United States v. 41 Cases, More or Less, Etc., Naremco, Inc., Claimant-Appellant, 420 F.2d 1126 (5th Cir. 1970). · Go Syfert
United States v. 41 Cases, More or Less, Etc., Naremco, Inc., Claimant-Appellant, 420 F.2d 1126 (5th Cir. 1970). Cases Citing This Book View Copy Cite
55 citation events (1 in the last 25 years) across 20 distinct courts.
Strongest positive: United States v. Two Plastic Drums, More Or Less Of An Article Of Food, Labeled In Part: Viponte Ltd. Black Currant Oil Batch No. Boosf 039 (ca7, 1993-03-31)
Treatment trajectory · 1970 → 2026 · click a year to view as-of
1970 1998 2026
Top citers, strongest first. 26 distinct citers. How cited ↗
discussed Cited as authority (rule) United States v. Two Plastic Drums, More Or Less Of An Article Of Food, Labeled In Part: Viponte Ltd. Black Currant Oil Batch No. Boosf 039
7th Cir. · 1993 · confidence medium
Drums of Pure Vegetable Oil, 961 F.2d 808 , 812 & n. 3 (9th Cir.) (Evening Primrose Oil ("EPO") held food additive when encapsuled with Vitamin E, since "EPO is not a single ingredient"--distinguishing the case of BCO encapsuled alone), cert. denied sub nom., Efamol, Ltd. v. United States, --- U.S. ----, 113 S.Ct. 375 , 121 L.Ed.2d 287 (1992); FoodScience, 678 F.2d at 738 (principal ingredient of food a food additive if combined with another active ingredient); United States v. 41 Cases, More or Less, etc., 420 F.2d 1126, 1130 (5th Cir.1970) (medicated poultry feed found adulterated as contain…
discussed Cited as authority (rule) United States v. 29 Cartons of an Article of Food
1st Cir. · 1993 · confidence medium
Drums, Etc., 961 F.2d 808 , 812 n. 3 (9th Cir.), cert. denied, — U.S. -, 113 S.Ct. 375 , 121 L.Ed.2d 287 (1992); FoodScience, 678 F.2d at 738 ; United States v. 41 Cases, Etc., 420 F.2d 1126, 1130 (5th Cir.1970). 6 .The longevity of an agency's position is often significant in assaying the degree of deference owed to it.
discussed Cited as authority (rule) United States v. 29 Cartons (2×) also: Cited "see"
1st Cir. · 1993 · confidence medium
Drums, ___ ____ _____________ __________________ Etc., 961 F.2d 808 , 812 n.3 (9th Cir.), cert. denied, 113 S. Ct. ____ _____ ______ 375 (1992); FoodScience, 678 F.2d at 738 ; United States v. 41 ___________ ______________ __ Cases, Etc., 420 F.2d 1126, 1130 (5th Cir. 1970). ___________ 11 word.
discussed Cited as authority (rule) United States v. Two Plastic Drums, More or Less of An Article of Food
7th Cir. · 1993 · confidence medium
Drums of Pure Vegetable Oil, 961 F.2d 808 , 812 & n. 3 (9th Cir.) (Evening Primrose Oil (“EPO") held food additive when eneapsuled with Vitamin E, since “EPO is not a single ingredient” — distinguishing the case of BCO eneapsuled alone), cert. denied sub nom., Efamol, Ltd. v. United States, — U.S. -, 113 S.Ct. 375 , 121 L.Ed.2d 287 (1992); FoodScience, 678 F.2d at 738 (principal ingredient of food a food additive if combined with another active ingredient); United States v. 41 Cases, More or Less, etc., 420 F.2d 1126, 1130 (5th Cir.1970) (medicated poultry feed found adulterated as c…
cited Cited as authority (rule) United States v. Articles of Drug
N.D. Ill. · 1985 · confidence medium
Naremco, 420 F.2d 1126, 1130 (5th Cir.1970); United States v. Articles of Drug ...
discussed Cited as authority (rule) Shook & Fletcher Insulation Co. v. Central Rigging & Contracting Corp.
11th Cir. · 1982 · confidence medium
Decker & Sons, 569 F.2d 357, 363 (5th Cir. 1978); Kentucky Fried Chicken Corp. v. Diversified Packaging Corp., 549 F.2d 368, 390-91 (5th Cir. 1977); Owens v. International Paper, 528 F.2d 606, 611 (5th Cir. 1976); Luhrsen v. Vantage Steamship Corp., 514 F.2d 105, 106 (5th Cir. 1975); United States v. 41 Cases, More or Less, 420 F.2d 1126, 1132 (5th Cir. 1970).I. 2 Central Rigging also contends that by virtue of the result in certain arbitration proceedings, Shook & Fletcher’s claim is barred by the doctrines of res judicata, collateral estoppel, and equitable estoppel.
discussed Cited as authority (rule) Shook & Fletcher Insulation Company v. Central Rigging & Contracting Corporation
11th Cir. · 1982 · confidence medium
Decker & Sons, 569 F.2d 357, 363 (5th Cir. 1978); Kentucky Fried Chicken Corp. v. Diversified Packaging Corp., 549 F.2d 368, 390-91 (5th Cir. 1977); Owens v. International Paper, 528 F.2d 606, 611 (5th Cir. 1976); Luhrsen v. Vantage Steamship Corp., 514 F.2d 105, 106 (5th Cir. 1975); United States v. 41 Cases, More or Less, 420 F.2d 1126, 1132 (5th Cir. 1970). 2 8 Central Rigging also contends that by virtue of the result in certain arbitration proceedings, Shook & Fletcher's claim is barred by the doctrines of res judicata, collateral estoppel, and equitable estoppel.
discussed Cited as authority (rule) United States v. An Article of Food, Etc., Foodscience Laboratories, Inc., Claimant-Defendant-Appellant (2×)
7th Cir. · 1982 · confidence medium
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. 1…
cited Cited as authority (rule) United States v. an Article of Drug ... Neo-Terramycin Soluble Powder Concentrate
N.D. Tex. · 1982 · confidence medium
Coli-Trol 80, 518 F.2d at 747 ; Bentex Ulcerine, 469 F.2d at 880 ; United States v. 41 Cases, More or Less, 420 F.2d 1126, 1130 (5th Cir. 1970); United States v. An Article of Drug . . .
cited Cited as authority (rule) National Agents Service Co v. Duiser (In Re Duiser)
Bankr. W.D. Va. · 1981 · confidence medium
United States v. 41 Cases, 420 F.2d 1126, 1132 (5th Cir. 1969); In re Kingston Investment Corp., 4 B.C.D. 840 , 842 (C.D.
discussed Cited as authority (rule) United States v. Aangamik 15 Calcium Pangamate
unknown court · 1980 · confidence medium
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... .
cited Cited as authority (rule) Ferrari v. Bonardi (In re Auburn Medical Realty)
D. Mass. · 1980 · confidence medium
United States v. 41 Cases, More or Less, 420 F.2d 1126, 1132 (5th Cir. 1970).
cited Cited as authority (rule) United States v. Sene X Eleemosynary Corp., Inc.
S.D. Fla. · 1979 · confidence medium
Naremco Inc., 420 F.2d 1126, 1130 (5th Cir. 1970).
discussed Cited as authority (rule) National Labor Relations Board v. Jacob E. Decker and Sons
5th Cir. · 1978 · confidence medium
As we held in United States v. 41 Cases, More or Less, 420 F.2d 1126, 1132 (5th Cir. 1970), “[n]ewly discovered evidence must be evidence in existence of which a party was excusably ignorant, discovered after trial.
cited Cited as authority (rule) National Nutritional Foods Ass'n v. Kennedy
2d Cir. · 1978 · confidence medium
United States v. 41 Cases More or Less, 420 F.2d 1126,1131 (1970).
discussed Cited as authority (rule) The National Nutritional Foods Association, the National Association of Pharmaceutical Manufacturers and Solgar Co., Inc. v. Donald Kennedy, Commissioner of Food and Drugs, and United States Department of Health, Education & Welfare, Food and Drug Administration, Miles H. Robinson, Pro Se v. Donald Kennedy, Commissioner of Food and Drugs, and United States Department of Health, Education & Welfare, Food and Drug Administration
2d Cir. · 1978 · confidence medium
Recognizing that the Commissioner must have power to prevent the sale of vitamin and mineral preparations of such high potency as to be dangerous, they say the Commissioner must proceed under more general provisions relating to adulteration on a case by case basis see, e. g. § 402(a)(1), (3)-(7), (b), rather than the more readily enforceable provisions relating to food additives. 72 The contention has its force, but, as the Fifth Circuit has noted 73 The sole criterion for identifying a food additive is whether a substance which may become a component of or affect the characteristics of any f…
discussed Cited as authority (rule) United States v. 1,048,000 CAPSULES, MORE OR LESS, ETC.
S.D. Tex. · 1972 · confidence medium
No adequate and well-controlled investigation of the drug had been accomplished, and there was an absence of literature establishing safety, both of which factors are relevant in proving that a product is not generally recognized, United States v. 41 Cases, More or Less, 420 F.2d 1126, 1130 (5th Cir. 1970); United States v. An Article *772 of Drug, Etc., 294 F.Supp. 1307, 1311 (N.D.Ga.1968), aff’d, 415 F.2d 390 (5th Cir. 1969).
discussed Cited as authority (rule) United States v. Standard Milling Co.
N.D. Tex. · 1970 · confidence medium
The standard for determining the competence of a witness is that “[t]he expert qualifications of a witness is a question for the trial judge, whose decision is conclusive unless clearly erroneous as a matter of law,” United States v. 41 Cases, More or Less, 420 F.2d 1126, 1130-1131 (5th Cir. 1970).
cited Cited "see" United States v. Articles of Drug Consisting of the Following: 5,906 Boxes, Etc., United States of America v. Alcon Laboratories (Puerto Rico), Inc.
1st Cir. · 1984 · signal: see · confidence high
See United States v. 41 Cases, More or Less, 420 F.2d 1126, 1130 (5th Cir.1970).
cited Cited "see" Fed. Sec. L. Rep. P 97,979 Charles A. Gower, as Trustee in Bankruptcy for Harry Cohn, Pauline Cohn and Larry Cohn v. Robert Cohn
5th Cir. · 1981 · signal: see · confidence high
See United States v. 41 Cases, More or Less, 420 F.2d 1126, 1132 (5th Cir. 1970).
cited Cited "see" United States v. Articles of Drug Consisting of the Following: 27/1000 Tablet Bottles, More or Less, Labeled in Part: 1000 Tablets Colchicine
S.D.N.Y. · 1978 · signal: see · confidence high
See United States v. 41 Cases More or Less, 420 F.2d 1126, 1130 (5th Cir. 1970).
cited Cited "see" Owens v. International Paper Co.
5th Cir. · 1976 · signal: see · confidence high
See United States v. 41 Cases, More or Less, 420 F.2d 1126, 1132 (5th Cir. 1970).
cited Cited "see" United States v. Irving Firtel, as of the Estate of Abraham Brown, Deceased
5th Cir. · 1971 · signal: see · confidence high
See United States v. 41 Cases, More or Less, 5 Cir. 1970, 420 F.2d 1126 .
cited Cited "see, e.g." United States v. Undetermined Quantities of Articles of Drug
D. Maryland · 2001 · signal: see, e.g. · confidence medium
See, e.g., United States v. II Cases More or Less, 420 F.2d 1126, 1130 (5th Cir.1970).
cited Cited "see, e.g." Ag Pro, Inc. v. Bernard A. Sakraida
5th Cir. · 1975 · signal: see also · confidence low
See also, United States v. 41 Cases, 420 F.2d 1126 (5th Cir. 1970); Stiers v. Martin, 277 F.2d 737 (4th Cir. 1960); and Greenspahn v. Joseph Seagram & Sons, Inc., 186 F.2d 616 (2d Cir. 1951).
Retrieving the full opinion text from the archive…
UNITED STATES of America, Plaintiff-Appellee,
v.
41 CASES, MORE OR LESS, Etc., Et Al., Defendants, Naremco, Inc., Claimant-Appellant
27771.
Court of Appeals for the Fifth Circuit.
Jan 13, 1970.
420 F.2d 1126
1970 U.S. App. LEXIS 11235
Neale, Newman, Bradshaw & Freeman, O. J. Taylor, Springfield, Mo., Spruiell, Lowry, Potter, Lasater & Guinn, J. Donald Guinn, Tyler, Tex., for claimant-appellant., Richard B. Hardee, U. S. Atty., Tyler, Tex., for plaintiff-appellee; William W. Goodrich, Asst. - Gen. Counsel, John C. Young, Atty., U. S. Dept, of Health, Education and Welfare, Washington, D. C., of counsel.
Gewin, Coleman, Dyer.
Cited by 49 opinions  |  Published
1 passage pin-cited by 1 case
Pinpoint authority: bottom 69%
Citer courts: E.D. California (1)
COLEMAN, Circuit Judge.

The condemnation of several parcels of the poultry medications “Myconox” and “Ferro-Lac” generated this appeal. Pursuant to libel filed under 21 U.S.C. § 301 et seq., the products were seized in May, 1966. Subsequently, the appellant[*1128] Naremco, Inc., filed claim and answer. The cases were consolidated. Upon a jury verdict there was judgment that the seized products be destroyed as not in compliance with the Federal Food, Drug, and Cosmetic Act. We affirm.

It was alleged that the medicated feed Ferro-Lac was a food as defined in 21 U.S.C. § 321(f) [1] which was adulterated within the meaning of 21 U.S.C. § 342(a) (2) (C) [2] in that Ferro-Lac contained a combination of methylrosaniline chloride, sodium porpionate and sodium phthalylsulfacetamide. Further, it was asserted that Myconox contained a combination of methylrosaniline chloride and sodium propionate which were unsafe food additives within the meaning of 21 U.S.C. § 348 [3] since the intended use of the chemical combinations was not in conformity with an exemption or regulation in effect pursuant to 21 U.S.C. § 348.

It was additionally alleged that both Ferro-Lac and Myconox were misbrand-ed when introduced into and while in interstate commerce in violation of 21 U. S.C. § 352(a) [4] in that the labeling represented that Ferro-Lac was effective in the treatment of enteric infections associated with non-specific disease in poultry, and that Myconox was effective in the treatment of mycotic infections and that these statements are false and misleading since neither is effective for the stated purpose.

Finally, there was an allegation that Ferro-Lac and Myconox were drugs, as defined by 21 U.S.C. § 321(g), and “new drugs” within the meaning of 21 U.S.C. § 321 (p). In the terms of the statute a new drug is

“Any drug * * * the composition of which is such that such drug is not generally recognized, among experts qualified by scientific training and experience to evaluate the safety and effectiveness of drugs, as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling thereof * *

The jury found that Myconox was misbranded, was a new drug, and was a food additive. As to Ferro-Lac the jury found in favor of the government only on the food additive charge, which alone is sufficient to support condemnation.

Predictably, the evidence as to the qualities of the constituent drugs had to be “expert opinion”. A Food and Drug Administration veterinarian testified that he fed directed dosages of Ferro-Lac to certain chickens. At the end of this experiment the chickens were killed and certain parts were forwarded to a government chemist, who conducted tissue or chemical residue tests. Although these studies were limited to only one of the ingredients of Ferro-Lac, the chemist did find sulfanilamide, a breakdown product of the ingredient phthalyl-sulfacetamide, in tissues of chickens[*1129] which had been fed Ferro-Lac at the dosage level of twenty pounds per ton.

Having followed up the identification of these chemical residues, Dr. James Dollahite, Texas A. & M. veterinarian and toxicologist, testified that there was no existing scientific information concerning the safety of the combination of chemicals in Ferro-Lac, nor was there any scientific information concerning the safety of sodium phthalylsulfaceta-mide. Consequently he could not say how the three chemicals would act in combination or whether they would be safe.

On the food additive question testimony bearing on the general recognition for safety among experts came from Dr. Maurice Cover of the University of Delaware, Dr. Walter Gross of VPI, and Dr. Benjamin M. Pomeroy. Each testified that he kept abreast of veterinary pathology through professional meetings, colloquia, and constant review of the literature. In substance their testimony was that the particular combinations of chemicals at issue were not generally recognized as having been shown to be safe, since the available scientific literature was silent on the ingredients in Ferro-Lac and Myconox. Substantially identical testimony relevant to the new drug issue was elicited from both Drs. Cover and Pomeroy. In sum, these experts averred that Myconox was not generally recognized among qualified experts as safe and effective for its recommended use; that there was a total absence of published information on the subject.

Two persons, Dr. S. W. Coleman, a commercial poultryman, and Dr. D. C. O’Meara, a University of Maine professor, testified on the effectiveness (i. e., misbranding) of Myconox. Resolution of this question turned on the meaning of “mycosis”. The claimant insisted that the term referred only to digestive difficulties while the government’s expert witnesses unanimously agreed that mycosis meant any fungus infection. At any rate, Dr. Coleman testified that he abandoned Myconox treatment for digestive symptoms when his birds developed respiratory symptoms as well. Dr. O’Meara, on the other hand, stated that five tests he had run using Myconox to treat the mycotic infection of aspergil-losis had been successful.

The claimant’s evidence was largely devoted to the claimed actual effectiveness of Ferro-Lac and Myconox. No evidence was presented on either the food additive or new drug issues. All but two of the claimant's witnesses testified as lay witnesses that mycosis was understood in the poultry industry to be a fungus infection of the digestive tract and that Myconox was effective in treating it. Claimant’s chief expert witness, Dr. Emil Lorz, testified that the ingredients of both Myconox and Ferro-Lac were no more harmful in combination than they were singly.

Also introduced into evidence as claimant’s Exhibit 1 was a letter written April 13, 1961, by Mr. George P. Lar-rick, who was at that time the Commissioner of Food and Drugs. The most significant portions of that letter were as follows:

“The ‘Ferro-Lac’ and ‘TSC’ products sponsored by Mr. Scott are not new drugs and are not subject to the certification regulation; they fall into the category of drugs which may be distributed entirely on the responsibility of the firm.”

The claimant made appropriate motions for a directed verdict and judgment N.O.V. at trial and here asserts that there was insufficient evidence to support the verdict for the government. Our question, then, is whether there was substantial evidence to support the verdict. Hogan v. United States, 5 Cir., 1963, 325 F.2d 276; United States v. Simmons, 5 Cir., 1965, 346 F.2d 213, 218; Helene Curtis Industries, Inc. v. Pruitt, 5 Cir., 1965, 385 F.2d 841, 850; Boeing v. Shipman, 5 Cir., 1969, 411 F. 2d 365.

The thrust of claimant’s argument is that the statutory definition of food additive in 21 U.S.C. § 321 (s) contains four elements: The substance must be (1) “not generally recognized, among ex[*1130] perts qualified by scientific training and experience, (2) to evaluate its safety, (3) as having been adequately shown through scientific procedures * * * (4) to be safe under the conditions of its intended use * * *.”

A. Ferro-Lac — Food Additive

Since no witness was asked a question which embodied each of the four statutory elements, appellant argues that the probative expert testimony of the government cannot amount to the required substantiality. For example the testimony of Dr. Cover shows the following exchange:

“Q: Will you state whether you have an opinion as to whether the combination of these drugs [1] is generally recognized among experts qualified by scientific training and experience [3] as having been adequately shown through scientific procedures [4] to be safe for use as an aid in reducing non-specific enteritis in chickens and turkeys ?

“A: There is no such information that it is safe.”

The fact that the qualification [2] to evaluate its safety was omitted, appellant argues, means that the class of experts is not sufficiently delimited. Having in mind the reminder of the United States Supreme Court in United States v. Dotterweich, 320 U.S. 277, 64 S.Ct. 134, 88 L.Ed. 48, rehearing denied 320 U.S. 815, 64 S.Ct. 367, 88 L.Ed. 492 (1943), that the Food and Drug Act is a working instrument of government and not a collection of English words, we do not find appellant’s argument to be decisive. The government’s questions very clearly inquired into the safety of the product in the opinion of qualified experts. Thus, component number two of the statute is clearly implied.

B. Myconox — Food Additive

Likewise, claimant asserts that elements [1] and [2] in the statutory definition are absent in this interrogation of Dr. Cover:

“Q: Based on your knowledge and experience, and in your review of scientific literature and the colleagues you have consulted with, do you have an opinion as to whether the combination of sodium propionate and methyl-rosaniline chloride [3] has adequately been shown through scientific procedures [4] to be safe for use by adding it to the feed of broilers and market turkeys for the control of mycosis? “A: I know of no such information.”

Attack on this question as reflecting only the personal view of Dr. Cover is unavailing. The absence of scientific knowledge on the part of an expert and his colleagues is sufficient to show lack of general recognition of safety. United States v. Article of Drug etc., (N.D.Ga., 1968) , 294 F.Supp. 1307, affirmed per curiam 415 F.2d 390 (decided July 25, 1969) . As in (A) element number two may be implied.

C. Myconox — A New Drug

Alleged discrepancies between the “new drug” statutory definition and the questions posed to witnesses are once again the main complaint, and do not differ in kind from those discussed above. Here claimant also attacks the testimony of the government’s expert witnesses because they were not qualified in areas required by the statute.

The government’s witnesses are all veterinarians specializing in avian diseases. Even assuming that the witnesses are not qualified to judge the safety of the products, they are qualified to testify as to whether there is general recognition of the safety of the products. This is true because the absence of literature establishing safety is proof that a product is not generally recognized. United States v. Article of Drug, etc., supra, 294 F.Supp. at 1307, 1311. In addition, no objection was made to the competency of the witnesses in the court below. The expert qualification of a witness is a question for the trial judge, whose decision is conclusive unless clearly erroneous as a matter of[*1131] law. St. Joe Paper Company v. United States, 5 Cir., 1946, 155 F.2d 93.

D. Misbranding of Myconox

Misbranding of Myconox turns on whether mycosis refers to fungal infections in general or encompasses only digestive disorders. Conceding a conflict in the evidence, there was, at most, a question of fact for the jury.

Claimant moved to limit evidence concerning tissue residue tests on the ingredient sulfanilamide in Ferro-Lac until the government showed that the feeding of the combination of ingredients was less safe than the residues which would have resulted from feeding the ingredients individually. The trial court denied this motion and also denied an instruction to the jury to the effect that either of the substances in Ferro-Lac or My-conox could not be food additives unless the ingestion of the ingredients in combination was less safe than the individual ingredients.

Taking up the government’s concession that no attack was being made on the ingredients individually, the claimant stresses the immateriality of the presence of sulfanilamide unless the government shows that the residue would not have been found but for its combination methylrosaniline. chloride and sodium propionate.

Claimant’s arguments misconceive both the language of 21 U.S.C. § 321 (s) [5] and the government’s method of meeting its burden of proof. It does not matter under the Act if Ferro-Lac is in fact safe or whether the residues would be different if the individual ingredients were tested. 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, 21 U.S.C. § 321 (s).

When this evidence was introduced the government had already shown that Ferro-Lac was not generally recognized as safe. The tissue residue evidence was directed to showing that sodium phthaly-sulfacetamide became a component of food for man (in line with the statutory definition of a food additive). If it is true, as the claimant alleges, that the introduction of this evidence was a scare tactic, the proper corrective device would have been a request for a precautionary jury instruction.

The use made of Commissioner Larrick’s letter at trial constitutes claimant’s next argument for reversal. The jury was instructed that they were to use the Commissioner’s forgiveness of the prior clearance requirement, 21 U.S. C. § 348(a) (2) only with respect to Ferro-Lac. Claimant challenges this instruction on the ground that Myconox is the same formulation as Ferro-Lac Feedmix with additional amounts of two of the active ingredients. The government supports the instruction on the theory that the change in formulation demonstrates that Myconox is a different drug.

The courts have been reluctant to give too narrow a construction to this statute since it touches public health. AMP, Inc. v. Gardner, 2 Cir., 1968, 389 F.2d 825, 830, cert. denied 393 U.S. 825, 89 S.Ct. 86, 21 L.Ed.2d 95. Thus it is sound policy to say that adding different amounts of two active ingredients might make the resulting formulation a “new drug” under 21 U.S.C. § 321 (p). In United States v. Articles of Drug Labeled in part Quick-o-ver, (D.Md., 1967), 274 F.Supp. 443, the Court made indi[*1132] vidual findings on the new drug issue as to each of the four variations and found that three were new drugs because one ingredient was dropped and another ingredient increased. Where the government can show that differing quantities of the active ingredients are present, an inference may arise that the drug is new. Then the opposing party can rebut the inference by showing that there is no material difference in the two formulations as far as general recognition for safety by experts is concerned. Here the claimant failed to make such a showing.

There is no legitimate basis in the record for the grant of a new trial based on newly discovered evidence. At trial Dr. James Dollahite, a government witness, testified that one-third of the persons taking sulfanilamide develop a sensitivity to any of the sulfa drugs and that further use of sulfa drugs in such a person might produce death. In conclusion, Dr. Dollahite claimed that a bird with enteritis (for which Ferro-L'ae might be prescribed) would absorb more of the drug than a normal bird. In support of the motion claimant proffered an affidavit by Dr. Omer E. Hagebush challenging Dr. Dollahite’s scientific conclusions.

In order to overturn a denial of a new trial we must find an abuse of discretion. Stilwell v. Travelers Insurance Company, 5 Cir., 1964, 327 F.2d 931, Newly discovered evidence must be evidence in existence of which a party was excusably ignorant, discovered after trial. In addition facts implying reasonable diligence must be provided by the movant. The evidence must be material, and not cumulative or impeaching, and it must be such as to require a different result. Chemical Delinting Company v. Jackson, 5 Cir., 1951, 193 F.2d 123.

On the due diligence ground claimant must fail. The assertion that Dr. Hagebush’s affidavit is backed by thirty years of scientific research puts to rest any notion that the evidence is newly discovered. Also, in interrogatories claimant admitted to making residue tests on the constituents of its products. Thus it cannot claim that it had no reason to anticipate that the government might make such tests and present testimony about the results.

This evidence is merely impeaching in nature and does not constitute newly discovered evidence. United States Fidelity and Guaranty Company v. Lawrenson, 4 Cir., 1964, 334 F.2d 464, cert. denied 379 U.S. 869, 85 S.Ct. 141, 13 L.Ed.2d 71. F. W. Woolworth v. Seckinger, 5 Cir., 1942, 125 F.2d 97. Finally, the evidence is not such as would require a different result upon retrial, Tracy v. Terminal Railroad Association of St. Louis, 8 Cir., 1948, 170 F.2d 635, since disagreement among experts as to the general recognition of a drug as being safe only creates a fact question for the jury, United States v. Articles of Drugs Labeled in part Quick-o-ver, sup ra, at 448.

Counsel for the claimant has vigorously presented every reasonable possible basis for a reversal in this case. Nevertheless, we perceive no error and the judgment of the District Court must be

Affirmed.

1

. 21 U.S.C. § 321(f) 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.

2

. 21 U.S.C. § 342(a) (2) (C) a food shall be deemed to be adulterated if it is, or if it bears or contains, any food additive which is unsafe within the meaning of § 348 of this title: * * *

3

. 21 U.S.C. § 348(a) a food additive shall, with respect to any particular use or intended use of such additives, be deemed to be unsafe for the purposes of the application of clause (2) (C) of § 342(a) of this title, unless — •

(1) It and its intended use conform to the terms of an exemption which is in effect pursuant to subsection (i) of this section ; or

(2) There is in effect, and it and its use or. intended use are in conformity with, a regulation issued under this section prescribing the conditions under which such additive may be safely used.

While such a regulation relating to a food additive is in effect, a food shall not, by reason of bearing or containing such an additive in accordance with the regulation, be considered adulterated within the meaning of clause (1) of § 342(a) of this title.

4

. 21 U.S.C. § 352. A drug shall be deemed to be misbranded (a) if its labeling is false or misleading in any particular.

5

. 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 * * *, 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 * * * to be safe under the conditions of its intended use; * * *.