Appeal from an order of the United States District Court for the Southern District of New York, Marvin E. Frankel, Judge, vacating a notice of deposition by plaintiffs, manufacturers of Vitamins A and D, and granting summary judgment dismissing plaintiffs' complaint, which sought declaratory and injunctive relief against regulations promulgated by the Food and Drug Administration classifying those vitamins in excess of certain potencies per dosage as "drugs" under 21 U.S.C. § 321(g)(1) and further as "prescription drugs" under 21 U.S.C. § 353(b)(1)(B). Remanded for further proceedings, including a determination of the basis for, and legality of, the Commissioner's conclusions that dosage levels of Vitamins A and D in the amounts specified are "drugs" within the meaning of the Act.
Lumbard, Waterman and Mansfield, Circuit Judges. Lumbard, Circuit Judge (concurring).
MANSFIELD, Circuit Judge:
This appeal by producers and vendors of vitamin preparations arises out of their unsuccessful attempt in the Southern District of New York to challenge regulations promulgated by the United States Food and Drug Administration ("FDA" herein) pursuant to § 701(a) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 301, et seq. (the "Act" herein), which classify as "prescription drugs" all preparations of Vitamin A containing more than 10,000 IU (international units) per dosage form and of Vitamin D containing more than 400 IU per dosage form.*fn1 In the district court appellants sought declaratory and injunctive relief against the regulations, claiming that the FDA has no power to issue binding regulations under § 701(a), that the vitamin preparations at issue are foods and were improperly classified as prescription drugs under the Act, that plaintiffs were entitled to a de novo trial in the district court of factual issues going to the basis of the regulations and that the FDA's action in promulgating them was unsupported by substantial evidence. Appellants further contended that the "whole record" of the agency's action was not before the district court, and sought to depose the Commissioner of Food and Drugs ("Commissioner" herein). The district court, Marvin E. Frankel, Judge, vacated the notice of deposition and granted summary judgment dismissing the complaint.
Purporting to act under the general rule-making power vested in the Secretary of Health, Education and Welfare ("HEW" herein) by § 701(a) of the Act, 21 U.S.C. § 371(a), which authorizes him "to promulgate regulations for the efficient enforcement of this Act," the Commissioner, to whom this rule-making authority is delegated, 21 C.F.R. 2.120(a)(1), followed the notice-and-comment procedure outlined by § 4(c) of the Administrative Procedure Act,*fn2 5 U.S.C. § 553(c), in promulgating the challenged regulations. First he published a statement in the Federal Register, 37 Fed. Reg. 26618, on December 14, 1972, giving notice of his proposal to adopt regulations which would require that, pursuant to the "prescription drug" law, § 503(b)(1) of the Act, 21 U.S.C. § 353(b),*fn3 Vitamins A and D in dosage units in excess of 10,000 IU and 400 IU, respectively ("higher dosage forms" herein) be restricted to prescription sale and deemed misbranded unless the label of the container in which they were sold or dispensed bore appropriate disclosure and warnings.
The Commissioner's initial statement advised that, according to medical literature, the ingestion of large dosages of Vitamins A and D over long periods could have serious toxic effects and that these vitamins were available over the counter in dosage forms many times the daily allowance recommended and published by the Food and Nutrition Board of the National Academy of Sciences -- National Research Council ("NAS/NRC" herein). According to the Commissioner's statement the excess dosage forms were the subject of widespread promotion to the public for prophylaxis and treatment of a variety of diseases and disorders. The American Academy of Pediatrics had published a statement warning physicians regarding the various forms of toxicity that could result from intake of the large amounts of Vitamin A being recommended by vendors to the public in the press, on radio and on TV. Many types of serious adverse effects from ingestion of excessive amounts of Vitamins A and D were listed, including some that resulted in death. The recommended daily allowance ("RDA" herein) published by the Food and Nutrition Board of the NAS/NRC as between 4,500 and 5,000 IU of Vitamin A for older children and adults, 6,000 IU during pregnancy and 8,000 IU during lactation. For Vitamin D preparations the RDA was 400 IU for all age groups. The Commissioner placed on public view an extensive bibliography of the medical literature employed by the FDA in formulating its proposed regulations. The Commissioner's statement invited interested persons to file with the HEW within 60 days any written comments they might desire to submit with respect to the proposals, together with memoranda and briefs, all of which would be available for public inspection.
Over, 2,500 written comments were submitted by a wide cross-section of the public, including consumers, physicians, nurses, pharmacists, pharmaceutical manufacturers, health food store operators. Various organized consumer and other groups, including the Academy of Pediatrics, American Medical Association, and the Pharmaceutical Manufacturers Association also responded. Both plaintiffs in this case submitted extensive comments opposing the regulations. According to the Commissioner, the comments fell into three general categories: (1) Those who viewed the proposed regulations as suitable. This group included the American Medical Association, the American Academy of Pediatrics, various consumer groups, physicians and others; (2) Those who agreed that vitamins could be toxic, but at higher levels than those proposed by the Commissioner. In this group were the majority of the drug manufacturers and trade associations plus some consumers; and (3) Those who disagreed with the proposals entirely, taking the view that such vitamin preparations are food and that consumption of desired quantities is an individual right. These comments came mostly from consumers and health food establishments.
In a report published in the Federal Register on August 2, 1973, 38 Fed. Reg. 20723, the Commissioner summarized the comments received by the FDA, concluded that the proposed regulations were in the public interest, and ordered that they become effective on October 1, 1973. In response to contentions that Vitamins A and D were foods rather than drugs, and thus not subject to regulation as "prescription drugs," the Commissioner referred to orders which he had published on January 19, 1973, promulgating as regulations §§ 80.1, 125.1 and 125.3 (21 C.F.R. §§ 80.1, 125.1 and 125.3).*fn4 He concluded that vitamins in daily amounts between the upper and lower limits specified in § 80.1 (i.e., 1,250 to 8,000 IU of Vitamin A and 200 to 400 IU of Vitamin D) were adequate for all nutritional needs of normal individuals and that nutrients at these levels could be considered as dietary supplements or foods for special dietary use. With respect to the higher level dosages, which were to be dispensed only upon prescription, however, he stated:
"No evidence was submitted in the comments to establish a food or nutritional use of vitamin A or vitamin D at higher levels, except for a limited number of persons with poor vitamin D absorption who need up to 1000 IU of this vitamin for nutritional purposes under medical supervision. With that one exception, which is recognized in the revised regulation, intake of vitamins at levels exceeding the upper limits as specified in § 80.1 are therefore appropriate only for therapeutic purposes and thus are properly classed as drugs."
On August 6, 1973, plaintiffs brought suit in the Southern District of New York seeking declaratory and injunctive relief that would prevent enforcement of the proposed regulations. In September 1973 Judge Frankel denied a motion for preliminary injunctive relief in an opinion at 366 F. Supp. 1341 (S.D.N.Y. 1973), which we affirmed, 491 F.2d 845 (2d Cir. 1973). On October 1, 1973, the regulations went into effect. In a further opinion dated April 5, 1974, published at 376 F. Supp. 142 (S.D.N.Y. 1974), Judge Frankel granted defendant's motion for summary judgment dismissing the complaint and upheld the regulations as having been promulgated pursuant to the Commissioner's authority under the Act. He further held that plaintiffs were not entitled to a de novo trial, preceded by discovery, to test the regulations, since the rule-making procedure followed by the FDA, which resulted in voluminous comments, was adequate and the regulations were not irrational, arbitrary or capricious, which he deemed to be the standard of review. From this decision plaintiffs appeal.
Appellants have launched a multifaceted attack upon the challenged regulations and the district court's grant of summary judgment. They contend that the FDA has no authority to issue regulations having the binding effect of law, other than those regulations which must be issued under the adjudicatory hearing procedures provided by § 701(e) of the Act, 21 U.S.C. § 371(e).*fn5 They argue that regulations issued under § 701(a), which does not provide for a hearing, at best represent merely administrative interpretations of the substantive statutory law, enforceable only on a case-by-case basis that would insure de novo adjudication of all issues by the district court. They further assert that, even assuming arguendo that the FDA had the power to promulgate binding regulations, the present ones are deficient because they are unsupported by substantial evidence and the record fails to contain adequate findings and a sufficient explanation of the basis and rationale of the FDA's action to enable a reviewing court to determine whether the FDA acted within the scope of its statutory authority and on the basis of supporting evidence. They argue that the district court improperly used the "arbitrary, capricious" rather than the "substantial evidence" standard of review but that even the former could not be met here, in view of the inadequacy of the record, which fails adequately to demonstrate the basis of the Commissioner's action.
If this case had been one governed by hearing requirements like those in § 701(e) or if the district court had held a de novo trial, appellants argue, crucial factual issues would have been resolved in their favor. They allege that they would have demonstrated that Vitamins A and D at the dosage levels specified in the regulations are not "drugs" as that term is defined in § 201(g) of the Act, 21 U.S.C. § 321(g),*fn6 because they were not intended for use in the treatment or prevention of disease but as dietary supplements, and that they could not lawfully be classified as "prescription drugs" under § 503(b)(1)(B) of the Act, 21 U.S.C. § 353(b)(1)(B), since the products are not toxic at the levels established by the regulations and are not inherently unsafe when used without prescription in a rational manner, but can become unsafe only when misused or used irrationally. The effect of the action of the FDA and of the district court, say appellants, is to withdraw a food from the market without a hearing and without findings, contrary to Congress' intent in enacting the prescription drug statute.
The FDA's Rule-Making Authority
Resolution of the issues raised by appellants requires an analysis of the FDA's rule-making power and of the federal court's role in reviewing the exercise of that power. As enacted in 1938 § 701 of the Food and Drug Act, 21 U.S.C. § 371, contained two grants of authority to the FDA to promulgate regulations. Section 701(a) broadly grants:
"(a) The authority to promulgate regulations for the efficient enforcement of this chapter, except as otherwise provided in this section, is vested in the Secretary."
No conditions were expressly imposed upon this expansive grant of authority. A few paragraphs thereafter, on the other hand, Congress prescribed in §§ 701(e) and (f) an elaborate procedure that must be followed by the FDA in promulgating regulations with respect to certain specifically enumerated subjects (e.g., standards of identity, 21 U.S.C. § 341, branding of food for special dietary uses, 21 U.S.C. § 343(j), distribution of potentially contaminated foods, 21 U.S.C. § 344(a)), including notice, comments by interested parties, promulgation of proposed rules, filing ...