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.

 
As NATSO has previously reported, it is illegal for retailers to sell electronic cigarettes to people under the age of 18.  [See NATSO's tobacco homepage for compliance guides related to sales of e-cigarettes and vaping products as well as traditional tobacco products.]
 
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.
David Fialkov's photo

David Fialkov

David Fialkov is the Vice President of Government Relations, as well as the Legislative and Regulatory Counsel, at NATSO. In this capacity, Mr. Fialkov directs NATSO's legislative, regulatory, and legal strategy on a range of issues, including transportation, energy and fuels, labor, data security, and taxes. Mr. Fialkov also oversees NATSO's political engagement program, including individualized legal and political counsel to member companies. Prior to joining NATSO, Mr. Fialkov was the senior associate in the Government Affairs and Public Policy practice at the law firm of Steptoe and Johnson in Washington, D.C. At Steptoe, Mr. Fialkov advised clients on legislative, regulatory, and political issues, as well as legal concerns. His primary clients included trade associations representing the motor fuel wholesale and retail industries, including the National Association of Convenience Stores and the Society of Independent Gasoline Marketers of America. Mr. Fialkov's focus was not only on the motor fuels business, but also the litany of other issues that retailers confront, including labor matters, foodservice issues, healthcare and employment issues, tax matters and data security. Prior to joining Steptoe, Mr. Fialkov graduated with honors from George Washington University Law School. He received his B.S. Summa cum laude with highest honors from Clark University in Worcester, MA. He lives in Washington, D.C. with his wife Allison and daughter Lilah. More

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