What are the advantages and disadvantages of pursuing tobacco product regulation using existing FDA drug and device authorities?
There are major advantages; the disadvantages are manageable. First, FDA is on strong scientific grounds for this approach. Because of the probability of resistance and legal challenge from the tobacco industry to proposed and future regulatory efforts by the FDA, the FDA will constantly need to assert the scientific basis of its actions. Second, the FDA has extensive experience and precedent for evaluating drugs and devices. This will be critical to give it the flexibility to respond to ongoing and future issues posed by the development of new tobacco products, and the probable continuing discovery of medical and health issues posed by existing products. The major disadvantage would appear to be the conventional FDA requirement of safety and efficacy. However, the reality is that all drugs and devices are evaluated with respect to public health impact. Thus, drugs and devices are routinely approved which may pose health hazards to some but benefits to others, and/or because they may p
Related Questions
- What are the advantages and disadvantages of pursuing tobacco product regulation using existing FDA drug and device authorities?
- What are the various advantages of the proposed product over the current existing products and technologies?
- Is the FSPTCA related to FDA’s attempt to regulate tobacco as a drug in the mid-90s?
