Court Opinion

ID: 9469207
Source: CourtListenerOpinion
Date Created: 2023-08-05 02:35:12.391403+00
Date Added: 2024-06-11T17:41:17.096219
License: Public Domain

CUDAHY, Circuit Judge,
concurring.
I concur fully in Chief Judge Cummings’ conclusion that the government in this case properly condemned defendant’s “Aangam-ik 15” tablets as an adulterated food because they contain an unsafe “food additive” — DMG—for which no exempting regulations have been issued. I write separately only to emphasize that, in my view, characterizing DMG as a “food additive” depends critically on its being added to or sold in combination with other active ingredients. Because FoodScience consistently represented to the public, and maintained throughout the pre-trial stages of this proceeding, that its “Aangamik 15” tablets contained two active and beneficial ingredients — DMG and calcium gluconate — I agree that the district court properly found DMG to be a “food additive” within the meaning of 21 U.S.C. § 321(s) (1976).1 I believe, however, as did the district court,2 that this would be a far different case if DMG were being marketed as a single food ingredient. In that case, the FDA would not be entitled to rely on the “food additive” presumption to condemn plaintiff’s product but would instead be obligated to shoulder its normal burden of proving, by a preponderance of the evidence, that DMG was an “adulterated food” within the meaning of 21 U.S.C. § 342(a)(1) (1976)3 or that the product was “misbranded” under the standards set forth in 21 U.S.C. § 343 (1976).
Limiting the definition of “food additive” to substances which are either added to or sold in combination with other active ingredients not only comports with common usage, but also makes sense from the point of view of informing the consumer. When food substances such as DMG are combined with other “beneficial” ingredients and sold under such unrevealing brand names as “Aangamik 15,” “Calcium Pangamate,” or “the famous Russian formula,” consumers may well be unaware of the presence of, or potential dangers associated with, each of the product’s individual ingredients; a broad prophylactic rule such as the burden-shifting “food additive” presumption is therefore appropriate. When substances such as DMG are marketed in pure form, however, and are properly labeled as such, consumers can more reasonably be expected to know what they are buying and, thus, can safely be given the opportunity to *742weigh for themselves the benefits and risks of their purchase. Of course, if DMG is in fact deleterious or dangerous to human health, the FDA may condemn it as an “adulterated food” under 21 U.S.C. § 342(a)(1) (1976).
In sum, I do not believe that merely because DMG may be properly classified as an “unsafe food additive” (since not generally recognized as safe) when sold as part of a multi-ingredient tablet, it may also be automatically condemned, via the “food additive” presumption, as an “adulterated food” when marketed alone. Accord United States v. An Article of Food Consisting of .. . L-Tryptophan, Civ. 77-687 (D.N.J. Jan. 23, 1979). The 1958 food additive amendment was designed to provide an extra measure of protection against the introduction into foods and food products of untested and potentially unsafe flavor, texture, processing and preservative agents. See S.Rep.No.2422, 85th Cong., 2d Sess. 1958, reprinted in [1958] U.S.Code Cong. & Ad.News 5300, 5304. It should not be stretched so far beyond its intended purposes as to significantly displace the FDA’s normal condemnation procedures.

. In its appellate briefs, FoodScience attempts to argue, apparently for the first time, that DMG is the sole active ingredient in Aangamik 15 and that all the other components of the tablet — including calcium gluconate — are merely buffering agents, lubricants or binder/fillers. Appellant’s Br. at 8; Reply Br. at 5-7. This contention is not supported by the record and is belied by FoodScience’s own Answers to Interrogatories. See Tr. 778; R. 10 (No. 77 C 1647); R. 22 (No. 77 C 662).

. See ante at 3 & n.2.

. 21 U.S.C. § 342(a)(1) provides that a food shall be deemed adulterated
If it bears or contains any poisonous or deleterious substance which may render it injurious to health; but in case the substance is not an added substance such food shall not be considered adulterated under this clause if the quantity of such substance in such food does not ordinarily render it injurious to health.
Under this provision the FDA may condemn a given food product only if the FDA can establish by a preponderance of the evidence that the product is in fact poisonous or deleterious and that it might in fact be injurious to health. See United States v. Lexington Mill & Elevator Co., 232 U.S. 399, 34 S.Ct. 337, 58 L.Ed. 658 (1914); United States v. 2,116 Boxes of Boned Beef, 516 F.Supp. 321 (D.Kan.1981).