FDA Makes “Historic” Move Forward On Substantial Equivalence

Klaus Kneale
by Klaus Kneale
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June 28, 2013

fda-logo1The U.S. Food and Drug Administration announced this week that it has handed down decisions on 6 substantial equivalence applications — 2 yeses and 4 nos.  FDA commissioner Margret Hamburg called the action historic.

A substantial equivalence exemption essentially states that a new tobacco product doesn’t need to go through full regulatory and product standards review because it doesn’t raise any new health questions not already raised or answered by other products already on the market.  This is an area of interest for the electronic cigarette world as the FDA has suggested substantial equivalence might be a route companies can take to get electronic cigarettes approved were they to be deemed as tobacco products.  Mostly it seems like a way to use red tape to prevent e-cigs from coming to or staying on market.

You can read the release here.

The announcement came with little to no warning.  This reporter, for one, received announcement of a media briefing about only 40 minutes before it was scheduled.  That briefing lasted less than a half hour (a half hour that Hamburg herself could be bothered to stay for the full duration of) and provided almost no additional insight into the issue save one tidbit.  According to Mitch Zeller, director of the FDA’s center for tobacco products, roughly 4000 substantial equivalence applications have been filed — 3,500 for products on the market already and 500 for products not yet on the market.

In addition to the 6 applications that the FDA made decisions on, 136 were formally withdrawn at the request of the applicants and 20 were deemed to be missing the requirements of exemption and therefore shouldn’t have been applied for in the first place.  That means about 4% of the total pile of applications have been resolved.

The 6 resolved applications were for products not yet on the market.  This means that there are applications for some 3,500 products on market that might raise new health concerns but the FDA hasn’t resolved whether this is true or not yet.  One hopes they aren’t taking their time.

Zeller mentioned also that applications for substantial equivalence were largely in very bad shape, not providing the appropriate information for the FDA to rule on them.  This could be entirely true.  Alternatively, it could be another stalling tactic the FDA uses to make up for its incredibly slow pace.  The FDA doesn’t seem to mind dragging its feet on tobacco issues to slow down the market.  This may be no different.

This “historic” action as of yet is not directly tied to the electronic cigarette industry.  Zeller himself admitted that the FDA was not currently reviewing electronic cigarette substantial equivalence applications as they aren’t exactly under FDA jurisdiction at the moment.

We’ll certainly let you know if that changes.

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