Fmali Herb, Inc. v. Margaret M. Heckler

This case presents a question of first impression arising under section 201(s) of the Food, Drug, and Cosmetic Act, 21 U.S.C. § 321 (s). The issue is whether the Food and Drug Administration (FDA) has properly interpreted the statute, which provides that the safety of substances added to food may be established by experience based on common use in food prior to 1958. We conclude that, even according the deference due an administrative agency’s interpretation of a statute that it is responsible for enforcing, the challenged FDA regulation does not fairly reflect either the language or purpose of the “common use in food” portion of section 201(s). We therefore reverse the district court’s declaration that the regulation is valid.

I

BACKGROUND

Section 201(s) of the Food, Drug, and Cosmetic Act, 21 U.S.C. § 321 (s) (1976), defines a “food additive” as a substance, added to food, that is

The question whether a substance is a “food additive” is significant because all “food additives” must by law undergo costly pretesting procedures before they may be marketed to the public. See 21 U.S.C. § 348 (1976).

In 1974, the FDA promulgated a regulation defining the term “common use in food”…

dissenting:

The Supreme Court stated in Federal Election Commission v. Democratic Senatorial Campaign Committee, 454 U.S. 27, 31-32 , 102 S.Ct. 38, 42 , 70 L.Ed.2d 23 (1981) that the “interpretation put on a statute by the agency charged with administering it is entitled to deference.” An agency’s interpretation will be upheld if its construction of the statute is “sufficiently reasonable.” Id. at 39 , 102 S.Ct. at 46 . “To satisfy this standard it is not necessary for a court to find that the agency’s construction was the only reasonable one or even the reading the court would have reached if the question initially had arisen in a judicial proceeding.” Id. See also Horizon Mutual Savings Bank v. Federal Savings & Loan Insurance Corp., 674 F.2d 1312, 1316 (9th Cir.1982).

The FDA’s regulation that limits the common usage test to use in the United States is a reasonable interpretation of the statute. The purpose of the amendment was to ensure that additives in foods consumed by Americans are safe to eat, taking into consideration such factors as the other items in the consumer’s diet and the consumer’s life span. S.Rep. No. 2422, 85th Cong., 2nd Sess. 3, reprinted in 1958 U.S.…

715 F.2d 1385 FMALI HERB, INC., Plaintiff-Appellant, v. Margaret M. HECKLER, * et al., Defendants-Appellees. No. 82-4604. United States Court of Appeals, Ninth Circuit. Argued and Submitted May 9, 1983. Decided Sept. 15, 1983. Barry Grossman, Edward T. Hand, William F. Baxter, Nancy C. Garrison, Dept. of Justice, Washington, D.C., for defendants-appellees. William R. Pendergrast, Hamel, Park, McCabe & Saunders, Washington, D.C., J. Bruce McCubbrey, Fitch, Even, Tabin, Flannery & Welsh, San Francisco, Cal., for plaintiff-appellant. Appeal from the United States District Court for the Northern District of California. Before PECK, ** FLETCHER, and PREGERSON, Circuit Judges. FLETCHER, Circuit Judge: 1 This case presents a question of first impression arising under section 201(s) of the Food, Drug, and Cosmetic Act, 21 U.S.C. § 321 (s). The issue is whether the Food and Drug Administration (FDA) has properly interpreted the statute, which provides that the safety of substances added to food may be established by experience based on common use in food prior to 1958. We conclude that, even according the deference due an administrative agency's interpretation of a statute…