Exclusive Interview with Patricia Kovacevic, Independent Consultant

Q. Your presentation will give an overview of developments in ENDS regulation in the US, what can we expect to learn from your talk?

The US is the most important ENDS market, and a very powerful government agency, the Food and Drug Administration, has primary jurisdiction over ENDS in the US. The participants will hear an overview of recent regulatory developments that impact anyone doing business in or with the US, and how these developments will affect ENDS business, also, what proactive measures businesses can take to thrive despite regulatory developments. Major developments include Harmful and Potentially Harmful Constituent testing deadlines, restrictions on sales of flavoured ENDS products, litigation developments and premarket tobacco product application and modified risk tobacco product application news.

 

Q. What do you see as the major challenges and opportunities in the US market at the moment?

The greatest threat to the US market is the increased perception by the government and by some public health advocates that there is a youth vaping crisis, which has shifted the discourse from harm reduction potential to youth initiation prevention, and this will continue to be reflected in the enforcement actions taken by the respective government bodies. The as-of-yet untapped massive opportunity is to bring to the FDA Center for Drug Evaluation and Research (CDER) a vaping product as a nicotine replacement therapy. Commissioner Gottlieb repeatedly sent the message to the investor community that FDA will entertain the review of such product in an expeditious manner - within, of course, the parameters of the law.
Another great opportunity is for UK-based laboratories to expand their client portfolio due to shortage of testing capacity in the US.

 

Q. What are you most looking forward to hearing about at ENDS 2019?

Very interested to hear about Brexit and how it will impact the ecigarette trade in the EU, and to hear about innovative product testing. 

 

Q. Which innovations in ENDS are you most excited about at the moment?

Any device that limits youth access and any product stewardship program, which ensures that the ingredients in the liquids have a reliable safety profile when heated above a certain temperature. Also, new testing methods.