Appeal from a final judgment of the United States District Court for the Eastern District of New York (Glasser, J.), directing summary judgment in favor of the United States on behalf of the Federal Drug Administration in an in rem condemnation and forfeiture proceeding and denying the Claimant-Appellant's cross-motion for summary judgment and dismissing its complaint. Affirmed.
Kaufman, Cardamone and Friedman*fn* , Circuit Judges.
Although the pursuit of an even suntan has long been fashionable, only lately has it been attained through pharmaceutical products. Manufacturers have begun marketing cosmetic products which impart color to the skin without the traditional exposure to the natural and perhaps dangerous rays of the sun. French Bronze Tablets, one such product, is the subject of this appeal.
The facts in this case are not in dispute. The United States, on behalf of the Food and Drug Administration ("F.D.A."), commenced a lawsuit on June 16, 1988, by filing a complaint in rem seeking the forfeiture and condemnation of a quantity of a product labelled "FRENCH BRONZE TABLETS," in the possession of the Claimant-Appellant, FBNH Enterprizes, Inc. ("FBNH"). The complaint alleged that the tablets are "adulterated" cosmetics within the meaning of 21 U.S.C. § 361(e) because they contain canthaxanthin and beta-carotene, allegedly unsafe color additives as defined by 21 U.S.C. § 376(a).
On September 30, 1988, the government filed an amended complaint removing the reference to beta-carotene*fn1 and challenging only the use of canthaxanthin in the defendant product. While the synthetic color additive canthaxanthin has been approved for use as a coloring agent in food and drugs, the F.D.A. has not issued regulations authorizing its use in cosmetic products. Each FRENCH BRONZE TABLET, Claimant concedes, is a cosmetic containing 30 milligrams of canthaxanthin.
In its opposition to the government's motion for summary judgment, FBNH nevertheless asserted that the existence of regulations for the use of a color additive as either a food or a drug is sufficient to permit its use in a cosmetic. Rejecting Claimant's interpretation of the relevant provisions of the Food, Drug, and Cosmetic Act, 21 U.S.C. § 301 et seq., Judge Glasser of the Eastern District of New York granted the government's motion for summary judgment, denied Claimant's cross-motion for the same relief and ordered forfeiture and destruction of the tablets. Claimant appeals.
On appeal, we must decide whether Judge Glasser correctly held that a cosmetic tanning product which contains a color additive approved for use in food and drugs but unapproved for use in cosmetics must be banned from the marketplace. As a matter of statutory interpretation and simple logic, we agree with the lower court and affirm.
We now commence our tortuous journey through the Food, Drug, and Cosmetic Act (the "Act"). Congress has delegated to the Secretary of Health and Human Services the authority to regulate food, drugs and cosmetics for the purpose of safeguarding the public health from deleterious, adulterated and misbranded articles. See United States v. Walsh, 331 U.S. 432, 434, 91 L. Ed. 1585, 67 S. Ct. 1283 (1947); see also United States v. Diapulse Corp., 457 F.2d 25, 28 (2d Cir. 1972) (purpose of Food, Drug and Cosmetic Act is to protect public from products not proven safe and effective). The Secretary of Health and Human Services has redelegated his authority under the Act to the Commissioner of the Food and Drug Administration. See 21 C.F.R. § 5.10. Among other powers, the F.D.A. has been given the authority to regulate the use of color additives in food, drugs, and cosmetics. See 21 U.S.C. § 376(b).
In particular, § 376(b) instructs:
(1) The Secretary shall, by regulation, provide for separately listing color additives for use in or on food, color additives for use in or on drugs, or devices, and color additives for use in or on cosmetics, if and to the extent that such additives are suitable and safe for any such use when employed in accordance with such regulations.
21 U.S.C. § 376(b) (emphasis added).
Thus, the F.D.A. is required to issue separate regulations approving color additives specifically for use in food, drugs and cosmetics to the extent an additive is suitable and safe for its intended use. As a means of protecting the public health, 21 U.S.C. § 376(a) creates a presumption that a color additive is "unsafe" if the F.D.A. has not issued a regulation approving its use in a food, drug or cosmetic. Any product that contains the presumptively unsafe color additive ...