United States v. Aangamik 15 Calcium Pangamate, 77 C 662
| Decision Date | 29 October 1980 |
| Docket Number | 77 C 3314 and 77 C 4219.,77 C 3210,77 C 1526,77 C 1647,No. 77 C 662,77 C 662 |
| Citation | 503 F. Supp. 925 |
| Parties | UNITED STATES of America, Plaintiff, v. An article of food consisting of the following: 60 cases more or less, each containing 12/50 tablet bottles . . . . . all labeled in part: ... (Bottle) "AANGAMIK 15 CALCIUM PANGAMATE, etc.," Defendant. FoodScience Laboratories, Inc., Claimant-Defendant. |
| Court | U.S. District Court — Northern District of Illinois |
James T. Hynes, Asst. U. S. Atty., Chicago, Ill., Nancy L. Buc, Chief Counsel, Stephen D. Terman, Asst. Chief Counsel for Enforcement, Rockville, Md., for plaintiff.
Robert Ullman, Bass, Ullman & Lustigman, New York City, for defendant.
FINDINGS OF FACT AND CONCLUSIONS OF LAW
This matter is before the court for a ruling following a bench trial beginning on December 12, 1979 and ending on December 19, 1979.
This is an action for a civil in rem seizure and injunction brought pursuant to the provisions of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 301, et seq., (the "Act"). Plaintiff is seeking condemnation, pursuant to 21 U.S.C. § 334, of an article of food generally referred to as Aangamik 15 tablets.
Plaintiff commenced six in rem seizure actions, one each in the Districts of New Jersey, Oregon, Hawaii and the Southern District of Florida, and two in the Northern District of Illinois. The six actions were consolidated for trial in the Northern District of Illinois pursuant to the provisions of 21 U.S.C. § 334(b).
FoodScience Laboratories, Inc. ("FoodScience"), manufacturer of Aangamik 15, filed a claim to the Aangamik tablets under seizure in this consolidated case.
Subsequently, plaintiff was allowed to amend the complaints to include a prayer for injunctive relief against claimant. Claimant filed an amended answer asserting as an affirmative defense this court's lack of in personam jurisdiction over the person of the claimant.
At trial, FoodScience moved to dismiss the complaint against it as a defendant in an injunction action. The court reserved ruling on that motion until the close of the case.
At this time, the court denies defendant's motion to dismiss the complaint against it as a defendant in an injunction action. The court finds that plaintiff's prayer for condemnation of the article and prayer for injunctive relief grow out of the same transaction and that the basic issues are identical. As stated in Fresh Grown Preserve Corporation v. United States, 143 F.2d 191, 195 (6th Cir. 1944):
... a court having jurisdiction of the principal cause, possesses jurisdiction over all its incidents, and may by motion, attachment, or execution enforce its decrees against all who become parties to the proceedings.
See, also United States v. 184 Barrels Dried Whole Eggs, 53 F.Supp. 652 (E.D.Wis.1943). Consequently, it is in the interest of judicial economy for the court to consider all of plaintiff's prayers for relief at the same time.
Plaintiff's complaint alleges that Aangamik 15 is a food which is adulterated within the meaning of 21 U.S.C. § 342(a)(2)(C) in that it bears or contains a food additive which is unsafe within the meaning of 21 U.S.C. § 348(a). Plaintiff further alleges that the Aangamik 15 is misbranded within the meaning of 21 U.S.C. § 343(a) and § 343(i)(2).
Finally, plaintiff alleges that claimant/defendant, FoodScience Laboratories, Inc., has been and is now engaged in the delivery or introduction for delivery into interstate commerce of the Aangamik 15 in violation of section 331(a) of the Act, 21 U.S.C. § 331(a). Plaintiff seeks injunctive relief pursuant to the provisions of 21 U.S.C. § 332.
Defendants are the articles of food seized in the consolidated cases and FoodScience Laboratories, Inc., a corporation organized and existing under the laws of the State of Vermont.
The Aangamik 15 tablets under seizure (the "Aangamik 15 tablets") contain a mixture of N,N-Dimethylglycine hydrochloride (N,N-Dimethylglycine), calcium gluconate, Avicel, Stearic Acid, and Dicalcium Phosphate.
The Aangamik 15 tablets were shipped in interstate commerce from the State of Vermont to the States of Illinois, Florida, Oregon, Hawaii and New Jersey. The tablets were shipped in interstate commerce to Illinois, Florida, Oregon, Hawaii and New Jersey prior to each of the seizures consolidated in this action.
The Aangamik 15 tablets are intended for oral ingestion by humans. The tablets contain the substance N,N-Dimethylglycine. N,N-Dimethylglycine is a naturally occurring constituent of foods.
N,N-Dimethylglycine is not a substance that was in common use in food prior to January 1, 1958.
The Food and Drug Administration ("FDA") has not provided for by regulation any exemption for investigational use of N,N-Dimethylglycine in foods or food supplements. The FDA has not published any regulations allowing the use of N,N-Dimethylglycine in foods or food supplements.
FoodScience has been and is now engaged in the delivery or introduction for delivery into interstate commerce of articles of food within the meaning of 21 U.S.C. § 321, containing N,N-Dimethylglycine.
The Aangamik 15 tablets were labeled containing calcium pangamate and were represented as being or containing Vitamin B-15. There is no scientifically recognized Vitamin B-15, and the tablets do not contain Vitamin B-15.
Neither N,N-Dimethylglycine nor calcium pangamate is a vitamin or pro-vitamin.
There are and have been many commercially marketed products referred to as "calcium pangamate", "pangamic acid", "Vitamin B-15", and "B-15", which contain varying chemical formulations. The labels on the Aangamik 15 tablets under seizure state,
This court has jurisdiction of this action under 28 U.S.C. § 1345 and 21 U.S.C. § 334.
The court has in personam jurisdiction over the claimant for purposes of injunctive relief pursuant to 21 U.S.C. § 332(a).
The seized articles of Aangamik 15 tablets are food within the meaning of 21 U.S.C. § 321(f). They are liable to seizure and condemnation if they are found to contain an unsafe food additive within the meaning of 21 U.S.C. § 348(a).
Both parties agree that the critical issue in this case is whether N,N-Dimethylglycine is an unsafe food additive within the meaning of 21 U.S.C. § 321(s) and § 348(a). Section 321(s) provides, in pertinent part:
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; 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; ....
Defendant argues that N,N-Dimethylglycine is a naturally occurring substance in food and is, itself, recognized as a food. Therefore, the fact that it is extracted from its natural habitat and offered in the form of a tablet does not change its character as a food.
Plaintiff contends that N,N-Dimethylglycine is a substance, the intended use of which resulted in its becoming a component of a food, specifically the Aangamik 15 tablets. According to 21 C.F.R. 170.3(g), "... `substance' in the definition of the term `food additive' includes a food or food component of one or more ingredients."
Section 321(f), 21 U.S.C. § 321(f), defines a "food" as follows:
The term "food" means (1) articles used for food or drink for man or other animals, (2) chewing gum, and (3) articles used for components of any such article.
It appears to be settled that a "food" may also be a "food additive" as defined by the Act. In United States v. Article of Food Consisting of 10 Drums, More or Less, of Orotic Acid, 414 F.Supp. 793 (E.D.Mo.1976), aff'd. No. 76-1554 (8th Cir. 1977), the court found that orotic acid is both a food and an unsafe food additive within the meaning of the Act. Although the orotic acid in question had been manufactured, orotic acid is found naturally in cow's milk.
Petitioner in National Nutritional Foods Association v. Kennedy, 572 F.2d 377 (2nd Cir. 1978), contended that vitamins and minerals are foods within the meaning of the Act and that, within the nature of things, a food cannot be a food additive. In rejecting this contention, the court quoted from United States v. 41 Cases, More or Less, 420 F.2d 1126, 1131 (5th Cir. 1970), as follows:
The sole criterion for identifying a food additive is whether a substance which may become a component of or affect the characteristics of any food be not generally recognized among qualified experts as having been shown to be safe....
The court went on to state that a substance does not gain immunity from this criterion merely because it also qualifies as a food.
This court finds that N,N-Dimethylglycine is a food additive within the meaning of 21 U.S.C. § 321(s). After reviewing the considerable amount of expert testimony presented by both parties, it is the court's opinion that N,N-Dimethylglycine is not generally recognized among qualified experts as having been shown to be safe under the conditions of its intended use.
The parties have stipulated to the fact that the FDA has not provided for by regulation any exemption for investigational use of N,N-Dimethylglycine in food or food supplements nor has the FDA published any regulations allowing the use of N,N-Dimethylglycine in foods or food supplements. Consequently,...
To continue reading
Request your trial
-
Miller Brewing Co. v. Falstaff Brewing Corp.
... ... Civ. A. No. 80-0382 ... United States District Court, D. Rhode Island ... , pursuant to § 43(a) of the Lanham Act, 15 U.S.C. § 1125(a), and for trademark dilution ... v. Miller Brewing Co., No. 77-100C (E.D.Mo. Aug. 17, 1978), the court granted ... ...
-
U.S. v. An Article of Food
...678 F.2d 735 ... UNITED STATES of America, Plaintiff-Appellee, ... AN ... numerous cases containing tablets of Aangamik 15, also known as "Calcium Pangamate," "Pangamic ... than 4% of each tablet's weight (Record 10, 77 C 1647, Claimant's Answers to Plaintiff's ... 778; R. 10 (No. 77 C 1647); R. 22 (No. 77 C 662) ... 2 See ante at 3 & n.2 ... 3 21 U.S.C. § ... ...
-
Foodscience Corp. v. McGraw-Hill, Inc., Civ. A. No. 80-186.
... ... Civ. A. No. 80-186 ... United States District Court, D. Vermont ... July 10, ... market health food products labeled "Anangamik-15" and "Gluconic-15." The complaint states these ... (SEC dep. III, A III 71 at pp. 76-77). The SEC deposed Orlandi for a second time on ... and impounded in 1977 six shipments of Aangamik 15 as an adulterated food, see 21 U.S.C. § 342, ... ...
-
§2.5 Foods for Special Dietary Uses and Food Additives: 1970-1990
...U.S. v. Article of Food Consisting of 10 Drums, Etc., 414 F. Supp. 793 (1976); see also, U.S. v. Aangamik 15 Calcium Pangamate, 503 F. Supp. 925 (1980).[396] 613 F.2d 947 (1979). In a case relating to acrylonitrile copolymers present in beverage containers, the FDA desired to label the copo......
-
Table of Cases
...(1913), §2.2 United States v. Two Plastic Drums of Article of Food, 791 F. Supp.751 (1991), §4.2 U.S. v. Aangamik 15 Calcium Pangamate, 503 F. Supp. 925 (1980), §2.5 U.S. v. Allan Drug Corporation, 357 F.2d 713 (1968), §2.4 U.S. v. American Laboratories, 222 F. 104, §2.2 U.S. v. An Article ......