Document MQRzDDZjO8MQRjY5on6xbERM

WASHINGTON \& (/& LETTER DRUG INVESTI GATION DRUG TESTING EXHIBIT \p ^> Bulletin No. 950 January 27, 1964 It is reported that the Senate Government Operations Subcommittee, under the Chairmanship ci Senator Hubert Humphrey {Dem. Minn,) is considering whether financial media have been misused to communicate to readers m is leading drug information. According to these reports the Committee has been assembling data on the manner in which drug firm s report financial news to the public. It is said that Senator Humphrey has been interested as to how much coordination exists between the Securities and Exchange Commission and the Food and Drug Administration. The Subcommittee is investigating, according to these reports, whether there have-been misleading statements in connection with sales of securities of drug companies about the products of the companies, such as the omission of information about adverse effects or the inclusion of information which may be premature, misleading or incomplete. The Food and Drug Administration issued Good Manufacturing Practice regulations on June 20, 1963. They were based on the Kefauver-Harris Amendments. When these regulations were published FDA announced that modification would be necessary in connection with their application to the manufacture of chem icals and other raw materials used as components of finished drugs and FDA promised that regulations dealing with them areas would be published at a later date. Thus far, the regulations relating to manufacture of chem icals and other raw m aterials used as components, have net yet appeared. The Good Manufacturing Practice rules, consequently, apply only to firms making finished dosage form drugs. This point has arisen in connection with the question of the responsibility for testing the components of drugs. FDA says that there is no provision in the Act or regulations which would require the maker of a raw material or a bulk chemical to be used as the component, to furnish to his customer a protocol of analysis of the article shipped. Further, FDA stresses the fact that even ii the dosage form firm should receive protocols of analysis from a supplier, the Good Manufacturing Practice regulations would, nevertheless, require the consignee to test the commodity which he receives. FDA cites Regulation 133.6 and 13S, 11 tc make it clear that firm s purchasing chemicals in bulk must test these components whether or not they receive protocols of assay from their Suppliers. Regulation 133.6 reads as follows: "Components used in the manufacture and processing of drugs, regardless of whether they appear on the finished products, shall be Identified, stored, examined, tested, inventoried, handled and otherwise controlled in a manner to assure that they conform to appropriate standards of identity, strength, quality and purity, and are free of contaminants at time of u se, and to provide that appropriate records are maintained of their origin, receipt, examination, testing, disposition, ana use in drug manufacture or processing." -3- PLAINTIFFS EXHIBIT WCD-335 WCD000880 I Regulation 133,11 reads in part as follows: "Laboratory, controls shall include the establishment of adequale specifications and test procedures .to assure that components *** conform to appropriate standards of identity, strength , quality,, and purity. Laboratory controls shall include: (a) The establishment of master records containing appropriate specifications for each, component used in drug production and a description of the test procedures used to check them, including provisionfortesting adequately representative sam ples. Such records shall also provide for appropriate retesting of m aterials subject to deterioration. " PRICING FTC has adopted revised Guides Against Deceptive Practicing, They are intended to serve as practical aids but are not to be considered as precise statements of law or fixed miles of "do's" and "don't's". Among Other things, guidance is given as to the proper use of manufacturers'suggested retail or lis t p rices. A national or regional advertiser w ill not be expected to investigatt in detail-the prevailing prices of h is`product throughout his large trade area. If he makes use of the suggested retail price as an honest estim ate of the actual :retail value, and the suggested price does not appreciably exceed the highest price at which substantial sales aremade in this trade area, he w ill not be ;chargeable under the Guides with having engaged in a deceptive practice. -A retailer competing in a local area, however, is charegable with at least a general knowledge of prices being charged in Ms area. Before advertising a manufacturer.'s lis t price as a basis for comparison of Ms own lower p rice, jFTC says that he should ascertain whether the lis t price is in fact the price j regularly charged by the principal outlets in h is area. Therefore, a retailer |who advertises a manufacturer's or distributor's suggested retail price .should Ibe careful to avoid creating a false im pression that he is offering a reduction {from a price at wMch the product is generally sold in his trade area. FDA PERSONNEL j One of the features of the current reorganization shuffle of personnel in FDA (finds M orris Yakowitz, who has headed the Advisory Opinions Section, moving | over to take over the Case Supervision Division, Harold O'Keefe, who has been [in charge of Case Supervision of drugs, w ill move over to Yakowitz`s former [job in charge of Advisory Opinions. TETHACSIINE Federal Trade Commission issued final order removing unlawful restraints of trade in the manufacture and sale of tetracycline. Under the order Chas. |P fizer & C o., Inc. is required to grant production licenses to all domestic j applicants under its tetracycline patent. The order is limited to "tetracycline Iso ld in dosage form for human consumption". The Commission order states 1 that the Pfizer patent was obtained through deliberate misrepresentation and |withholding of information. Sim ilarly, American Cyanamid Co. was ordered to [open up its patents on Aureomycin. iCyanamid is required to license only those applicants intending to use j Aureomycin for "making and selling tetracycline", and is not deprived of the I right to stop other parties from selling the patented product Aureomycin. FTC I further ordered P fizer, Cyanamid and four other concerns -- B ristol M yers Co. 1 B ristol Laboratories, In c ., Olin Mathieson.Chemical Corp, (Squibb), and 1 Upjohn Co. --to stop conspiring to fix prices and submitting rigged bids on Itetracycline, and to individually and independently cancel existing prices a Predetermine new ones within sixtv days. * WCD000881 rETRACXCIME Con't. ) PEED AND LIVESTOCK .CARSON FRAILEY'S WASHINGTON LETTER (Con't. J Specific provisions of the order ar -- (1) Royalties collected by Pfizer and. Oyanamid may not exceed 2 1/2 percent of licensees' net sa les of tetracycline; (2) an applicant may be required to pay $2,500 upon being issued a license, which amount shall be applied against future royalties. -This provision is to preclude "harassment by fly-by-night operators who have no bona fide intent to manufacture and sell tetracycline; (3) - Pfizer and Oyanamid must furnish licen sees, upon written request, all technical information and know-how relating to the manufacture of chlortetracycline and tetracycline exchanged by the two companies in the past. (It is expected that appeals to the courts w ill delay the effective date of this a c tio n .} The FDA'has announced official definitions for a variety of term s used in the feed and livestock industries. The purpose of this is to aid in the interpretation of Federal regulations governing the use of drugs and other ingredients in feeds. For example, the definitions are given for "complete feed"," food additive concentrate"; "feed additive premix", "premix11, "broiler chickens", "laying chickens", "pre-starter ration", "grower rations". DGAT will forward copies-of this if you request it. Art. #7 . Research 'Grants Art. #8 Fuel Cells Art. #9 Foreign N otes W ASHINGTON DIG EST (C o n 't.) Dr. John F . Sherman has been named Associate Director cf the Nationai Institutes of Health, a new position in which he w ill he responsible for over-all policies and procedures relating to award of NIHfunds to non-Federalinstitutions. The Air Force says a solid-electrotyle fuel cell concept is feasible. 3-cell units weighing 6 g ., occupying 0.2 cu,.cm. have been built delivering 2.1 watts operating at electrolyte densities of 750 ma. /sq . and at an operating tempera ture of 1, 000 C. Report on request, $2.00 (a) Drue Residues - The Canadian Food and Drugs Act is proposed to beamended by the addition of the following section: "No person shall se ll a drug recommended for use in animals which may be consumed as food unless the manufacturer thereof has, on request, filed with the Director, inform , manner and content satisfactory to him, a submission, in duplicate, that includes details of tests carried out to demonstrate that no residues of the drug remain in meat, meat by-products, eggs or milk except as provided in these Regulations. " Absence of residues may be achieved either by adjusting the conditions of use of the drug or by terminating its use at a time which w ill ensure the absence of residues. In either case, the manufacturer should submit information to demonstrate that residues w ill not be present in edible products at the ti-mp they are proposed to he sold. If a withdrawal period is required for drugs to be adminstered to lactating cattle, it must not exceed 96 hours, Since some drugs cannot be used effectively on a "no residue basis", consideration w ill be given to the establishment of appropriate tolerances. Detailed reports of tests made to establish the safety of such residues will be required before consideration can be given to their establishment. Comments should be addressed to C. A. M orrell, Director, Food& Drug Directorate, Department of National Health and Welfare, Ottawa, before February 15, WCD000882 I ir t. #10 Articles of interest from. Joe Trade hre s s rhl is tbws s-'?jaa ib) Paint - A relatively sm all but w ell established paint maker in Baghdad Iraq, seeks the technical assistance of a U .S. paint manufacturer.- -The firm wants to improve arid, expand production which at present runs at the annual rate of $200,000 in term s of local currency. (c) Acids in Spain - Licensing and financial assistance is sought from a U.S. firm in order to expand present production to include sorbic and terephthaHc acids. ' Name on request. (d) tttbb./ Ammenia Plant - American private investments' largest enterprise in Taiwan to date is the $22.5 million urea/ammonia dant which is a joint investment of Socony Mobil, Allied Chemical, China Petroleum Corp. The plant u tilizes abundant natural gas in expected annual production of 100,00C tons of urea and 50,000 tons of ammonia. ' (e) Baby Feeding - A U. S. licensee is sought to produce and sell a Trench-developed device for feeding infants or young animals solid or sem i solid foods. The developer of the device, who has applied for U. S. patent, fb iffls that his invention provides a completely new, safe and easy method of infant feeding. Complete drawings and additional information available. D id y o u k n o w that: E. R. SQUIBB & SONS DIVISION received the OLJN MATHIESON CHEMICAL COUP. 's President's Annual Safety Award, which passes permanently to Squibb for.having received the award three years out of five........POLAK'S FRUTAL WORKS, INC.,Middletown, N .Y ., is celebrating its 50th anniverary this year. The company was founded in Amersfoort, Holland in 1914.-.... THE OTT CHEMICAL COMPANY, Muskegon, M ich., has acquired the Fine Chemicals Div. of L. Perrigo Company, Allegan, Mich........ LEE RAMSDELL & CO,, INC, has opened a New Ygrk office at 355 Lexington Avenue........ CHAS. PFIZER & CO,, INC, recently presented its Paul-Lewis Award, established in 1946 to stimulate fundamental research in enzyme chemistry in the United States by young men and women........ CELANESE CORPORA TION OF AMERICA announced plans for major expansion of its Pampa, Texas, plan t.' _____________ .__________ t11Auto and Appliances Put Shmein ABS1Sales11; Consumption of acrylonitrile- |butadiene- styrene, led by auto and appliance uses, reached 100 million lbs. in j1963. New capacity is planned and prices are lower. CHEMICAL & ENGI- INEERING NEWS, January 13, Page 25. .. | 11Kidney HomotganspiantationT,: Human Kidney homotransplantation is a Itechnically sound procedure for replacing irreversibly diseased kidneys, but assurance that the homograft w ill not be rejected is still lacking except in 5identical twins. MODERN MEDICINE, January 20, Page 155. . H1Nickel Consumption Hits Record High in 1963"; Free World used 525 million | pounds of nickel metal last year and more gains are expected. However, 1capacity still remains substantially in excess of consumption. CHEMICAL & ;ENGINEERING NEWS, January 6, Page IS. i"Recommend Kidney Study With Cerebral Viewing11: JOURNAL OF THE iAMERICAN MEDICAL ASSN., January 18. i"Rehabilitation of the Burned Hand": Original A rticles describing managelnient of thermal injury of the hands. MODERN MEDICINE, January 20, Page 126 a m yop.k FFsea 3S3 F'fA Yers t, H.Y. Taisph*s PSaav!lv}!a soA, 6k m . Y . P. __ "mT- WASH/H(SirSri RSPBHSBMTAT1V3 A line SaiiiJiiig, 'E>tegK>a S, rJ.C, Tiilttjfisit; ;)?,a.s . fin?* ?*? ?wI57, Attrey*oi.law WCD000883  \3EGUIA- IXGNSFOB The Pood and Drug Administration has published regulations for color addi tives used in foods, drugs, and cosm etics. The regulations implement the COLOR i Color Additive Amendments. ADDITIVES 1. Additional safety precautions are provided for lipsticks, rouge, eyebrow and lash color and other substances that apply color to the human body. Under E n tire the new regulations, FDA w ill require that an entire product--not just the product color ingredient--rbe shown by the manufacturer to be safe before it is ' must be safe - released for sa le. Previously only color of the coal tar type ingredients had been subject to the requirement'for pre-marketing proof of safety. Commis-. sioner Larrick said the new requirement is based on the language in the law Pre-market., and the legislative intent to insure that the entire'formulatlon of a "color J proof additive" is safe for the consumer. Hair dyes 2, The language of the regulation dealing with exemption of M ir dyes from the safety clearance and certification requirement has been clarified to show., that the "patch test" requirement applies only tD hair dyes which are dangerous because the.user may be sensitive to .them. Patch.i; test.' ^:yic . -y:-1. v Commissioner Larrick says that the exemption in the 1938 law was conditioned on labeling requirement calling for the use of a^patch test to ' determine whether the user is. sensitive to the color before'the hair dye is applied. The patch testing requirement offers no protection from other types 4 ..of toxicity, says la rrick , and the purpose of the new regulation is to close the gap.. Hair dyes that do not cause a reaction with the patch test must now be demonstrated to be safe before they can be marketed, ' FDA may *'. refuse to .c e r tify ^ . 3. The regulations provide tha!t FDA may refuse to certify a color additive --if the manufacturer refuses FDA inspectors access to manufacturing ' fa c ilities, p rocesses, and formulas involved in manufacture of the additive. .Many subjects covered FDA cannot determine whether the conditions *for safe use of color additives, including products exempt from certification, are being met unless a complete inspection of the plant and formulas can b^made, according to L a rrick . The regulations cover such matters as definition of term s, fees to be charged- for listin g and certification of batches of colors, labeling requirements for . colors, tim e schedules for acting upon petitions, protection of-trade secrets, procedures for obtaining certification, or exemption from certification ofbatches of both coal tar and non-coal tar colors ; and procedures for filing objections and requesting public hearings on regulations. . ' : -Jj-.. ; Ssifety^v x factor ' Safety data which may be required under the regulations Include d'etailed ; data from appropriate animal and other biological experiments; information -"I as to chem ical identity and composition and physical, chemical and biological & properties; a description of tests, facilities and'controls used,.in manufacture; data on stability, including a proposed expiration date where necessary; and, ' when needed, satisfactory methods for detecting and measuring the color .In .the products in which it would be used. *- PaJH The rgulations provide that a safety factor of 100 to 1 will ordinarily he used aA-2 in applying animal experimentation data to man, unless use of a different factor is -supported by the data submitted; and provide for taking into account M 'any probable.additive effect of the toxicity of the color with that of other . h related colors or with food additives or pesticides which may also be present in foods,_________ .' ... Y p*t WCD000884 DRt'G INVESTI GATION DRUG TESTING ;It is reported that the Senate Government Operations Subcommittee, under the Chairmanship :of Senator Hubert Humphrey (Dm. Minn, ) is considering [whether financial media have been misused to communicate to readers m is| leading drug information. According to these reports the Committee has been | assembling data on the manner in which drug firm s report financial news to 1 the public, It is said that Senator Humphrey has been interested as to how much icoordination exists between, the Securities and Exchange Commission and the 'Food and Drug Administration. The Subcommittee is investigating, according to these reports, whether there have-been misleading statements in connection with sa les of securities of drug companies about the products of the companies, | such as the omi'ssion of information about adverse effects or the inclusion of |information which may be premature, misleading or incomplete. jThe Food and Drug Administration issued Good Manufacturing'Practice Iregulations on June 20, 1963. They were based on the Kefanver-Harris | Amendments. When these regulations were published FDA announced that | modification would be necessary in connection with their application to the imanufacture of chem icals and other raw materials used as components of !finished drugs and FDA promised that regulations dealing with these areas would be published at a later date. Thus fa r , the regulations relating to manufacture !of chem icals and other raw m aterials used as components, have net yet appeared, ;The Good Manufacturing Practice ru les, consequently, apply only to firm s making finished dosage- form drugs. This point has arisen in connection with | the question of the responsibility for. testing the components of drugs. FDA says that there is no provision in. the Act or regulations which would require the maker of a raw material or a bulk chemical to be used as the component, to furnish to h is customer a protocol-of analysis of the article shipped. Further, FDA stresses, the fact that even ii the dosage form firm should receive protocols of analysis from a supplier, the Good Manufacturing Practice regulations would, nevertheless, require the consignee to test the commodity which he receives. FDA. cites Regulation 133.6 and 133.11 to make it clear that firm s purchasing chemicals in bulk must test these components whether or not they receive protocols of assay from their Suppliers. Regulation 133.6 reads as follows: "Components used in the manufacture and processing of drugs, regardless of whether they appear on the finished products, shall be identified, stored, examined, tested, inventoried, handled and otherwise controlled in a manner to assure that they conform to appropriate standards of identity, strength, quality and purity, and are free of contaminants at time of u se, and to provide that appropriate records are maintained of their origin, receipt, examination, testing,, disposition, and use in drug manufacture or processing. " -3- WCD000880 Regulation 133.11 reads in part as follows: 11Laboratory.controls shall include the establishment of adequate specifications and test procedures .to assure that components *** conform to appropriate standards of identity, strength , quality,. and purity. Laboratory controls shall include: (a) The establishment of master records containing appropriate specifications for each component used in. drug production and a description of the test procedures used to check them, including provisionfortesting adequately representative sam ples. Such records shall also provide for appropriate retesting of m aterials subject to deterioration. " PRICING . FTC has adopted revised Guides Against Deceptive Practicing. They are |j intended to serve as practical aids but are not to be considered as precise statements of law or fixed rules of "do's" and "don't's,!. Among Other things, guidance is given as to the proper use of manufacturers'suggested retail or list p rices. A national or regional advertiser w ill not be expected to investigate in detail-the prevailing prices of his'product throughout his large trade area. If he makes use of the suggested retail price as an honest estimate of the actual retail value, and the suggested price does not appreciably exceed the highest price at which substantial sales aremade in this trade area, he w ill not be chargeable under the Guides with having engaged in a deceptive practice. -A Iretailer competing in a local area, however, is charegable with at least a Igeneral knowledge of prices being charged in h is area. Before advertising a !manufacturer.'s lis t price as a basis for comparison of his own lower p rice, !FTC says that he should ascertain whether the lis t price is in fact the price ]regularly charged by the principal outlets in his area. Therefore, a retailer Iwho advertises a manufacturer's or distributor's suggested retail price .should be careful to avoid creating a false im pression that he is offering a reduction I'from a price at which the product is generally sold in his trade area. FDA PERSONNEL One of the features Of the current reorganisation shuffle of personnel in FDA Sfinds M orris Yakowitz, who has headed the Advisory Opinions Section, moving ;over to take over the Case Supervision Division. Harold O'Keefe, who has been | in charge of Case Supervision of drugs, w ill move over to Yakowitz`s former | job in charge of Advisory Opinions, TEFRCSCUNE Federal Trade Commission issued final order removing unlawful restraints of Itrade in the manufacture and sale of tetracycline. Under the order Chas. \Pfizer &C o ., Inc. is required to grant production licenses to all domestic _ (applicants under its tetracycline patent. The order is limited to "tetracycline Isold in dosage form for human consumption". The Commission order states I that fhe Pfizer patent was obtained through deliberate misrepresentation and |withholding of information. Sim ilarly, American Cyanamid Co. was ordered to | open up its patents on Aureomycin. ICyanamid is required to license only those applicants intending to use I Aureomycin for "making and selling tetracycline", and is not deprived of the 1 right to stop other parties from selling the patented product Aureomycin. FTC I further ordered P fizer, Cyanamid and four other concerns -- B ristol M yers Co. 1 Bristol Laboratories, In c., Olin Matfaieson Chemical Corp. (Squibb), and I Upjohn Co. --to stop conspiring to fix prices and submitting rigged bids on |j{tetracycline, and to individually and independently cancel existing prices a1 Ir e determine new ones within sixty da^s. WCD000881 TETRAC2CIKE (C on 't.} FE2D AND livesto ck napflnN FRAiLEY'S WASHINGTON LETTER (CoaftJ_ gneciiic provisions of the order ar - (1) Royalties collected byP fizer and g u a r n id may not exceed 2 1/2 percent of licensees' net sa les of 2) an applicant may be required to pay $2,500 upon being issued a license , which amount shall be applied against future royalties. This provision is to preclude "harassment by fly-by-night operators who have no bona fidei intent to manufacture and sell tetracycline (3}- Pfizer and C^anamid must furnish licen sees, upon written request, all technical information and know-how relating to the manufacture of chlortetracycline and tetracycline exchanged by the two companies in the past. _ (It is expected that appeals to the courts will delay the effective date of this a c tio n .} ____________ ______ _________ The FDA has announced official definitions for a variety of term s used in the feed and livestock industries. The purpose of this is to aid in the interpretation of Federal regulations governing the use of drugs and other inp^ements in feeds For example, the definitions are given for "complete feed"," food L tiW v m c e t t u L - , "leed adfttve p rsm ii, "premit", "tooer c h it o s " , "laying chickens", "pre-starter ration", "grower rations . DCAT will forward copies-of this if you request it. Art. #7 Research 'Grants Art. #8 Fuel Cells Art. #9 Foreign Notes WASTTiNGTON DIGEST ( C o n ' t . ) Dr John F. Sherman has been named Associate Director of the National institutes of Health,a new position in which he w ill be responsible for over-all policies and procedures relating to award of NIB funds to non-Federalinstitutions. The Air Force says a solid-electrotyle fuel cell concept is feasible. 3-cell units weighing 6 g , occupying 0.2 cu. cm, have been built delivering 2 1watts TM K g gat electrolyte densities of 750 ma. /ag. and at an operating tempera ture of 1,000 C. Report on request, $2.00_______ ., ' amended by p-d d n es _ The Canadian Food and Drugs Act is proposed to be of teefSlow in g section: "No person shall se ll a drug emimals which may be consumed as food unless the wlt t o Director, inform , manner in ,m Pli=ato, thati-cM es S ^ X e ^ S S d o J t r i m o n a t r a t e that no r s s i t o of the drag remain in meat, meat by-products, eggs or mlUt except as provided in Blese Regulations. " _ Absence of residues may be achieved either by adjusting the conditions of use of the drug or by terminating its use at a time which w ill ensure the absence 5 s S . a either case, the manufacturer should submit information to demonstrate that residues w ill not be present in edible products at the tune they are proposed to be sold. If a withdrawal period is required for drugs to be adminstered to lactating cattle, it must not exceed 96 hours. Smce 1 some drugs cannot be used effectively on a "no residue basis", consideration w ill be given to the establishment of appropriate tolerances. Detailed resorts of tests made to establish the safety of such residues will be I r e q ^ ^ before consideration can be given to.their establfehment. Comments should be addressed to C. A. M orrell, Director, Food&Drug Directorate, I Department of National Health and Welfare, Ottawa, before February 15. WCD000882 i fb> Paint - A relatively sm all but w ell established paint maker in.BSghdae if : Iraq, seeks the technical assistance of a U. S. paint manufacturer.- -The firm 1wants to improve and expand production which a t present runs at the annual | rate of S200,000 in term s of local currency. ' i (o) A dds in Spain - Licensing and financial assistance is sought from a ! U.S. firm in order to expand present production to include sorbic and :terephthalic acids. ' Name on request. I (d) TTfoa^AmmnHa. Plant * American-private investments1largest Ienterprise in Taiwan to date is the $22. 5 minion urea/ammonia jfant which is la joint investm ent of Socony Mobil, Allied Chemical, China Petroleum Corp. The plant u tilizes abundant natural gas in expected annual production of 100,00C itons of urea and 50,000 tons of ammonia. ` : (e) Bab? Feeding - A U, S, licensee is sought to produce and sell a ;French-developed device for feeding infants or young animals solid or sem i solid foods. The developer of the device, who has applied for U .S. patent, rfatwis that his invention provides a completely new, safe and easy method of infant feeding. Complete drawings and additional information available. ir t. #10 Articles of interest from ine Trade ^ress D id yo u k n o w that: . E. SQUIBB & SONS DIVISION received the OLIN MATHIESON CHEMICAL COEP. `s President's Annual Safety Award, which passes permanently to Squibb for. having received the award three years out of five........ POLAK'S FRUTAL WORKS, INC^Mddletown, N. Y ., is celebrating its 50th anaiverary this year. Th company was founded in Amersfoort, Holland in 19 1 4 ... ., THE OTT CHEMICAL COMPANY, Muskegon, M ich., has acquired the Fine Chemicals Div, of L. Perrigo Company, Allegan, Mich., . . .LEE RAMSDELL & CO,, INC. has opened a New York office at 355 Lexington Avenue.. . . . CHAS. PFIZER & CO., INC. recently presented its Paul-Lewis Award, established in 1946 to stimulate fundamental research in enzyme chemistry in the United States by young men and women........ CELANESE CORPORATTON OF AMERICA announced plans for major expansion of its Pampa, Texas, plant. ' ______________.___________ "Auto and Appliances Put Shinein. ABS Sales" ; Consumption of acrylonitrilebutadiene-styrene, led by auto and appliance uses, reached 100 million lbs. in 1963, New capacity is planned and prices are lower, CHEMICAL St ENGI NEERING NEWS, January 13, Page 25. . "Kidney Homotransplantation"; Human Kidney homotransplantation is a technically sound procedure for replacing irreversibly diseased kidneys, but assurance that the homograft w ill not be rejected is still lacking except in identical twins. MODERN MEDICINE, January 20, Page 155.. "Nickel COTisumntion Hits Record High in 1963"; Free World used 525 million pounds of nickel metal last year and more gains are expected. However, capacity still rem ains substantially in excess of consumption. CHEMICAL & ENGINEERING NEWS, January 6, Page 18. "Recommend Kidney Study With Cerebral Viewing": JOURNAL OF THE AMERICAN MEDICAL ASSN., .January 18. "Rehabilitation of the Burned Hand": Original Articles describing manage ment of thermal injury of the hands. MODERN MEDICINE, January 20, Page 126 ?hi* jc -fttwa iHKf'-* Eg UK YORK OFFICE g|s 3S9 PS-fK feresse, ksvY#s 1- H.Y. ?i53B |K Tsiaphaae: FSaa*??sah! &83S4-S L , Bsfcr, ilrcsfl. V . P, WASH-iif.vT'gfc SSPHSSHfiTATIV^ Alisrsc "Ssaisiegwa S, 5.C . ''isliijtiEttiiii fiAilorse; fUilSa-S g6-&c ?*? AfiSiCfiiy-cV'Lsi? WCD000883 itEGULA- ISONSFOR (rt COLOR ADBim ES The Food and Drug Administration has published regulations for color addi tives used in foods, drugs, and cosm etics. The regulations implement th Color Additive Amendments. 1 Additional safety precautions are provided for lipsticks, rouge, eyebrow and iash color and other substances that apply color to the human body. Under Sniire product must be safe g S r a t t e n s , FDA w ill require that an entire product--not just the color ingredient-Tbe shown by the manufacturer to be sa fetefo re it is for sa-ie Previously only color of the coal tar type ingredients had b M ? ^ 5 e c t to the r e q S e S t t o prs-m erk etto Pboef of safety Cototofen si< sloner lir r lo k said fbe new requirement to based on the language to the law Pre-market., proof Hair dyes and the legislative intent to insure that the entire formulation of a color S'-1 additive" is safe for the cnnsumer. 2 The language of the regulation dealing with exemption of ha* 4* >*> the safety clearance and certification requirement has been clarifed to show . that the "patch test" requirement applies only to hair dyes which are dangerous because the.user may be sensitive to .them. PatcM^-.-test.' Commissioner Laxrick says that the exemption in the 19|8 law was : conditioned on labeling requirement calling for the use of a$tch determine whether the user is. sensitive to the color before the hatr dye is ftfiniiad The patch testing requirement offers no protection from other types < toxicity, says H arriet, and the purpose of the new regulation is to close the gap. Hair dyes that do not cause a reaction with the patch test must now be demonstrated to be safe before-they can be marketed, FDA may refuse to certify 3 The regulations provide that FDA may refuse to certify a color additive - i f the manufacturer refuses FDA inspectors access to inan ^ ctartag fa cilities, p rocesses, and formulas involved in manufacture of the additive, FDA cannot determine whether the conditions - for safe use of color .additives, fodluding products exempt from certification, are beirq met unless a complete inspection c the plant and formulas can be made, according to .Many subjects .covered V:>* *.*r -Safety.:1.,v factor-- ' -r-rLV The regulations cover such m atters as definition of term s, fees to be chargedfor listin g and certification, of batches of colors, labeling requirements for colors, tim e schedules for acting upon petitions, protection of-teade secrets, procedures for obtaining certification, or exemption from certification of batches of both coal tar and non-coal tar colors; and procedures for filing objections and requesting public hearings on regulations. . Safety data which may be required under the regulations^include detailed i , data from appropriate animal'and other biological experiments; m for^ tion as -to chem ical identity and composition and physical, chemical and biological properties: a description of tests, facilities and'controls used..in manu&cture; data on stability, including a proposed expiration date where necessary; and, when needed, satisfactory methods for detecting and measuring the color .in .the products in which it would be used. ., The regulations provide that a safety factor of 100 to 1 will ordinarily be used in applying animal experimentation date to man, unless use of a different factor is -supported by the data submitted; and provide for taking into account any probable additive effect of the toxicity, of ihe color with that of other . related colors or with food additives or pesticides which may also be present iinfmoods.' -V Si -r-- WCD000884