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NATIONAL NUTRITIONAL FOODS ASSN. v. MATHEWS

July 2, 1976

NATIONAL NUTRITIONAL FOODS ASSOCIATION and Solgar Co., Inc., Plaintiffs,
v.
F. David MATHEWS, Secretary of Health, Education and Welfare and Alexander M. Schmidt, Commissioner of Food and Drugs, Defendants


Frankel, District Judge.


The opinion of the court was delivered by: FRANKEL

FRANKEL, District Judge.

This case, on remand now "to conduct an Overton-type hearing," National Nutritional Foods Ass'n v. Weinberger, 512 F.2d 688, 703 (2d Cir.), cert. denied sub nom. National Nutritional Foods Ass'n v. Mathews, 423 U.S. 827, 96 S. Ct. 44, 46 L. Ed. 2d 44 (1975), was brought in August of 1973, seeking declaratory and injunctive relief against regulations of the Food and Drug Administration requiring that preparations of Vitamins A and 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 labelled accordingly, 21 C.F.R. §§ 250.109 and 250.110 (1976). Plaintiff's motion for a preliminary injunction was denied on September 25, 1973, 366 F. Supp. 1341 (S.D.N.Y.), aff'd, 491 F.2d 845 (2d Cir. 1973), and the regulations became effective on October 1, 1973. Defendants' subsequent motion for summary judgment was granted, 376 F. Supp. 142 (S.D.N.Y.1974), a decision which has been, as noted, vacated and remanded. Moving at a rather leisurely pace, the parties have now submitted additional materials and arguments, supplementing those already before the court from the two previous motions. For the reasons hereinafter outlined, the regulations are upheld as not "arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law," 5 U.S.C. § 706(2)(A), and the complaint will be dismissed.

 I.

 A couple of procedural issues are presented at the threshold. Plaintiffs argue, on principle and under the terms of the mandate of the Court of Appeals, that Commissioner Schmidt should be subjected to cross-examination concerning the grounds on which he classified high-potency Vitamins A and D products as "drugs." In addition, there is a question as to the scope of the "record" upon which the court should make its determination. On both subjects, the court is in disagreement with plaintiffs' position.

 A. "The great developer is responsibility." *fn1" That familiar bit of Brandeis wisdom remains vital. Time and travail, even Watergates, should and must not close it from our minds. There may be imaginable occasions when judges ought rightly to summon high agency officials to undergo cross-examination about the legislative premises underlying their formally published rules. There may even be occasions when legislators could be commanded to do likewise. But the instances would surely be rare, marked by circumstances of some extraordinary character.

 An Overton-type hearing is not an open invitation, much less a direction, to cast aside this familiar learning, recognized for administrative decisionmaking since United States v. Morgan, 313 U.S. 409, 422, 61 S. Ct. 999, 85 L. Ed. 1429 (1941). The case for which the present "hearing" is named recognizes, first, the limited circumstances in which the administrator's mind may be probed by examination, and, second, the discretionary nature of such an examination even when the exceptional circumstances have been met. Citizens to Preserve Overton Park, Inc. v. Volpe, 401 U.S. 402, 420-21, 91 S. Ct. 814, 28 L. Ed. 2d 136 (1971); see also Camp v. Pitts, 411 U.S. 138, 142-43, 93 S. Ct. 1241, 36 L. Ed. 2d 106 (1973). *fn2" The Court of Appeals demanded no more in this case, 512 F.2d at 703 ("including such affidavits or testimony as to the Commissioner's reasoning as the court deems necessary").

 In this light, the court requested, and received an affidavit from the Commissioner. Plaintiffs have pitched various arguments against the affidavit, and these have been considered. Their contention that they are entitled to more -- entitled to cross-examination the Commissioner as well -- is unfounded as a matter of law, and unsupported, insofar as it is a matter of discretion, by any demonstration of great necessity. The niceties of the Administrative Procedure Act were nowhere neglected in this case. The indicia of due notice, full deliberation, and general regularity are all present. There is nothing so irregular or peculiar as to justify the expedient of having the agency head grilled on the witness stand about what he thought he knew, what he now thinks he believes, and how he may have reasoned, in making the mixed judgments of fact, policy, and law which underlay the decision to define these high-potency vitamin pills as "drugs."

 B. The question about the "record" is narrower, and still less gripping. The record originally before this court consisted of the materials produced by the "notice and comment" provisions of the Administrative Procedure Act -- to wit: (1) the official notices by the F.D.A., with cited reference materials incorporated by reference; (2) the voluminous comments, some 45 folders full, received in response; and (3) the promulgated rules and their published explanations. The agency contends that this satisfies the proper definition of the record. *fn3" Even so, in a spirit of accommodation, the Commissioner has now placed before the plaintiffs and the court other material found in his files, namely, correspondence with third parties antedating the proposed regulations and postdating the final regulations, a few additional medical articles, and five other "miscellaneous" pieces of paper. The only items withheld from plaintiffs are a sheaf of some two dozen papers, all consisting of internal F.D.A. memoranda or proposed drafts of the original notice. *fn4"

 Plaintiffs press for these papers as well, contending that they should be treated as a part of the agency record. *fn5" The contention is not persuasive. What plaintiffs seek are presumptively privileged documents, whose privacy is left untouched by the Freedom of Information Act's exemption from disclosure for "inter-agency or intra-agency memorandums or letters which would not be available by law to a party other than an agency in litigation with the agency," 5 U.S.C. § 552(b)(5). There is no reason to think that the need to compile a "record" for a judicial review proceeding makes this limitation inapplicable, especially in light of the general proscription against probing the mind of the administrator. And there is, in any event, no showing of justification for the kind of invasion plaintiffs propose.

 In short, the material now before the court and the agency, supplemented, as it is, by the voluntary production by defendants of all non-privileged documents, has given plaintiffs all, and probably more, than they are entitled to have as the administrative record for judicial review of informal agency rulemaking. See Rodway v. United States Dept. of Agriculture, 168 U.S.App.D.C. 387, 514 F.2d 809, 817 (1975); Phillips Petroleum Co. v. F.P.C., 475 F.2d 842, 850 (10th Cir. 1973), cert. denied, 414 U.S. 1146, 94 S. Ct. 901, 39 L. Ed. 2d 102 (1974); City of Chicago v. F.P.C., 147 U.S.App.D.C. 312, 458 F.2d 731, 740-41 n.45 (1971), cert. denied, 405 U.S. 1074, 92 S. Ct. 1495, 31 L. Ed. 2d 808 (1972); Automotive Parts & Accessories Ass'n v. Boyd, 132 U.S.App.D.C. 200, 407 F.2d 330, 336 (1968); see also National Petroleum Refiners Ass'n v. F.T.C., 392 F. Supp. 1052, 1053 (D.D.C.1974). *fn6"

 II.

 The central substantive question to be examined on this remand is whether or not the Commissioner's classification of high dosage preparations of Vitamins A and D as "drugs" within the Food and Drug Act's statutory definition, § 201(g)(1), 21 U.S.C. § 321(g)(1), was "arbitrary, capricious or otherwise not in accordance with law." The start of our inquiry, the statutory definition of a drug, reads, to the extent relevant:

 
"The term 'drug' means (A) articles recognized in the official United States Pharmacopoeia, official Homoeopathic Pharmacopoeia of the United States, or official National Formulary, or any supplement to any of them; and (B) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and (C) articles (other than food) intended to affect the structure or any function of the body of man or other animals * * *."

 With respect to whether the record supports the classification of high-dosage preparations of Vitamins A and D as drugs, the focus in these proceedings has been on subsections (A) and (B) of the definition.

 Respecting subsection (A), both sides recognize that the intervening decision in National Nutritional Foods Ass'n v. F.D.A., 504 F.2d 761, 788-89 (2d Cir. 1974), cert. denied, 420 U.S. 946, 95 S. Ct. 1326, 43 L. Ed. 2d 424 (1975) precludes any simple reliance on the presence of an item in the official United States Pharmacopoeia or the official National Formulary: "the argument would prove too much, for it would lead to the conclusion that all vitamin and mineral preparations even within the limits are drugs * * *." Not accepting this as the end of the matter, the Commissioner, in his affidavit, counters by arguing:

 
"Unlike most articles recognized in the U.S. Pharmacopoeia and the National Formulary, which are included because of therapeutic usage, vitamins A and D are specifically recognized in the U.S.P. and N.F. for prophylactic (food) usage as well as for therapeutic (drug) usage. In my judgment, while the Act provides that an article is deemed to be a drug if 'recognized' in the U.S.P. or N.F., a vitamin preparation should nevertheless not be classified as a drug on this basis with respect to a usage which is specifically recognized by these compendia to be a prophylactic (food) usage. Consistent with this principle, the vitamin preparations subject to the regulations exceed the levels of potency recognized as 'prophylactic' in the United States Pharmacopoeia and National Formulary * * *." (Emphasis in original.)

 The argument has weight, for otherwise it is unclear what force would remain of subsection (A) of the definition. It appears, however, to be a new thesis, not evident to justify the regulations as originally promulgated. If this were all the Commissioner had, his position could be highly vulnerable. It would appear to suffer the fatal disorder of post hoc rationalization. Cf. National Nutritional Foods Ass'n v. FDA, 504 F.2d at 788-89. However, the court finds enough that is valid and substantial to sustain the agency.

 The bulk of the contentions concerning the validity vel non of the decision to classify the affected preparations as drugs has focused on subsection (B) of the definition. The course of decision is guided by the decision ...


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