[Federal Register: August 11, 1995 (Volume 60, Number 155)] [Notices] [Page 41532-41533] From the Federal Register Online via GPO Access [wais.access.gpo.gov] [Note: The official version of this document was published in the Federal Register from camera copy provided by the Food and Drug Administration (FDA). The graphic (TIFF) files are scanned images of those Federal Register Pages. This ASCII text version of the document (TEXT) is not an official copy and has not been certified as identical to the text published in the Federal Register. The ASCII text was provided by FDA at a later time solely to facilitate online access.] [[Page 41532]] PART TWO: FINDINGS I. NICOTINE HAS DRUG EFFECTS ON THE BODY........................... 73 A. NICOTINE HAS PHYSIOLOGICAL AND CENTRAL NERVOUS SYSTEM EFFECTS 74 B. NICOTINE IS ADDICTIVE......................................... 78 1. Major Public Health Groups and Leading Experts Concur....... 78 2. Epidemiological Data Establishes That Tobacco Users Display the Clinical Symptoms of Addiction............................ 86 3. Laboratory Studies Establish That Nicotine Produces Pharmacological Effects Similar to Those of Other Addictive Substances.................................................... 94 4. Nicotine's Sensory Effects Are Secondary to its Psychoactive Effects....................................................... 102 5. Other Factors Associated with Tobacco Use Are Secondary..... 106 C. MARKETED TOBACCO PRODUCTS DELIVER PHARMACOLOGICALLY ACTIVE DOSES OF NICOTINE............................................... 108 1. Amount of Nicotine Necessary to Produce a Physiological Response in the Central Nervous System........................ 108 2. Nicotine Delivery From Currently Marketed Tobacco Products.. 110 D. CONSUMERS USE TOBACCO PRODUCTS FOR DRUG EFFECTS............... 115 1. To Satisfy Addiction........................................ 115 2. To Affect Mood and Control Weight........................... 118 II. STATEMENTS, RESEARCH, AND ACTIONS BY TOBACCO COMPANIES......... 121 A. INDUSTRY STATEMENTS ON NICOTINE'S DRUG EFFECTS................ 122 1. Statements That Nicotine's Drug Effects Are Essential to Tobacco Use................................................... 123 2. Statements Recognizing That Nicotine Is Addictive........... 143 3. Statements That Tobacco Products Are Nicotine Delivery Systems....................................................... 156 B. INDUSTRY RESEARCH ON THE DRUG EFFECTS OF NICOTINE............. 160 1. Industry Research on Nicotine's Effects on the Brain........ 164 2. Industry Research on Nicotine Delivery to the Blood and Brain......................................................... 174 3. Industry Research Establishes That Nicotine Produces Pharmacological Effects Similar to Those of Other Addictive Drugs......................................................... 179 C. INDUSTRY RESEARCH ON THE CONSUMER'S NEED FOR AN ADEQUATE DOSE OF NICOTINE..................................................... 183 1. Industry Research on Importance of Supplying Sufficient Nicotine to Provide Consumer Acceptance and ``Satisfaction''.. 183 2. Industry Research to Determine the Minimum and Maximum ``Dose'' of Nicotine Required by Consumers of Tobacco......... 188 3. Industry Research on How Consumers ``Compensate'' to Achieve an Adequate Dose of Nicotine.................................. 198 [[Page 41533]] 4. Industry Research and Knowledge of Tobacco Users' Inability to Quit....................................................... 206 D. INDUSTRY PRODUCT DEVELOPMENT RESEARCH TO ENSURE AN ADEQUATE DOSE OF NICOTINE................................................ 213 1. Industry Emphasis on Nicotine in Product Development Research...................................................... 213 2. Industry Research on Maintaining Adequate Nicotine Delivery When Lowering Tar............................................. 222 E. INDUSTRY MANIPULATION AND CONTROL OF NICOTINE DELIVERY IN MARKETED TOBACCO PRODUCTS....................................... 232 1. Industry Manipulation and Control of Nicotine in Cigarettes. 232 2. Industry Manipulation and Control of Nicotine in Smokeless Tobacco....................................................... 273 F. INDUSTRY ALTERNATIVE TOBACCO PRODUCTS......................... 289 1. Industry Development of Nicotine Substitutes That Mimic Nicotine's Drug Effects....................................... 289 2. Industry Research on Acetaldehyde As a Reinforcer........... 298 3. Industry Development of Alternative Cigarettes That Deliver Nicotine...................................................... 302 G. INDUSTRY KNOWLEDGE THAT NICOTINE'S SENSORY EFFECTS ARE SECONDARY TO ITS PHARMACOLOGICAL EFFECTS........................ 311 H. INDUSTRY FAILURE TO REMOVE NICOTINE FROM TOBACCO DESPITE AVAILABLE TECHNOLOGY............................................ 318