A fundamental rethink of U.S. regulation of reduced-risk products is now essential and urgent. This introductory post looks at a set of 11 possible principles that could guide a revised regulatory framework. Readers’ views are solicited.
A science-based regulatory framework for implementing tobacco harm reduction should conform to the following 11 principles:
- Manufacturers of tobacco products, whether conventional or modified, should be required to obtain quantitative analytical data on the ingredients of each of their products and to disclose such information to the regulatory agency.
- All tobacco products should be assessed for yields of nicotine and other tobacco toxicants according to a method that reflects actual circumstances of human consumption; when necessary to support claims, human exposure to various constituents of tobacco smoke should be assessed using appropriate biomarkers. Accurate information regarding yield range and human exposure should be communicated to consumers in terms that are understandable and not misleading.
- Manufacturers of all potential reduced exposure products should be required to conduct appropriate toxicological testing in preclinical laboratory and animal models and appropriate clinical testing in humans to support the health-related claims associated with each product and to disclose the results of such testing to the regulatory agency.
Clive Bates – The Counterfactual – 2022-10-01
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