While FDA has postponed the deadline to submit Ingredient Listings from February 8, 2017 to June 2017, it has yet to act with regard to the Health Document Submissions requirement. That said, February 8, 2017 remains a critical date for manufacturers and importers of newly deemed tobacco products.

The guidance provided by FDA provides that for this submission, FDA seeks toxicological, health, behavioral and/or physiological studies relating to newly deemed tobacco products –of note, is that FDA is currently only seeking such documents  created between June 23, 2009 and December 31, 2009. It is noted, however, that manufacturers and importers should retain these types of documents that were created after December 31, 2009 as these specifications may be updated in the future.

Also of note:

1.      Only importers and manufacturers are subject to this requirement; and,

2.      FDA does NOT want to receive multiples of the same documents, thus to that end FDA has stated the following should NOT be produced:

a.       Duplicates 

b.      Articles from peer reviewed journals

c.      Published news articles, books, and other documents available to the general public

d.      Material safety data sheets

e.       HHS (Dept of Health and Human Services) correspondence

Additionally, for importers working with foreign manufacturers, FDA has explained that the documents should only be produced by one of those two entities. That said, if the importer opts to file the submission, it would submit any responsive documents it has in its possession as well as any responsive documents retained by the foreign manufacturer.

To the extent manufacturers and importers are not in possession of any such documents, FDA does require a submission indicating just that. Accordingly, the February 8, 2017 deadline remains important. Submissions can be made through the CTP Portal (https://ctpportal.fda.gov/ctpportal/login.jsp) –but note, there is an initial process for first obtaining an account, including mailing a written request to CTP so be sure to complete that in the next week or so to ensure you can meet the deadline.

For more information please contact Thomas Norby or Lindsey Streicher.