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Understanding the FDA Compliance Deadlines for e-liquids and e-cigs

by Chris Ford May 11, 2016

Understanding the FDA Compliance Deadlines for e-liquids and e-cigs

The deeming regulation’s ambiguous language and confusing references to various regulations, coupled with conflicting information passed along during FDA’s teleconference last week has left the vaping industry and vapers questioning the future of e-liquids and e-cigarettes in the U.S.

The FDA's revised compliance policy for premarket review is intended to balance the public health concerns, while allowing the Agency to more efficiently manage the flow of incoming applications, and encourage high-quality premarket submissions from applicants.

Emerging evidence that some adults “may potentially use certain flavored tobacco products to transition away from combusted tobacco use.”

According to FDA, the Agency established staggered “compliance periods” for e-liquids and e-cigs to enable FDA to balance concerns regarding the extended availability of newly deemed vaping products without scientific review, to address concerns regarding flavored tobacco products' appeal to youth, and to consider emerging evidence that some adults “may potentially use certain flavored tobacco products to transition away from combusted tobacco use.”

The deadline schedule is based on the expected complexity of the applications to be submitted, followed by continued compliance periods for FDA review such that enforcement discretion will end twelve months after each initial compliance period.

In other words, manufacturers of all newly deemed e-liquids and e-cigs will have a 12-, 18- or 24-month initial compliance period in which to prepare applications for marketing authorization, as well as a 12-month continued compliance period after those dates in which to obtain authorization from FDA, resulting in total compliance periods of 24, 30, or 36 months.

After the close of the continued compliance period, vaping products will be subject to enforcement unless they are grandfathered or have been issued a Substantial Equivalence Report.

All e-liquids and e-cigs on the market as of August 8, 2016 and were NOT on the market on or before February 15, 2007 are subject to these requirements. Generally, the staggered deadline schedule allows for:

  • a 12-month initial compliance period for e-liquids and e-cigs manufacturers to submit (and FDA to receive) a Substantial Equivalence (SE) exemption request,
  • an 18-month initial compliance period for e-liquids and e-cigs manufacturers to submit (and FDA to receive) Substantial Equivalence (SE) applications, and
  • a 24-month initial compliance period for e-liquids and e-cigs manufacturers to submit (and FDA to receive) a PreMarket Tobacco Application (PMTA).

What’s the point of staggering the compliance dates?

The earlier submission period for the SE exemption pathway is intended to allow the e-liquids and e-cigs manufacturer time to consider other pathways if the exemption request is denied or if FDA refuses to accept the request if, for example, the application is incomplete.

FDA will issue an order finding substantial equivalence when it finds that the new tobacco product, when compared to a predicate tobacco product, either: (1) Has the same characteristics as the predicate tobacco product; or (2) has different characteristics and the information submitted contains information, including clinical data if deemed necessary by FDA, that demonstrates that it is not appropriate to regulate the product under the more extensive premarket requirements because the product does not raise different questions of public health.

Once a SE finding is made, you may submit a SE Report that contains a brief, specific set of information (Same Characteristics SE Report) for other distinct products that have the same characteristics.

If manufacturers submit (and FDA receives) the applications during their respective compliance periods, FDA intends to continue the compliance policy and does not intend to initiate enforcement action for these products remaining on the market without FDA authorization for a certain period of time:

  • SE Exemption pathway: continued compliance period will close 24 months after the effective date
  • SE Application pathway: compliance period will close 30 months after the effective date
  • PMTA pathway: compliance period will close 36 months after the effective date

FDA encourages the use of Tobacco Product Master Files

Both the deeming regulation and the FDA representatives on the teleconference last week encourage manufacturers to use the master file system to significantly reduce the cost and resource burden imposed by the PMTA submission.

Products on the market as of August 8, 2018 will be considered misbranded by FDA and subject to enforcement, even if your application is still pending.

Deadlines and Tasks

 

 

August 8, 2016

Regulation effective date

  • Comply with marketing, advertising, labeling and sales requirements.
  • Assess internal systems to determine gaps for GMP compliance. Implement quality systems required by the deeming regulation.
  • Assess records and documentation to determine gaps in the PMTA

June 30, 2017

Annual Registration and Product Listing Deadline for all tobacco products (originally 12/31/2016)

  • Create FURLS account at FDA
  • Register establishments and list all products electronically and pay fees
    • An email address, to facilitate correspondence between registrants and FDA.
    • The name and full address of each establishment
    • The name and places of business of the owner or operatorA Data Universal Numbering System (D-U-N-S®) Number
    • A reference to the authority for the marketing of the tobacco product
    • A list of all tobacco products manufactured for commercial distribution
    • A representative sampling of advertisements for the product

August 8, 2017

End of 12-month Compliance Period. Deadline to submit Substantial Equivalence Exemption requests

  • Submit SE Request for review
  • Engage with FDA
  • Resolve discrepancies
  • Respond to decision
    • Conduct necessary clinical evaluation / studies
    • Prepare SE Application

February 8, 2018

End of 18-month Compliance Period. Deadline to submit Substantial Equivalence Applications

  • Submit SE Application for review
  • Engage with FDA
  • Resolve discrepancies
  • Respond to decision
    • Conduct necessary additional clinical evaluation / studies / testing
  • Prepare PMTA

August 8, 2018

End of 24-month Compliance Period. Deadline to submit PMTAs.

Any product still on the market and not submitted to FDA on a SE application or PMTA by this time are subject to enforcement.

  • Submit PMTA

February 8, 2019

Compliance Period for SE products ends.

FDA begins enforcement.

August 8, 2019

Compliance Period for PMTA products ends.

FDA begins enforcement.

 

There could be hefty penalties for those who don’t register and list in December, and as the new policies roll out, FDA is preparing its internal resources in enforcement procedures. The failure to register or provide information in accordance with section 905 of the act is prohibited, and your products will be considered misbranded. Violations relating to registration and product listing under section 905 are subject to regulatory and enforcement action, including, but not limited to, seizure and injunction, so be sure to mark your calendars for this one.




Chris Ford
Chris Ford

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