Education for better regulation

摘要

Dr John Lauterbach, a member of the FDA's Tobacco Products Scientific Advisory Committee, wonders whether a committee to educate FDA scientists is needed. In early September, the Center for Tobacco Products (CTP) at the US Food and Drug Administration(FDA) issued a document entitled "Draft Guidance for Industry and FDA Staff. Demonstrating the Substantial Equivalence of a New Tobacco Product: Responses to Frequently Asked Questions." While the answers to several of the questions seemed to have beenwritten by bureaucrats and not those really familiar with tobacco products, the answer to Question 11 under Part II. C. Additives/Specifications is particularly troubling not only because it appears to have been written by someone with knowledge of ingredients, but also because it appears to be an initial step to drive the small tobacco product manufacturers out of business.