The opinion of the court was delivered by: FRANKEL
On October 1, 1973, regulations of the Food and Drug Administration became effective requiring that preparations of Vitamin A and Vitamin D in excess of 10,000 IU (international units) per dosage unit and 400 IU per dosage unit, respectively, be restricted to prescription sale and that such vitamins be labeled accordingly. 21 C.F.R. §§ 3.94 and 3.95 (1973). The regulations were declared to have been promulgated to implement the "efficient enforcement" of §§ 502(a), (f) and (j) and 503(b) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. §§ 352(a), (f), and (j) and 353(b), under the general authority of the Act's § 701(a), 21 U.S.C. § 371(a), and pursuant to powers delegated to the Commissioner by 21 C.F.R. § 2.120(a) (1) (1973).
Plaintiffs, involved in the manufacture, distribution, and sale of Vitamins A and D, filed suit on August 6, 1973, seeking declaratory and injunctive relief against the regulations. Their motion for a preliminary injunction was denied on September 25, 1973. National Nutritional Foods Ass'n v. Weinberger, D.C. 366 F. Supp. 1341, aff'd 491 F.2d 845 (2d Cir., 1973).
Defendants have now moved for summary judgment dismissing the complaint. Counsel have made extensive submissions, and the court has heard further oral argument, supplementing the things read and heard on the motion for a preliminary injunction. For reasons hereinafter outlined, the complaint is now to be dismissed.
Plaintiffs claim that the questioned regulations were issued by the Commissioner without statutory authority. They argue that the legislative history of the prescription drug statute, 21 U.S.C. § 353(b) (1)
reveals a purpose to prohibit regulations of this kind. The history shows, plaintiffs say, that the prescription requirement was meant to be for case-by-case determination in court, not for administrative rules like those before us. This intended limitation, they argue, may not be surmounted or avoided by the more general authority of the Commissioner to issue regulations under 21 U.S.C. § 371(a). These contentions have substance. Having considered them, however, the court concludes that the legislative history is by no means clear enough to preclude a look at the statutory text,
and that the legislative mandate as a whole sustains the agency's position.
The Food, Drug and Cosmetic Act (the Copeland Act), 21 U.S.C. § 301 et seq., was passed in 1938, superseding a 1906 statute touching the subject (the Wiley Act, c. 3915, 34 Stat. 768). The new Act was designed to respond to "profound changes in methods of manufacturing and selling foods and drugs" which had developed since 1906 and to remedy "textual weaknesses in the measure that were not foreseen when it was enacted." 79 Cong. Rec. 4758 (remarks of Sen. Copeland); see generally Jackson, Food and Drug Legislation in the New Deal (1970). Section 503(b) of the Act, 21 U.S.C. § 353(b) (the prescription drug statute), was further amended in 1951 by the Durham-Humphrey Amendment, c. 578, 65 Stat. 648 (1951). This amendment and its history are the central subjects of plaintiffs' case.
The general purpose of the 1951 legislation was to adapt the Food, Drug and Cosmetic Act --
"to deal realistically with the labelling and dispensing of drugs that may be sold only upon the prescription of licensed practitioners. Its provisions are remedial in the sense that they are intended to protect the public from abuses in the sale of potent prescription medicines. They will also relieve retail pharmacists of unnecessary restrictions in the dispensing of drugs that are safe for use without medical supervision." S. Rep. No. 946, 82d Cong., 1st Sess. cited in 1951 U.S. Code Cong. and Admin. Serv. p. 2454.
Accordingly, the amended section 503 created a new prescription requirement encompassing a statutory definition of drugs that may be dispensed only on prescription and specifying the conditions under which these drugs may be dispensed. Before, the law had simply commanded that the labeling of drugs bear adequate directions for use. While the Commission had provided some regulatory suasion,
it had been for the drug manufacturer to make the primary determination as to whether a prescription was necessary; the resulting lack of uniformity had left the retail druggist adrift in identifying his statutory (and health) obligations. One manufacturer might determine that a prescription legend was required for the same drug that a competing manufacturer considered suitable for over-the-counter sale. See H.R. Rep. No. 700, 82d Cong., 1st Sess. 3 (1951). As originally proposed, in H.R. 3298, the amended § 503(b) would have conferred authority on the F.D.A. to issue an administrative list of drugs requiring prescription prior to sale. While this provision was opposed by many drug manufacturers, it remained in the bill as reported out by the House Committee on Interstate and Foreign Commerce. Among the considerations which influenced the Committee in its decision to retain this aspect of the bill was the recognition that "the task of determining which drugs shall be sold only on prescription is, in its nature, essentially a legislative or rule-making function, unsuited for solution solely through the judicial process." H.R. Rep. No. 700, supra at 10.
A minority report asserted that "the present method which leaves this determination [of whether a prescription is required] to the courts, should be left unchanged except that a proper standard to be applied in determining whether a drug is dangerous should be incorporated in the statute." Id. at 28. The minority argued that providing the Administrator with power to issue regulations was a "dangerous delegation of authority" which would "add to present difficulties by increased bureaucratic regulation." Id.
H.R. 3298 reached the floor of the House on July 31, 1951, 97 Cong. Rec. 9235 (1951). The minority view on handling the prescription requirement gathered support, on stated grounds both of general principle and of specific hostility to the then Administrator. On August 1, Congressman O'Hara of Minnesota introduced an amendment to strike the sections of the bill providing for the promulgation of an administrative list of drugs requiring a prescription for sale. The amendment carried. In its amended form H.R. 3298 was passed by the House and sent to the Senate, where it was reported out favorably and passed with minor amendments (and no significant debate) on October 15, 1951.
The Senate Committee which considered H.R. 3298 as passed by the House had before it both H.R. 3298 and a companion Senate Bill, S. 1186 with various amendments in the nature of a substitute by Senator Humphrey designed to reintroduce the administrative list. While the Committee ultimately accepted the House version, it noted that the statutory definition simpliciter would be difficult or impossible to administer. The Committee Report explicitly contemplated the formulation of implementing regulations under 21 U.S.C. § 371(a) to effectuate the statutory objective of protecting the public health:
"In order to give this general definition a more precise meaning so that it may be applied with greater uniformity by the drug trade the Administrator can exercise the authority he has under section 701(a) of the Federal Food, Drug, and Cosmetic Act to issue interpretative regulations. It is to be understood that the inclusion of the statutory definition does not, of course, in any way derogate from the Administrator's authority to interpret and enforce the definition through the issuance of any regulations necessary or appropriate to protect the public from indiscriminate ...