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ESTEE LAUDER, INC. v. UNITED STATES FDA

June 16, 1989

ESTEE LAUDER, INC., Plaintiff,
v.
UNITED STATES FOOD & DRUG ADMINISTRATION, et al., Defendants


Aubrey E. Robinson, Jr., Chief United States District Judge.


The opinion of the court was delivered by: ROBINSON

AUBREY E. ROBINSON, JR., CHIEF UNITED STATES DISTRICT JUDGE

 Plaintiff Estee Lauder Inc. ("Lauder"), a cosmetic manufacturer, filed a complaint on September 23, 1988, seeking a declaration that a Food and Drug Administration ("FDA" or "Administration") employee's position regarding proposed labeling is unlawful, unreasonable, arbitrary, and capricious. In a September 2, 1988, letter, the employee had advised Lauder that its proposed labeling of certain skin creams would render the products "drugs," which could only be sold if Lauder secured FDA approval for them or could show that the products were generally recognized as safe and effective by qualified experts. Plaintiff also seeks an injunction barring the FDA from taking legal action against any of its products based upon that employee's interpretation of the Federal Food, Drug, and Cosmetic Act ("FDCA" or "Act"), 21 U.S.C. § 321(g)(1)(C). Claiming there are no genuine issues of material fact, plaintiff filed a motion for summary judgment in November 1988.

 Also in November 1988, the government moved to dismiss the complaint pursuant to Rule 12(b)(1) and (6) of the Federal Rules of Civil Procedure. The government argues that the case is not ripe for adjudication, that Lauder has failed to exhaust its administrative remedies, and that this Court does not otherwise have jurisdiction to enjoin the FDA from instituting enforcement actions.

 This Court heard oral argument on these motions on April 19, 1989. The legal memoranda, supporting exhibits, final arguments, and post-hearing memoranda have all been fully considered. For the reasons set forth below, the Court grants the government's motion to dismiss and denies plaintiff's motion for summary judgment.

 I. BACKGROUND

 The Food and Drug Administration enforces the FDCA, which provides for different and more stringent regulation of drugs than of cosmetics. The FDA is authorized to take action against cosmetic manufacturers that make false and deceptive therapeutic claims about their products. The Administration and Lauder have engaged in lengthy discussions over certain Lauder cosmetics; they have disputed whether these products were being touted as having the effect of drugs and they have argued over the proper labeling of these goods. Given this context, it is appropriate to begin with a review of the statutory scheme of the laws regulating drugs and cosmetics.

 A. "DRUG" AND "COSMETIC" STATUTES

 Because drugs and cosmetics are subject to different regulations regarding testing, approval, labeling, and advertisement, the products are distinctly described in the Federal Food, Drug, and Cosmetic Act. The FDCA defines "drugs" as:

 
Articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease . . . and articles . . . intended to affect the structure or any function of the body. . . .

 21 U.S.C. § 321(g)(1). "Cosmetics," on the other hand, are defined as:

 
Articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance. . . .

 21 U.S.C. § 321(i)(1).

 While both drugs and cosmetics are subject to the misbranding and adulteration provisions of the FDCA, 21 U.S.C. §§ 351, 361 (adulteration), 21 U.S.C. §§ 352, 362 (misbranding), drugs are subject to much stricter regulatory requirements. For example, it is well-established that drugs must comply with registration and labeling requirements. 21 U.S.C. §§ 360, 352(e), (f), (o), (p). Even more important, a drug cannot be sold until it is either specifically approved by the FDA or the manufacturer shows that the drug is generally recognized as safe and effective ...


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