Case Brief Summary & Legal Analysis

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tl;dr: FoodScience challenged condemnation of its Aangamik 15 tablets, arguing that DMG’s role as a principal ingredient excluded it from food-additive regulation. The court affirmed: DMG was not generally recognized as safe and lacked an exemption. It also upheld an injunction restricting interstate marketing, including conditional restrictions on drug marketing.

Legal Significance: The decision rejects a principal-ingredient exception to the statutory definition of food additive. It confirms that an ingredient’s importance does not eliminate the manufacturer’s burden to establish general recognition of safety and upholds restrictions designed to prevent circumvention of a food injunction through drug labeling.

Case Facts & Court Holding

Key Facts & Case Background

FoodScience Laboratories, Inc. produced Aangamik 15 tablets in Burlington, Vermont, and shipped them nationwide. DMG was the lesser of two active components and accounted for less than 4% of each tablet’s weight. The parties stipulated that Aangamik 15 was food and that no exempting regulations covered DMG.

The United States sought condemnation and an injunction, alleging that the tablets contained an unsafe food additive and were misbranded through vitamin claims and inadequate ingredient identification. FoodScience denied the critical allegations.

After a nonjury trial of six consolidated cases, the district court found the tablets adulterated and misbranded, condemned 60 cases, and restricted FoodScience’s manufacture and interstate distribution of Aangamik 15. The injunction excepted sales as a single ingredient for food use and provided conditional avenues for drug marketing.

FoodScience appealed the findings that DMG was an additive and was not generally recognized as safe, and challenged the injunction’s application to drug marketing. It did not challenge the finding that DMG lacked common food use before January 1, 1958, the misbranding determination, or condemnation as a consequence of adulteration and misbranding.

Court Holding & Legal Precedent

Issue: Did DMG qualify as an unsafe food additive in Aangamik 15 despite its asserted status as a principal ingredient, and could the injunction conditionally restrict marketing the product as a drug?

The court affirmed the condemnation and injunction. DMG was a component of Aangamik 15, and its asserted importance as a principal ingredient did not remove it from the statutory definition. The evidence supported the finding that DMG was not generally recognized as safe. Without an exemption, it was an unsafe food additive rendering the tablets adulterated. Conditional restrictions on drug marketing appropriately prevented circumvention of the injunction. Misbranding and the resulting entitlement to condemnation were unchallenged.

IRAC Legal Analysis

Legal Issue

Did DMG qualify as an unsafe food additive in Aangamik 15 despite its asserted status as a principal ingredient, and could the injunction conditionally restrict marketing the product as a drug?

Conclusion

The decision establishes that asserted principal-ingredient status does not exempt a component from food-additive regulation. Its controlling application concerns DMG in these tablets; the concurrence separately addressed marketing DMG alone.

Legal Rule

Under 21 U.S.C. § 321(s), a substance whose intended use makes it a food component qualifies as a food additive when it lacks the required general recognition of safety; principal ingredients have no categorical exception. Under 21 U.S.C. § 348(a) and (i), an additive without an applicable regulatory exemption is deemed unsafe, making food containing it adulterated under 21 U.S.C. § 342(a)(2)(C). The manufacturer bears the burden of establishing general recognition of safety. Section 332(a) authorizes injunctive relief against prohibited conduct.

Legal Analysis

The statutory term “component” encompasses ingredients present in large or small quantities. Congress’s broad definition therefore foreclosed FoodScience’s proposed exception for principal ingredients, regardless of consumers’ particular interest in DMG’s potential benefits.

National Nutritional Foods Ass’n v. Kennedy, 572 F.2d 377, 389–392 (2d Cir. 1978), supported treating a substance as a food additive even when it also qualifies as food. United States v. Ewig Bros. Co., Inc., 502 F.2d 715, 718–722 (7th Cir. 1975), explained the statutory framework’s allocation of the safety burden and its preference for uniform regulatory tolerances over case-by-case proof of actual injury. The court applied that framework rather than creating a judicial exception for DMG.

The evidence also supported the absence of general recognition of safety. All five government experts testified that DMG lacked such recognition. FoodScience’s four experts considered the dosages safe, but only one testified to general recognition of safety. The district judge was entitled to credit the government’s witnesses. Thus, the court’s conclusion rested on statutory unsafe status, not a finding that DMG actually caused injury.

FoodScience did not challenge misbranding or condemnation as a consequence of adulteration and misbranding. Finally, although FoodScience argued that drug-related restrictions required proof of unsafe drug use, the injunction provided avenues for lawful drug marketing if safety were established. The court upheld those restrictions as necessary to prevent evasion through relabeling.

Separate opinions

Cudahy, concurring: Cudahy agreed that the tablets were properly condemned but emphasized that DMG’s classification depended on its combination with other active ingredients. In his view, DMG marketed alone would require the government to prove adulteration or misbranding through ordinary procedures, rather than rely automatically on the food-additive presumption. He considered combination products less transparent to consumers and cautioned against extending the amendment beyond its intended purposes.

The Opinions

Summary

A substance is a “food additive” under the FDCA even if it is a principal ingredient; the statutory term “component” is interpreted broadly.
Classifying a substance as a food additive shifts the burden of proof to the manufacturer to show it is “generally recognized as safe” (GRAS).
Courts will enforce the FDCA’s regulatory framework strictly to manage risks from new food products with uncertain safety profiles.

Full text

Complete unedited opinion text as published by the court

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.

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:

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."

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 ofFood, 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 L.Ed.2d 423; United States v. General Foods Corp.,446 F.Supp. 740, 753 (N.D.N.Y.), affirmed mem., 591 F.2d 1332 (2d Cir. 1978).

In Ewig Bros., then Circuit Judge Stevens resolved the difficult question of whether DDT in fish was an "additive" by viewing it as a matter of assigning the burden of proving safety. In that case, placing the burden on the government might entail inconsistent decisions by different federal judges determining danger to health on a case-by-case basis; whereas, since DDT is not generally recognized as safe, placing the burden on the fishing industry (by deeming the DDT to be an "additive") would mean that "all of the fish in the Great Lakes are `adulterated' as a matter of statutory definition." 502 F.2d at 717, 719. To decide who should bear the burden of showing safety, Judge Stevens examined the history of adulterated food regulation prior to the Food Additives Amendment of 1958 and concluded that it "reflected a consistent desire to rationalize the law by reducing the circumstances in which the F.D.A. must prove actual danger to a quantity of food and by establishing a system of tolerances which will protect the public and enable industry to operate effectively." Id. at 721. With regard to the 1958 Act's definition of "additive," Judge Stevens found that "[a]lthough Congress was primarily concerned with substances used by a food processor, neither the language nor the history of the 1958 Act limits its application to such substances. The words `the intended use of which' are not confined, as they easily could have been confined, to use in food processing." Id. at 722 (footnote omitted). Thus DDT was held to be a food additive and the Food and Drug Administration would not have the burden of proving injury, but rather under 21 U.S.C. § 348 it would be permitted to set uniform tolerances for consumption of DDT in fish. As Judge Stevens noted in a footnote,

Id. at 722 n.27 (quoting United States v. 1,500 Cases More or Less, Tomato Paste,236 F.2d 208, 211 (7th Cir. 1956)).

If FoodScience cannot shoulder the burden of proving that DMG is "generally recognized as safe" and cannot persuade the Food and Drug Administration to grant an exemption under 21 U.S.C. § 348, it would certainly be unwise for this Court to create a judicial exception from the definition of "food additive" for DMG simply because it is a primary ingredient of Aangamik 15. When the quality and magnitude of hazards potentially associated with a new food product are as uncertain as they are here,5 the proper judicial response is aversion to the risks and strict enforcement of the regulatory framework for risk management established by Congress. See M. Shapo, A Nation of Guinea Pigs 248-262 (1979).

The second half of the statutory definition of a food additive requires that the substance "not be generally recognized, among experts qualified by scientific training and experience to evaluate its safety, as having been adequately shown through scientific procedures * * * to be safe under the conditions of its intended use." 21 U.S.C. § 321(s). The district court found that DMG is not "generally recognized as safe," and this finding was amply supported by the evidence. Five experts presented by the government all testified that DMG is not generally recognized among experts as safe. FoodScience's four experts testified that DMG is safe at the dosages used in Aangamik 15, but only one of these experts testified that DMG is "generally recognized as safe." Judge Roszkowski, who heard the expert witnesses, was entitled to credit the testimony of the government's five doctors that DMG is not generally recognized among qualified experts as safe for its intended use of human consumption in these tablets.

Because it meets the two statutory tests in Section 321(s), the DMG contained in these tablets is a food additive. Since DMG has not been exempted by the Food and Drug Administration pursuant to 21 U.S.C. § 348, it is an unsafe food additive and the tablets are an adulterated food under 21 U.S.C. § 342(a)(2)(C).

The district court also held that the tablets are misbranded under 21 U.S.C. § 343 because (1) the labels all suggest that the tablets contain a vitamin whereas the stipulation of facts and testimony show that the tablets contain no vitamin or pro-vitamin, and (2) the labels do not bear the common or usual name of each ingredient in the tablets.6 FoodScience has not challenged that its tablets are misbranded.

Since the tablets were both adulterated and misbranded, the district court concluded that they should be condemned under 21 U.S.C. § 334, which permits the condemnation of any article of food "that is adulterated or misbranded." FoodScience has not contested this corollary to the adulteration and misbranding.

Finally, the district court enjoined FoodScience pursuant to 21 U.S.C. § 332(a) from introducing Aangamik 15 into interstate commerce in food or drug form.7 FoodScience complains that the injunction is overbroad because there was no proof that Aangamik 15 would be unsafe as a drug. However, the district judge provided FoodScience with appropriate escape hatches for marketing the tablets as a drug should the tablets be found safe for drug usage. Specifically, FoodScience has been enjoined regarding Aangamik 15 as a drug only

Any competitive disadvantage that FoodScience may suffer as a result of following the above procedures is more than offset by the need the district court perceived to prevent FoodScience from circumventing the injunction. FoodScience should not be permitted to market adulterated foods by relabeling them as drugs.

Affirmed.

UNITED STATES v. AN ARTICLE OF FOOD Case Brief

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