FDA'S NEW TOBACCO SUBMISSION REQUIREMENT

Written by Jeff Boatman - Senior Subject Matter Expert

 

Companies must file reports by March 2011 "or else" ...

 

On January 5th, Health and Human Services Secretary Kathleen Sebelius announced that FDA was introducing a new notification initiative to review and clear tobacco products placed into commercial distribution since 2007.  In a stunning and perhaps unprecedented move, FDA simultaneously issued a guidance on the required submission (called a "905(j) report" after the corresponding section of the Tobacco Control Act) that was released as a final document without public comment or even Federal Register notification. The guidance, while "optional for implementation," is as mandatory as they come: noncompliance = illegal distribution.

 

As explained in FDA's news release <http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm238924.htm>, every manufacturer of a "tobacco product"--which includes not only cigarettes and cigars but any accessory marketed as part of tobacco use, both to the public such as pipes and rolling papers and wholesale for further manufacturing such as filters and tips--that was not already on the market prior to 15 Feb 2007 must submit a 905(j) BEFORE MARCH 22 OF THIS YEAR, otherwise such products will be misbranded and adulterated.

 

Small companies that often introduce new products are obviously a target, and noncompliance will make it simple for the feds to shut them down. But large cigarette companies may be affected as well, not only for new consumer products but especially for changes in their manufacturing suppliers. FDA warns that each manufacturer is responsible for maintaining objective evidence of when their products were placed into commercial distribution (presumably with adequate change control records).

 

This is no doubt just the first salvo on a new front in the government's efforts to limit tobacco use and shut down small operators, one that has explicit congressional authority. Companies that sell tobacco products, including sundries such as papers, pipes, filters, and especially "specialty" cigarettes and cigars would do well to make every effort to get their 905(j) reports in before the deadline.

 

Many small companies probably will not have the knowledge or resources to get these reports in on time, which of course is likely exactly what the feds are hoping for.  Since this guidance literally came out of the blue, there are no "905(j) tobacco consulting experts" to turn to.  The best bet is probably to hire a consulting company that deals in similar submissions--medical device 510(k)s, for example--because these people are already used to the types of information and the expected format that will get the new 905(j) through the review process efficiently. (510(k)s are particularly appropriate, because much of the information required in the new reports are very similar to medical device design history files, even if FDA isn't using that exact term).

 

Can a company simply hang on until after March and then submit? Alas, no: FDA explains that this is an interim step to "catch up" all the products placed on the market since 2007 (a date that Congress basically post-dated the Tobacco Act back to), and then a new, more formal premarket notification process (again, similar to a 510(k)) will be introduced going forward.

 

If you make tobacco products, call us. Soon!