Ahead of his participation at ENDS US 2018, we reached out to Chris Howard, VP, General Counsel and Chief Compliance Officer at E-Alternative Solutions, to learn more about FDA warning statements, emerging opportunities, and the uncertain future of the ENDS industry.
Your presentation at this year’s ENDS conference will cover complying with FDA warning statement requirements. Why is it important for others in your industry to hear this message? What are some of the key take-aways?
- FDA has recently started enforcing a variety of rules related to the ENDS category. Failure to comply with FDA warning statement requirements could result in significant penalties to manufacturers.
- While compliance with respect to several FDA requirements is onerous (e.g., PMTA), meeting the FDA warning statement requirement seems relatively straightforward.
- This forum presents an opportunity for stakeholders to pose questions regarding how to apply the FDA warning statement to non-traditional media not specifically addressed in FDA guidance and rules.
What are some of the biggest opportunities gaining attention within the ENDS industry? How has your company chosen to react/adapt to stay on trend?
- FDA has recently focused its attention on improper marketing practices which could attract and/or be dangerous to youth. E-Alternative Solutions has employed key talent in the areas of marketing and compliance, and as a result, no significant modification was required. E-Alternative Solutions has been following the rules and leading the charge to ensure proper packaging, marketing and sales of vapor products to adult smokers.
- FDA has been receptive to dialoguing with stakeholders regarding requirements related to the ENDS category. EAS has taken full advantage of this development by working with the Vapor Technology Association to move industry standards forward.
What does E-Alternative Solutions hope to achieve over the next 5 years with regards to the future of the ENDS industry?
- EAS hopes FDA will implement clear standards for product safety, marketing and advertising and regulatory compliance for the ENDS category.
- By fully engaging with FDA, EAS along with its industry partners hopes to achieve science- based (as opposed to emotion-based) standards and rules to govern the ENDS category.
Which presentations (topics) are you most looking forward to hearing about at ENDS?
- EAS is interested in learning more about other companies’ approaches to handling upcoming deadlines (e.g., HPHC, PMTA, etc.) considering the vague guidance currently available.
Hear more from Chris during his presentation "Don’t Make Me Warn You Again – Complying with FDA Warning Statement Requirements", which will take place on Day 2 of the conference - December 7 - at 9:30 AM Eastern.