FDA Initiates Action Targeting E-Cigarette Retailers, Manufacturers

The Food and Drug Administration has put the makers of electronic cigarettes on notice that they have sixty days to demonstrate that they can keep their devices away from minors, warning that failure to do so could resulting in flavored electronic cigarette products being removed from the market. The FDA also announced that it was sending letters to more than one thousand retailers, including convenience stores and fuel retailers -- along with issuing fines for selling e-cigarettes to minors.
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The Food and Drug Administration has put the makers of electronic cigarettes on notice that they have sixty days to demonstrate that they can keep their devices away from minors, warning that failure to do so could resulting in flavored electronic cigarette products being removed from the market. The FDA also announced that it was sending letters to more than one thousand retailers, including convenience stores and fuel retailers -- along with issuing fines for selling e-cigarettes to minors.

 
 
FDA has been keeping a close eye on the popular Juul products, which offer strong nicotine hits in the form of a device that looks similar to a computer flash drive. 
 
NATSO members that are fined for failing an FDA inspection must respond within 30 days of receiving the complaint.  In responding, tobacco retailers will generally have five options at their disposal:
  1. Pay the fine in full.
  2. Request a conference with FDA to negotiate a settlement (i.e., a lesser fine or a Warning Letter).
  3. Request a hearing before an Administrative Law Judge to challenge the validity of the allegation.  The results of these hearings may be appealed.
  4. Request an extension of time to respond for “good cause.”
  5. Do nothing and be subject to a default judgment.

In considering how to respond, tobacco retailers should consider the following:

  • Committing one violation will lead to increased penalties for future violations.
  • No retailer should be subject to a fine unless the retailer has first received a Warning Letter.

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