Cherries, canned/Minneapolis, Minn.
10/22/70

Diet Dr. Pepper/Mobile, Ala, 12/4/70
Feta cheese/New York, N.Y. 10/23/70
Lima beans/Greeley, Colo. 12/15/70

Ma Cohen's Home Made Pickled Schmaltz
Herring, Ma Cohen's Imported Party
Snack in Wine Sauce/Pittsburgh, Pa.
11/25/70

"Old Fashion Candies" Wild Cherry,

Sea Coast Mints, Honey Horehound, Butterscotch, Fruit Mix, Spice Mix, Anise/Milwaukee, Wis. 9/8/70 Peanuts, Virginia, blanched, and Spanish, salted/Salt Lake City, Utah 11/30/70 Senf Gurken pickles/St. Louis, Mo. 12/3/70

United Refrigeration Services, Inc./
Oklahoma City, Okla. (D)

New England Fish Co./Vessel “Flamingo” from Alaskan waters (S)

Brown Bun Baking Co./Detroit, Mich. (D)

Winchester Bay Seafood Co./Winchester
Bay, Oreg. (M,S)
Johnson Nut Co./Hopkins, Minn. (M,S)

J. C. Murray/Brooklyn, N.Y. (S) (Imported from Argentina)

Economic and Labeling Violations
Jebavy-Sorenson Orchard Co./Manistee,
Mich. (P,S)

Pepsi Cola-Dr. Pepper Bottling Co./Mobile,
Ala. (D)

William Faehndrich, Inc./New York, N.Y.
(D)

Mar-Bo Quality Foods, Inc./Fresno, Calif. (P,S)

City Smoked Fish Co.(label)/Detroit, Mich. (M)

Arlington Candy Co., Inc./Somerville, Mass. (M,S)

Thrifty Foods, Inc./Salt Lake City, Utah (D) Atkins Pickle Co./Atkins, Ark. (M,S)

Decomposed and rancid.

Contain decomposed scallops.

Held under insanitary conditions; rodent and insect contaminated.

Prepared and packed under insanitary conditions; staphylococci.

Prepared and packed under insanitary conditions; moldy and insect damaged. Decomposed.

NOTICES OF JUDGMENT on Seizure Actions

FOOD / Poisonous and Deleterious Substances

Chubs, eviscerated, frozen, at Chicago, N. Dist. III.

Charged 12-30-69: while held for sale, the article contained the nonconforming food additives, DDT, DDE, DDD, and dieldrin; 402(a)(2)(C). Default decree ordered destruction. (1)

Eggs, frozen, at Grantsville, Dist. Md.

Charged 5-22-70: when shipped by Roof Garden Egg Co., Meyersdale, Pa., the article contained the added poisonous and deleterious substance, Salmonella micro-organisms; 402(a)(1). Default decree ordered destruction. (2)

Eggs, frozen, at Meyersdale and Somerset, W. Dist. Pa.

Charged 6-19-70: when shipped by Roof Garden Egg Co., from Grantsville, Md., the article contained the added poisonous and deleterious substance Salmonella micro-organisms; 402(a)(1). Default decree ordered destruction. (3)

FOOD / Contamination, Spoilage, Insanitary Handling

Cornhusks, at Phoenix, Dist. Ariz.

Charged 6-1-70: when shipped by George Walcher, Weimar, Tex., the article contained insect filth and moldy cornhusks; 402(a)(3). Default decree ordered destruction. (4)

Cornmeal, yellow, at Oblong, E. Dist. III.

Charged 4-27-70: while held by Mont Eagle Mills, Inc., Oblong, Ill., the article was held under insanitary conditions; 402(a)(4). Default decree ordered destruction. (5)

Eggs, frozen, at Louisville, W. Dist. Ky.

Charged 8-11-70: when shipped by Illini Egg Products, Inc., Olney, III., the article contained decomposed eggs and had been prepared and packed under insanitary conditions; 402(a)(3), 402(a)(4). Default decree ordered destruction. (6)

Flour, rye, at Seattle, W. Dist. Wash.

Charged 6-1-70: while in transit and while held in a railroad car, the article was held under insanitary conditions; 402(a)(4). Consent decree authorized release to Union Pacific R.R. Co., Seattle, Wash., for salvaging. (7)

Milk, nonfat, dried, at Salem, W. Dist. Va.

Charged 6-18-70: when shipped by Newman Grove Cooperative Creamery Co., Newman Grove, Nebr., the article, labeled in part "Valley Lee Brand Pasteurized Nonfat Dry Milk Mid-West Producers Creameries, Inc., South Bend, Ind. Distributor," had been prepared and packed under insanitary conditions; 402(a)(4). Default decree ordered destruction. (8)

Onion rings, breaded, frozen, at Wilmington, E. Dist. N.C.

Charged 12-24-69: when shipped by Southern Frozen Foods, Inc., Montezuma, Ga., the article, labeled in part "Gold King Raw Breaded Onion Rings Packed by Gold King Frozen Foods, Inc., Thunderbolt, Ga.," contained E. coli, and bacterial filth, and was prepared and packed under insanitary conditions; 402(a)(3), 402(a)(4). Default decree ordered destruction. (9)

Orange and grapefruit sections, canned, at Norwood, Dist. Mass.

Charged 6-17-70: when shipped by Florida Citrus Canners Corp., Plant City, Fla., the article, labeled in part "Food Club Pure Florida Grapefruit & Orange Sections Distributed by Topco Associates, Inc., Skokie, Illinois," had been packed and held under insanitary conditions; 402(a)(4). Default decree ordered destruction. (10)

Pecan pieces, at Louisville, W. Dist. Ky.

Charged 5-8-70: when shipped by Sunny South Pecan Co., Statesboro, Ga., the article contained E. coli; 402(a)(3). Default decree ordered destruction. (11)

Rice, at Phoenix, Dist. Ariz.

Charged 6-12-70: while held by Arctic Storage Co., Phoenix, Ariz., the article contained rodent filth and was held under insanitary conditions; 402(a)(3), 402(a)(4). Default decree ordered destruction. (12)

Shrimp, breaded, Trade Winds, at Florence, Dist. S.C.

Charged 5-15-69: when shipped by Trade Winds Co., Thunderbolt, Ga., the article contained coagulase positive staphylococcus and had been prepared and packed under insanitary conditions; 402(a)(3), 402(a)(4). Default decree ordered destruction. (13)

Walnut meats, at Seattle, W. Dist. Wash.

Charged 6-1-70: when shipped by Willamette Valley Walnuts, McMinnville, Oreg., the article contained E. coli; 402(a)(3). Consent decree ordered destruction. (14)

Whiskey, Seven Crown, at Relay, Dist. Md.

Charged 5-19-70: when shipped by Seagram Overseas Sales Co., New
York, N.Y., the article had been held under insanitary conditions, since
it had been inadvertently dropped overboard into the harbor waters at
Hoboken, N.J.; 402(a)(4). Consent decree authorized release to Joseph E.
Seagram & Sons, Inc., New York, N.Y., for reconditioning. (15)

FOOD / Economic and Labeling Violations

Beans, peas, and lentils, dried, at Greeley, Dist. Colo.

"

Charged 6-17-70: when beans, peas, and lentils, labeled in part "Casserole Brand California Baby Lima Beans [or "Split Peas," or "Great Northern Beans," or "California Large Lima Beans," or "California Blackeye Beans" or "Lentils" or "Whole Peas" or "Split Peas"] American Bean & Pea Growers, Inc., Spokane, Wash.,' were shipped by Marbo Quality Foods, Inc., Fresno, Calif., Inland Empire Pea Growers Association, Spokane, Wash., and Big Horn Cooperative Marketing Association, Basin, Wyo., and when beans, labeled in part "High Protein Outwest Brand Idaho Red Beans Distributed by Outwest Bean, Inc., Denver, Colo.," were shipped by Bean Growers Warehouse Association,

Filer, Idaho, the articles were in violation of the Fair Packaging and Labeling Act, in that the quantity of contents declaration was not in the lower 30 percent of the principal display panel, in that for all lots except the 4-lb. bags of Great Northern Beans the quantity of contents was expressed as "Net Wt. 1 Lb." or "Net Wt. 2 Lbs." instead of "Net Wt. 16 Oz. (1 Lb.)" and "Net Wt. 32 Oz. (2 Lbs.)," and the principal display panels of the packages had an area between 25 and 100 square inches and the statements of the net quantity of contents stated on the panel contained letters and numerals in a type size less than 3/16 inch high; 15 U.S.C. 1453(a)(2), 1453(a)(3)(A), 1453(a)(3)(C)(i). Consent decree authorized release to Outwest Bean, Inc., Denver, Colo., for relabeling. (16)

Candies, orange, grape, and coffee flavored, Stix Pak, at San Francisco, N. Dist. Calif.

Charged 6-2-70: when shipped by Jolly Rancher, Inc., Wheatridge, Colo., the articles were in violation of the Fair Packaging and Labeling Act, in that the principal display panel of the label lacked a declaration of the net quantity of contents; 15 U.S.C. 1453(a)(2). Default decree ordered destruction. (17)

Corn, cream-style, canned, Good Pak, at Salt Lake City, Dist. Utah.

Charged 5-20-70: when shipped by Big Horn Canning Co., Cowley, Wyo., the article was in violation of the Fair Packaging and Labeling Act, in that the net quantity of contents declaration was not separated from other printed label information appearing above or below the declaration, in that the net quantity of contents statement was expressed as "Net Weight 1 Pound" rather than "Net Wt. 16 Oz. (1 Lb.)," 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, and in that the label did not state the net quantity of each of the servings of label statement "Servings 4"; 15 U.S.C. 1453(a)(2), 1453(a)(3)(A)(1), 1453(a)(3)(C)(i), 1453(a)(4). Default decree authorized donation to public institution. (18)

Herring fillets in sour cream, and herring cuts, spiced, Lasco, at Phoenix, Dist. Ariz.

Charged 5-1-70: when shipped by Los Angeles Smoking & Curing Co., Los Angeles, Calif., the articles were 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, and in that the principal display panel had an area 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.Č. 1453(a)(2), 1453(a)(3)(C)(i). Consent decree authorized release to the shipper for relabeling. (19)

Peas, canned, Stokely Van Camp, at Pauline, Dist. Kans.

Charged 6-18-70: when shipped by Kuner-Empson Co. (Stokely Van Camp, Inc.), Brighton, Colo., the article was in violation of the Fair Packaging and Labeling Act, in that the declaration of the net quantity of contents was not in the bottom 30 percent of principal display panel, in that the net quantity of contents was expressed as "Net Weight 1 Lb. 1 Oz." instead of "Net Wt. 17 Oz. (1 lb. 1 oz.)," and in that the principal display panel had an area 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)(4). Consent decree authorized release to shipper for relabeling. (20)

Pineapple, canned, at Stockton, E. Dist. Calif. Charged 8-5-70: when shipped from Malaysia, the article, labeled in part "Nugget Brand Sliced Pineapple Distributed by Nugget Distributors, Inc., Stockton, Calif.," fell below the standard of quality for canned pineapple because more than 72 percent of the more than 27 units in the cans were excessively trimmed; 403(h)(1). Default decree ordered donation to a charitable organization. (21)

Salad dressing, Flav-O-Rite, at Liberty, W. Dist. Mo.

Charged 6-10-70: when shipped by Guy's Foods, Inc., Tulsa, Okla., the article lacked conformity to the standard of identity, since it was deficient in vegetable oil; 403(g)(1). Consent decree authorized release to shipper for compliance operations. (22)

VITAMINS / DIETARY FOODS

lodine dietary supplement tablets, at Grand Rapids, W. Dist. Mich. Charged 10-12-70: while held by Muir Drug Labs., Inc., Grand Rapids, Mich., who manufactured the article from kelp shipped in interstate commerce, the valuable constituent, iodine, had been in part omitted or abstracted from the article, and the label lacked required information concerning the minimum daily requirement for iodine supplied by the article; 402(b)(1), 403(j). Default decree ordered destruction. (23) FOOD ADDITIVES

Cattle feed, medicated, Hi-Energy Range Cubes, at LaSalle, Dist. Colo. Charged 5-28-70 and amended 6-3-70: while held by John Ewing Co., LaSalle, Colo., who manufactured the article from a premix which contained neomycin sulfate and had been shipped in interstate commerce, the article was an animal feed containing a new animal drug, and no approval of an application filed with respect to such animal feed was in effect; and the labeling contained false and misleading claims concerning the efficacy of the article in the prevention of scours in calves by feeding to the mother cow; 501(a)(6), 502(a). Consent decree authorized release to the dealer for compliance operations. (25)

Pig feed, medicated, at Horse Cave, W. Dist. Ky.

Charged 8-27-70: when shipped by Cooperative Mills, Inc., Cincinnati,

Ohio, the article, labeled in part "SS Pig Starter Medicated

Southern States Cooperative Inc., Cooperative Mills Div. General Office Baltimore, Maryland," was deficient in arsanilic acid (approx. 90 percent), and its labeling with respect to its arsanilic acid content was false and misleading; 501(c), 502(a). Consent decree ordered destruction. (26)

Ohio.

DRUGS/Human Use

Amphetamine-barbiturate-vitamin combination capsules, at Mansfield, N. Dist. Charged 5-27-70: when shipped by Plymouth Labs., Inc., Plymouth, Mich., the strength of the article, labeled in part "Amvidex Timecaps Distributed by The Caldwell & Bloor Company, Mansfield, Ohio," differed from that which it purported to possess, and the label declaration of potency was false and misleading, since the article contained only 73.3 percent of the dec.ared amount of dextro-amphetamine sulfate and 79.1 percent of the declared amount of amobarbital; 501(c), 502(a). Default decree ordered destruction. (27)

Bacitracin ointment, U.S.P., at Atlanta, N. Dist. Ga.

Charged 5-26-70: when shipped by Abbott Laboratories, North Chicago, Ill., the article's strength differed from U.S.P. standard, since the article was understrength in bacitracin (approx. 24 percent); 501(b). Default decree ordered destruction. (28)

Calcium chloride injection, N.F., at Detroit, E. Dist. Mich.

Charged 2-13-70: while held for sale after manufacture locally by Atlas Pharmaceutical Labs., Inc., Detroit, Mich., from ingredients shipped in interstate commerce, the labeling lacked adequate directions for use and did not comply with the Rx drug exemption requirement for disclosure of information; and the article was not packaged as prescribed by the National Formulary, since it was packaged in multiple dose containers; 502(f)(1), 502(g). Default decree ordered destruction. (29) strontium-bromide combination injection, at

Calstron calcium-gluconate

Mableton, N. Dist. Ga.
Charged 6-30-70: when shipped by Farnsworth Laboratories, Inc., Chicago
Heights, Ill., the article was a new drug without an effective approved
New Drug Application, and the labeling contained false and misleading
claims for various types of dermatological conditions; 505(a), 502(a).
Default decree ordered destruction. (30)

Cold Sore IVO camphor thymol combination cream, at Minneapolis, Dist. Minn. Charged 6-25-70: when shipped by Walter S. Wanecke, t/a Ivo Co., Milwaukee, Wis., the labels of both lots of the articles lacked a quantity of contents statement, and some labels of one lot of the article lacked the established name of each active ingredient; 502(b)(2), 502(e)(1)(A)(ii). Default decree ordered destruction. (31)

Formula 1275 KI and lobelia combination elixir, at Keokuk, S. Dist. Iowa. Charged 5-14-70: when shipped by Ulmer Pharmacal Co., Minneapolis, Minn., the labeling lacked adequate directions for use and did not comply with the Rx drug exemption requirement for disclosure of information; 502(f)(1). Default decree ordered destruction. (32)

lodinated casein tablets, at Louisville, W. Dist. Ky.

Charged 9-11-69: 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. (33)

Lipo-K lipotropic factor combination injectable, Ossonate Plus mucopoly saccharide extract combination injectable, at Philadelphia, E. Dist. Pa. Charged 10-24-69: when shipped by Marcen Laboratories, Inc., New Rochelle, N.Y., the articles were new drugs without effective approved New Drug Applications; 505(a). Default decree ordered destruction. (34) Lubricating jelly, sterile, at Augusta, S. Dist. Ga.

Charged 4-7-70: when shipped by Badger Laboratories, Inc., Jackson, Wis., the article's quality and purity were deficient and its labeling was false and misleading, since the article was not sterile; 501(c), 502(a). Default decree ordered destruction. (35)

Pentaerythritol tetranitrate tablets and reserpine tablets, U.S.P., at Chicago, N. Dist. III.

Charged 4-17-69: while held by G & G Drug Co., Chicago, Ill., who was repacking the articles, their labeling failed to bear adequate directions for use and the articles were not exempt from such requirements; 502(f)(1). Consent decree authorized release to the dealer for compliance operations. (36)

Thyrodig T-13 tablets and T-32 tablets (thyroid-digitalis combinations), Thyrodig anterior pituitary tablets (thyroid, digitalis, and anterior pituitary combination), and thyroid 5 gr. tablets, at Houston, S. Dist. Tex. Charged on or about 5-28-68: when shipped by Western Research Labs., Inc., Denver, Colo., the labeling of the Thyrodig T-13 tablets and Thyrodig anterior pituitary tablets contained false and misleading claims that thyroid-digitalis combinations were of value in the treatment of individuals requiring the thyroid effect and that thyroid safely accelerated cellular metabolic processes increasing the metabolic rate; the labeling of the Thyrodig T-32 tablets contained false and misleading claims that thyroid safely accelerated cellular metabolic processes, increasing the basal metabolic rate, that Western Research Labs., Inc., had overcome many of the thyroid disadvantages, and that Western Research Labs.' thyroid-digitalis preparations were safe and effective adjuncts in the treatment of obesity; the labeling of the thyroid 5 gr. tablets contained false and misleading claims that such tablets accelerated cellular metabolic processes, were safe and effective as an adjunct to the dietary treatment of obesity, and were safe and effective in the treatment of menstrual disorders, infertility, threatened abortion, and skin diseases; the labeling of the thyroid 5 gr. tablets failed to reveal the material facts that such tablets were not safe and effective in treatment of obesity, menstrual disorders, infertility, threatened abortion, and certain skin diseases except where such conditions were associated with hypothyroidism, and that the overwhelming number of persons suffering from such conditions are not afflicted with hypothyroidism; the labeling of all the articles lacked adequate directions for use and did not comply with the Rx drug exemption requirement for disclosure of information; all articles were dangerous to health when used in the dosage and with the frequency and duration suggested in their labeling; and all articles were new drugs without effective approved New Drug Applications; 502(a), 502(f)(1), 502(j), 505(a). Consent decree ordered destruction. (37)

MEDICAL DEVICES

Dynatone electronic facial stimulator, at Minneapolis, Dist. Minn.

Charged 9-27-67 and amended 6-28-68: when shipped by Dynatone, Inc.,

Wichita, Kans., and while held by Powers Dry Goods Co., Minneapolis, Minn., the accompanying labeling contained false and misleading claims for firming and toning key age-revealing areas of the face and neck, firming underlying areas strengthening sagging muscles electronically exercising hidden face and neck muscles, firming delicate facial muscles thereby preventing or eliminating double chins, crow's feet, and other facial contour problems, and making the user look years younger; the article's label lacked the name and place of business of the manufacturer, packer, or distributor, and an accurate statement of the quantity of contents in terms of weight, measure, or numerical count; the article's labeling lacked adequate directions for use, since a number of packages did not bear or contain directions for use; and the article's labeling lacked adequate warnings against unsafe use; 502(a), 502(b)(1)(2), 502(f)(1), and 502(f)(2).

The article was claimed by Dynatone Electronic Corp., New York, N.Y., who denied that the article was misbranded as alleged in the complaint. Thereafter the Government served interrogatories upon the claimant and moved to amend the complaint to include misbranding charges in addition to the original 502(a) charge. The claimant objected to the interrogatories and resisted the motion to amend the complaint. The court overruled the claimant's objections to the interrogatories, except where, on the authority of United States v. Article of Drugs, 43 F.R.D. 181(D. Del. 1967), the court sustained the claimant's objections to a number of interrogatories which depended upon the identification of certain exhibits as being copies of brochures seized in the action. The court also concluded that the Government was entitled to amend its complaint pursuant to Rule 15(a), saying:

"The United States failed to amend its complaint within the time allowed as a matter of right. Rule 15(a) provides as to amendments on motion that 'leave shall be freely given when justice so requires.' The claimant objects under Rule 7(b)(1) contending that the moving papers lack the necessary particularity. In fact the moving papers do fail to set forth any reasons for requesting the amendment. However, each proposed paragraph in the amendment alleges the violation of a precise statutory provision of the Federal Food, Drug, and Cosmetic Act and the interests of justice and the lack of showing of any significant prejudice to the claimant militates in favor of permitting the amendment. The new paragraphs of the amendment speak for themselves in alleging violations of statutory provisions. The grounds for seeking leave to amend are implicit in the amendment and it is obvious from a quick perusal that the United States believes that the device Dynatone infringes additional statutory provisions beyond those alleged in the original complaint. Trial date is some months off and claimant has adequate time to prepare his defense without prejudice."

The case came in for trial by the court. Two expert medical witnesses testified for the Government in a test involving use of the device; and "Before and after" color photos were received in evidence. To the court and according to the testimony of those experts, there was no distinguishable or observable difference or improvement in facial difference in any of the subjects. The court said:

"More forceful and convincing however than the above experiment was the medical testimony concerning the effect of aging on the skin and the results not obtained by muscle contraction. One of the aforementioned experts and two other medical experts called by the Government, one a specialist in physical medicine and rehabilitation, the other a dermatologist, testified in summary that facial and neck muscle exercise or contraction would have no effect on wrinkling of the skin, or if anything would promote or increase it. The testimony was to the effect that exercise does nothing for wrinkled skin overlying a muscle. Electrical stimulation, while causing a muscle contraction, will not cause muscle growth, i.e., hypertrophy, though it might slow down but will not stop muscle atrophy. Voluntary exercise can cause increase in muscle size, and to that extent would or might stretch the overlying skin and thus reduce wrinkles therein to some extent. No such result can be obtained however by artificial electrical musc.e contraction. The testimony was clear that the use of the device would not be effective to help or reduce crow's feet, double chins, or jowls. These conditions relate to the elasticity of the skin itself and have no relation to muscle tone or the loss thereof nor to weakness or atrophy of facial muscles. Wrinkling is in large part caused by the skin's failure to resume its normal state after a bending or folding caused by muscle contraction. Increased exercise of underlying facial muscles if it affects the wrinkling process at all, probably makes the wrinkles worse. This evidence was very convincing to the court and the court finds it to be true."

On the basis of the evidence received at the trial, a study of the parties' memoranda, and in all of the files, records, and proceedings of the action, the court found that the article was in violation of 502(a), condemned the article and authorized delivery of the article to FDA for destruction or use only for exhibition purposes. (38)

Oxygen mask, Respirex, at Los Angeles, C. Dist. Calif.

Charged 9-5-69: when shipped by Respirex International, Guadalajara, Mexico, the labeling contained the false and misleading claim that the article contained a 10-minute supply of life-sustaining oxygen for vital emergency first aid; the labeling lacked adequate directions for use for heart attack, drowning, stroke, asthma, shock and smoke inhalation, and such directions could not be written for safe use by the untrained laity; and the labeling lacked adequate warnings against use; 502(a), 502(f)(1), 502(f)(2). Consent decree authorized release to the Respirex Corp., Los Angeles, Calif., for export to the original foreign supplier, and perpetually enjoined the Respirex Corp., and its agents, servants, employees, and attorneys, and all persons in active concert or participation with them from introducing into interstate commerce the Respirex device consisting of a mask and oxygen container purportedly containing 38 liters of oxygen. (39)

Respirator, at Nashville, M. Dist. Tenn.

Charged 7-24-69: 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 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)