Ahead of his presentation at ENDS US 2017, we sat down with Azim Chowdhury, Partner at Keller and Heckman LLP, to discuss the impact of FDA's comprehensive regulatory plan for tobacco and nicotine, innovation in the ENDS industry and more.
What do you consider to be the biggest challenge in achieving and maintaining regulatory compliance in the ENDS and E-Cigarette industry?
Because the February 15, 2007 “grandfather date” remains effective for deemed vaping products, the biggest hurdle to regulatory compliance for the industry will be developing the scientific data necessary to navigate FDA’s Premarket Tobacco Product Application (PMTA) process. Although FDA’s new compliance policy extended the PMTA deadline for products on the market as of August 8, 2016 until August 8, 2022, developing the necessary non-clinical, clinical and population-level data needed to support that an individual vaping product is “appropriate for the protection of the public health” can take years, and companies need to start working on their PMTA strategies now. The industry was very glad to hear the new Commissioner announce that the agency would be publishing additional guidance documents on both the PMTA and Modified Risk Tobacco Product (MRTP) application processes.
What innovations or new technologies are being developed within the ENDS industry to develop safer products for the end user?
Device innovations that allow wattage and temperature control and enhanced battery reliability have improved the safety of vaping products remarkably over the last several years. Improvements in manufacturing processes and the voluntary removal by many companies of certain e-liquid flavor compounds that may present inhalation toxicity concerns have demonstrated the industry’s ability to self-regulate in the absence of any meaningful FDA regulations or standards.
The problem, however, is that companies today are prohibited from making any changes to their current products that could make them safer because doing so would trigger FDA’s onerous premarket authorization requirements. The August 8, 2016 market freeze has the unfortunate effect of preventing companies not only from innovating, but from making improvements to products that could reduce harm and improve product safety.
From your perspective, how does the FDA’s new comprehensive regulatory plan for tobacco and nicotine regulation impact the ENDS industry?
FDA’s new comprehensive regulatory plan is definitely a step in the right direction, and a signal that the agency may finally be focusing on tobacco harm reduction. The first step in achieving harm reduction requires recognition that a continuum of risk exists between nicotine product categories. If FDA wants rapid, significant impact on tobacco related disease and death, FDA must focus on the most harmful product – cigarettes – and allow safer alternatives to remain on the market. The public health impact of reducing nicotine in cigarettes is not yet clear, but the goal is to help prevent the next generation of potential smokers from becoming addicted. But current smokers should not be forgotten, and will need to have reduced harm alternatives available to turn to so that they do not simply smoke more cigarettes or seek black market products. Vaping products offer that alternative.
What are you most looking forward to at ENDS US 2017?
Presentations from various members of the ENDS community, networking with industry leaders, and hearing about FDA’s progress – in particular, identifying solutions to the many regulatory hurdles the vaping industry is facing!