On November 9th at the ENDS US 2022 Conference, scientific and regulatory consultancy Broughton will be presenting on the regulatory approval process for Electronic Nicotine Delivery Systems (ENDS)...
What Every ENDS Company Should be Doing Leading up to October 22nd 2018
Sep 6, 2018 | Published by Andrew Mooney
Save the date. Monday 22nd October is looking like a key day for the US ENDS industry.
In its recent blog, the FDA referenced the one year anniversary of its Comprehensive Plan for Tobacco and Nicotine Regulation with its goal to lower nicotine in cigarettes to non-addictive levels and create more predictability in tobacco regulation. In effect, the FDA has reframed the argument around two key areas - nicotine levels and harm reduction.
The nicotine reduction argument states that people smoke because they are addicted to nicotine. If we reduce the nicotine content, they will not become addicted to smoking and therefore avoid the associated damaging effects to their health.
The harm reduction discussion questions what regulatory framework will allow alternative nicotine delivery products such as ENDS to exist on the market as safer alternatives to smoking. Evidence is growing that vaping is a safer alternative with the often-referenced Public Health England report (based on a study carried out at Kings College London) stating that they are 95% safer.
So, why is October 22nd so important? This the start date of a two day public meeting held by FDA on the premarket review regulatory framework. The goal of the meeting is to solicit comments on processes and provide a dedicated venue for specific suggestions on how to further improve them. Potential topics for discussion include: how to achieve greater efficiencies in review, while continuing to protect public health; how to review products that are rendered “new” due to changes made to comply with a product standard; and, how to facilitate greater company consultation with the FDA prior to submitting applications.
There is also speculation that updated FDA PMTA guidance will be issued soon (likely to be before the public meeting) giving the ENDS industry the certainty that is has been so desperate for.
What you should be doing now:
- Register for the event. FDA is including a webinar option to ensure the maximum reach to industry and opportunity for debate.
- Start planning now for your PMTA. Whatever happens, PMTA is not going away. Have you identified the team of experts that you will require to achieve regulatory compliance?
- Sign up your selected PMTA delivery team before it is too late. August 8th 2022 (the current deadline for the submission of PMTA applications to ensure you remain on the market) may seem a long way off but availability of the required expertise is limited. If you do not move soon you may be unable to secure the services of the team you require.
- Finally, remember that there is an earlier deadline of November 8th 2019 to submit analytical data on quantities of harmful and potentially harmful constituents (HPHC’s) in your products.