How does the regulation of tobacco products differ from FDA’s regulation of drugs or medical devices?
FDA’s regulatory role for drugs and medical devices is usually based on a safety and effectiveness standard. The tobacco act establishes a new standard: to regulate tobacco products based on a public health and population health standard. When FDA gets an application for a new drug to treat a disease, we normally consider studies of patients who have the disease. But when we get an application for a new tobacco product, the law tells us we have to consider whether permitting the product’s marketing protects the public health and we have to evaluate the effects of the product on the population as a whole. We’re directed to consider both users and nonusers, and whether our action might encourage people who don’t use tobacco products to begin using them, or encourage people who might otherwise quit to continue using them. Q: What can FDA do to help ensure that children are no longer targeted to become the next generation of smokers? A: Research has proven that children begin using tobacco
