FDA Deeming Rule Update

The past few weeks have seen some activity at FDA relating to the Deeming Rule, which is of particular interest given the looming deadlines for submitting the Establishment Registration and Product Listing (9/30/2017) and the Ingredient Listing (11/8/2017). Of note is that FDA is seeking industry insights and participation, presumably in an effort to better inform FDA on the ENDS industry--a nod to the commentary surrounding the May 2017 deadline pushback.

On September 8, 2017, FDA submitted for public comment in the Federal Register, a request for insights on how "to achieve meaningful burden reduction" related to the paperwork requirements of the Deeming Rule. The comment period closes on December 7, 2017.

These comments and data will supplement and inform our own ongoing, systematic review of our regulations.

September 8, 2017 Federal Register.

As part of its solicitation for comments FDA submits for response the following questions:

  • Is the regulation still current, or is it outdated or unnecessary in some way?
    • Have there been advancements an innovations in science, technology, or FDA or industry practice, or any other changes that suggest repeal of or modification to the regulation may be warranted or appropriate?
    • Has the regulation been superseded or made irrelevant or unenforceable by statute, another FDA regulation or guidance, a regulation by another Federal Agency, or controlling legal authority?
    • Is this regulation duplicative of requirements in other FDA regulations or other Federal Agency regulations?
  • Have regulated entities had difficulties complying with the regulation? If yes, identify what entity or entities have had such difficulties and the nature of the difficulties.
  • Does the regulation impose requirements that are also provided for in voluntary or consensus standards or guidance by third party organizations [ ]? Do the entities covered by these standards or guidance take steps to meet the standards and to document that they meet the standards? If met, do the standards achieve the same level of public health protection as the FDA regulation?
  • Does the regulation contain redundant, outdated, or unnecessary collections of information or retention of records, e.g., reporting, recordkeeping, or labeling requirements?
  • 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?

Id. (emphasis added).

While maintaining a level of skepticism, this request for comments could be indicative of a step in the right direction (according to the ENDS industry, at least) as it appears to assess whether the Deeming Rule is even necessary at all. This harkens back to President Trump's executive order affecting the regulatory sphere: for every one proposed regulation, two must be withdrawn (aka "one-in, two-out" policy).

In addition, FDA has also requested industry participation in informing FDA on tobacco flavoring, seeking opportunities to tour flavoring manufacturing facilities. September 19, 2017 Federal Register.

This program is intended to give CTP staff an opportunity to visit companies that develop and/or manufacture flavors (including flavor mixtures) that are sold to tobacco product manufacturers in order to gain a better understanding of the development, testing, and production of flavors and flavor mixtures used in the manufacturing of tobacco products. The site tours in this program are not intended as regulatory inspections.


This is significant because, currently, FDA has not taken a position on flavored "tobacco products" under the Deeming Rule. Thus, this could either be an opportunity to deter FDA restrictions on flavored ENDS products, or it could result in bolstering a potential desire on FDA's part to ban or limit flavored ENDS products.

While FDA initially stated,

FDA is not banning flavored tobacco products with this final deeming rule.

in response to comments and concerns that a ban on flavored ENDS products

would be a tantamount ban of newly deemed products

its current interest in flavoring facilities could indicate a sea change, particularly in light of local level regulations concerning menthol and flavored tobacco products. Deeming Rule. In recent months, various states and municipalities have imposed flavored tobacco bans, including menthol. For more see our previous blog post on the Minneapolis, found here.

**UPDATE 9/21/2017: Since the initial publishing of this post the morning of September 21, 2017, FDA has released a publication in "CTP Connect" in which it outlines its strategy to reduce tobacco use among youths. See here.

FDA intends to issue advance notices of proposed rulemaking (ANPRMs) relating to kid-appealing flavors in tobacco products and the public health impacts from premium cigars.

In the same publication, FDA states that it

recognizes the role potentially less harmful tobacco products could play in reducing tobacco’s tragic toll. * * * To encourage innovation that could improve public health, the FDA has extended timelines for submitting tobacco product review applications for newly regulated products that were on the market as of Aug. 8, 2016.

While it is not yet clear what this all means, it could be indicative of a step in the right direction, starting with FDA taking an interest in informing itself on the ENDS industry, and potentially ending with curtailing some of the Deeming Rule requirements, or, elimination of the Deeming Rule altogether. We will continue to monitor these issues and other topics concerning the ENDS industry.

For more information, please contact Tom Norby or Lindsey Streicher.

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