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PUBLIC CITIZEN v. HHS

February 13, 1986

PUBLIC CITIZEN, et al., Plaintiffs,
v.
DEPARTMENT OF HEALTH AND HUMAN SERVICES, et al., Defendants, CERTIFIED COLOR MANUFACTURERS ASSOCIATION and THE COSMETIC, TOILETRY AND FRAGRANCE ASSOCIATION, Intervenors-Defendants; FOUNDATION FOR NUTRITIONAL ADVANCEMENT, et al., Plaintiffs, v. DEPARTMENT OF HEALTH AND HUMAN SERVICES, et al., Defendants, THE COSMETIC, TOILETRY AND FRAGRANCE ASSOCIATION, Intervenor-Defendant


Stanley S. Harris, United States District Judge.


The opinion of the court was delivered by: HARRIS

Stanley S. Harris, United States District Judge

 This matter is before the Court on the motion of plaintiffs Public Citizen, Nancy H. Simpson, Phillip L. Weinberg, and Mary L. Rooney (hereinafter collectively Public Citizen) for summary judgment, the motion of plaintiff Foundation for Nutritional Advancement for summary judgment, the cross-motion for summary judgment filed by the federal defendants, the Department of Health and Human Services (HHS), Margaret M. Heckler, the former Secretary of HHS, the Food and Drug Administration (FDA), and Frank D. Young, the Commissioner of the FDA, and the cross-motions for summary judgment filed by intervenor-defendants Certified Color Manufacturers Association (CCMA) and the Cosmetic, Toiletry and Fragrance Association (CTFA).

 In their complaints, plaintiffs challenge the defendants' actions relating to nine color additives. *fn1" These additives currently are "provisionally" listed as safe for use pursuant to the transitional provisions of the 1960 Color Additive Amendments (CAA) to the Food, Drug and Cosmetic Act (FDC Act), 21 U.S.C. § 376 (1982). Plaintiffs allege that the defendants have violated the CAA and the underlying FDC Act, as well as the unreasonable delay prohibition in the Administrative Procedure Act (APA), 5 U.S.C. § 706(1) (1982), by continuing to provisionally list the nine additives. Plaintiffs seek to have the Court enjoin the defendants from using the provisional list or any other means to allow the sale of these nine additives unless, within 30 days of the Court's order, they have been listed as safe pursuant to the requirements of the CAA.

 Statutory Framework

 The CAA of 1960, 21 U.S.C. § 376, established a comprehensive system for regulating the use of color additives in foods, drugs, and cosmetics. The CAA provide that a color additive is "unsafe" under the FDC Act, and thereby prohibited from sale in interstate commerce, unless the Secretary has "permanently listed" the additive on the basis of a finding that it is safe for its intended use. 21 U.S.C. §§ 376(a), (b).

 While proof of safety is being developed, the CAA permit the continued use of color additives that were established commercially before the statute was enacted. The criteria for the continued use of those colors are contained in special transitional provisions. Pub. L. No. 86-618, § 203, 74 Stat. 404 (1960). *fn2" Under those provisions, all existing colors were automatically deemed to be "provisionally listed" for the first two and one-half years after the CAA's enactment. Id. at § 203(a)(2). Thereafter, the FDA was given discretion to grant additional extensions of the provisional listings "if in [the FDA's] judgment such action is consistent with the objective of carrying to completion in good faith, as soon as reasonably practicable, the scientific investigations necessary for making a determination" concerning the colors' permanent listing. Id. The statute provides that the purpose of the transitional provisions is

 
to make possible, on an interim basis for a reasonable period, through provisional listings, the use of commercially established color additives to the extent consistent with the public health, pending the completion of the scientific investigations needed as a basis for making determinations as to [permanent] listing of such additives. . . .

 § 203(a)(1).

 Regulatory Background

 In the early 1960's, more than 190 color additives were provisionally listed. By September 1976, that number had been reduced to 84. The FDA then decided that, because of evolving scientific standards, additional testing was required with respect to 52 of the colors. For 32 of those colors, long-term chronic toxicity studies were required to replace those deemed insufficient for a final decision. Accordingly, the Commissioner extended the closing dates for those 32 additives until January 31, 1981. Shorter extensions were provided for the other 20. Public Citizen challenged the Commissioner's decision in Health Research Group v. Califano, No. 77-293 (D.D.C. 1977); the District Court upheld the FDA's action.

 By 1981, the number of additives on the provisional list had been reduced to 23. At that time, the Commissioner further extended the closing dates to permit the completion and regulatory evaluation of the ongoing chronic toxicity tests. Public Citizen again challenged the extensions, which again were upheld by the District Court and the Court of Appeals. See McIlwain v. Hayes, 530 F. Supp. 973 (D.D.C. 1981), aff'd, 223 U.S. App. D.C. 304, 690 F.2d 1041 (D.C. Cir. 1982).

 In the period between McIlwain and the filing of the instant case, the agency resolved the status of 13 of the 23 colors that remained on the provisional list. Closing dates for the other ten were periodically extended to allow for the review of scientific test data. On December 17, 1984, Public Citizen petitioned the FDA to ban the use of the ten colors that remained on the list. On January 22, 1985, Public Citizen filed its complaint in this case, seeking the same relief. The Foundation for Nutritional Advancement, and its Executive Director Curtis C. Cutter, filed a complaint on May 16, 1985, which also sought removal from the market of the remaining provisionally listed color additives. The two cases were consolidated by Order of July 15, 1985. On June 21, 1985, the Commissioner of Food and Drugs denied Public Citizen's December 1984 petition. That action mooted the federal defendants' earlier motion to dismiss, or in the alternative, for summary judgment (which was based on a failure to exhaust administrative remedies).

 After the filing of the cross-motions for summary judgment at issue here, the FDA issued a final rule extending the provisional listing of nine color additives (50 Fed. Reg. 35783-89 (Sept. 4, 1985)) and permanently listing Yellow No. 5 for cosmetic ...


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