Theramatic model A-6DT40 electronic instrument, at Daytona Beach, M. Dist. Fla.

Charged 5-27-70: when shipped by unknown shipper, the article's labeling contained false and misleading claims for infections, otitis media, fractures, bone and tissue healing, smooth muscle spasm, bursitis, arthritis, low back pain, headaches-parietal and occipital, urinary tract infections, ulcers-decubital, prostatitis, and sinusitis; 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 in its labeling, since it was ineffective for the treatment of the serious disease conditions for which it was recommended and by reason of its ineffectiveness, it was unsafe for such use; 502(a), 502(f)(1), 502(j). Default decree ordered destruction. (41)

COSMETICS / BEAUTY PRODUCTS

Hair brushes, at Buffalo, W. Dist. N.Y.

Charged 5-18-70: when shipped by unknown shipper from outside the United States, the article, labeled in part "Vienna [or "Vienco"] Made in France," contained nits; 601(b). Default decree ordered destruction. (42)

HAZARDOUS SUBSTANCES

Cherry bombs, at Hanna Junction, Dist. Wyo.

Charged 6-30-70: while held at a fireworks stand, Hanna Junction, Wyo., the articles were banned hazardous substances, since they 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. (43) Lime-Elim rust and lime eliminator, at St. Paul, Dist. Minn.

Charged 6-10-70: when shipped by Winn-Sol Products, Inc., Oshkosh, Wis., the article was an irritant substance containing approximately 15 percent phosphoric acid, and it lacked a number of the required conspicuous label statements; 2(p)(1)(B,D,E,G,J). Default decree ordered destruction. (44)

NOTICES OF JUDGMENT on Criminal Actions
FOOD

Atlanta Textile Corp., and Isahag Aprahamian, president, at Brooklyn, E.
Dist. N.Y.

Charged 3-18-70: when received from Brazil and delivered for pay in Brooklyn, N.Y., black pepper contained mold-402(a)(3); and when shipped from New York to Illinois, black pepper contained mold-402(a)(3). Guilty plea by corporation; fine. Nolo contendere plea by individual; fine. (45) City Sales Co. of Mobile, Inc., and John P. Finlayson, president, Mobile, S. Dist. Ala.

Charged 4-7-70 by grand jury: flour was held in a building accessible to rodents and insects and was contaminated with rodent and insect filth; 402(a)(3), 402(a)(4). Nolo contendere pleas; fines. (46)

Hollar & Greene Produce Co., a partnership, and Lige C. Hollar and Dale L. Greene, partners, Boone, M. Dist. N.C.

Charged 4-9-70: when shipped, cabbage contained quantities of toxaphene and parathion in excess of the tolerances; 402(a)(2)(B). Guilty plea by partnership; fine. Guilty pleas by individuals; fines and probations. (47) Zatarain's, Inc., and Chloe R. Anderson, president, at Gretna, E. Dist. La. Charged by grand jury 3-26-70: when shipped, Fish-Fri corn flour, Chick-Fri seasoned corn flour, and Zatarain's Crab Boil seasoning contained insect filth and had been prepared and packed under insanitary conditions; 402(a)(3), 402(a)(4). Nolo contendere plea by corporation; fine. Nolo contendere plea by individual; probation. (48)

HAZARDOUS SUBSTANCE

Richard Chalaire, t/a Plaquemines Parish Bar, and Murray D. Latapie, bartender, Braithwaite, E. Dist. La.

Charged by grand jury 10-30-69: while held for sale, silver salute fireworks (count 1) were sold to a child, and cherry bombs (counts 2, 3, 4) were sold to FDA inspectors, which resulted in such fireworks being banned hazardous substances in that they were toys which were flammable substances and generated pressure through explosion when ignited; 2(4)(1)(A). The defendants pleaded not guilty and moved to dismiss the indictment on the grounds that (1) the Federal Hazardous Substances Act did not prohibit the sale of banned hazardous substances that have been shipped in interstate commerce and (2) the silver kings and cherry bombs were exempt as common fireworks. The court denied the motion and the case came on for trial before the court. The court found both defendants guilty. In its opinion, the court said:

"A. Defendants Chalaire and Latapie did and caused the doing of an act with respect to a hazardous substance by selling silver kings and cherry bombs.

"Selling a hazardous substance is 'the doing of any act with respect to a hazardous substance.' The legislative history of the Act clearly shows that Congress intended to ban the sale of toys and other children's articles containing hazardous substances.' 1966 U.S. Code Congressional and Administrative News 4095 (Emphasis added). The Supreme Court has so interpreted an anologous provision of the Food, Drug and Cosmetic Act. U.S. v. Wiesenfeld Warehouse Co., 376 U.S. 86 (1964). * "Here, the evidence showed beyond a reasonable doubt that the silver king and cherry bombs were (1) flammable, (2) generated pressure through decomposition and heat, and (3) may cause substantial personal injury as a proximate result of any reasonably foreseeable handling or use.

"Both defendants are liable for selling the hazardous substances. Section 1263(b) expressly provides that The following acts and the causing thereof are hereby prohibited' (Emphasis added). The evidence that defendant Latapie personally sold the cherry bombs in Counts 2, 3 and 4 is undisputed. Defendant Chalaire is liable on all 4 counts because he caused the sales. U.S. v. Dotterweich, 320 U.S. 277 (1943); Palmer v. U.S., 340 F.2d 48 (5 Cir. 1964). Here, Chalaire admitted that he owned the bar, purchased the inventory of silver kings and cherry bombs, advertised them, hired persons to sell them and collected the profits. The fact that Chalaire did not personally do the selling is immaterial. "B. The silver kings and cherry bombs were held for sale after shipment in interstate commerce.

"The interstate shipment of a product is proved if the evidence shows that the product is found within a state, and that the product was either not manufactured there or was manufactured in another state. Palmer v. U.S., 340 F.2d 48 (5 Cir. 1964). Here, the evidence showed that no

Louisiana business had ever been licensed to manufacture silver kings or cherry bombs. In fact manufacture of those type fireworks (Class B) was prohibited. In addition an expert in the chemical analysis of fireworks testified that the silver kings were manufactured in Ohio and the cherry bombs were manufactured in New Jersey. I find beyond a reasonable doubt that they were so manufactured.

"C. The sale of the silver kings and the cherry bombs resulted in those hazardous substances being banned hazardous substances.' "Silver kings and cherry bombs are 'toys' within the meaning of the Act. The Act itself expressly excludes Class C (common) fireworks but not Class B fireworks. 15 U.S.C. §1261(q)(1)(ii). Also the legislative history of the Act clearly shows that Congress intended to include silver kings and cherry bombs (Class B fireworks) within the definition of toy. 1966 U.S. Code Congressional and Administrative News, 4095, 4096, see especially 4099.

The silver kings and cherry bombs are not exempt from the definition of banned hazardous substances because (1) they are not common fireworks and (2) they were not intended and used for bona fide agricultural

purpose.

"Here the evidence showed that the silver kings and cherry bombs produced audible effects by a charge of more than 2 grains of pyrotechnic composition. The cherry bombs contained 20 grains and the silver kings about 40 grains. The evidence also showed that the fireworks were not intended or used for bona fide agricultural purposes. The buyers were never asked whether they intended to use the fireworks for agricultural purposes and the fireworks never were so used.

"The sale of silver kings and cherry bombs to a child or to an adult without first asking the adult whether a child would use them results in those hazardous substances being a banned hazardous substance. The purpose of the Child Protection Act is to protect children. This is accomplished by banning hazardous toys from channels of interstate commerce that lead to children. All fireworks are not absolutely banned. Class B fireworks are not banned from channels of interstate commerce leading to persons who use them for bona fide agricultural purposes. But Class fireworks are banned from channels that lead to children. Of course Class C fireworks are not banned at all even if the channel leads to children. "Here, Chalaire is liable for the sale of silver kings to Dolese because Dolese was a child at the time of the sale. Chalaire admitted that Dolese was a child and should not have been sold Class B fireworks as a matter of common sense. The fact that the cherry bombs in Counts 2, 3 and 4 were sold to an adult is immaterial. The cherry bombs were toys. No one asked the buyer whether children would use them. The seller had a duty to inquire. cf. U.S. v. Dotterweich, 320 U.S. 277 (1943). Both Chalaire and Latapie are liable for this sale.

"D. Knowledge and willfulness are not elements of the offense. But in any event knowledge and willfulness were proved beyond a reasonable doubt. "Knowledge and willfulness are not an element of 15 U.S.C. §1263(b). Nowhere in the statute is this element mentioned. It is clear from the legislative history of the statute that Congress intended that knowledge and willfulness not be an element. The Child Protection Act of 1966 amended the Federal Hazardous Substances Labeling Act of 1960. The prohibited Acts section of the latter Act is 'patterned after the corresponding section of the Federal Food Drug and Cosmetic Act [21 USC § 331]'. 1960 U.S. Code Congressional and Administrative News 2840. The Supreme Court and the Fifth Circuit have interpreted 21 U.S.C. §331 as not requiring knowledge and willfulness. U.S. v. Dotterweich, 320 U.S. 277 (1943); U.S. v. Wiesenfeld Warehouse Company, 379 U.S. 86 (1964); Palmer v. U.S., 340 F.2d 48 (5 Cir. 1964)." *** (49)

NOTICES OF JUDGMENT on Injunction Action

Maizel Labs, Inc., and Benjamin L. Maizel, president, Chicago, N. Dist. III. Charged 10-3-69 in complaint for injunction: that the defendants were engaged in manufacturing, packing, and labeling various drugs, in holding a number of such drugs for sale after shipment of one or more of their components in interstate commerce, and in distributing a number of such drugs in interstate commerce; that the circumstances of the defendants' manufacture, packing, and holding lacked conformity with current good manufacturing practice; that a number of the drugs differed in strength from, and their quality and purity fell below, the U.S.P. and N.F. standards, or that which the drugs themselves purported and were represented to possess; that the labeling of a number of drugs contained false and misleading statements concerning the identity, quality, and strength of the drugs; and that the labeling of a number of drugs lacked adequate directions and did not comply with the Rx drug exemption requirement for disclosure of information; and that the defendants had distributed a new drug, Robese Gel, without an effective approved New Drug Application; 501(a)(2)(B), 501(b), 501(c), 502(a), 502(f)(1), 505(a). A consent decree of permanent injunction was entered enjoining the defendants from the violations complained of, and enjoined the further interstate shipment and the manufacture of drugs at the defendants' plant unless and until a number of specified good manufacturing practices were established, assays were made of drugs in possession of the defendants, recalls were made of such assayed drugs as were necessary, and the assayed and recalled drugs were destroyed or brought into compliance with the law. (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 involv. ing seizure proceedings, criminal proceedings, and injunction proceed. ings. 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., March 1, 1971

36/ March 1971 / FDA Papers

✩U.S. GOVERNMENT PRINTING OFFICE: 1971-435-650/21

HANDBOOK AVAILABLE The American Pharmaceutical Association announces that its new, revised 1971 edition of the Handbook of Non-prescription Drugs is off the press and available for immediate order. In a special prepublication period that ended in January, nearly 5,000 copies of the Handbook were sold, APhA said, indicating its exceptional acceptance by pharmacists and other health professionals. The new 202-page Handbook is 20 percent larger than the previous (1969) edition and contains 31 chapters, each devoted to a specific class of home remedies. It includes the formulas of more than 1,000 different brand-name products in almost 1,200 dosage forms, and, in addition to a cross-reference product index, it has an index of nearly 300 manufacturers, 76 pages containing tables and charts of products, and a score of medical illustrations and scientific graphs.

The Handbook is available at $6.50 per copy from the Order Desk, American Pharmaceutical Association, 2215 Constitution Avenue, N.W., Washington, D.C. 20037. Orders under $10 must be accompanied by payment.

ANNUAL IFT MEETING The 31st Annual Meeting and Exposition of the Institute of Food Technologists will be held May 23-27 at the Americana Hotel in New York City. IFT's New York Section will be host and has built its program around the theme, "New YorkNew Ideas."

For further information contact George R. Foster, Director of Field Services, Institute of Food Technologists, Suite 2120, 221 North LaSalle Street, Chicago, Illinois 60601.

These workshops and conference are designed to respond to the needs of the regulated industries for information about various problems in compliance, and to clarify for industry any fine points of the laws administered by the Food and Drug Administration. Normally, these workshops are initiated in FDA Districts because they are most familiar with industry's needs in their geographical areas. The Office of Compliance, Bureau of Foods, is gratified by the cooperation from industry to date in these areas.