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December 18, 2015 AEMSA Returns to OMB/OIRA

AEMSA has been and continues to be, proactive at the forefront of the Federal Regulatory/Rule-making processes since our inception in October 2012.  December 2013, when the draft NPRM was released to OMB/OIRA from the FDA, AEMSA met with OMB/OIRA and submitted the most accurate information available at that time.  Once again, now that the FDA has released the final draft rule to OMB/OIRA, AEMSA returned to the White House on December 18, 2015 submitting the most accurate information available today.


Our comprehensive submission covers the following primary points with substantiations, independently verifiable confirmations and more:

  • FDA and OMB/OIRA Obligations Under Executive Order 12866
  • Economic Impact of AEMSA Members
    • Industry Size
    • Survey of AEMSA Member Companies
  • AEMSA Position on E-Vapor as “Tobacco Products”
  • Purpose of the Tobacco Control Act
  • Concerns with the Proposed Deeming Regulation
    • FDA Should have Published an Advanced Notice of Proposed Rulemaking
    • Alternate Frameworks for Regulation
  • Impact on Public Health
    • Understanding the Continuum of Risk
      • Safety of E-Liquid Ingredients
        • Nicotine
        • Propylene Glycol and Vegetable Glycerin
        • Flavorings
        • Concerns Regarding Formation of Aldehydes in E-Vapor
      • Assessing the Population-Level Impact of E-Vapor Products
        • FDA’s Authority to Initiate a Separate Rulemaking Procedure to Assess Population-Level Impact of E-Vapor Products
        • Public Health Benefit of E-liquid Flavors
        • As Cigarette Smoking Rates continue to Decline No Evidence the E-Vapor is a Gateway to Smoking
          • Declining Smoking Rates
          • No Evidence of Gateway Effects
        • Creation of an Unregulated and Untaxed Black Market and Other Unintended Consequences
      • Proposed Regulatory Solutions
        • Amend the current Grandfather Date
          • FDA’s Enforcement Discretion and Rulemaking Authority
          • Potential New Grandfather Date
          • Baseline Products Standards Needed
        • Create a Streamlined/Expedited PMTA Process
      • Conclusion

See our full Submission here: AEMSA’s OMB/OIRA 12/18/15 Meeting Submission

All AEMSA Public Comment Submissions and Testimonials are posted here:

AEMSA is committed to furthering our stated Missions of providing professional product stewardship, providing consumer protections through responsible good manufacturing practices and advocating for re-fillable e-liquids.

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We wish one and all a most Happy and Healthy Holidays and New Year Season!