higher dose levels.

Superpharm Corp. recalled six lots of the product and told FDA's Brooklyn district office about the recall. An investigator was dispatched to identify the cause of the labeling error. He found several violations of Good Manufacturing Practice regulations that could have led to the mixup and that could cause problems in the labeling of other products. The district sent a letter to the firm describing the violations and then met with Superpharm officials to discuss methods to improve the label identification system.

A follow-up inspection found that the firm had corrected its procedures.

Name That Color

The labeling on about 254,000 cases of Hi-C Lemon Flavor Drink Mix wasn't explicit enough. One ingredient that was listed on the label as "artificial color" should have read "FD&C Yellow No. 5." FDA has required since 1981 that this particular color be identified by name because some people are allergic to it. The allergic responses, which occur primarily in people also allergic to aspirin, range from a stuffed-up or runny nose to difficulty in breathing and hives. Approximately 47,000 to 94,000 people in the United States are allergic to the color additive.

The labeling omission on the Hi-C Drink Mix, manufactured for the CocaCola Co., Houston, Texas, caught the attention of a competitor, who complained to FDA's Dallas district office. The district inspected the Texas custom manufacturer that packaged the product and confirmed the violation. Coca-Cola officials told FDA that there had been no njuries reported from use of the product and that the labels would be corrected.

The company relabeled approximately 33,000 cases of the drink mix stored in its warehouses and destroyed empty containers with the incorrect labeling. However, about 6,000 cases were in the hands of distributors in California, Nebraska and Texas.

These distributors were supplied with stickers bearing a new list of ingredients --this time with Yellow No. 5 listed by name. The company also sent letters explaining the problem and asking that the stickers be attached to each case of the product, as well as similar explanatory letters for the distributors to give to their

An infant apnea monitor is a medical device that's supposed to alert parents or nursery personnel when a sleeping baby stops breathing. But when the monitor doesn't even sound its alarm when it has accidentally become disconnected, it's time for FDA to look into the matter.

Apnea monitors are used to keep a "mechanical" watch over infants who have pathological apnea, a condition in which breathing stops for 15 seconds or more and resuscitation is needed to revive the baby. Prolonged lack of breathing is dangerous because it can reduce the body's oxygen supply, leading to irreversible brain damage or even death. Apnea is suspected in some, but not all, cases of sudden infant death syndrome (SIDS). Parents of infants thought to be at high risk of SIDS are often urged to use an apnea monitor while their baby is sleeping.

Apnea monitors are designed to sound an alarm if the infant stops breathing for a predetermined interval-10 to 30 seconds. Most such devices detect apnea by indirect methods, such as a lack of chest motion. A direct-method monitor detects actual air flow and thus is less likely to be "fooled" by other movements. But, because this type of monitor generally restricts movement, it may be uncomfortable for the baby. Thus, direct-method monitors are usually used only during intensive care in the hospital.

Last June, FDA received a complaint involving the Model 16900 Infant Monitor (IM) manufactured by Home Care Products Inc., a division of Healthdyne. The complaint came from a mother who said that although a wire from the monitor to her child had become disconnected, the monitor continued to reflect normal conditions instead of sounding an alarm, as it should have. If the baby had stopped breathing, it would have gone undetected. An investigator from FDA's Atlanta district office and a biomedical engineer from the agency's Winchester Engineering and Analytical Center visited the firm's Marietta, Ga., plant. A review of the firm's files revealed that 201 complaints about the Model 16900 IM had been received from January to March 1984. Fifty-three percent of the complaints concerned failure of the alarms to sound when wires had become loose.

The firm's quality analysis engineers, as well as an outside testing lab, determined that these failures were due to the build-up of static electricity within the unit. Static discharge, in turn, caused failure of a transistor within the circuit that was supposed to detect disconnected wires. In addition, the static discharge affected the sensitivity of the units, causing some to sound false alarms when conditions were normal.

The build-up of static electricity could be caused simply by contact with the baby's night clothes, or by the parent walking across a carpeted floor and then touching the wires.

To correct the problem, the firm had developed an anti-static plug adaptor for the units and was making these adaptors available free to its customers. The firm viewed these efforts as a "product improvement," and not a recall. Thus, it had not notified FDA.

However, because of the high risk of serious injury or death if the alarm system failed to work, FDA classified the firm's action as a Class I recall.

The firm then notified all consignees of the potential problems with the infant monitor, and alerted purchasers to the availability of the free adaptors, with follow-up visits to make sure all consignees were notified. Approximately 7,000 monitors had been distributed.

(For more about SIDS and apnea monitors, see "The Mystery Of Crib Death" in the April 1983 FDA Consumer.)

-Information for this small sample of reports from the field was provided by Carolyn Hommel, Lynne Isaacs and John Miceli.

Summaries of Court Actions are given pursuant to section 705 of the Federal Food, Drug, and Cosmetic Act. Summaries of Court Actions 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 or cosmetics 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.

Summaries of Court Actions are prepared by Food and Drug Division, Office of the General Counsel, HHS.

Published by direction of the Secretary of Health and Human Services.

SEIZURE ACTIONS

Foods/Poisonous and Deleterious Substances

PRODUCT: Sugar peas, at Chicago, N. Dist. Ill.; Civil No. 84-C-6368.

CHARGED 7-25-84: When shipped by Talley Farms, Inc., Arroyo Grande, Calif., the article (labeled "California TF Vegetables.. Sugar Peas... Talley Farms, Inc.") bore and contained the pesticide chemical Acephate (approximately 0.19 ppm), and there was no tolerance or exemption for such chemical on sugar peas -402(a)(2)(B).

DISPOSITION: Default-ordered destroyed. (F.D.C. No. 64349; S. No. 84-314-798; S.J. No. 1)

Foods/Contamination, Spoilage, Insanitary Handling PRODUCT: Cashews, blanched, at Minneapolis, Dist. Minn.; Civil No. 4-79-301.

CHARGED 6-25-79: When shipped by Kane International Corp., Larchmont, N.Y., the article (labeled "Cata Nuts Product of Tanzania... Blanched Cashew") contained insect filth—402(a)(3). DISPOSITION: Consent-authorized release to the shipper for bringing into compliance. The article was reconditioned and re-exported. (F.D.C. No. 62344; S. Nos. 79-129-707/8; S.J. No. 2) PRODUCT: Cereal, and other grocery stocks, at Atlanta, N.

Dist. Ga.; Civil No. C84-317 A.

CHARGED 2-17-84: While held by Capitol Fish Co., t/a Capitol Foods & t/a National Meat Purveyors, Atlanta, Ga., the articles were held under insanitary conditions-402(a)(4). DISPOSITION: Consent-authorized release to the dealer for bringing into compliance. (F.D.C. No. 64212; S. No. 84-376-242; S.J. No. 3)

PRODUCT: Coffee creamer, non-dairy, at New Sharon, S. Dist. Iowa; Civil No. 83-664-E.

CHARGED 12-1-83: While held by Frostline-Harkema Food Processing Plant (Div. Grain Processing Corp.), New Sharon, Iowa, the article contained rodent filth and had been held under insanitary conditions-402(a)(3), 402(a)(4).

DISPOSITION: Consent-authorized release to the dealer for salvaging. (F.D.C. No. 64144; S. No. 84-318-632; S.J. No. 4)

PRODUCT: Fennel seed, at Joplin, W. Dist. Mo.; Civil No. 83-5188-CV-SW-O.

CHARGED 11-17-83: When shipped by Totino's Frozen Foods (Div. Pillsbury Co.), Fridley, Minn., the article (labeled "Whole Fennel Seed . . . Pillsbury Code 13406, Bacteria Treated, The Baltimore Spice Co., Baltimore, Md.") contained rodent filth402(a)(3).

DISPOSITION: Default-ordered destroyed. (F.D.C. No. 64138; S. No. 84-250-540; S.J. No. 5)

PRODUCT: Fennel seed, at Norfolk, E. Dist. Va.; Civil No. 84-209-N.

CHARGED 3-23-84: While held for sale, the article contained mammalian and bird filth-402(a)(3).

DISPOSITION: Default-ordered destroyed. (F.D.C. No. 64230; S. No. 84-395-358; S.J. No. 6)

PRODUCT: Pancake-waffle mix, at Mayaguez, Dist. Puerto Rico; Civil No. 83-3036(JF).

CHARGED 12-14-83: While held for sale, the article contained insect filth-402(a)(3).

DISPOSITION: Default-ordered destroyed. (F.D.C. No. 64141; S. No. 83-348-121; S.J. No. 7)

PRODUCT: Popcorn, at Vinton, N. Dist. Iowa; Civil No. C84-31. CHARGED 3-7-84: When shipped by Galyen Land & Cattle Co., Atkinson, Neb., the article contained rodent filth-402(a)(3). DISPOSITION: Default-ordered destroyed. (F.D.C. No. 64225;

S. No. 84-354-101; S.J. No. 8)

PRODUCT: Salmon, dressed, frozen, at Everett, W. Dist. Wash.; Civil No. C83-1724V.

CHARGED 12-6-83: When shipped by Sea Fresh Co., Ltd., Kodiak, Alaska, the article contained decomposed fish402(a)(3).

DISPOSITION: Default-ordered destroyed. (F.D.C. No. 64149; S. No. 84-335-724; S.J. No. 9)

PRODUCT: Salmon, canned, at Seattle, W. Dist. Wash.; Civil No. C-84-281.

CHARGED 3-2-84: When shipped by Queen Fisheries, Inc., Dillingham, Alaska, the article contained decomposed fish -402(a)(3).

DISPOSITION: Consent-authorized release to the shipper for salvaging. (F.D.C. No. 64202; S. No. 84-313-417 et al.; S.J. No. 10)

PRODUCT: Salmon, dressed, frozen, at Seattle, W. Dist. Wash.; Civil No. C-83-1393.

CHARGED 10-5-83: When shipped by SeaPro-Transfresh Co., Anchorage, Alaska, the article contained decomposed fish -402(a)(3).

DISPOSITION: Default-ordered destroyed. (F.D.C. No. 64089; S. No. 83-373-434; S.J. No. 11)

Foods/Economic and Labeling Violations

PRODUCT: "Maple" syrup, and "honey", at Louisville, W. Dist. Ky.; Civil No. C-80-0346-L(B).

CHARGED 7-3-80: When shipped by Anthony's Syrup Co., Philadelphia, Miss., the articles (labeled "Anthone's Wild Flower Brand Honey [or 'Pure Clover Honey'] packed By Oliver Anthony," and "Anthone's Pure Maple Syrup Made and Distributed By: Anthony Syrup Co., Inc. . . . Philadelphia, Miss.") had substances other than maple syrup or honey substituted for the articles-402(b)(2); the articles' labeling was false and .misleading in representing that the articles consisted wholly of maple syrup or honey-403(a)(1); the "maple" syrup failed to conform to the definition and standard of identity for maple syrup, because the article was made with syrup derived from a source other than the maple tree-403(g)(1); and the "honey" (both lots) was also in violation of the Fair Packaging and Labeling Act, since the quantity of contents statements were expressed as "Net Wt. 38 Oz." and "Net Wt. 20 Oz.," instead of "Net Wt. 38 Oz. (2 Lb. 6 Oz.)" and "Net Wt. 20 Oz. (1 Lb. 4 Oz.)"-15 U.S.C. 1453(a)(3)(A)(i).

DISPOSITION: Default-ordered destroyed. (F.D.C. No. 63082; S. Nos. 80-235-487/9; S.J. No. 12)

Drugs/Human Use

PRODUCT: Caffeine and ephedrine sulfate tablets and capsules, and other combination stimulant drugs, at Dubuque, N. Dist. Iowa; Civil No. C84-1010.

CHARGED 2-3-84: When shipped by JSP, Inc., Central Islip, N.Y., and other shippers, the articles were new drugs without effective approved New Drug Applications-505(a); and while held for sale by R&C Distributors, Inc., Dubuque, Iowa, the articles' labeling lacked adequate directions for use and they were not exempted due to their new drug status-502(f)(1). DISPOSITION: The dealer filed a claim to the articles but did not file any answer to the charges. A default decree condemned the articles and ordered them destroyed. (F.D.C. No. 64184; S. No. 84-325-798 et al.; S.J. No. 13)

PRODUCT: Carbo-Lite protein concentrate (starch blocker) tablets, and Calorex protein concentrate (starch blocker) tablets, at Knoxville, E. Dist. Tenn.; Civil No. 3-82-602. CHARGED 10-20-82: When shipped by Bio-Tech Laboratories, Inc., and Vita-Lite Laboratories, Batesville, Ark., the articles were new drugs without effective approved New Drug Appli-| cations-505(a).

DISPOSITION: Default-ordered destroyed. (F.D.C. No. 63820; S. Nos. 82-276-707/8; S.J. No. 14)

PRODUCT: Reserpine, hydralazine HCl, and hydrochlorothiazide tablets, at Northvale, Dist. N.J.; Civil No. 82-1139 (HLS). CHARGED 4-13-82: While held by Zenith Laboratories, Inc., Northvale, N.J., who had manufactured the article using imported reserpine, the strength of the article differed from, and the quality of the article fell below, the U.S.P. standard, since the article failed the U.S.P. content uniformity test—501(b).

DISPOSITION: The article was claimed by the manufacturer, who denied that the court had jurisdiction, and denied the charge. The claimant also asserted a number of defenses, including gross laches on the part of the government, established custom and usage as to the manner of testing of the article, the insufficiency of the U.S.P. tests and the sufficiency of a proposed U.S.P. variant test, and the proper strength and purity of the article as tested using such variant test. The claimant served written interrogatories on the government. The government served written interrogatories and requests for admissions on the claimant. The government objected to a

E

number of the claimant's interrogatories.

The claimant moved to dismiss the government's complaint for lack of jurisdiction, alleging that the seized articles were not "held for sale" after interstate shipment, as required by statute. The claimant argued that, although the article had been placed in the stream of commerce before Zenith had been advised concerning any deficiency, Zenith was, at the time of the action, voluntarily withholding the article from sale in the expectation that the Zenith method of testing would be approved by the U.S.P. or that some reformation would bring the article into compliance. The government moved (in limine) to preclude the submission by the claimant of evidence concerning the claimant's alternative test method, which found the article unadulterated.

On March 21, 1983, the court denied the claimant's motion. The court found that Zenith's intention to cure any possible adulteration non-conformance with the U.S.P. standard) did not alter the conclusion that the tablets were being held for sale, and was immateral to the government's right to forfeit the article.

At the same time, the court granted the government's motion in imine, despite the claimant's argument that the results of the alterhative test had relevance with respect to the article's compliance with the U.S.P. test. The court found that the clear language of the statute prescribed that the determination of whether a drug met U.S.P. standards was to be in accordance with the U.S.P. tests and methods and that the only two exceptions were exceptions not applicable to the case. Accordingly, evidence of the results of other esting methods was irrelevant, and the fact that the claimant's method had been proposed for inclusion in the U.S.P. did not give the court authority to make any determination based on results of such alternative test method.

Subsequently, the claimant withdrew his claim and answer and a default decree ordered the article destroyed. (F.D.C. No. 63700; S. No. 82-286-309; S.J. No. 15)

N.Y.; Civil No. 83-CIV-4507(RO). CHARGED 6-15-83: The article, which had been shipped by Bloomex International, Inc., Yonkers, N.Y. (accompanied by labeling such as (manual) "P-8 Portable Professional Muscle Exerciser Bloomex International, Inc. . . . Yonkers New York. . . Product of Bio-Medical Research Ltd.," (brochure) "Slim-Tone Cellulite Centers, Inc., Direct from Europe," and (instruction manual) "eureduc ateliers et bureau . . . Phlebodynamic . . . MODE OPERATOIRE"), had been accompanied by false and misleading labeling, since the name Slendertone or Slim-Tone and other statements contained false and misleading claims for tightening flabby areas, reducing inches, restoring elasticity and firmness, controlling cellulite, restoring a youthful appearance, bringing back waist and body definition, tightening saggy buttocks, breaking up fatty tissue, and reducing inches from hips, thighs, stomach and buttocks; and the labeling lacked adequate directions for safe use by a layman, because such directions could not be written for the device's intended use, because the device was potentially harmful, and because the device did not qualify for exemption-502(a), 502(f)(1).

DISPOSITION: Default-ordered destroyed. (F.D.C. No. 63302; S. No. 80-200-210; S.J. No. 17)

PRODUCT: Negative ion generator, Golden Zephyr, at San Jose, N. Dist. Calif.; Civil No. C-83-5639 SC. CHARGED 11-21-83: The article, which was manufactured locally upon the specifications of the distributor, and which was promoted, labeled and distributed by that distributor, Source Research, Inc., San Jose, Calif., was accompanied by false and misleading labeling (e.g., (leaflet) "The Golden Zephyr... The Ion Experience" and (brochure) "Golden Zephyr... The Natural Air Purifier") that made claims for relief of the effects of allergies and allergic reactions, lowering the incidence of bronchitis and asthma, lowering the incidence of sudden infant deaths and legionnaire's disease,

CHARGED 11-15-82: When shipped by Pharmaceutical Dynamics, Inc., South Hauppauge, N.Y., the article (labeled "Natural Starch Blocker... Tablets Distributed by Continental Advertisng, Grand Blanc, MI.") was a drug without an effective approved New Drug Application-505(a).

the device was processed in an unregistered establishment and was not included in the required listing and was not the subject of a required notice-502(0); and the article's label lacked the name and place of business of the manufacturer, packer or distributor —502(b)(1).

Medical Devices