Vapouround magazine ISSUE 23 | Page 19

“While any and all potential risks should be investigated, this release by the FDA is incredibly irresponsible. There is absolutely nothing to suggest that these seizures were caused by vaping” – American Vaping Association (including ‘Orally Inhaled Nicotine-Containing Drug Products’). These would be distinct from the usual e-cigarette, which is classed as a recreational tobacco product, not a therapeutic drug. This pathway is a potential alternative for e-cigarette manufacturers facing the daunting Premarket Tobacco Applications (PMTA) deadline. This will require products for sale in the US to undergo extensive tests before gaining market approval. Azim Chowdhury is a regulatory and public policy attorney at Keller and Heckman LLP specialising in vape, nicotine and tobacco product regulation. He told this magazine: “You have to consider all those types of factors, develop studies and surveys, data, to address those population-level questions for a PMTA. The attorney believes that the so-called teen vaping epidemic in the US has created a new sub-arena for approved products to help young people quit the nicotine products they are currently using, such as tobacco products like e-cigarettes. The development of new drugs is of significant financial interest to the FDA. The Prescription Drug User Fee Act allows the FDA to collect funds from pharmaceutical companies developing new products. Between 1992 when the act was past and 2016, the pharmaceutical industry contributed $7.67 billion (that’s roughly £6 billion) to the FDA, according to healthcare consultancy firm, Avalere. But regardless of the FDA’s motives, the seizure warning could have a lasting impact on adult smokers wanting to switch to a less harmful alternative. Chowdhury agrees. “No e-cigarettes have been able to do that yet so it’s not quite clear what the FDA’s going to require. We’re still waiting for their final guidance on the PMTA process.” “Given the youth situation, [the FDA wants to] put as much information out there as possible to dissuade young people from using these products. Mr Chowdury believes that smaller US companies will have more difficulty making it through either the PMTA or New Drug Application (NDA) process. “A consequence of that is adult smokers who could benefit from these products may not do so because they’re seeing these things that are basically scaring them away from e-cigarettes.” “I think the pharmaceutical companies are in the best position because they do have experience, they can build off of their own nicotine products and take advantage of the situation in the US right now which is a lot of people using nicotine who weren’t before.” VM23 | 19