With all the recent litigation, legislative efforts, and controversy centered around the U.S. Food and Drug Administration’s Deeming Rule, perhaps there is now a more direct opportunity for stakeholders to influence the FDA on ways the agency can modernize its regulatory framework for tobacco products while reducing burden on industry. Recently, the FDA published Federal Register notices seeking to collect information and public feedback on how the agency can more efficiently and effectively regulate the various products under its regulatory jurisdiction, including food, drugs, devices and tobacco. These requests for stakeholder comment follow on the heels of President Trump’s executive orders from earlier this year directing federal agencies to establish Regulatory Reform Task Forces to review and identify existing regulations that may need to be modified, replaced or repealed.
Acknowledging that some of its regulations “may not adequately reflect advances in science, technology or changes in industry practice,” FDA’s Deputy Commissioner for Policy, Planning, Legislation and Analysis Anna Abram describes the Agency’s goal as developing “policies that are as modern as the products that [FDA is] being asked to evaluate, and a regulatory framework that uses efficient tools to achieve [FDA’s] vital consumer protection role.” Specifically, and of particular interest to the tobacco and vaping industries, FDA has requested comments on the Center for Tobacco Product’s regulation of the manufacture, marketing, and distribution of tobacco products. FDA intends to consider these public comments to identify CTP regulations that may: (1) be outdated, unnecessary, or ineffective; (2) impose costs that exceed benefits; or (3) create a serious inconsistency or otherwise interfere with regulatory reform initiatives and policies, among other criteria. FDA has provided the following considerations that stakeholders can address in their comments:
- Have there been advancements and innovations in science, technology, or FDA or industry practice, or any other changes that suggest repeal of or modification to the regulation?
- Have regulated entities faced difficulties in complying with the regulation?
- Is this regulation duplicative of requirements in other FDA regulations or other Federal Agency regulations?
- Does the regulation impose requirements that are also addressed in voluntary or consensus standards or guidance by third party organizations?
- Does the regulation contain redundant, outdated, or unnecessary collections of information or retention of records?
- Could the goal of the regulation be achieved by less costly means that would provide the same level of public health protection?
- What factors should FDA consider in selecting and prioritizing regulations and reporting requirements for reform?
Of course, industry members and other stakeholders are not restricted by the points listed above and may submit any other comments relevant to the FDA’s initiative. This is a rare and welcome opportunity for stakeholders to make their voices heard and engage the FDA on alternative, less burdensome measures for efficient and effective product regulation. Stakeholders have until December 7, 2017 to submit comments.