NOTICES OF JUDGMENT on Seizure Actions FOOD/Poisonous and Deleterious Substances

Carrots, at Grant, W. Dist. Mich.

Charged 7-10-70: when shipped by Romar Carrot Co., Guadalupe, Calif., the article contained a quantity of the pesticide chemical, dieldrin, in excess of the tolerance; 402(a)(2)(B). Consent decree ordered destruction. (1)

Chubs, gutted, iced, at Monmouth Beach, Dist. N.J.

Charged 11-3-69: when shipped by Acme Smoked Fish Corp., Brooklyn, N.Y., the article, labeled in part "Acme Smoked Fish Corp... From Union Fisheries Corp.. Chicago, Ill.," contained the pesticide chemicals, DDT, DDE, TDE, and dieldrin for which no tolerance or exemption on fish had been prescribed; 402(a)(2)(B). Default decree ordered destruction. (2)

Meat scraps, dried, at Memphis, W. Dist. Tenn.

Charged 8-5-70: when shipped by Sars of Louisiana, Div. of Gulf Soap Corp., Baton Rouge, La., the article contained the poisonous and deleterious substance, Salmonella micro-organisms; 402(a)(1). Consent decree authorized release to the shipper for reprocessing. (3)

FOOD/Contamination, Spoilage, Insanitary Handling

Butter, at Louisville, W. Dist. Ky.

Charged 8-11-70: when shipped by Sugar Creek Foods, Louisville, Ky., and thereafter returned to the shipper from Cincinnati, Ohio, the article contained decomposed butter; 402(a)(3). Default decree ordered destruction. (4)

Cornhusks, at Phoenix, Dist. Ariz.

Charged 6-25-70: when shipped by George Walcher, Weimar, Tex., the article contained insect filth and moldy cornhusks; 402(a)(3). Default decree ordered destruction. (5)

Egg yolks, frozen, at Louisville W. Dist. Ky.

Charged 8-24-70: when shipped by Illini Egg Products, Inc., Olney, Ill., the article contained decomposed eggs; 402(a)(3). Default decree ordered destruction. (6)

Milk, nonfat, dried, at St. Louis, E. Dist. Mo.

Charged 7-9-70: when shipped by N. M. Swank Co., Inc., Iowa City, Iowa, the article contained insect fragments and burnt particles, and was unfit for food due to an uncharacteristic odor and flavor; 402(a)(3). Default decree ordered destruction. (7)

Onion rings, breaded, frozen, at Dallas, N. Dist. Tex.

Charged 7-24-70: when shipped by Miller's Prepared Potato Co., Inc., Blue Island, Ill., the article contained insect filth and had been prepared and packed under insanitary conditions; 402(a)(3), 402(a)(4). 'Default decree ordered destruction. (8)

Pecan pieces, Sunny South, at Charlotte, W. Dist. N. C.

Charged 5-14-70: when shipped by Sunny South Pecan Co., Statesboro, Ga., the article contained E. coli; 402(a)(3). Default decree ordered destruction. (9)

Rice, at Tulsa, N. Dist. Okla.

Charged 7-23-70: while held by Downtown Warehouse Co., Tulsa, Okla., the article contained rodent filth and was held under insanitary conditions; 402(a)(3), 402(a)(4). Default decree ordered destruction. (10) Soy grits, toasted, at Vernon, C. Dist. Calif.

Charged 8-6-70: while held by Flour, Inc., Vernon, Calif., the article contained insect filth and was held under insanitary conditions; 402(a)(3), 402(a)(4). Consent decree authorized release to Archer Daniels Midland Co., Decatur, Ill., for conversion to animal feed. (11) Spaghetti in a sauce, canned, at Alma, W. Dist. Ark.

Charged 3-6-69: while held by HLH Products Division, Hunt Oil Co., Alma, Ark., who manufactured the article from flour shipped in interstate commerce, the article contained rodent hair and was prepared and packed under insanitary conditions; 402(a)(3), 402(a)(4). The article was claimed by the dealer. Interrogatories were served by the Government and by the dealer, and subsequently answered. A Government request for admissions was also served on the dealer. Thereafter a consent decree of destruction was entered. (12)

Sugar, beet, granulated, at Baltimore, Dist. Md.

Charged 8-6-70: when shipped by Pine Street Trading Corp., New York, N.Y., from the premises of the Chesapeake Operating Co., Baltimore, Md., to Elizabethtown, Pa., and thereafter returned to Baltimore, Md., the article had been held under insanitary conditions in bags contaminated with antimony ore dust; 402(a)(4). Default decree ordered destruction. (13)

Sugar, beet, granulated, at Morgantown, N. Dist. W. Va.

Charged 7-1-70: when shipped by The Chesapeake Operating Co., Baltimore, Md., the article had been held under insanitary conditions in bags contaminated with antimony ore dust; 402(a)(4). Consent decree ordered destruction. (14)

FOOD/Economic and Labeling Violations

Cheese dip, frozen, K-SO Dip, at Denver, Dist. Colo.

Charged 7-20-70 and amended 7-31-70: when shipped by Ashley's Frozen Foods, El Paso, Tex., the article was in violation of the Fair Packaging and Labeling Act, in that the declaration of net quantity of contents was stated on only one of the two alternative principal display panels, since the net quantity of contents on the one panel was not separated from printed information above it; and in that the area of that panel was between 5 and 25 square inches and the net quantity of contents was stated in a type size less than 8 inch high; 15 U.S.C. 1453(a)(2), 1453(a)(3)(C)(i). Default decree authorized donation to charitable institution. (15)

Crawfish Etoufee, frozen, at San Antonio, W. Dist. Tex.

Charged 7-17-70: when shipped by Cajun Country, Inc., Breaux Bridge, La., the article, labeled in part "Cajun Country Crawfish E'Touffe'E Breaux Bridge Fine Foods Compagnie, Inc., Breaux Bridge, Louisiana," was in violation of the Fair Packaging and Labeling Act, in that the quantity of contents declaration was not in the bottom 30 percent of the principal display panel; in that the area of that panel was between 5 and 25 square inches and the quantity of contents was stated in a type size less than 8 inch high; and in that the label stated "Serves One or two" and lacked the net quantity of each such serving; 15 U.S.C. 1453(a)(2), 1453(a)(3)(C)(i), 1453(a)(4). Consent decree authorized release to the shipper for relabeling. (16)

Flounder, frozen, at Gloucester, Dist. Mass.

Charged 7-16-70: while held for sale after being repacked by Massachusetts Coastal Seafoods, Inc., Gloucester, Mass., codfish had been substituted for flounder, the label statement "Flounder" was false and misleading, and the label lacked the name and place of business of the manufacturer, packer, or distributor and the common or usual name of the article, namely, codfish; 402(b)(2), 403(a), 403(e)(1), 403(1)(1). Consent decree authorized release to F. W. Bryce, Inc., Montreal, Canada, for relabeling. (17)

Honeys, clover, sage, orange, and clover-alfalfa, Miller's, at Denver, Dist. Colo. Charged 7-15-70: when shipped by Miller's Honey Co., Salt Lake City, Utah, the 1-lb. size jars of clover honey were approximately 3 percent short weight 403(e)(2); and all the honeys were in violation of the Fair Packaging and Labeling Act, in that both the 1-lb. size and 7-oz. size jars of clover honey had their label statements of identity and their quantity of contents declaration on lines not generally parallel to the jar's base, and the quantity of declaration was not separated from other printed label information appearing above and to the left of the declaration-15 U.S.C. 1453(a)(1), 1453(a)(2); the net quantity of contents of the sage, orange, and clover-alfalfa honeys were expressed as "Net Wt. 1 Lb." and "Net Wt. 1 Lb. 8 oz." instead of "Net Wt. 16 oz. (1 lb.)" and "Net Wt. 24 Oz. (1 lb. 8 oz.)"-15 U.S.C. 1453(a)(3)(C)(i); and the sage honey, the orange honey, and the 1-lb. size and 7-oz. size clover honeys had principal display panel areas of between 5 and 25 square inches and their net quantity of contents were stated in a type size less than 1/8 inch high-15 U.S.C. 1453(a)(3)(C)(i). Consent decree authorized release to the shipper for relabeling. (18)

Lollipops, liquor flavored, at New York, S. Dist. N.Y.

Charged 12-26-67: when shipped by Four Star Candy Co., Inc., Newark, N.J., the article's labeling contained statements which were misleading, since they suggested and implied that the article was flavored with liquor, whereas it was not so flavored; 403(a). A. Freed Novelty, Inc., New York, N.Y., filed an answer denying that the labeling was misleading and affirming that the labeling was such that the ordinary individual under customary conditions of purchase and use would understand that the article contained no alcohol or liquor but merely simulating flavoring. A motion for judgment on the pleadings was filed by the Government and was denied by the court in an opinion in which it held that the motion should be treated as one for summary judgment and that it could not be concluded as a matter of law that no material issue existed with respect to the misleading character of the labeling. Thereafter an order for the discontinuance of the action was entered pursuant to stipulation of the parties. (19)

Noodles, frozen, Grandma's, at Salt Lake City, Dist. Utah.

Charged 7-20-70; when shipped by L.A. King Food Products Co., Inc., Denver, Colo., artificial color had been added to the article so as to make it appear better or of greater value than it was; its label lacked the common or usual name of each ingredient, since the artificial colors FD&C Yellows No. 5 and No. 6 had not been declared, and it contained artificial coloring and lacked a label stating that fact-402(b)(4), 403(i)(2), 403(k); and the article was in violation of the Fair Packaging and Labeling Act, in that the declaration of net quantity of contents was not in the bottom 30 percent of the principal display panel, in that the net quantity of contents was not separated from printed label information below it, in that the principal display panel had an area of between 25 and 100 square inches, and the net quantity of contents was stated in a type size less than 16 inch high, and in that the label stated "Four Servings" and lacked the net quantity of contents of each such serving-15 U.S.C. 1453(a)(2), 1453(a)(3)(C)(i), 1453(a)(4). Default decree authorized donation to a public institution. (20)

Salmon, smoked, at Santa Rosa, N. Dist. Calif.

mon ...

Charged 7-27-70: when shipped by Specialty Seafoods, Anacortes, Wash., the article, labeled in part "Specialty Brand Smoked Barbe-Cured SalPacked for International Packing Co.. Minneapolis, Minn.," was in violation of the Fair Packaging and Labeling Act, in that the quantity of contents statement was not in the bottom 30 percent of the principal display panel, and in that the area of that panel was between 5 and 25 square inches and was stated in a type size of less than 1/8 inch high; 15 U.S.C. 1453(a)(2), 1453(a)(3)(C)(i). Default decree authorized donation to charitable institution. (21)

Shrimp, frozen, Belle O'Sea, at Milwaukee, E. Dist. Wis.

Charged 7-2-70: when shipped by Palacios Freezer, Inc. (subsidiary of Atlanta Trading Corp.), Palacios, Tex., the article was in violation of the Fair Packaging and Labeling Act, in that the net quantity of contents statement was expressed as "Net Wt. 3 Lbs." instead of "Net Wt. 48 Oz. (3 Lbs.)," and in that the principal display panel of the packages had an area of between 100 and 400 square inches and the net quantity of contents on the panel was stated in a type size less than 1/4 inch high; 15 U.S.C. 1453(a)(3)(A)(i). 1453(a)(3)(Ć)(i). Consent decree authorized release to shipper for relabeling. (22)

Soups, minestrone and vegetable, frozen, Kubro, at Chicago, N. Dist. III. Charged 5-25-70: when shipped by Kubro Foods, Los Angeles, Calif., the label statement "Positively.. No Sugar, No Starches" was false and misleading, since the articles contained macaroni, potatoes, barley, peas,

beans, and other vegetables, which contained carbohydrates including sugar and starch; the label statement, "Kubro Soups are Richer & Tastier, yet have only 1/3 the Calories of Ordinary Soups," was false and misleading, since it was contrary to fact; and the articles were represented for special dietary use and lacked the percent by weight of protein, fat, and available carbohydrates and the number of available calories 403(a), 403(); and the articles were also in violation of the Fair Packaging and Labeling Act in that the labeling stated "to make 5-6 servings to make 2-3 servings" but lacked a net quantity statement for each such serving-15 U.S.C. 1453(a)(4). Consent decree authorized release to shipper for relabeling. (23) Spaghetti, Golden Wheat, at Millard, Dist. Nebr.

Charged 6-29-70: when shipped by Creamette Co., Minneapolis, Minn., the article was in violation of the Fair Packaging and Labeling Act, in that the quantity of contents was expressed as "2 Lbs. Net" instead of "Net Wt. 32 Oz. (2 Lbs.)"; 15 U.S.C. 1453(a)(3)(A)(i). Consent decree authorized release to shipper for relabeling. (24)

Strawberry fruit filling, canned, Juliann, at Chicago, N. Dist. III.

Charged 7-10-70: when shipped by Emerald Foods, Inc., Emerald, Wis., the article was in violation of the Fair Packaging and Labeling Act, in that the declaration of net quantity of contents was not in the bottom 30 percent of the principal display panel; in that the net quantity of contents was expressed as "Net Wt. 1 Lb. 2 Ozs." instead of "Net Wt. 18 Oz. (1 Lb. 2 Oz.)"; and in that the principal display panel had an area between 5 and 25 square inches and the quantity of contents was stated in a type size less than 1/8 inch high; 15 U.S.C. 1453(a)(2), 1453(a)(3)(A)(i). Default decree authorized donation to a charitable organization. (25)

Tea mix, lemon-flavored, Lipton, at Philadelphia, E. Dist. Pa.

Charged 7-17-70 and amended 8-5-70: when shipped by Thomas J. Lipton, Inc., Flemington, N.J., the article was in violation of the Fair Packaging and Labeling Act, in that the label statement of net weight on the bottles was expressed as "Net Wt. 24 Oz." instead of "Net Wt. 24 Oz. (1 Lb. 8 Oz.); 15 U.S.C. 1453(a)(3)(A)(i). Consent decree authorized release to the shipper for relabeling. (26)

Tomato juice cocktail, Red Label, at Cranston, Dist. R.I.

Charged 7-29-70: when shipped by S. S. Pierce Co., Boston, Mass., the article was in violation of the Fair Packaging and Labeling Act, in that the declaration of net quantity of contents was not placed within the bottom 30 percent of the principal display panel, in that the net quantity of contents was expressed as "Net Cont. 1 Pt. 10 FI. Oz." instead of "Net Contents 26 Fluid Oz. (1 Pt. 10 Oz.)," and in that the principal display panel had an area of between 5 and 25 square inches and the net quantity of contents was stated in a type size less than 1/8 inch high; 15 U.S.C. 1453(a)(2), 1453(a)(3)(A)(i), 1453(a)(3)(C)(i). Default decree ordered destruction or donation to charitable institution. (27)

VITAMINS/DIETARY FOODS

Cola beverage, New Diet Rite, at St. Paul, Dist. Minn.

Charged 10-13-70: while held by Gold Medal Beverage Co., St. Paul, Minn., who manufactured the article from a concentrate shipped in interstate commerce, statements on the bottle labels were false and misleading as to the absence of sugar and as to the presence of sodium cyclamate, .1 percent or less carbohydrates, and 1/6 or less calories per ounce; the bottle label failed to declare the ingredient sugar; [and the carton labels lacked a notice to disregard as incorrect any information on the bottles of the article which was contrary to that on the cartons, i.e. (carton) "Sugar Added No cyclamate 6 Calories and approximately 12 grams of carbohydrates"]; 403(a), 403(1)(2). Consent decree authorized release for relabeling. (28)

FOOD ADDITIVES

Lime beverage mix, and lime beverage concentrate, at Auburn, Dist. Mass. Charged 6-12-70: while held for sale, the articles contained the nonconforming food additive, cyclamate; 402(a)(2)(C). Default decree ordered destruction. (29)

Noodles, 2 seizure actions, at Pocatello, Dist. Idaho.

Charged 9-29-70: when shipped by Pot O' Gold Noodle Co., Inc., Helena, Mont., the article contained the nonconforming food additive, chlordane; 402(a)(2)(C). Default decree ordered destruction. (30)

DRUGS/Human Use

Digoxin tablets, U.S.P., at St. Petersburg, M. Dist. Fla.

Charged 8-17-70: when shipped by Morton Pharmaceuticals, Inc., Memphis, Tenn., the quality of the article, labeled in part "Cardioxin. Digoxin U.S.P. Manufactured For Daniels Pharmaceuticals, Inc. St. Petersburg, Florida," fell below U.S.P. standards, since the article failed the U.S.P. test for content uniformity; 501(b). Default decree ordered destruction. (31)

Frenquel azacyclonol hydrochloride tablets, N.F., at Vinita, N. Dist. Okla.

Charged 8-3-70: while held for sale, the labeling lacked adequate directions for use, and the article was not exempt from such requirement, since it was a new drug for which no approval of a New Drug Application was [currently] effective and no notice of claimed investigational exemption was on file; 502(f)(1). Default decree ordered destruction. (32) lodinated casein tablets, at Garfield, Dist. N.J.

Charged 10-24-69: when shipped by Beth Corp., Miami, Fla., the article was a new drug without an effective approved New Drug Application; 505(a). Default decree ordered destruction. (33)

lodinated casein tablets, at San Francisco, N. Dist. Calif.

Charged 10-1-69: when shipped by Beth Corp., Miami, Fla., the article was a new drug without an effective approved New Drug Application; 505(a). Consent decree ordered destruction. (34)

Lane Formula 4 lanolin-combination medicated skin lotion, at Oakland, N. Dist. Calif.

Charged 8-19-70: while held by Lura-Glo Products, Inc., who manufactured the article from ingredients shipped in interstate commerce, the circumstances of the article's manufacture, processing, packing, and holding lacked conformity with current good manufacturing practice501(a)(2)(B); the bottled article lacked an accurate statement of the quantity of contents-502(b)(2); both the bottled article and the article in bulk containers lacked the established name of each active ingredient and lacked adequate directions for use in the conditions for which it was offered, since those conditions were not amenable to treatment by laymen-502(e)(1)(A)(ii), 502(f)(1); and the bottled article was in violation

of the Fair Packaging and Labeling Act in that the net quantity of contents was not stated on the principal display panel-15 U.S.C. 1453(a)(2). Default decree ordered destruction. (35)

...

Vitamin, mineral, and hormone combination tablets, at Hollywood, S. Dist. Fla. Charged 4-20-70: when shipped by Bates Labs., Inc., Chicago, Ill., the article, labeled in part "Tablets Geriatromone Geriatric-Vitamins, Minerals and Lipotropic Factors with Hormones Generix Drug Sales, Hollywood, Florida Distributor," was manufactured and packed under circumstances that lacked conformity with current good manufacturing practice, and the article's labeling lacked adequate directions for use and did not comply with the Rx drug exemption requirements, since the labeling failed to bear an identifying lot or control number; 501(a)(2)(B), 502(f)(1). Default decree ordered destruction. (36)

DRUGS/Veterinary

Diethylcarbamazine syrup, at Brunswick, S. Dist. Ga.

Charged 10-26-70: when shipped by Babineaux's Pharmacy, Metairie, La., the article was a new animal drug without an effective approved New Animal Drug Application; 501(a)(5). Default decree ordered destruction. (37)

MEDICAL DEVICES

Dynabelt electronic muscle stimulator belt, at Kansas City, W. Dist. Mo. Charged 5-5-69: when shipped by Dynatone Electronics Corp., Wichita, Kans., the accompanying leaflet contained false and misleading claims for effortless muscle exercise, taking inches off of problem areas such as waistline, tummy, hips, and back, giving trimmer, sharper figure, and the achievement and maintenance of such results without special dieting and weight loss; and the labeling lacked adequate warnings against unsafe use; 502(a), 502(f)(1). The shipper claimed the article and denied that the article was misbranded. The claimant and the Government served written interrogatories on each other. Following notice that the claimant had filed a petition for reorganization and after claimant failed to appear as ordered, a default decree ordering destruction was entered. (38) Oxygen inhaler and cartridge, Air-Aid, at Miami, S. Dist. Fla.

Charged 4-7-70: when shipped by Universal Cryogenics, Inc., New York, N.Y., the labeling lacked adequate directions to supply emergency oxygen for lay medical use, and adequate directions for safe use could not be written, since the article contained an insufficient quantity of oxygen; 502(f)(1). Default decree ordered destruction. (39)

Respirator, at Myers, N. Dist. N.Y.

Charged 9-22-69: when shipped by Crown Products Co., Cleveland, Ohio, the article, labeled in part "For Every Breathing Difficulty... Res-QAire 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 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. (40) Theramatic model A-6DT40 electronic instrument, at El Paso, W. Dist. Tex.

Charged 6-30-70: when shipped, the article's labeling lacked adequate directions for use for purposes intended, and adequate directions could not be written for use by laymen for such purposes; and the article did not comply with the Rx device exemption requirements, since adequate information could not be furnished under which practitioners could use the article safely and for the purposes intended; 502(f)(1). Default decree ordered destruction. (41)

Theramatic model A-6DT40 electronic instrument, at Odessa, W. Dist. Tex. Charged on or about 7-8-70: when shipped, the article's labeling contained false and misleading claims for the treatment of infections, otitis media, fractures, bone and tissue healing, smooth muscle spasm, bursitis, arthritis, low back pain, sinusitis, urinary tract infections, prostatitis, and hepatitis; its labeling lacked adequate directions for such uses, and adequate directions could not be written, since the article was worthless for such uses; and the article was dangerous to health when used in the dosage and with the frequency and duration recommended since it was ineffective for the treatment of the serious

in its conditions represented, and by reason of its ineffectiveness it

disease was unsafe for such use; 502(a), 502(f)(1), 502(j). Default decree ordered destruction. (42)

HAZARDOUS SUBSTANCES

Cherry bombs, and M-80 fireworks, at Kansas City, Dist. Kans. Charged 7-2-70: while held by A. J. Eickhoff, Kansas City, Kans., the articles were banned hazardous substances within the meaning of the hazardous substances regulations, since they were intended to produce audible effects by a charge of more than 2 grains of pyrotechnic composition; 2(q)(1)(B). Default decree ordered destruction. (43)

M-80 firecrackers, "Scram" aerial bombs, and "Sky-Jet 1/2 Mile High w/Report" aerial bombs, at Smoot, Dist. Wyo.

Charged 7-6-70: while held by Shumway's Fireworks Stand, Smoot, Wyo., the articles were banned hazardous substances, since the articles were packed in a form suitable for use in the household and were intended to produce audible effects by a charge of more than 2 grains of pyrotechnic composition; 2(q)(1)(B). Default decree ordered destruction. (44)

NOTICES OF JUDGMENT on Criminal Actions
FOOD

Matson Terminals, Inc., San Francisco, N. Dist. Calif.

Charged 5-26-70: green coffee was held in a building accessible to rodents and was contaminated with rodent filth; 402(a)(3), 402(a)(4). Nolo contendere plea; fine. (45)

Sweeney & Co., Inc., and Warren C. Miller, general manager, McAllen, S. Dist. Tex.

Charged 4-14-70: flour was held in a building accessible to insects and was contaminated by insect filth; 402(a)(3), 402(a)(4). Guilty pleas; fines. (46)

NOTICES OF JUDGMENT on Injunction Actions

Yates & Wheeler, Inc., and George Yates, president, West Jefferson, M. Dist. N.C.

Charged 10-1-70: when shipped, cabbage contained the pesticide chemical, toxaphene, in excess of the tolerance; 402(a)(2)(B). Guilty plea by corporation; fine. Guilty plea by individual; probation. (47)

Lanpar Co., a corporation, Dallas, N. Dist. Tex.

Charged on or about 6-26-68 in a complaint for injunction: that the defendant was engaged in manufacturing, packing, labeling, promoting, and selling various drugs most of which were recommended by the defendants for use in the Lanpar Treatment for Obesity, in distributing such drugs in interstate commerce, and in holding a number of the drugs for sale after shipment of one or more of their components in interstate commerce; that a number of the drugs were manufactured and held under circumstances which lacked conformity with current good manufacturing practice, their strength differed from standards set forth in the U.S.P., or their strength differed from and their quality and purity fell below that which they purported to possess, and their labeling contained false and misleading representations with respect to their strength, quality, or purity; that the labeling of the drugs involved in the Lanpar Treatment for Obesity contained false and misleading claims that the drugs were safe and effective in the treatment of hypothyroidism, amenorrhea, and hypomenorrhea, could safely bring about weight loss without rigid dieting, would cause a change toward normal metabolism, and were safe and effective adjuncts in the treatment of all obesity; that the labeling of the drugs involved in the Lanpar Treatment for Obesity lacked adequate directions for use and that the drugs designated as Thyalis, Parloid, Digitalis Leaves, Thy-Odone, Desoxyephedrine, Ammonium Chloride, Cal-Trol, Bar-It, and Potassium Chloride were dangerous to health when used in the dosage, and with the frequency and duration recommended in their labeling; that the drugs in the Lanpar Treatment for Obesity were new drugs without effective approved New Drug Applications; and that the defendant was well aware that its activities were in violation of the law; 501(a)(2)(B), 501(b), 501(c), 502(a), 502(f)(1), 502(j) and 505(a).

Following the denial of a temporary restraining order the case came on for trial at the conclusion of which the court handed down its findings of fact and conclusions of law. The Government filed a motion for amended and additional findings of fact and conclusions of law, which was considered by the court, and thereafter a decree was entered enjoining the defendant, its successors, assigns, officers, agents, employees, representatives, and all persons in active concert or participation with any of them from doing the following acts:

(1) introducing into interstate commerce Parloid, digitalis, ethinyl estradiol, Thy-Odone, Ethimens, Progest-L, testosterone, Parmone, testradol, Thyrac, Racs, Trep-En-Ol, ammonium chloride, potassium chloride, phenobarbital, amobarbital, Phe-Bel, Cal-Trol, Bar-It, desoxyephedrine, Cellobese, Encholezyme, Glutain, Pepadain, As-Ma-Pa, and Heplan, or similar products until the methods, facilities, and controls for their manufacture, packaging, and holding were in conformity with current good manufacturing practices; (2) introducing into interstate commerce or holding for sale after such shipment any of the drugs described above in subparagraph (1) when accompanied by the Lanpar Technical Reports and Bulletins, Lanpar Clinical Reviews and leaflets, and any similar written, printed, or graphic matter previously sent to physicians; (3) introducing into interstate commerce or holding for sale after such shipment any of the drugs described in subparagraph (1) when accompanied by written, printed, or graphic matter which represented and suggested among other things that such drugs, singly or in combination, were safe and effective in the treatment of hypothyroidism, amenorrhea, and hypomenorrhea, could safely bring about weight loss, would cause a change toward normal metabolism, and were safe and effective adjuncts in treatment of all obesity; (4) making oral statements which contain the representations and suggestions referred to above in subparagraph (3); (5) introducing into interstate commerce any of the above-named drugs unless their labeling bore adequate directions to enable a layman to safely and effectively employ the drugs for their intended use or, in case of prescription drugs, unless their labeling bore adequate information for use including indications, dosage, side effects, precautions, and relevant hazards; (6) shipping in interstate commerce or holding for sale after shipment in interstate commerce any drugs (except those returned for reworking) unless and until the drugs were properly labeled and assayed to assure that their strength, iden. tity, potency, and other characteristics were not different from that which they purported to possess; (7) introducing into interstate commerce or holding for sale after such shipment any digitalis product for treatment of obesity, Thyalis, or any drug containing a combination of thyroid and digitalis; (8) introducing into interstate commerce, or delivering after holding for sale after shipment in interstate commerce any digitalis products to any person whom the defendant has reason to believe may use such products in the treatment of obesity; (9) introducing into interstate commerce any thyroid or digitalis preparations unless their labels contain certain prescribed warnings; and (10) selling digitalis and thyroid drugs in any container holding more than 28 tablets or capsules so as to insure that the required warnings appear on each container received by the ultimate consumer.

The decree also ordered that each drug on hand in any facility owned or controlled by the defendant, which was not in compliance with the law or the decree, should be destroyed, reworked, or otherwise brought into compliance with the law and the decree; that all Lanpar Technical Reports and Bulletins, Lanpar Clinical Reviews, and leaflets be recalled and destroyed; that magnetic tapes of Lanpar symposia in possession of the defendant or previously sent to its customers be erased; that all drugs containing a combination of thyroid and digitalis be returned and destroyed or reworked to eliminate the active components of digitalis; and that all costs of court be taxed against the defendant. The defendant filed a motion to alter and amend the decree of injunction which was overruled by the court. The defendant also filed an objection to the cost bill, which objection was allowed by the court to tax only those costs consisting of clerk and marshal fees, fees for witnesses, and docket fees. The court also, as a result of the Government's motion referred to above, subsequently filed amended findings of fact and conclusions of law. 293 F. Supp. 147 (1968). (48) Potomac Creamery Co., Inc., and Joseph J. Kirk, president, Hagerstown, Dist. Md. Charged 6-20-67 in a complaint for injunction: that the defendants had

been receiving from intrastate and interstate sources fluid milk from which they were preparing, packing, holding, and distributing nonfat dry milk to customers in interstate commerce; that the nonfat dry milk contained the added poisonous and deleterious substance, Salmonella micro-organisms, that the nonfat dry milk had been prepared, packed, and held at the defendants' plant at Hagerstown under insanitary conditions whereby such food may have been contaminated with filth and rendered injurious to health; and that by reason of FDA inspections, an FDA hearing, a recall and seizures, the defendants were well aware that their activities were in violation of the law; 402(a)(1), 402(a)(4). A temporary restraining order and a preliminary injunction were entered that enjoined the acts complained of and enjoined the preparation and distribution of nonfat dry milk unless and until a number of specified conditions were met including the bringing into compliance of the stocks on hand of nonfat dry milk. Subsequently, the defendants were authorized to have the stock on hand reconditioned by another firm.

Thereafter, a consent decree of permanent injunction was entered, which dismissed the complaint as to the president, and which enjoined Potomac Creamery Co., Inc., from committing at its Hagerstown, Maryland, plant the acts complained of and from preparing at and distributing from that plant nonfat dry milk unless and until a number of specified conditions were met. (49)

NOTICE OF JUDGMENT on Miscellaneous Action Meprobamate and meprobamate combination products, judicial review suit, U.S. Court of Appeals for 4th Circuit.

Petitioned 2-29-68 by Carter-Wallace, Inc., a Maryland corporation, in a suit against H.E.W. Secretary Gardner and F.D.A. Commissioner Goddard for judicial review of the order imposing the added controls of the Drug Abuse Control Amendments of 1965 upon meprobamate and meprobamate combination products: that meprobamate was generally classified as a "tranquilizer," had been widely prescribed, and was marketed by Carter-Wallace under the brand name "Miltown"; that_the order would adversely affect Carter-Wallace, due to the added Drug Abuse Control restrictions, due to changed acceptance of meprobamate by physicians, patients, and drug abusers, due to required relabeling by Carter-Wallace of its meprobamate, and due to competitive disadvantage of Carter-Wallace with respect to competitive products not subject to such added restrictions; and that the order was unreasonable, arbitrary, not in accordance with law, and in excess of statutory authority, because: (a) FDA failed to sustain its burden of proof concerning any connection between meprobamate's potential for abuse and its effect on the central nervous system; (b) the order was based on a presumption created by an unauthorized and invalid FDA regulation [21 CFR 166.2(e)]; (c) the order was erroneously based on a finding of a "potential for abuse" instead of "substantial past abuse"; (d) the meprobamate combination products were erroneously included; and (e) the Hearing Examiner had made a multitude of erroneous and highly prejudicial rulings.

The Court of Appeals affirmed the Commissioner's order, saying: that there could be no doubt about the sufficiency of proof that meprobamate had a depressant effect on the central nervous system, that the examination of the records as a whole led the court to conclude that meprobamate did have a potential for abuse, and such was proper basis for the order, that the Government's case did not rest on any presumption alleged by the petitioners to have been created by the regulation 21 CFR 166.2(e), that since the combination drug contained meprobamate, they were covered by the plain language of the statute, that Carter-Wallace's contention that the Examiner was biased was not supported by the record, and that there was no merit in Carter-Wallace's other complaints about the conduct of the hearing or in Carter-Wallace's charge that the Examiner and the Commissioner ignored Carter-Wallace's evidence. In reviewing the evidence of connection between the depressant effect of meprobamate and its potential to affect the health of an individual or the safety of the community, the court said:

"Though the record contains no direct evidence or verified theories to explain meprobamate's effect, the Commissioner's order does not lack evidentiary support. Circumstantial evidence, or indirect proof, can satisfy the requirement that an administrative order be undergirded by substantial evidence. Dubin-Haskell Lining Corp. v. NLRB, 375 F.2d 568, 573 (4th Cir. 1967), cert. denied, 393 U.S. 824 (1968).

"We conclude that although the evidence is largely circumstantial, it substantially supports the Commissioner's findings that tolerance, withdrawal reactions, and euphoria are a result of meprobamate's central nervous system depressant effects. Physical dependence (as manifested by withdrawal symptoms and tolerance) and euphoria are among the characteristics of a drug that lead to its abuse. Therefore, taking into account our imperfect knowledge of how drugs injure people, we hold that substantial evidence supports the Commissioner's finding of a causal relation between meprobamate's depressant effect upon the central nervous system and its potential for abuse." 417 F.2d 1086 (1969); cert. denied 398 U.S. 938 (1970). (50)

Notices of Judgment are given pursuant to section 705 of the Federal Food, Drug, and Cosmetic 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., April 1, 1971

44/April 1971/FDA Papers

U.S. GOVERNMENT PRINTING OFFICE: 1971-435-651/34