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FDA Publishes Revised Compliance Deadline Guidance Following Recent Pushback of PMTA Deadline

The current Deeming Rule deadlines for ENDS products that were on the market August 8, 2016 or prior are as follows:

  • November 8, 2017 -
    • Deadline to submit ingredient listing
    • Deadline to remove modified risk statements from packages (e.g. "low", "light", "mild", etc.)

 

  • August 10, 2018 - Packaging requirements:
    • Manufacturers and retailers must ensure their product packages and ads contain the addictiveness warning statement (21 C.F.R. § 1143.3(a) and (b))
      • “WARNING:This product contains nicotine. Nicotine is an addictive chemical.”
        • If product does not contain nicotine:
          • “This product is made from tobacco.”
          • Manufacturers must submit to FDA a self-certification
      • The warning must follow size and format requirements
    • Packaging must include a label providing the following information:
      • The name and place of business
      • Quantity of the contents
      • Percentage of domestic and foreign- grown tobacco

 

  • September 11, 2018 - Manufacturers cannot distribute products with non-compliant packaging - IRRESPECTIVE of the date of manufacture

 

  • November 8, 2019 - Deadline to submit report of Harmful and Potentially Harmful Constituents

 

  • August 8, 2022 -
    • Deadline to submit a substantial equivalence exemption request and a substantial equivalence report under § 910 of FD&C Act
    • Alternatively, the deadline to submit a PMTA -- if there is no substantially equivalent grandfathered product on the market

 

Note, these deadlines are for non-small-scale tobacco product manufacturers -- for "small scale" please see guidance, as there is an extended timeframe for such manufacturers.

For more information, or if you have any questions, please contact our regulatory law attorneys Tom Norby or Lindsey Streicher.

Please see here for a copy of the FDA revised guidance

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