safe was not a “new drug”, the Amendments defined a drug as “new” if it were not generally recognized as both safe and effective. Furthermore, they replaced the provision for automatic approvals of applications not disapproved within a fixed time with a requirement of a positive act of approval on the part of FDA.10 They proceeded to provide that the Secretary must find as a basis for clearance of a new drug not only safety but “substantial evidence” of effectiveness, “consisting of adequate and well-controlled investigations, including clinical investigations, by experts qualified by scientific training and experience to evaluate the effectiveness of the drug involved.” The applicability of these amendments, including the revised definition of “new drug” to drugs already marketed, either under previously issued NDAs, or as “old drugs” requiring no FDA approval, was carefully spelt out in the Amendments and certain “grandfather rights” were granted. For all previously NDA’d drugs, the Amendments conferred a grace period of two years after the effective date of the Amendments within which to prepare evidence to satisfy the new requirement of efficacy added by the revised definition of “new drug”; during that “transitional” period no revocation or withdrawal of approval because of a lack of substantial evidence of efficacy of such drugs was permitted.11 For a drug, however, which on the day prior to the enactment of the Amendments was (1) being “commercially used or sold in the United States,” (2) “was not a new drug as defined by” the preAmendment statute and (3) “was not covered by an effective (new drug application), * ' *” “on the day immediately preceding the enactment date” of the Amendments, there was a permanent exemption from the efficacy provisions [367] of the Amendments so long as the drug’s labeling remained the same.12 In summary, these provisions required that, “Those drugs which had obtained effective NDAs must be proven efficacious after two years; those which had not need never be proven efficacious so long as they had become safe prior- to the 1962 Amendments.” 13
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RUSSELL, Circuit Judge:
This appeal turns on a construction of the Federal Food, Drug, and Cosmetic Act of 1938, as amended in 1962.1 21 U.S.C. § 301 et seq. This statute requires premarketing approval and clearance of any “new drug” by the Secretary of Health, Education and Welfare.2 The term “new drug” is defined as one “not generally recognized, among experts qualified by scientific training and experience to evaluate the safety and effectiveness of drugs, as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling thereof * * 3 From a denial of a pre-marketing approval or a withdrawal of a previously given approval, an appeal, originally to the District Court, now to the Circuit Court of Appeals, is authorized.4 Drugs, which do not fit the definition of a “new drug” do not require FDA clearance for marketing. There is no provision in the Act for administrative determination whether a particular drug is a “new drug” nor for any right of appeal from any such determination. The FDA sometimes offers to render “informal advice” as to whether it considers a product a “new drug” but it uniformly designates such opinion “advice”.5 Accordingly, the responsibility for determining whether its [366] product is a “new drug” requiring premarketing clearance by FDA, rests on the manufacturer, who must act at its peril.6 If it makes an incorrect determination and seeks to market without FDA clearance a drug meeting the definition of a “new drug”, it lays itself open to drastic judicial procedures that may be invoked by FDA, i. e.: The product may be seized in an in rem action instituted by the Government;7 its sale may be enjoined in an action begun by the Government;8 in addition, the manufacturer may be subjected to criminal action.9 All these remedies must be prosecuted in the District Court and the role of the Secretary is that of plaintiff or prosecutor. The Act thus establishes two forums for the regulation of drugs: One is administrative and deals with the procedures for securing pre-marketing clearances for the statutorily defined “new drug”, with right of appeal from a denial of approval, or withdrawal of a previous approval, to the District Court, later changed to the Court of Appeals; the other is judicial and is intended to make effective and give strength to the requirement that “new drugs” be cleared as safe before marketing by providing the Government with certain potent judicial remedies, available exclusively in the District Court.
Under the 1938 Act, a new drug was one “not generally recognized, among experts * * * as safe for use.” The Amendments added “effectiveness” as well as “safety” to the definition. Simply stated, the change effected by the Amendments was that, whereas prior to the 1962 Amendments a drug which was generally recognized as safe was not a “new drug”, the Amendments defined a drug as “new” if it were not generally recognized as both safe and effective. Furthermore, they replaced the provision for automatic approvals of applications not disapproved within a fixed time with a requirement of a positive act of approval on the part of FDA.10 They proceeded to provide that the Secretary must find as a basis for clearance of a new drug not only safety but “substantial evidence” of effectiveness, “consisting of adequate and well-controlled investigations, including clinical investigations, by experts qualified by scientific training and experience to evaluate the effectiveness of the drug involved.” The applicability of these amendments, including the revised definition of “new drug” to drugs already marketed, either under previously issued NDAs, or as “old drugs” requiring no FDA approval, was carefully spelt out in the Amendments and certain “grandfather rights” were granted. For all previously NDA’d drugs, the Amendments conferred a grace period of two years after the effective date of the Amendments within which to prepare evidence to satisfy the new requirement of efficacy added by the revised definition of “new drug”; during that “transitional” period no revocation or withdrawal of approval because of a lack of substantial evidence of efficacy of such drugs was permitted.11 For a drug, however, which on the day prior to the enactment of the Amendments was (1) being “commercially used or sold in the United States,” (2) “was not a new drug as defined by” the preAmendment statute and (3) “was not covered by an effective (new drug application), * ' *” “on the day immediately preceding the enactment date” of the Amendments, there was a permanent exemption from the efficacy provisions [367] of the Amendments so long as the drug’s labeling remained the same.12 In summary, these provisions required that, “Those drugs which had obtained effective NDAs must be proven efficacious after two years; those which had not need never be proven efficacious so long as they had become safe prior- to the 1962 Amendments.” 13
The “grandfather clause” set forth in Section 107(c) (4) simply continues for the products satisfying its criteria the pre-1962 definition of a “new drug”. Its effect is to assure that a drug which was generally recognized by qualified experts as safe for the purposes recommended for its use on October 9, 1962, need not be NDA’d as effective under the new requirements for the issuance of an NDA as a “new drug”. But any drug, whether requiring an NDA or not, whether a “new drug” or an “old drug”, is subject to the misbranding provisions of the Act and may be proceeded against on that basis. A false claim of either safety or effectiveness constitutes misbranding, rendering a drug subject to both civil and criminal penalties. United States v. Article of Drug Labeled Decholin (D.C.Mich.1967) 264 F.Supp. 473, 482-483; United States v. Lanpar Company (D.C.Tex.1968) 293 F.Supp. 147, 153-154.14 Accordingly, in United States v. Guardian Chemical Corporation (2d Cir. 1969), 410 F.2d 157, a drug manufacturer was acquitted of a charge of marketing a “new drug” without securing an NDA, but was convicted under a separate count of the indictment charging misbranding. “Thus”, as one commentator has aptly stated, “the amplications of the FDA’s authority (as granted by the 1962 Amendments) is (was) not due to the absence of power to proceed against ineffective drugs, but rather to authorize the exercise of that power at the initial stage, that is, before marketing, and also to shift the burden of proof to the applicant.” Jurow, The Effect on the Pharmaceutical Industry of the “Effectiveness” Provisions of the 1962 Drug Amendments, 19 Food, Drug, Cosmetic Law Journal, 110, at p. 116 (1964).15
[368] The plaintiffs, manufacturers of a prescription drug containing pentylenetetrazol and nicotinic acid, claim the protection of the “grandfather clause” included in Section 107(c) (4) for their products and that contention represents the substantive issue in this case. It is undisputed that plaintiffs had marketed their product commercially for many years prior to and on October 9, 1962,16 without an NDA under the claim that it was not a “new drug” within the definition of the Act, and therefore required no NDA. Such claim was supported, it is asserted, both by previous informal advice of the Secretary and by the general recognition of the safety of such product by “experts qualified by scientific training and experience” to make such evaluation. The defendants, the Secretary of HEW and the Commissioner of Food and Drugs, in their brief, concede that “Over the years since 1938” and until 1968, the Food and Drug Administration had given the opinion that certain pentylenetetrazol combinations similar to those of the appellants were not “new drugs.” 17 Moreover, the District Court observed in its opinion that there was “no contention (by the FDA) that the use of the plaintiffs’ drugs in treatment of the symptoms of senility in geriatric patients is in any way harmful to them, either directly or indirectly by causing the disuse of better drugs.” On this basis, the plaintiffs contended that they met exactly the criteria established for exemption from the requirements of general recognition by qualified experts of the effectiveness of their products as provided in the permanent grandfather section of the 1962 Amendments.
Prior to the filing of this action, however, the defendants withdrew their advice that products such as those distributed by the plaintiffs were “old drugs” and contended that such products did not qualify for exemption under the “grandfather clause”, Section 107(c) (4). The basis for this contention was the claim (1) that these drugs were not generally recognized by qualified experts as safe as of the effective date of the Amendments of 1962 and (2) that they wez’e “me-too” drugs, whose marketability without FDA clearance depended in turn on the NDA’s granted the basic drug, and for that reason must be regarded as drugs covered by an effective NDA on the effective date of the Amendments.18 Faced with this threat, the plaintiffs began this action for a de[369] claratory judgment sustaining their right to exemption from proof of the effectiveness of their product and for injunctive relief awaiting the disposition of their claim for exemption. The defendants directed against the complaint a motion to dismiss or for summary judgment, which, in essence, (1) asserted primary jursidiction in the Secretary to determine whether the products of the plaintiffs met the requirements for exemption under Section 107(e) (4), particularly whether they were “new drugs”, requiring pre-marketing approval under the Act, (2) denied the propriety of a declaratory judgment action, and (3) claimed that the products of the plaintiffs were “new drugs” which did not qualify for exemption under the “grandfather clause”.
The District Court sustained the right of the plaintiffs to maintain a suit for a declaratory judgment and the jurisdiction of the Court in such action to determine judicially whether the products of the plaintiffs were “new drugs”, on the effective date of the Amendments, and whether they were or were not entitled to the benefits of the “grandfather clause”.19 However,' — and this is the nub of the controversy between the parties on this appeal — it concluded that the Secretary had concurrent jurisdiction * to determine whether plaintiffs’ products were “new drugs”, requiring pre-marketing clearance, and that, because of the greater expertise of the Secretary in the field, it deferred to the Secretary’s assumed jurisdiction to determine whether the drugs of the plaintiffs came within the exemption provided by the “grandfather clause”. It enjoined any action against the plaintiffs and their products until the plaintiffs had been accorded a hearing before the Secretary on the issue of the qualifications of these drugs for protection under the “grandfather clause”. It is the conclusion of concurrent jurisdiction in the Secretary and deference to that assumed concurrent jurisdiction from which the plaintiffs have prosecuted this appeal.
The defendants, on the other hand, have not cross-appealed and have accordingly acquiesced in the decision of the District Court that the action is properly maintainable as a declaratory judgment proceeding under Section 2201, 28 [370] U.S.C. and that the District Court has jurisdiction over the substantive issue in this case, i. e., whether plaintiffs’ products are “new drugs”, as defined in the Act. The question in the case is thus whether the Secretary has concurrent jurisdiction to determine whether a drug is a “new drug” under the Act or whether that issue is cognizable only in the District Court. Contrary to the conclusion of the District Court, we conclude that the Act confers no such jurisdiction on the Secretary, and, therefore is no basis for any deference by that Court to the concurrent jurisdiction of the Secretary.
The FDA has neither primary jurisdiction, as the defendants argue, nor concurrent jurisdiction, as the District Court concluded, to adjudicate whether a product is an old or a new drug. It may, in its prosecutorial role, reach a conclusion that a product being marketed is a “new drug” requiring pre-marketing approval; but that opinion is not adjudicatory, it is only the basis on which the FDA, as the prosecutor or initiator of either a seizure or injunctive action in the District Court, may invoke the jurisdiction of that Court to determine, among other issues, whether the drug challenged is a “new drug”. There is manifestly no provision in the Act for an administrative proceeding before the Secretary to compel the filing of a “new drug” application or to halt the marketing of a drug for which there is no approval, by the Secretary. It is not without significance that, so far as the official reports reflect, the Secretary has never attempted directly to exercise such jurisdiction. The only occasions on which he has sought to assert such jurisdiction has been as an element in his defense to a declaratory judgment action.20 Moreover, when FDA undertook its new responsibilities under the 1962 Amendments, it sought merely to review “the efficacy of all new drugs that had been cleared, for safety only, between 1938 and October 10, 1962” (Italics added) and enlisted the services of the National Academy of Sciences— National Research Council for this limited task.21 It did not assert the right to review, or assume the burden of reviewing, for efficacy, drugs such as those involved here, which had been commercially marketed on the basis of a general recognition of safety without an effective NDA as of the effective date of the 1962 Amendments. It, thus, recognized that its adjudicatory rights extended merely to the approval, or the withdrawal of approval,22 of a drug embraced in a “new drug” application that had been approved. This confirms the conclusion that the halting of the marketing of a drug, for which there is no NDA, may not be by administrative action but must be by an injunction or an in rent seizure proceeding, in which the Secretary appears, not in a judicial but in a prosecutorial role.23 Those are the procedures prescribed and available to the Government under the Act.24 The Secretary, it [371] is true, has offered to provide “advice” on whether a product meets the qualification of an old drug but he categorizes his action in such instances as merely “advice” and makes no claim of finality therefor. Nor is there, as we have already observed, any provision for judicial review of such “advice”.25 The only adjudicatory right vested by the Act in the Secretary relates to approval, or withdrawal of an approval, of a “new drug” application.26 That this is so follows from-the limitations placed by the Act on judicial review of the decisions of the Secretary. The Secretary himself asserted, shortly after the enactment of the 1962 Amendments, in Turkel v. Food and Drug Administration, Dept. of H. E. W., supra, 334 F.2d at p. 845, that the Act “grants a right to appeal only from an order of the Food and Drug Administration approving or disapproving a New Drug Application”. In keeping with the Secretary’s contention as to the extent of his adjudicatory powers, the Court in that case held that the right of appeal from an order of the Secretary “applies only to an order of the Secretary refusing or withdrawing approval of an application for sale and distribution of a new drug” (334 F.2d at pp. 845-846). It is not to be assumed that the Act confers an adjudicatory right on the Secretary from which no judicial review, however limited, is provided or allowed. Yet this is the unusual situation that would be presented if the Secretary were held to have jurisdiction to adjudicate whether a drug meets the statutory criteria of a “new drug”.27
The District Court, in finding concurrent jurisdiction, held that “This grant of authority to approve or withhold approval of new drug application, * * * necessarily implies authority for F.D.A. to determine the threshold question of whether the article involved is a drug which required an approved new drug application for lawful interstate shipment.” This reasoning assumes that an application for approval by the Secretary under the Act poses as its initial issue whether the product is a new drug. No such issue is posed by the application. The very filing of the application is a concession and recognition by the applicant-manufacturer that the article is a “new drug”; otherwise, there would be no reason to file the application. As a matter of fact, in the prescribed form of application, the applicant describes his product as “a new drug”. 21 C.F.R. 130.4. The applicant makes the determination whether his product is a “new drug” and whether he must file for pre-marketing clearance by the Secretary. And when filed, the application puts in issue only one question: Is the article safe and effective? That and that alone is the issue to be considered by the Secretary in connection with an application for approval filed by a manufacturer under Section 355(d), 21 U.S.C. That issue is quite different from that presented when there is an issue whether a drug fits the statutory definition of “new drug” in the Act. The criterion for ascertaining whether a product is within the statutory definition of “new drug” under the Act is not safety and effectiveness per se, which, as we have observed, is the issue before the Secretary in connection with application for approval of a “new drug”, but “whether the government has shown by a preponderance of the evidence that the ‘drug is not generally recognized, among experts qualified by scientific training [372] and experience to evaluate the safety and effectiveness of drugs, as safe and effective for use under the conditions prescribed, recommended or suggested in the labeling thereof.’ ” 28 That is an issue that must be and is resolved, sometimes with, and at other times without a jury, in practically every injunctive, seizure, or criminal proceeding under the Act. See, for instance, United States v. Articles of Drug Labeled “Quick-O-Ver”, supra; United States v. 41 Cases, More or Less (5th Cir. 1970) 420 F.2d 1126, 1128; United States v. Article of Drug, etc., supra, 415 F.2d 390 at p. 392; United States v. Article . . . Consist. of 216 Carton (2d Cir. 1969) 409 F.2d 734, 742; United States Article Consisting of 36 Boxes, etc., supra, 284 F.Supp. at p. 113; see, also, United States v. Article of Drug, etc. (D.C.Md. 1971) 331 F.Supp. 912, 915-917. That was one of the issues resolved in the declaratory action of Lemmon Pharmaeal Co. v. Richardson, supra.29 It is manifestly a justiciable issue and the plaintiffs are entitled to a judgment on that issue by the Court, which alone has the jurisdiction to resolve it. In the absence of any statutory review proceedings within which they may assert their claim of exemption, the plaintiffs are not to be compelled to proceed at their peril, subject to the possibility of both civil and criminal penalties, but are entitled to seek relief by way of a declaratory judgment action. The District Court should accordingly have retained jurisdiction and proceeded to determine whether the plaintiffs’ drugs met the criteria for exemption under Section 107(c) (4). We deem it premature for us to consider at this stage whether plaintiffs’ products meet such criteria. That issue was not developed in the record before, or ruled on by, the District Court.30 Upon remand, the issue can be considered by the Court in the light of the record that may be made by the parties.
Remanded, with directions.