FDAs release of the draft deeming regulations has caused an explosion of interest in the law and politics relating to e-cigarettes among those who have not followed the topic previously. Some are new to the entire world of vaping-related chatter, while others have been immersed in the social media but have never understood the governance side. Here are some very basic facts for getting up to speed and trying to take effective action.
- In 2010, a federal court ruled that FDA could not regulate e-cigarettes as medicines unless therapeutic claims were being made in marketing. It suggested that FDA the option of asserting authority over them as tobacco products. (Contrary to how it is sometimes interpreted, the ruling did not give FDA that authority directly, nor did it say they had to take it.) That assertion of authority is what is happening now.
- There is no serious doubt that, under the Family Smoking Prevention and tobacco Control Act (TCA), FDA has the authority to exert such authority. There is no point in trying to argue that these products are not technically tobacco (they clearly meet the definition of tobacco products in the TCA), nor that FDA cannot do this (they can). There are, however, arguments to be made that FDA should not exercise its available authority (either in whole or in part).
- FDA has a great deal of flexibility about how they regulate tobacco products that are already under their purview, as well as the products that they are in the process of deeming to be tobacco products. However, the TCA imposes some limits on their flexibility. (The full details of how those break down are complicated, but it is useful to just know that this is the case.)
- Specifically, declaring various products to be tobacco does not mean that they will all be treated the same. Unfortunately, the low-risk products that FDA already regulates (smokeless tobacco) have basically been treated the same as cigarettes.
- One of the biggest concerns about the FDA process is that it is already broken. The main approval process that e-cigarettes and other new products would have to go through is already in place for cigarettes and smokeless tobacco, and it is failing miserably, with an enormous backlog of applications that they have failed to act on. Moreover, the separate approval process available for introducing a product because it is low risk, or allowing low-risk claims to be made, is so onerous that it has never been applied.
