On March 15, the FDA reported that it had made determinations on more than 99 per cent of the nearly 26 million deemed products for which Premarket Tobacco Product Applications (PMTAs) were...
ENDS manufacturers encouraged to take the lead on flavors
Jan 31, 2020 | Published by Andrew Mooney
Are you confused by the ENDS flavor debate?
Dr. Ian Fearon, Broughton subject matter expert for clinical studies, has recently published an article with leading sector publication Tobacco Reporter regarding the use of flavors in e-cigarettes.
This is undoubtedly the hottest topic in our disruptive sector at present, and an area where we’ve already seen regulatory announcements since the beginning of 2020 leading to US market industry changes.
Ian’s article discusses the challenges faced by manufacturers within the industry, which include the toxicological impact of flavors, their effects on vaper behavior and nicotine delivery and, most importantly, their impact on population use among different types of users.
The impact on use amongst different user groups in particular, presents a significant threat to the industry as a whole. However, we should all understand that the urgency of the public health threat of youth use of e-cigarettes needs to be balanced with the potential role they play in helping adult smokers transition away from combustible cigarettes to a potentially less risky form of nicotine delivery.
When the piece was written (towards the end of 2019), Ian stressed the importance of the industry taking a pro-active approach to self-regulation to avoid harmful, knee-jerk regulatory action. It comes as no surprise then that the US Food and Drug Administration (FDA) have since published their final guidance regarding Enforcement Priorities for Electronic Delivery Systems. Within this the FDA make clear their intention to prioritize enforcement against flavored, cartridge-based products which don’t have premarket authorization. More recently, in July 2020 the Center for Tobacco Products at FDA issued a series of warning letter to numerous manufacturers highlighting FDAs concerns that certain flavoured products “appear to imitate a food product that is typically marketed toward and/or appealing to children”. For those manufacturers, this is strong evidence that regulatory authorities intend to take serious action, leading to the removal of products from store shelves and the potential for further enforcement action.
The impact of the flavor debate is expected to be more far-reaching than the US alone, with Canadian provinces outlining proposals to regulate flavored products and the expected revision of the EU Tobacco Products Directive.
Ian’s full article, which highlights how manufacturers are encouraged to take charge with sensible industry self-regulation, concludes by stressing the importance of preventing improper regulatory measures that could stifle the potential positive effects of e-cigarettes in advancing a smoke-free future. Many responsible members of the industry already understand the importance of complying with regulatory requirements and are committed to doing so. In fact, in terms of the US market, many have already begun preparing premarket tobacco product applications with urgency.
To discuss pro-active strategies to ensure the regulatory compliance of your products, request a meeting with our team.