Charged 1-7-68: while held by Salasnek Fisheries, Inc., Detroit, Mich., the article was rodent gnawed, and was held under insanitary condi tions; 402(a)(3), 402(a)(4). Consent decree authorized release to dealer for reconditioning. (3)

Mushrooms, dried, at Brooklyn, E. Dist. N.Y.

Charged on or about 2-19-69: while held by Richard Street Warehouse, Brooklyn, N.Y., the article contained insect filth and was held under insanitary conditions; 402(a)(3), 402(a)(4). Default decree ordered destruction. (4)

Peanuts, shelled, at Santa Fe Springs, C. Dist. Calif.

Charged 11-21-69: while held by Shoemaker Candies, Santa Fe Springs, Calif., the article contained rodent filth and had been held under insanitary conditions; 402(a)(3), 402(a)(4). Default decree ordered destruction. (5)

Peas, black-eyed, dried, at Mobile, S. Dist. Ala.

Charged 12-8-69: when shipped by Cal Bean & Grain Co-op, Pixley,
Calif., the article had been held under insanitary conditions; 402(a)(4).
Default decree ordered destruction. (6)

Poppyseed, at Brooklyn, E. Dist. N.Y.

Charged 7-10-69: while held by Joseph Korn Bakery, Brooklyn, N.Y., the article contained rodent filth and was held under insanitary conditions; 402(a)(3), 402(a)(4). Default decree ordered destruction. (7)

Rice and pinto beans, at San Francisco, N. Dist. Calif.

Charged 7-28-69: while held by Ideal Distributing Co., Division of Big Bonus Foods, Inc., San Francisco, Calif., the articles contained rodent filth and were held under insanitary conditions; 402(a)(3), 402(a)(4). Default decree ordered destruction. (8)

Salmon, frozen, at Bellingham, W. Dist. Wash.

Charged 11-8-67: when shipped by Marine Foods Packing Co., Yakutat, Alaska, the article contained decomposed fish; 402(a)(3). Consent decree authorized release to shipper for salvaging. (9)

Tomatoes, canned, at Starkville, N. Dist. Miss.

Charged 10-14-68: when shipped by Emerson Canning Co., Reed Springs,
Mo., the article, labeled in part "Deck's Tomatoes Distributed by
Deck Sales Agency Springfield, Mo.," contained insect filth; 402(a)(3).
Default decree ordered destruction. (10)

Walnuts, black, shelled, at Detroit, E. Dist. Mich.

Charged 8-4-69: when shipped by Continental Nut Co., Chico, Calif., the article contained E. coli and had been prepared and packed under insanitary conditions; 402(a)(3), 402(a)(4). Consent decree authorized release to shipper for reconditioning. (11)

FOOD ADDITIVES

Salmon slices, smoked, Gold Coast, at Brooklyn, E. Dist. N.Y.

Charged 12-10-68: when shipped by Roodman's, Inc., St. Louis, Mo., the article contained the food additive sodium nitrate in excess of the prescribed limit of 500 p.p.m.; 402(a)(2)(C). Default decree ordered destruction. (12)

DRUGS/Human Use

Ahead hair restorer cream, 3 seizure actions, at Encino, El Segundo, Santa Fe Springs, and Los Angeles, C. Dist. Calif.

Charged 3-13-67, 3-15-67, and 3-27-67: when shipped by Kelly Products, Inc., Royal Oak, Mich., the article was a new drug without an effective approved New Drug Application, the label lacked the established name of each active ingredient, and the article had been manufactured in an unregistered establishment; 505(a), 502(e)(1)(A)(ii), 502(0). Default decrees ordered destruction. (13)

Aspirin tablets, at Midland, E. Dist. Mich.

Charged 8-7-68: when shipped by Formulations, Inc., Milwaukee, Wis., the article had been prepared, packed, and held under insanitary conditions and under circumstances that lacked conformity with current good manufacturing practice; 501(a)(2)(A), 501(a)(2)(B). Default decree ordered destruction. (14)

sulfate

Atropine sulfate and salol combination tablets, at South Bend, N. Dist. Ind. Charged on or about 7-22-69: when shipped by Standard Pharmacal Corp., Elgin, Ill., the article, labeled in part "Prepared for Garland Pharmaceuticals, Inc. Rena-Spaz Tablets contains atropine hyoscyamine.. gelsemium methenamine ... salol benzoic acid methylene blue," had been manufactured, processed, packed, and held under circumstances that lacked conformity with current good manufacturing practice; and the article's strength differed from its purported strength, and the labeling was false and misleading, since the article was approximately 27 percent deficient in salol; 501(a)(2)(B), 501(c), 502(a). Default decree ordered destruction. (15)

D-Matropinal homatropine combination tablets, Matropin homatropine combination tablets, and Vi-Hepamin hydrocholeretic vitamin-mineral tablets, at Houston, S. Dist. Tex.

Charged 5-16-67: while held by Comatic Labs., Inc., Houston, Tex., the labeling of the articles, which had been manufactured on order of the dealer, lacked adequate directions for use and did not comply with the Rx drug exemption requirement for disclosure of information; 502(f)(1). Consent decree ordered destruction. (16)

Drug samples, partially labeled drugs, and repacked drugs, at Teaneck, Dist. N.J. Charged 9-5-69: while held by Camar Sales, Teaneck, N.J., who was repacking the articles, which had been manufactured outside the State of New Jersey, the circumstances of the articles' processing, packing, and holding lacked conformity with current good manufacturing prac

tice, and the articles were prepared and processed in an establishment in New Jersey which was not duly registered; 501(a)(2)(B), 502(0). Default decree ordered destruction. (17)

Fever Junior aspirin-aconite combination tablets, Palmosan palmetto extract combination tablets, Hemophos hemoglobin and nux vomica combination tablets and Sed-A-Cel phenobarbital combination syrup, at Auburn, N. Dist. N.Y.

Charged 7-7-69: when shipped by C. M. Bundy Co., Cincinnati, Ohio, and while held by Jenkins Labs., Inc., Auburn, N.Y., who was repacking the articles, the labeling of the Fever Junior tablets and Hemophos tablets lacked adequate directions for use and did not comply with the Rx drug exemption requirement for disclosure of information, and the shipper's labeling of the bulk Palmosan tablets was false and misleading, since it claimed effectiveness for the articles as a urinary antiseptic-502(f)(1), 502(a); and while held by Jenkins Labs., Inc., Auburn, N.Y., who was repacking the articles, the Sed-A-Cel syrup lacked adequate directions and did not comply with the Rx drug exemption requirement for disclosure of information-502(f)(1); and the dealer's labeling of the repacked Palmosan tablets was false and misleading, since it claimed effectiveness for the article as a urinary antiseptic-502(a). Default decree ordered destruction. (18)

Miscellaneous drugs, at Birmingham, N. Dist. Ala.

Charged 10-10-69: when the articles (which had been involved in a drugstore fire at Dallas, Tex., and thereafter purchased as salvage_drugs by Mazer Salvage Sales, Birmingham, Ala.) were shipped from Dallas, Tex., and while the articles were held in a semiopen shed by the purchaser at Birmingham, Ala., the articles were held under insanitary conditions, the circumstances of the holding of the articles lacked conformity with current good manufacturing practice, and the labeling of many of the articles lacked adequate directions or information for use due to loss or damage of labeling; 501(a)(2)(A), 502(a)(2)(B), 502(f)(1). Default decree ordered destruction. (19)

Miscellaneous drugs, at Jacksonville, M. Dist. Fla.

Charged 9-30-69: while held by Underwriters Salvage Co. of New York, at Jacksonville, Fla., after being stored in a warehouse damaged by a hurricane, the articles had been held under insanitary conditions, the labels lacked the name and place of business of the manufacturer, a quantity of contents statement, and the established name of the drug or the established name of each active ingredient, and the labeling lacked adequate directions for use; 501(a)(2)(A), 502(b)(1), 502(b)(2), 502(e)(1)(A), 502(f)(1). Default decree ordered destruction. (20)

Testosterone enanthate disposable syringes, at Jacksonville, M. Dist. Fla. Charged 1-18-67: when shipped by Safety Syringe Corp., Massillon, Ohio, the article, labeled in part "1 cc. Syringes SafTCel.. Testosterone Enanthate, U.S.P. 100 mg. [or "200 mg."] per cc. Distributed by

Ortega Pharmaceutical Company, Jacksonville, Florida,' was a new drug without an effective approved New Drug Application; 505(a). The Government filed a motion for summary judgment which was denied; thereafter, a consent decree of condemnation ordered destruction of the article. (21)

Thiamine hydrochloride injection, U.S.P., at Queens Village, E. Dist., N.Y. Charged on or about 8-12-69: while held by Torigian Laboratories, Inc., Queens Village, N.Y., who manufactured the article from thiamine hydrochloride shipped in interstate commerce, the article's quality fell below the U.S.P. standard, since the article failed the test for pyrogenicity; 501(b). Default decree ordered destruction. (22)

Thyroid tablets, at Detroit, E. Dist. Mich.

Charged 1-30-68: while held by Cord Laboratories, Inc., Detroit, Mich., who manufactured the article from thyroid powder shipped in interstate commerce, the labeling contained the false and misleading claims for safely accelerating cellular metabolic processes, for increasing the basal metabolic rate and for being a safe and effective adjunct in the treatment of obesity; the labeling lacked adequate information for use by licensed practitioners; and the article was dangerous to health when used with the frequency and duration prescribed in its labeling; 502(a), 502(f)(1), 502(j). Default decree ordered destruction. (23)

MEDICAL DEVICES

Kandle-Vak ear candle, at Amarillo, N. Dist. Tex.

Charged 10-31-69: when shipped by O. W. Swofford, D.C., doing business as Kandle-Vak Co., Glendale, Ariz., the article's labeling contained false and misleading claims for ear troubles, and the labeling lacked adequate directions for use and adequate warnings against unsafe use; 502(a), 502(f)(1), 502(f)(2). Default decree ordered destruction. (24) Miscellaneous devices, at Birmingham, N. Dist. Ala.

Charged 10-10-69: when the articles (which had been involved in a drugstore fire at Dallas, Tex., and thereafter purchased as salvage articles by Mazer Salvage Sales, Birmingham, Ala.), were shipped from Dallas, Tex., and while the articles were held in a semiopen shed by the purchaser at Birmingham, Ala., the articles were held under insaní tary conditions, and the labeling of many of the articles lacked adequate directions or information for use due to loss or damage of labeling: 501(a)(2)(A), 502(f)(1). Default decree ordered destruction. (25)

Respirator, at Santa Barbara, C. Dist. Calif. when shipped by unknown shipper, the article, Charged 9-19-69: labeled in part "For every breathing difficulty Res-Q-Aire Emergency Respirator" bore the name Res-Q-Aire and statements on the carton label and attached card which were false and misleading as to the adequacy and effectiveness of the article as a means of resuscitation; the labeling lacked adequate directions for use, and such could not be written, since the article was neither effective nor safe for its intended purpose; the labeling lacked warnings against use involving obstructions, aspirated objects and dentures, and involving infants or children where the volume of air would be excessive; and the article was dangerous to health when used as directed by its labeling; 502(a), 502(f)(1), 502(f)(2), 502(j). Default decree ordered destruction. (26) Respirator, 2 seizure actions at Wilmington, E. Dist. N.C., and New York, S. Dist. N.Y. Charged 8-1-69 and 8-11-69: when shipped by Crown Products Co., Cleveland, Ohio, the article, labeled in part "For every breathing difficulty Res-Q-Aire Emergency Respirator A product of Machsa Incorporated Distributed exclusively by Crown Products Co. A Division of The Chilcote Company," bore the name Res-Q-Aire and statements on the carton label and attached card which were false and misleading as to the adequacy and effectiveness of the article as a means of resuscitation; the labeling lacked adequate directions for use, and such could not be written, since the article was neither effective nor safe for its intended purposes; the labeling lacked warn

ings against use involving obstructions, aspirated objects and dentures, and involving infants or children where the volume of air would be excessive; and the article was dangerous to health when used as directed by its labeilng; 502(a), 502(f)(1), 502(f)(2), 502(j). Default decrees ordered destruction. (27)

HAZARDOUS SUBSTANCES

Aerosol lubricant, at Hamburg, W. Dist. N.Y.

Charged 2-16-66: when shipped by American Aerosol, Inc., Holland, Mich., the article, labeled in part "Ladco THIS Stops Also Waterproofs and Lubricates THIS is a miracle silicone cure-all Ladco Chemical Products Co., Inc., Hamburg, N.Y.," was a flammable substance in a self-pressurized container; its container (which the shipper had labeled with labels supplied by Ladco Chemical Products Co., Inc., Hamburg, N.Y.) lacked a number of the required label statements; and the signal word "CAUTION" and the statement of "Contents Under Pressure" were inconspicuous, since they were not placed on the label with adequate contrast, and since the signal word was not in 18 point type, and the statement of hazard was not in capital letters and was not in 12 point type; 2(p)(1), 2(p)(2). Default decree ordered destruction. (28) Bursting comet fireworks, repeating mines, star shells, aerial battle, and similar fireworks, at Hamer, Dist. S. C.

Charged 6-27-68 and amended 1-10-69: while held by Pedro Land, Inc., Hamer, S. C., the articles were banned hazardous substances, since they were toys which were flammable solids and generated pressure through explosion when ignited; 2(q)(1)(A). Default decree ordered destruction. (29)

Cherry bomb salutes, Kannon Kracker Flash salutes, and Super Bulldog salutes, at Rialto, C. Dist. Calif.

Charged 4-22-68: when shipped by New Jersey Fireworks Manufacturing Co., Inc., Vineland, N.J., the articles were banned hazardous substances, since they were toys which were flammable solids and generated pressure through explosion when ignited; 2(q)(1)(A). Consent decree authorized release to Clipper Pyrotechnic Corp., t/a Red Devil Fireworks Co., Lynwood, Calif., for salvaging. (30) Sanifilt pool filter cleaner, at Woodbury, Dist. N.J.

Charged 7-19-68: when shipped by Paragon Swimming Pool Co., Inc.,
Pleasantville, N.Y., the article was a corrosive substance containing
sodium bisulfite with more than 10 percent chemically unneutralized
sulfuric acid, and its container lacked a number of the required con-
spicuous label statements; 2(p)(1)(B, E, F, G, J), 3(b). Default decree
ordered destruction. (31)

NOTICES OF JUDGMENT on Criminal Actions
FOOD

Akin Distributors of Florida, Inc., Jacksonville, M. Dist. Fla.

Charged 3-10-67: whole wheat flour, white flour, wheat germ meal, and soya flour were held in a building accessible to insects and rodents, and were contaminated with insects; 402(a)(3), 402(a)(4).

The defendant pleaded not guilty. The defendant filed a motion for the Government to elect as to which of the four counts the defendant was to be prosecuted upon. The defendant alleged that the four products charged in the four counts became adulterated because the defendant's refrigerators broke down, that the four foods were adulterated by one single act, that the act complained of was one continuous one, and that there could be only one sentence for one violation. After a hearing, the court denied the defendant's motion.

Thereafter the defendants moved to suppress the articles and documents which were collected by the FDA inspectors during their inspection of the defendant's warehouse, on the ground that the inspection was conducted without a warrant, that the inspection was an illegal search, and, that the evidence collected constituted an illegal seizure. The court denied the defendant's motion. After trial, the court found the defendant guilty and fined it $500 on each count. The defendant appealed its conviction. The Court of Appeals for the Fifth Circuit affirmed the district court, and rendered the following opinion:

"Akin, a wholesale food distributor, was convicted in a non-jury trial on all counts of a four-count information charging that appellant had received foods and allowed same to become adulterated within the meaning of Title 21, U.S.C., $342(a)(3) and (4). after such foods had been shipped in interstate commerce, in violation of Title 21, U.S.C., §331(k).

"Appellant's first contention that the four counts of the information were duplicitous and that the district court should have sustained its motion to elect is without merit. The counts are not identical since each count involved a different food. United States v. Justin M. Schneider, Criminal No. 10170, E.D. Ky., December 31, 1959; United States v. Direct Sales Company, 252 F.882 (W.D.N.Y. 1918). See also United States v. Wiesenfeld Warehouse Co., 376 U.S. 86 (1964). Though duplicity was not at issue, the Supreme Court in Wiesenfeld reversed the trial court's dismissal of an information similar to the one here. "Also, the fact that the evidence supporting the alleged adulteration of the food named in each count was different for each food further precludes a holding that the four counts were actually the same. Bins v. United States, 5 Cir. 1964, 331 F.2d 390; Blockburger v. United States, 284 U.S. 299 (1932).

"Appellant also maintains that the evidence was the product of an illegal entry and search. As to the entry, there is ample evidence to support the trial court's determination that appellant's agent had sufficient authority to permit it. See Golden Grain Macaroni Company, Inc. v. Uuited States, 9 Cir. 1953, 209 F.2d 166, for a similar determination. Likewise, it is undisputed that the agent's consent to the search was given freely and voluntarily." 399 F.2d 306 (1968); cert. denied 393 U.S. 1021 (1969). (32)

Citra-Sweet Juices, Inc., and Elliott V. Reed, president, Austell, N. Dist. Ga. Charged 8-10-67: when shipped, the article, labeled in part "Orange Juice Contents One Liquid Quart Contains: Fresh orange juice, reconstituted orange juice and sucrose Bottled by: Citra-Sweet Juices, Inc. General Offices Lakeland, Florida," had the valuable constituent orange juice in part omitted or abstracted; and citric acid, water, and sorbic acid had been substituted in part for the orange juice; 402(b)(1), 402(b)(2). Nolo contendere pleas; fines. (33)

use,

DRUGS

Guardian Chemical Corp., and Alfred R. Globus, chairman of the board of directors, president, and treasurer, Long Island City, E. Dist. N.Y. Charged 10-20-65: Count 1, when shipped, Renacidin powder was a new drug without an effective approved New Drug Application-505(a); Count 2, when shipped, the labeling of Renacidin powder lacked the common or usual name of each ingredient, lacked adequate directions for and was not exempt, since it failed to comply with the conditions prescribed for Rx drug exemption, and lacked the prescription legend-502(e)(2), 502(f)(1), 503(b)(4). Not guilty pleas by both defendants. After trial by court and jury, verdict as to both defendants of not guilty of Count 1 and of guilty of Count 2. Corporation fined $1,000; and individual fined $1,000 and placed on 5 years' probation. The defendants appealed on the grounds that the evidence was insufficient to warrant conviction, that there was error in the court's instructions to

the jury and that the court erred in issuing inadequate corrective instruction concerning prejudicial remarks of the prosecutor. In af firming the conviction of the defendants, the Court of Appeals summarized the history of Renacidin: the article's first manufacture (under another name) for use in cleansing dairy equipment, its subsequent marketing as Renacidin for cleansing catheters which had been removed from the human body, its use by urologists in the treatment of human kidney and bladder stones, the distribution of literature by Globus concerning the treatment and prevention of urinary tract obstructions, and the failure of the article's label to mention the use of the product to cleanse catheters while they were still inserted in the body or the use in treating bladder or kidney stones. In its opinion, the court said:

"In order to accompany' an article and thus constitute 'labeling' for it, printed pamphlets or brochures need not be shipped along with the article. They may be sent out either before or after the article and still 'accompany' it, as long as the distribution of the drug and the brochures are parts of an integrated distribution program.' [Citations omitted.]

"How do all these rules apply to this case? As far as the question of what constituted the labeling' is concerned, the jury could find on the evidence that at least the two brochures, which defendants sent to doctors both before and after November 14, 1962, were distributed by defendants as part of an integrated program which included the sale and distribution of the Renacidin. Consequently, assuming for the moment that Renacidin is indeed a drug, the brochures constituted its labeling. The information, or lack of it, in the brochures could therefore be properly considered in determining whether or not the product was misbranded.

"There is more doubt about Globus' longer article which defendants handed out at the American Medical Association convention in November 1962. It seems to stretch the meaning of words beyond the limit of elasticity to say that this dissertation accompanied' the Renacidin. In our view, however, it makes no difference whether or not this article is considered labeling. If it was not, it was immaterial, as far as the question of misbranding goes. If it was, it did not affect the result one way or the other. Despite its length, the article added little to the previous brochures on any point relevant to the misbranding issue, or at least the jury could have so found.

"Still on the assumption that Renacidin is a drug, we turn briefly to the evidence bearing upon whether it was misbranded. Under Section 352(e) we are to look only to the 'label' which must state 'the common or usual name of each active ingredient.' There may be some question as to whether the Renacidin label failed to comply with this requirement. It did, at least, make some attempt to do so. It bore a heading 'Active Ingredient,' after which the following words appeared:

'Edible, multivalent organic acids selected from the group; gluconic, citric, malic, and acid salts of same... 65% (Buffered to a pH of approx. 4.0 in a 10% solution.)'

"It is unnecessary, however, to dwell on this point. The government was called upon to prove only that one of the misbranding sections had been violated, not all three. The evidence was clearly sufficient to establish that at least one of the other two had not been complied with. If Renacidin could safely be administered only with a doctor's prescription, then under Section 353(b)(4) its label had to bear the statutory 'Caution.' Concededly it did not. If, on the other hand, Renacidin was not something which could be dispensed only by a physician, then under Section 352(f) its labeling, i.e., its label and the 'accompanying' brochures, were required to state adequate directions for use. There was testimony from which the jury could find that the labeling did not contain such directions, even if the word 'labeling' were broadened to include the long article as well as the brochures. Hence, under either alternative, the jury was justified in finding that at least one statutory requirement was not observed.

"We have thus far discussed the evidence on the assumption that Renacidin is a drug, and necessarily so, for if it is not, that is an end of the case and all other issues are unimportant. We have not the slightest doubt, however, that it is. Judge Dooling submitted the issue to the jury, as doubtless he was required to do. Presumably the jury found Renacidin to be a drug. There was abundant evidence to sustain that finding.

"On this appeal defendants do not deny that Renacidin is a drug. Their argument is that it has both a drug and a non-drug use. It may be employed to dissolve bladder and kidney stones, or it may be used to clean tubing outside the human body. Defendants claim that there was no evidence to show a specific intent on the part of defendants that the particular bottles of Renacidin shipped to Holzer Hospital on November 14, 1962 were to be used for drug purposes."

The court's opinion continued citing United States v. Dotterweich for the rule that awareness of wrongdoing on the part of defendants need not be proved, and saying that, although there was evidence which would justify the jury in believing that the defendants intended this particular shipment to be used in the human body, it made no difference whether or not the defendants knew or intended that this particular shipment was to be used by the buyer for drug purposes. 410 F.2d 157 (1969). (34)

Gary Robert Iske, Boulder, Dist. Colo.

Charged 2-21-67: LSD was unlawfully sold and delivered; 301(q)(2). A plea of not guilty was made initially. The defendant moved for a bill of particulars, and moved to dismiss the charges on the ground that the statutes, rules, and regulations involved were unconstitutional. After hearing argument, the motion for the bill of particulars was denied in part and granted in part by the court; and the motion to dismiss was denied as being without merit. Defendant then pleaded guilty and was sentenced to imprisonment for one month and was to be placed on probation for 11 months. The defendant appealed on the ground that the statute, rules, and regulations involved were unconstitutional. The Court of Appeals reviewed the statute, the statutory history, and the delegation of the control and supervisory functions. The Court of Appeals stated, "To argue that unsupervised use of LSD entails no dangers is to ignore the obvious"; and, in affirming the defendant's conviction, the Court of Appeals concluded:

"We conclude Congress may properly delegate an executive duty to effectuate its legislative policy, United States v. Howard, 352 U.S. 212, 218-219 (1957), and that the standard potential for abuse' is sufficient in the light of its legislative history." 396 F.2d 28 (1968). (35) Bobby Jean McKissick, pharmacist, Montgomery, M. Dist. Ala.

Charged 12-23-64: amphetamine sulfate tablets and Syndrox tablets were dispensed without a prescription; 503(b)(1). Not guilty plea. During trial of the case before court and jury, the defendant's attorneys withdrew from the case and the court declared a mistrial. After a second trial, a verdict of guilty was returned by the jury; and the defendant was sentenced to imprisonment for two years. (36)

NOTICES OF JUDGMENT on Injunction Actions

Aiello Dairy Farms Co., Inc., Benjamin Aiello, an officer, and Lucien Sergile, plant manager, Heuvelton, N. Dist. N.Y.

Charged 7-10-68 in complaint for injunction: that the defendants were engaged in preparing, packaging, and labeling at their plant in Heuvelton,

NY, ricottone cheese, pastry ricotta cheese. mozzarella cheese, and pizza cheese, and in introducing into interstate commerce from their Brooklyn, NY. warehouse and in delivering to Brooklyn, NY., for intro duction into interstate commerce various quantities of such food that said food when shipped contained coagulase positive staphylococci, E. coli, excessive coforms and a high total bacterial court. and had been prepared, packed, and held at the plant at Heuverton under insanitary conditions, 4028/3), 402181 and that the defendants were We aware that their activities were in violation of the law. A con sent decree of permanent injunction was entered which enjoined the defendants against the introduction and the delivery for introduction into interstate commerce of the kinds of cheese described above which contained faith or had been prepared packed or held under insanitary conditions, and which required the defendants before making any further shipments or deliveries for shipment in interstate commerce of cheese prepared and packed at the Heuvelton plant to clean the plant and make it suitable for the preparation, packing, and holding of cheese, and to destroy or recondition the cheese on hand at such plant or at the defendants Brooklyn warehouse. (37)

Boilesen Seed Co., a corporation, Floyd A. Boilesen, president and manager, and Mildred Boilesen, secretary-treasurer, Ord. Dist. Nebr. Charged 2-2-65 in a complaint for injunction: that the defendants were engaged in processing and storing at said defendants popcorn processing and storage facility, and introducing and delivering and causing to be introduced and delivered for introduction into interstate commerce, popcorn for human consumption; that when shipped, the article contained rodent, bird, and insect filth and had been held under insani

tary conditions 402/a/3), 40218/4); and that the defendants had been warned of the filth in their popcorn and the insanitary conditions under which it was held. A temporary restraining order was entered enjoining the defendants against the acts complained of. The case was subse quently dismissed on the basis of an understanding that the defendants would no longer handle popcorn for human consumption. (38)

Capitol Smoked Fish Corp., and Benjamin Fertel, president, Paterson, Dist. N.J.

Charged on or about 4-19-57 in complaint for injunction: that the defendants were engaged in receiving fish from sources outside the State of New Jersey, and in preparing, smoking, packing, holding, and distributing such fish for human consumption, and that such fish, when distributed, had been prepared, packed, and held at the defendant's plant at Paterson, NJ., under insanitary conditions: 402(a)(4): and that the defendants had been warned of the insanitary conditions in their plant. Consent decree of permanent injunction enjoined the defendants against doing the violative acts complained of; and against preparing. packing, holding. or distributing fish while held for sale in defendants' plant after shipment in interstate commerce unless and until the plant was cleaned and made suitable for the preparation, packing, and holding of fish. The injunction was subsequently dissolved after inspection disclosed the defendants' plant to be operating under sanitary conditions. (39)

Rand Development Corp., and H. James Rand, a/k/a James H. Rand and H. J. Rand, president, Cleveland, N. Dist. Ohio.

Charged on or about 2-7-67 in complaint for injunction: that the defendants were engaged in the manufacture, processing, packing, introducing and causing to be introduced and delivering and causing to be delivered for introduction into interstate commerce of an article of drug, which was designated by the name of "Rand Coupled Fortified Antigen" or "Human Tumor-Diazo-Rabbit Gamma Globulin Complex"; that the article was composed as follows: (1) frozen human tumor tissue was processed to form what was asserted to be a lyophilized human tumor antigen, (2) such processed tissue and lyophilized rabbit gamma globulin fraction II were mixed in the presence of the chemical bisdiazobenzidine and an alleged tumor protein antigen complex was produced, (3) the alleged tumor protein antigen complex was mixed with equal parts of the "Freund's Incomplete Adjuvant" (a combination of a surfactant and mineral oil), and (4) the mixture was placed into 1 cc rubber-capped glass vials; that, when shipped, the vials of the article lacked labels; that, when shipped, the article was sometimes accompanied by no labeling at all and at other times the article was accompanied by the following labeling: (1) leaflets entitled "Immunological Approaches to Cancer Therapy" and "Human Tumor-Diazo-Rabbit Gamma Globulin Complex Administration and Schedule of Human Immunization,' and (2) Rand Development Corp. form letters reading in part "the Rand Coupled Fortified Antigen (Vaccine) should be used every (7) days"; that, when shipped, the article was a new drug. since its asserted composition was not generally recognized among qualified experts as safe and effective for use in the treatment of cancerous diseases in humans; that there was no effective approved New Drug Application and the article was not exempt, due to deficiencies in the investigational new drug plan filed with NIH, due to failure of the article to bear "Investigational Use" legend, and due to failure to supply adequate data; that the defendants had been notified not to distribute the drug in interstate commerce until an acceptable investigational new drug plan had been first filed; that the circumstances of the article's manufacture, processing, and packing lacked conformity with current good manufacturing practice; that the label of the article lacked the name and place of business of the manufacturer, packer, or distributor, and lacked an accurate statement of the quantity of contents; that the components lyophilized rabbit gamma globulin and Freund's Incomplete Adjuvant, which were shipped in interstate commerce for use in the manufacture of the article, were held under insanitary conditions, and that the circumstances used in the processing of such components lacked conformity with current good manufacturing practice in that the component drugs were processed under conditions whereby they might and did become contaminated with Bacillus bacteria; 505(a), 501(a)(2)(A), 501(a)(2)(B), 502(b)(1), 502(b)(2). After a hearing, the court, on 4-5-67, permanently enjoined and restrained the defendants from doing the violative acts of which the Government had complained. Thereafter, the defendants appealed the court's order of permanent injunction. On 3-1-69, the appeal was dismissed pursuant to stipulation. (40)

NOTICE OF JUDGMENT on Miscellaneous Actions

Coffee beans, judicial review suit, San Francisco, N. Dist. Calif.

Charged 3-31-67 by Harry Sugarman, owner, salvor, and reconditioner of detained coffee beans, against Jack B. Forbragd and Fred E. Norman, Food and Drug Officers in a suit for mandatory injunction to compel the Food and Drug Officers to approve Sugarman's reconditioned coffee beans to be used in the production of blended coffee in the United States: that Forbragd and Norman's action in refusing Sugarman's ap plication to allow the beans to enter the United States for use in the production of blended coffee was invalid; that they committed prejudicial abuse of discretion in not confirming their decision to the record and papers of the hearing; that the hearing record did not support the Food and Drug Officers' decision; that the required available administrative remedies had been exhausted; and that Sugarman did not have a plain, speedy, and adequate remedy in the ordinary cause of law; and that his only remedy was a petition such as this.

The defendants moved to dismiss on the grounds that the plaintiff's

petition failed to state a claim upon which relief can be granted and that the court jacket jurisdiction over the subject matter; the defendants also moved for an afternative order granting summary judgment in favor of the defendants. The plaint moved for summary judgment in his favor

Thereafter, the court stated that these coffee beans were being transported from Colombia to Japan. whET a fire aboard ship required the captain to enter a Ca forma distress port because the extensive efforts from March 17 through March 23 to extinguish the fire at sea had been unsuccessfu] that at the port the Firemen used CO2. fresh water, harbor sea water, fresh water wetted with Solvoid and ultimately flooded the ship's hoid that wher unidaded the beans were blackened, heated, and in a steaming condtion that the beans stayed piled on an area adjacent to the dock for approximately one week since it was necessary to flood the pile of beans because of spontaneous heating and smoking: and that Sugarman and three other joint venturers purchased the damaged coffee beans for salvage reconditioned them, and offered them for import The court thereupon found (267 F. Supp. 817, N.D. Calif. 1967 that the admissiblity of imports subject to the Federal Food, Drug, and Cosmetic Act was committed to agency discretion by law, and was accordingly not subject to review under the Administrative Procedure Act, that the mere appearance of adulteration was enough to compel refusal to admit, that in finding as a fact, such appearance of adulteration there need not be exclusive reliance upon testimony offered at the hearing, since such finding may derive the examination of samples or otherwise, that the agency action was not reviewable in a judicial proceeding and the action was an unconsented suit against the Government and for those the court lacked jurisdiction of the subject matter; and that the affidavits, exhibits, and physical specimens before the court showed sound reason for holding that the charred beans appeared to be adulterated. Sugarman appealed the decision of the district court. Upon appeal the appellate court said: "The question presented is whether absent arbitrary or capricious action which clearly is lacking here) such an order excluding material from import under $ 381 a is subject to judicial review. The District Court held that it was not. We agree." 405 F.2d 1189 cert. denied 395 U.S. 960. (41) Low-moisture Mozzarella cheese, judicial review suit, U.S. Court of Appeals for 2nd Circuit

reasons

Petitioned 3-10-65 by Brunetto Cheese Manufacturing Corp., Yonkers, NY. C. & F. Cheese Distributors, Inc., East Haven, Conn., Falcone Dairy Products. Inc. Brooklyn, NY., J. J. Giammalvo. Inc., Andover, N.J., M. Maggio Co. Philadelphia, Pa., Polo Dairy Products Corp., Brooklyn, NY. Sorrento Cheese Co. Inc., Buffalo, NY., Sunbury Cheese Co., Inc., Sunbury, Pa. and Italian Fresh Cheese Manufacturers Association, Inc.. Brooklyn, NY. in a suit against H.E.W. Secretary Anthony J. Celebrezze for judicial review of the order promulgating definitions and standards of identity for Mozzarella and certain other cheeses; that the order adversely affected the petitioners: that they had for many years been ergaged in manufacturing Mozzarella cheese and in distributing it in the United States: that the name "Low-Moisture Mozzarella Cheese" was not the common or usual name applied in the trade or by consumers to the product so defined in the promulgated definition and standard of identity; that such product had been sold in accordance with existing standards of identity as "Pizza Semisoft Part-Skim Cheese" and as "Pizza Cheese"; that such product was different in manufacture, moisture content, and in ingredients from Mozzarella cheese: and that the order, establishing the name "LowMoisture Mozzarella" for such product, appropriated to a different product the common and usual name of "Mozzarella" by which petitioners' product had been known and identified for many years, thereby causing damage and injury to the goodwill and trade acceptance built up by the petitioners: 701(f).

In affirming the order's choice of the name "Low-Moisture Mozzarella," the Court of Appeals concluded:

"While there was evidence to indicate that the two cheeses [Mozzarella and Low-Moisture Mozzarella) are different in color, taste, texture, and consistency, and it was not disputed that the eastern cheese was of earlier origin, and more closely resembles authentic Italian Mozzarella, there was also evidence that the consuming public identified as Mozzarella the midwestern product. Most of the midwestern producers included the name Mozzarella in their labels. There was testimony that the midwestern cheese was marketed throughout the country and known as Mozzarella, and that due to its high moisture content and resultant perishability the eastern cheese was not marketed to any great extent outside the east. Yet the consuming public was not confined to the east.

"Thus the [FDA) Commissioner could find that the public knew as Mozzarella two different cheeses, and that there was a need for separate standards of identity. Accordingly he preserved the name Mozzarella for each, but added the description 'low-moisture' to the midwestern product. The Act requires that the product when given standards be known by its 'common or usual name so far as practicable.' Thus the ultimate question is whether there was substantial evidence on the record to support the name chosen. Petitioners do not appear to disagree that common or usual name means that name by which the product is known to the community at large. United States v. Crescent-Kelvan Co., 164 F.2d 582 (3 Cir. 1948) (construing similar language in $502(e) of the Act, 21 U. S. C. §352(e)).

"The fact that some midwestern producers labeled their product also as 'pizza cheese' indicates more a recommended use than a name. There was substantial evidence that the consuming public identified the low-moisture product as Mozzarella. And as long as the name chosen is appropriate, it is no argument that the Commissioner rejected another name which is also appropriate. Columbia Cheese Co. v. McNutt, 137 F.2d 576 (2 Cir. 1943). We cannot substitute our judgment for his. Since his finding is supported by substantial evidence the order is affirmed." 356 F.2d 874 (1966). (42)

Notices of Judgment are given pursuant to section 705 of the Federal Food, Drug, and Cosmetics Act and section 13 of the Federal Hazardous Substances Act. Notices of Judgment report cases involving seizure proceedings, criminal proceedings, and injunction proceedings. Seizure proceedings are civil actions taken against goods alleged to be in violation, and criminal and injunction proceedings are against firms or individuals charged to be responsible for violations. The cases generally involve foods, drugs, devices, cosmetics, or hazardous substances which were alleged to be adulterated or misbranded or otherwise violative of the law when introduced into and while in interstate commerce, or while held for sale after shipment in interstate commerce.

Notices of Judgment are prepared by Food, Drug, and Environmental Health Division, Office of the General Counsel, DHEW. Published by direction of the Secretary of Health, Education, and Welfare.

Charles C. Edwards, M.D., Commissioner of Food and Drugs Washington, D.C., June 1, 1970

UNITED STATES

GOVERNMENT PRINTING OFFICE DIVISION OF PUBLIC DOCUMENTS WASHINGTON, D. C. 20402

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SEMINAR PROCEEDINGS The Packaging Institute in the near future will publish the proceedings of the Second Nationwide Seminar on Unit Packaging for Pharmaceuticals, held May 18-20 at St. Louis.

Over 300 representatives from hospitals, pharmaceutical firms, and the packaging industry attended the seminar, cosponsored by The Packaging Institute, The American Society of Hospital Pharmacists, and FDA. Papers presented stressed the need for quality control at every step of the manufacture and packaging of drugs in unit-of-use containers. Among the speakers were a nurse who spoke of the need for safe, easy-to-open packages with legible labeling and hospital pharmacists who were greatly concerned about the variance in the size and shape of the outer containers of unit doses.

FDA participants on the program were Charles Armstrong, Region VII food and drug director, Kansas City District; and headquarters personnel Jonas L. Bassen, Theodore E. Byers, Dr. Arthur W. Steers, and Richard F. Heuermann—all from the Bureau of Drugs.

Further information on the planned publishing of the proceedings is available from the Packaging Institute, 342 Madison Avenue, New York, N.Y. 10017.

ANNUAL CONFERENCE The tenth annual Conference on Pharmaceutical Analysis will be held August 3-7 at the Gateway Hotel, Land O'Lakes, Wisconsin. The program this year concerns advances in analytical techniques and computer application. It will bring both background knowledge and authoritative reviews of current analytical trends to the conference registrants. The conference faculty will be drawn from educational, research, and industrial environments to provide maximum opportunity for enlightened discussions.

Interested persons should contact J. Thurg Carstensen, Conference Director, Extension Services in Pharmacy, The University of Wisconsin, 190 Pharmacy Building, Madison, Wisconsin 53706.