On the heels of a Maryland federal judge’s order advancing to May 2020 the deadline for premarket review submissions (discussed here), a group of public health advocates (led by Iowa Attorney General Tom Miller) has petitioned the Secretary of Health and Human Services to appeal the court’s decision and to revamp the premarket review process for electronic nicotine delivery systems (ENDS).

Warning of a impending public health predicament if the vast majority of ENDS products are forced to exist the market as a result of the premarket review process, the group urges the FDA to pursue the following remedial actions:

  1. Appeal and seek a stay of the Maryland federal court’s decision, which would otherwise require the FDA to enforce a premarket review deadline of May 2020.
  2. Revisit the Deeming Regulations’ Regulatory Impact Analysis, which underestimated the burdens of the premarket review process and the economic impact of companies leaving the ENDS market.
  3. Clarify how the FDA intends to apply the public health standard for PMTA marketing authorization so that applicants have a better understanding of the Agency’s standards for approval.
  4. Streamline the premarket review process for ENDS, including through product standards and post-market surveillance.
  5. Reassess the Agency’s nicotine plan and update its 2017 strategy for regulating nicotine.
  6. Overhaul risk communications regarding tobacco and nicotine so that consumers understand that ENDS are a less risky alternative to combusted products.

You can read the letter here.