Searching over 5,500,000 cases.


searching
Buy This Entire Record For $7.95

Download the entire decision to receive the complete text, official citation,
docket number, dissents and concurrences, and footnotes for this case.

Learn more about what you receive with purchase of this case.

COSMETIC, TOILETRY & FRAGRANCE ASSN., INC. v. SCHM

February 3, 1976

COSMETIC, TOILETRY AND FRAGRANCE ASSOCIATION, INC., Plaintiff,
v.
ALEXANDER SCHMIDT, Commissioner, Food and Drug Administration and FOOD AND DRUG ADMINISTRATION, Defendants



The opinion of the court was delivered by: RICHEY

 This case comes before the Court on the parties' cross motions for summary judgment. Plaintiff, a non-profit association whose members include nearly two hundred manufacturers and distributors of cosmetic products, asks this Court to declare invalid certain regulations promulgated by the defendant Food and Drug Administration on the ground that the regulations are arbitrary and capricious. The Court has jurisdiction over the present matter pursuant to the jurisdictional provisions of the Administrative Procedure Act (APA), 5 U.S.C. §§ 702-706, which provide a right of review to persons aggrieved by final agency action. Both parties agree that all available administrative remedies with respect to the Food and Drug Administration's final regulations have been exhausted.

 The regulations in question require that the following warning appear on the labels of all aerosolized food, drug, and cosmetic products:

 
21 C.F.R. § 740.11(a)
 
Warning -- Avoid spraying in eyes. Contents under pressure. Do not puncture or incinerate. Do not store at temperatures above 120 degrees F. Keep out of reach of children.

 In addition, the regulations require that the following warning appear on the labels of all aerosolized food, drug, and cosmetic products which contain halocarbon or hydrocarbon propellants:

 
21 C.F.R. § 740.11(b)
 
Warning -- Use only as directed. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.

 The regulations will become effective May 31, 1976.

 The administrative history of this case spans nearly three years. On March 7, 1973, the Commissioner of Food and Drugs published notice of proposed rulemaking in the Federal Register (38 Fed.Reg.6191) and invited public comment thereon, pursuant to 5 U.S.C. § 553. On May 7, 1973, Cosmetic Toiletry and Fragrance Association, Inc. (CTFA), the plaintiff herein, filed a letter of comment on the proposed rules. CTFA maintained, essentially, that the defendants' regulations were arbitrary and capricious in that the regulations failed to reflect a consideration of the specific nature of aerosol fragrances which, CTFA alleged, had no history of abuse. Final regulations were promulgated on March 3, 1975, and published at 40 Fed. Reg. 8912-8917. On June 23, 1975, representatives of CTFA met with representatives of the Food and Drug Administration to discuss further objections to the final regulations. Defendants recommended that plaintiff file a petition for reconsideration. On June 27, 1975, defendants received CTFA's petition for reconsideration, or in the alternative, to amend the regulation. In a three-page letter dated August 4, 1975, defendants denied CTFA's petition for reconsideration.

 The issues presented for review concern whether, in promulgating the regulations, the agency acted in an "arbitrary and capricious" manner, 5 U.S.C. § 706(2)(A). Plaintiffs also contend that the Commissioner's requirement that all warning statements appear on the product "label" as opposed to anywhere on the product "labeling", *fn1" see 21 C.F.R. §§ 740.2, 740.11, is (a) beyond the statutory authority of the Commissioner, and (b) represents a clear error of judgment on the part of the Commissioner. For the reasons discussed below, the Court finds that the defendants' regulations were not promulgated in an arbitrary and capricious manner in that there is ample evidence in the administrative record to support the Commissioner's assertion as to the need for the warning requirements of 21 C.F.R. §§ 740.11(a) and (b). In addition, the Court finds that the Commissioner had the statutory authority to require that the warnings appear on the product label, and that the record reveals that said requirement was not a clear error of judgment. Plaintiff's motion for summary judgment is denied and defendants' motion for summary judgment is hereby granted.

 I. In Reviewing Informal Rulemaking, this Court Must Apply the "Arbitrary and Capricious" Standard.

 As an initial matter, the Court notes that while the parties agree that the "arbitrary and capricious" standard should be applied in reviewing the defendants' informal rulemaking in the instant case, *fn2" see 5 U.S.C. § 702(2)(A), they differ as to the meaning of that standard. In the case of Citizens to Preserve Overton Park v. Volpe, 401 U.S. 402, 28 L. Ed. 2d 136, 91 S. Ct. 814 (1971), Mr. Justice Marshall, for the Court, addressed this very issue:

 
To make this finding [under § 706(2)(A)], the Court must consider whether the decision was based on a consideration of the relevant factors and whether there has been a clear error of judgment. Although this inquiry into the facts is to be searching and careful, the ultimate standard of review is a narrow one. The Court is not empowered to substitute its judgment for that of the agency. 401 U.S. 402, 91 S. Ct. 814, 28 L. Ed. 2d 136 (1971) (citations omitted).

 See also National Nutritional Foods Ass'n v. Weinberger, 512 F.2d 688, 700-01 (2d Cir. 1975), (clarifying the Overton Park standard and applying it to an informal rulemaking proceeding); Weinberger v. Hynson, Westcott & Dunning, Inc., 412 U.S. 609, 622, 37 L. Ed. 2d 207, 93 S. Ct. 2469 n.19 (1973). The court of appeals for this circuit has also addressed the meaning of "arbitrary and capricious." For example, in Automotive Parts and Accessories Ass'n v. Boyd, 132 U.S. App. D.C. 200, 407 F.2d 330 (1968), Judge McGowan, for the court, held that the "paramount objective [in judicial review of the informal rulemaking procedure] is to see whether the agency, given an essentially legislative task to perform, has carried it out in a manner calculated to negate the dangers of arbitrariness and irrationality in the formulation of rules for general application in the future." 407 F.2d at 338. In this connection, according to Judge McGowan, "Our function is to see only that the result is reasonable and within the range of authority conveyed, that it has been formulated in the manner prescribed, and that the disappointed have had the opportunity provided by Congress to try to ...


Buy This Entire Record For $7.95

Download the entire decision to receive the complete text, official citation,
docket number, dissents and concurrences, and footnotes for this case.

Learn more about what you receive with purchase of this case.