Tobacco Company Influence on the FDA-Commissioned IOM Report, Clearing the Smoke

Background: Spurred by potential modified risk tobacco products, the Food and Drug Administration (FDA) commissioned the Institute of Medicine (IOM) to assess the science base for tobacco “harm reduction,” leading to the 2001 report Clearing the Smoke. Methods: Analyzed >1000 documents in the University of California, San Francisco Legacy Tobacco Documents Library. Results: Tobacco companies considered the IOM report to have high-stakes regulatory implications. They developed and implemented strategies with consulting and legal firms to access the IOM proceedings. When the IOM study staff invited the companies to share ideas and information on exposure and disease markers, clinical trial design for safety and efficacy, and implications for initiation and cessation, tobacco company lawyers and in-house regulatory staff manipulated the presentation of data from company scientists and consultants. The companies were pleased with the final report, particularly the recommendations for a tiered claims system (with separate tiers for exposure and risk, which they believed would ease the process of qualifying for a claim) and license to sell products comparable to existing conventional cigarettes (“substantial equivalents”) without prior regulatory approval. Some principles from the IOM report, including the substantial equivalents recommendation, were incorporated into the Family Smoking Prevention and Tobacco Control Act. Conclusions: Tobacco companies strategically interacted with the IOM to win their favored scientific and regulatory recommendations. Policymakers should recognize that the industry's desire to “collaborate” on scientific issues is driven by political and financial motives rather than aspirations to high-quality science and interferes with effective public health policymaking.