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Ur. 0. T, Scriba Law Department Boom 1901 30 East 42nd Street Dr* V* B. Ackart Mr. L* 0* Howard Nr. J. V* McLaughlin, Jr. February 26, 1958 Andrew Jergens Company VBA-9020 Hatural Dear Hr. Scribat In my letter of February eleventh regarding VBA-9020 natural, Z took into consideration the points you raised in y ur letter of February eighteenth. Zt can be demonstrated that the components of this film are materials considered acceptable for food packaging applications based upon published reports. Rone of the com ponents would be hazardous if It were transferred to the soap. X refer to increasing the oral toxicity of the soap r rendering it more irritating or sensitising, this state ment is based upon judgment regarding the toxicity of the Individual components as well as the quantities involved. Tory truly yours* Thomas V. Rale, K. D MEDICAL DIRECTOR ucc 063644 ftr J# W, McLaughlin, Jr, - 292 Jtadieon Ave. 10th Floor P'Ui.' - (for. K, B. Aekert - Bound Brook nr, L, 0, Howard - Cincinnati Dr. T. V, Mala LAW Federal Food, Drug and Cosmetic Act Andrew Jargons Company VBA-902C natural Dear Hr, McLaughlin: X have your letter oi February 10 and my copy of Dr, Nale's letter to Mr. Howard of February 11 regarding the above cast film which, X understand. Is used in packaging aolid aoap. Soap as such is specifically excluded from the definition of a eosmetie in the Federal Food, Drug and Coa* metis law. However, the Federal Food and Drug Administration long ago took the position that *this exemption doe# not apply to shampoos, shaving creams, or to any Other eosmetie except soap, even though the article under such nomenclature be essentially soap. A shampoo is a soap within the meaning of the exemption and the insertion of the word 'soap* in the name of the product will not entitle It to the exemption provided for soaps. If a aoap bears representations which make It a drug (that la if its label makes therapeutic claims for it - GTS), it must conform to the drug provisions. TC-146, March 7# 1S40". Since we are dealing with the Jergena Company X would Ilk# to know more about the particular aoap we are talking about, la it simply ordinary soapT la it a shampoo or a shaving cream or something elaet When we have this information X hope Dr. Kale will say whether there is a poisonous or deleterious substanoe in ^ ^ VBA-9020 Natural which might render the "soap" injurious t '"users under the conditions of use. We are concerned mot only with oral toxicity (getting it in babies mouths), but more v-;"- Importantly with akin irritation and offset on eyas. RECEIVED Oeorge T. torlba fn t - * OTSilt F.S. - X have gome off oo a legalistic Food and Drug Act aagl In this letter. We will be equally concerned with any hasarda Dr. |ale {ggogjl* van if the Jergena product la aoap and la xempt Ucc 063645 A 44.A BAKEL1TE COMPANY DIVISION or UNION CARSIDI CORPORATION ,Hr T forlbi : taw frepartomt 30 East It? street Moi 1901 Dr. v. B. Aefcert - BB Hr* L 0, Reward - Cincinnati Pr. T. V# Kale - Et '/ Ptbroary 10, 195? ip * 4- *1 s *r,*.* 'T Andrew Jerpens Conpany Attached it the coTTPtpcndenoc relating te the aub^eet 9ampsa\y end their evaluation of our cast film designated T?A-90?o Ketural for uae In packaging aoap. Sine* I an not certain whether oap ia considered in the ootnwlic category* T an referrlnf this entire natter to yoo for consideration and advice, Twr cewsent* will be appreciated. Jvi'ic' era att. J. V. Helauf-lin >- lr ucc 063646 FuCLiVED f irr' 13 i;:s 1` 1 i'AtT, 7 Nr* L. f. Howard iakollt* Cospany #330 Victory rarkway CineInn*ii a, Obit Br, tf. >. *kirt HP. 0. 0. Btanler Nr. V. HeLaughlia Nr. T. R* Orwe Nr. 0* T. gerlba Nr. M. ft. Salt* fcr. II. F. Sajrth# J*. Nr. v. B. flbbet* FrtWMjr Ui Andrew Jtrgena Ceapany TBA*$020 Katural Beer Nr. lonrdi X would tenant u follow* on the proposed w*e ef this cut file by Andrew Jergen* Coepany to F*ebage eake eoap in the muter yea describe In your letter ef February fourth to Nr. NoUuihlU. Xt would UM that there eewld be no ebJettlea to eueh wae. Xn thl* Instance we are net dealing with a feed ltew but with a cake ef eoep. In general, VBA-9020 U very tlnllar to eur VBAA-ftttX# whleh ha* been declared acceptable fer feed packaging wee lavelvlag feed* ef lew fat eentent. Very truly yeure. Them v. Bale, N. I NKOXCAL NtftgCTOB .j 1 uco 063647 f V. McLaughlin BUkelite Company flew fork, Haw fork February h, 1958 Cincinnati PSO V Dr, V. B. Acksrt * B.B. Mr. 0. C. Klnoler B.B. Or. T. W. ffele K.T.i--'' Mr. T* H. brae - Chicago Mr. G. T. Serb* - K.X. Kr. v. a. S'.ith - Er H. F. 8j>the * Mellon Xoatitute Kr. H*. H. Tibbeta - 8,3. Andrew J argons Company This la in reply to your letter of January f7# 1958 regarding Andrew J argon* application In w* leh deterrents are to be packaged in our V A-9020 !Jatur*l caet film. It has now been determined that subject do not intend to package liquid deter* gent? ac ves flret resorted, however, if their preear.t package is accepted there la a possibility that It vlll be tried. Ae reported in recent eorreapandenee, subject actually intend* to package cakes of aoap la a new akin tight package, liquid soap, at 150F, Is punned Into * host sealed beg ef Tal-9020, and just prior to setting up Into a solid the package is plaoed in a nold which fores the cake Into * doughnut shape, leaving the xlddla auction approximately 1/f`the thickness of the cake. The ability of the .002s film to be forecd end retain its ohapt results In an ideal skin tight package. To date, we hare not been eoneemed with toxelty, however, this point will be covered by letter If you think it la advisable. Our prellninoxy studies have bf>en itoafined to selecting the best possible film for the application. Since the product to be packaged will be cake soap, do you forsee any problene with toxeltyf I believe we are ea safe ground. Ieetdently, the above is confidential and axplains, in party why we were not given all the facts during the initial stages. Tery truly yours. UJStjav S L. 0, Bowsrd RECEIVED FES 6 1353 ucc 063648