U.S. v. An Article of Food

• Decision Date: 21 May 1982
• Docket Number: No. 81-1114,81-1114
• Citation: 678 F.2d 735
• Parties: UNITED STATES of America, Plaintiff-Appellee, v. AN ARTICLE OF FOOD, etc., Defendant, FoodScience Laboratories, Inc., Claimant-Defendant-Appellant.
• Court: U.S. Court of Appeals — Seventh Circuit

Page 735

678 F.2d 735

UNITED STATES of America, Plaintiff-Appellee, v. AN ARTICLE OF FOOD, etc., Defendant, FoodScience Laboratories, Inc., Claimant-Defendant-Appellant.

No. 81-1114.

United States Court of Appeals, Seventh Circuit.

Argued Dec. 8, 1981.

Decided May 21, 1982.

Robert Ullman, New York City, for claimant-defendant-appellant.

Stephen D. Terman, Asst. Chief Counsel for Enforcement, Food and Drug Administration, Rockville, Md., for the U. S.

Before CUMMINGS, Chief Judge, SWYGERT, Senior Circuit Judge, and CUDAHY, Circuit Judge.

CUMMINGS, Chief Judge.

The United States filed its amended complaint in this in rem food condemnation case in May 1979. The defendant food comprises numerous cases containing tablets of Aangamik 15, also known as "Calcium Pangamate," "Pangamic Acid," "Vitamin B-15," "Gluconic 15," "Sport 15," or "the famous Russian formula." Aangamik 15 is produced in Burlington, Vermont by the other defendant and claimant herein, FoodScience Laboratories, Inc., and then shipped to various points around the country. According to the government's complaint, the tablets are an adulterated food under 21 U.S.C. § 342(a)(2)(C) of the Federal Food, Drug and Cosmetic Act in that they contain a food additive-N,N-Dimethylglycine hydrochloride ("DMG")-which allegedly is unsafe under 21 U.S.C. § 348(a).

The government also claimed that the Aangamik 15 is misbranded under 21 U.S.C. § 343(a) because the label describes the article as "Vitamin B-15," although calcium pangamate is neither a vitamin nor a pro-vitamin and since indeed "there is no accepted scientific evidence which establishes any nutritional properties of the substance or has identified a deficiency of calcium pangamate in men or animals * * *." The government further charged that the substance was misbranded because it is "fabricated from two or more ingredients and its label fails to bear the common or usual name of each such ingredient * * *." Finally, the government alleged that FoodScience violated 21 U.S.C. § 331(a) by introducing this "adulterated and misbranded" article of food into interstate commerce. The government therefore urged the district court to condemn these cases of Aangamik 15 and to enjoin FoodScience from delivering any more of it into interstate commerce.

FoodScience denied the critical paragraphs of the amended complaint and the six consolidated cases were tried without a jury during the week of December 12, 1979. On October 29, 1980, the district court decided all issues in favor of the government. United States v. An Article of Food, etc., 503 F.Supp. 925 (N.D.Ill.1980). Judge Roszkowski first held that DMG is a food additive and, because the parties stipulated that the Secretary had issued no exempting regulations under 21 U.S.C. § 348(i), that DMG is deemed to be unsafe under 21 U.S.C. § 348(a). ¹ The court next held that the tablets under seizure are adulterated under 21 U.S.C. § 342(a)(2)(C) and misbranded under 21 U.S.C. § 343(a) and (i)(2). Therefore, in January 1981, the district judge entered an order condemning the 60 cases involved in the consolidated cases and enjoined FoodScience from manufacturing or introducing Aangamik 15 into interstate commerce except "when offered as a single ingredient for food use." ² This appeal by FoodScience followed.

I

The relevant provisions of the Federal Food, Drug, and Cosmetic Act are straightforward. "A food shall be deemed to be adulterated-* * * if it is, or it bears or contains, any food additive which is unsafe within the meaning of section 348 of this title * * *." 21 U.S.C. § 342(a)(2)(C). Under Section 348, a food additive is presumed to be unsafe unless the Secretary of Health and Human Services has promulgated a regulation "prescribing the conditions under which such additive may be safely used" or providing for "investigational use by qualified experts." 21 U.S.C. § 348(a) and (i). The parties stipulated prior to trial that Aangamik 15 is a food and, as noted, that the Secretary has promulgated no exempting regulations regarding the Aangamik 15 component DMG. The remaining question in the determination whether Aangamik 15 is an adulterated food, then, is whether DMG is a "food additive."

The Federal Food, Drug, and Cosmetic Act defines "food additive" as follows:

The term "food additive" means any substance the intended use of which results or may reasonably be expected to result, directly or indirectly, in its becoming a component or otherwise affecting the characteristics of any food (including any substance intended for use in producing, manufacturing, packing, processing, preparing, treating, packaging, transporting, or holding food; and including any source of radiation intended for any such use), if such substance is not generally recognized, among experts qualified by scientific training and experience to evaluate its safety, as having been adequately shown through scientific procedures (or, in the case of a substance used in food prior to January 1, 1958, through either scientific procedures or experience based on common use in food) to be safe under the conditions of its intended use * * *.

21 U.S.C. § 321(s). The district court found that DMG was not commonly used in food prior to January 1, 1958, and FoodScience has not challenged that finding on appeal. Rather, FoodScience asks us to set aside the district court's findings that under the foregoing definition (1) DMG is an "additive" (a "substance the intended use of which results * * * in its becoming a component or otherwise affecting the characteristics of" Aangamik 15), and (2) DMG is not "generally recognized as safe."

DMG Is an "Additive"

Even though DMG is quite clearly a "substance" that has become a "component" of Aangamik 15, FoodScience would have us read into the definition of "food additive" an exception for substances that become "principal ingredients" of the food to which they are added. Although DMG is the lesser of two active components of the tablets (Tr. 154, 755) and accounts for less than 4% of each tablet's weight (Record 10, 77 C 1647, Claimant's Answers to Plaintiff's Interrogatories, p. 11), FoodScience argues that DMG is a "principal ingredient" because the tablets' consumers are particularly hopeful of "the potential usefulness of DMG as a metabolic enhancer (whether or not it is a nutrient in the strict sense) * * *." Reply Brief 5. Since many ordinary additives come in relatively small quantities and food manufacturers often attempt to make their presence inconspicuous, an exception from the definition for "principal ingredients" might agree with the notion of "food additive" used in common parlance. But had Congress intended the Food and Drug Administration and the courts to rely on common parlance it would not have so carefully crafted the foregoing definition of the term. ³

FoodScience argues it is apparent from the statutory definition that Congress intended to limit the definition of "food additive" to substances that become a component of or affect food in some subtle or incidental fashion, such as substances "intended for use in producing, manufacturing, packing, processing etc." 21 U.S.C. § 321(s) (parenthetical clause), supra, p. 737. Once again, therefore, important and principal ingredients like DMG in Aangamik 15 should be excepted from the definition, according to FoodScience. The argument is ironic. In drafting Section 321(s), Congress obviously was concerned with creating a very broad definition of food additive that could not be escaped by food purveyors claiming that particular substances were present in too small a quantity or had affected the food too indirectly. FoodScience's argument is that because Congress was concerned with small amounts of unsafe substances, Congress could not similarly be concerned with unsafe substances present in relatively larger quantities. But the definition itself shows the absurdity: "(t)he term 'food additive' means any substance the intended use of which results * * * in its becoming a component * * * of any food * * *." The term "component" of course includes large quantities of unsafe substances as well as small quantities.

The case law agrees with our interpretation. For example, in National Nutritional Foods Ass'n v. Kennedy, 572 F.2d 377, 389-392 (2d Cir. 1978), the Court of Appeals concluded that the Food and Drug Administration may regulate high-potency vitamins and minerals as "food additives." The pill manufacturers in that case argued "that vitamins and minerals are foods (by themselves) * * * and that in the nature of things a 'food' cannot be a 'food additive,' especially when it is just more of the same (i.e., a high-potency vitamin or mineral)." Id. at 391. The Court answered that "We do not believe a substance gains immunity from (being a food additive) merely because it also qualifies as a food, * * * we see no reason why (the Food and Drug Administration) cannot determine that too much of even a good thing may come within the definition of a 'food additive.' " Id. at 391, 392. ⁴ See also United States v. Article of Food, etc., 414 F.Supp. 793 (E.D.Mo.1976), affirmed mem., No. 76-1554 (8th Cir. 1977) ("Orotic Acid" sold as a dietary supplement is a "food additive"); United States v. 41 Cases, More or Less, etc., 420 F.2d 1126, 1131 (5th Cir. 1970) (primary components of "Ferro-Lac" medicated chicken feed are "food additives").

The practical effect of holding that DMG is an additive is to place the burden of showing safety upon FoodScience. In order to avoid the label "food additive," FoodScience must now show that DMG is "generally recognized as safe," whereas if DMG were not an "additive," the Food and Drug Administration would have the burden under 21 U.S.C. § 342 of proving by a preponderance of the evidence that DMG is "injurious to health." See United States v. Ewig Bros. Co., Inc., 502 F.2d 715, 718-719 (7th Cir. 1975), certiorari denied, 420 U.S. 945, 95 S.Ct. 1324, 43...