Document VKx6a7v3RLDv8RxejnDOrqMQg

DATE OCTOBER 12, ^972 FOR FRED ROESCH W H I T T A K K R , C L A R K a, DANIELS, I N C . ATT:_______________________________________ _ C .T .F .A . - VOLUNTARY REGULATION SUBJ: SEMINAR ON PRODUCT INGREDIENT DIS CLOSURE COMPLIANCE F .D .A . INTER - OFFICE CORRESPONDENCE Dear Fred: A ttached is a com plete packet o f in form a tion g iven out at the sem inar, O ctober 6,1972. It contains: 1. P rogr am 2. V o lu n ta ry in g red ie n t statement forms 3. D irections for com pletions. T h is seminar was conducted by I D r. Norman Eskin, CTFA 2. D r. H arold S chw artz, The Mennen Company 3. D r, E. R ichardson, F .D .A . 4. D r. J , W e n ning e r, F .D .A . D r, R ichardson, you w ill re c a ll, has w orked in the in d u s try , The bulk o f the meeting was devoted to the ways one would disclose his form ula and the methods one could use to keep h is form ula "s e c re t". A ll of th is in form a tio n is covered in the in s tru c tio n s . However, in o rd e r to keep a form ula "se cre t" it must meet the follow ing test. It is: Unique Im p orta n t to the product Not knowtito comDetitors Should you not meet the test, you could then w ith d raw the application w ith o u t p re ju d ic e . It should be noted that even if co n fid e n tia lity is allowed the F .D .A . could release th is inform ation under certain circum stances (litig a tio n , p u b lic pressure, etc.) O bviou sly the main th ru s t o f the meeting was re g ardin g th is co n fid e n tia lity point. M any of the members o f the in d u s try appear to fee! threatened inasmuch as they feel this in d u s try is based on unique combinations of w eil known ing red ie n ts. I posed the q ue stio n to the panel as to "w h y one has to ju s tify a request fo r c o n fid e n tia lity and who passes ju d g m e n t". T h is was not adequately re p lie d to it appears th a t the in d u s try v o lu n te e rin g to d isclo se w ill then fo re sta ll such people as Senator Eagletcn and V irg in ia K nauer who believe all inform ation should be in the p u b lic domain. EXHIBIT WCD-193 LoGiudice/WCD/0100 DATE OCTOBER 12, 1972 FOK FRED ROESCH W HITTAKER, CLARK & DANIELS, INC- INTER - OFFICE ATT:__________________ ____________ ______________ C .v .F .A . - VOLUNTARY REGULATION SUBJ; SEMINAR ON PRODUCT INGREDIENT DIS CLOSURE COMPLIANCE F .D .A . - ............. ....... - ------ Fa ; .:- ? - CORRESPONDENCE T h e A u g u s t II, 1972 Federal R e g is te r, Volume 37 co nta in s g u id e lin e fo r cosmetic p ro d u ct in g re d ie n t la b eling . In o rd e r to avoid confusion o f acceptable in g red ie n t names CTFA have developed a d ic tio n a ry w hich w ill be a vailable at a modest fee sometime a fte r J a n u a ry I, 1973. T he effective date fo r v o lu n ta ry re g ula tio n is nowj o r in the case o f a new product^ I BO days a fte r in itia l m a rk e tin g . D r . S chw artz b r ie f ly re vie w e d the p re se n t talc s itu a tio n . He e xplain e d th a t any of the people "p ic k e d up" fo r excess amounts of asbestos would be review ed again If the y w ould send c u rre n t p ro d u c tio n pro du cts to D r. Lew in o f N Y .U , T h is is done on the basis that many items surveyed were several years old. The p o s s ib ility o f theft of form ulas or a Pentagon paper type if disclosed w ill not be possible und e r the F .D .A . computer system w hich fractions the Inform ation in several com puter banks which can only be brought together w ith certain key know ledge and steps. O ur re s p o n s ib ility as a s u p p lie r would be only if o u r customers used an in g re d ie n t from us and they d id not know the com position. T h ey would then request we relate th is data to the F .D .A . T h is was a v e ry w ell attended sem inar The c ru x o f the problem is that if the in d u s try does not v o lu n ta rily regulate its e lf, someone else w ill. A ll in attendance agreed the fo rm e r is the p ru d e n t strategy. The serious shortcom ings of d is c lo s u re of c o n fid e n tia lity inform ation is the m ajor s in g le co n ce rn . The consensus o f o p in io n appeared to be i f you tr u ly have a unique p ro d u c t,d o not disclose 4 t-b y re g is te rin g . It is a vo lu n ta ry program , DL. mv e n c lo s u re LoGiudice/WCD/0101