Respira is focused on solving the world’s largest cause of preventable death resulting from tobacco and nicotine related diseases. As a result, we have submitted a 165 page document, covering draft legislative proposals and standards that are aligned with and advance the U.S. FDA’s mission for the protection of public health.
Respira has requested that the FDA Commissioner take specific regulatory actions and to refuse the approval of any PMTA (or to rescind such approval) for an ENDS product that fails to satisfy the new requirements requested in our document.
The six topics of proposed regulatory action, cover:
- A Nicotine Standard
- An HPHC Standard
- Required HPHC Disclosures
- Restrictions on Sale and Distribution
- Fast Track Pathway for Innovative Products
- Expanded Post Market Reporting
View our Citizen’s Petition, submitted to the FDA, HERE
View our comments on HPHCs standards submitted to the FDA on regulations.gov, HERE