sample="quota" bates="511466579" isource="rjr" decade="1990" class="ni" date="19900626" INTEROFFICE MEMORANDUM DATE: June 26, 1990 TO: T. A. Perfetti B. M. Lawrence FROM: J. H. Reynolds SUBJECT: Tobacco-Based Flavors (TBF's) as Casing Materials PROPOSAL NO. R9025 The Human Research Review Committee met on June 26, 1990 to consider your proposal. The consensus of the Committee is that your proposal is approved, subject to the following limitations: 1. TBF's. even though without added amino acids, are not to be considered as a tobacco type at present. The Committee feels that it needs a better and more organized review of this technology. In addition, the Committee feels that data on the types of compounds that arise in the heating of aqueous amino-acid/sugar systems should be provided to it. We invite you to consider making a special presentation to the Committee on these points at your convenience. Please see Dr. Lawrence or myself if you need clarification. 2. TBF's with added amino acids are likewise not considered to be merely tobacco types. 3. TBF's (see note below), as described in your memorandum of June 21, 1990, are approved for use at application rates up to 3% by weight in tests in which consumers will receive a maximum of two packs of such products. More data are needed before approval for more than two-pack tests. 4. Product Review Committee approval must be secured prior to production start and market introduction of any TBF-containing product. 5. The use of up to 25% by weight of the TBF with glutamic acid/C-dust in tests requiring the provision of no more than two packs to a consumer is approved. 6. More data are needed at the 3%, 25%, and possibly intermediate levels of application before the provision of more than two-pack quantities to consumers will be approved. Please consult with Scientific Affairs (Steve Saunders) to determine what tests will be required. (Note: the Committee recommends that the use of glutamine-containing systems be postponed, given the spotty Ames results seen in some previous tests.) If you have questions or comments, please refer to the Proposal Number above in communications regarding this proposal. John H. Reynolds, Chairman, RJRT R&D HRRC