In thinking about the current vaping issues, which have been associated with a significant number of deaths and hundreds, if not thousands, of lung-related injuries, I think the path to the future of these products needs to be critically evaluated by the FDA. The introduction of e-cig came so fast that the FDA was not prepared to deal with the issue. Remember that the initial introduction of these products was based on the premise that they were a safer alternative to tobacco cigarettes and were a way for smokers to get off traditional tobacco-based products. A good idea in theory but, as we have seen in actuality, the products were too attractive to kids and there were unforeseen, serious health risks for all users associated with their use.
E-cigarettes are actually electronic nicotine delivery devices (ENDDs). However, they are basically unregulated nicotine delivery devices (NDDs). All other NDDs, including gum, lozenges, and transdermal patches (all now OTC), as well as an oral inhalant product and a nasal spray (Rx), are all subject of FDA approval through NDAs or ANDAs. There is also a pending NDA for an OTC nasal spray product that has just received an advisory committee recommendation for approval.
All of these FDA-approved products went through extensive clinical, safety, and/or bioequivalence testing, have defined doses (which may not be the case with the available unapproved marketed products), have had their inactive ingredients reviewed for safety, and have been quality controlled to provide the correct dose upon each use. Those that have a device component have had those devices reviewed for consistent performance and to be certain that the device will deliver as expected throughout its shelf-life. The products also have appropriate labeling to ensure that the product is used in accordance with its labeled instruction.
One might ask why the Agency did not act to require that these ENDDs followed the same path forward as others that required approval? This is a question that is well beyond the scope of this blog post, but now with the emerging health crisis associated with the use of these products (whether legal or illegal – whatever that may mean in this context), the Agency should act to bring these product under the regulatory umbrella to ensure a safe and effective product, including additives with appropriate controls on dose, contents, and labeling, and on distribution and use, before more users are injured.
A tall order and task for the FDA to try to reel in a multi-billion-dollar unregulated industry that has sprung up over the last few years. The Agency must recognize these products as what they are and what they were intended to do. They are NDDs, designed to help smokers quit the cigarette habit. Nothing more or nothing less. Hopefully the Agency will find the right path for these products.
