NACS Submits Comments to FDA on Warning Letters, Multiple Violations

NACS Submits Comments to FDA on Warning Letters, Multiple Violations

WASHINGTON, D.C. — The National Association of Convenience Stores (NACS) submitted comments to the Food and Drug Administration’s (FDA) Center for Tobacco Products (CTP) on its interpretation of the use of warning letters and multiple violations for tobacco retailers.

The comments were prompted by the FDA’s indication that tobacco retailers could be penalized for multiple violations found during a single inspection, something NACS said it does not believe is allowable under current written law.

“It is unclear whether or not CTP’s policy is to charge retailers with more than one violation resulting from single inspections. It is also worth noting that treating a warning letter as encompassing multiple violations would directly contradict the CTP’s position…that retailers are not entitled to due process to challenge warning letters,” NACS said.

However, in its comments, NACS also noted its support for the CTP’s indications that it will issue regulations on retailer training programs and what retailers can do to make sure the FDA pre-approves their training programs, resulting in lower penalties for violations. NACS also urged the FDA to approve the We Card program.

The FDA’s regulations and enforcement options were a hot topic at the 2011 NACS Show in Chicago earlier this month. During the workshop, “Blowing Through the Smoke: What’s Up With Tobacco,” David Fialkov, an associate of Steptoe & Johnson LLP, educated attendees on what retailers could expect from the FDA and what aspects of penalties remain unclear.

“We’re troubled by the lack of due process,” Fialkov said during his presentation, noting that the FDA does not provide a process for contesting allegations in a warning letter.



#1 Jerseyboy on 10.19.11 at 12:40 AM

I saw this story and it just makes me wonder how we can trust the FDA at all to manage the tobacco space with any real sense of fairness. Just doesn’t make sense how they can be so vague on such a significant issue to those like myself that are retailers.

#2 Makes no sense on 11.02.11 at 11:28 PM

I was at the NACS show and Mr. Fialkov was spot on. Not only is fda violating the law but they are not telling retailers what to do to comply.

#3 Copenhagen Charley on 11.03.11 at 12:39 AM

The FDA really needs to be open here and help the situation.

#4 OTP Kid on 11.09.11 at 1:02 PM

The FDA sends a warning letter 60-90 days after the violation and somehow the retailer is supposed to disute it? How is this possible? Also, the FDA doesn’t send a letter telling the store they were inspected and they passed. Hypocritical!

#5 Dion on 11.29.11 at 8:48 PM

I received a warning letter 90 days after the “alleged” violation. No information on what time of day or what clerk supposedly made this transaction. No way for me take corrective measures should it be true. We all know the law and my store does NOT sell tobacco to minors. No one identified themselves after the “alleged” incident. I wonder, does the FDA actually have the authority to be sending under-age persons into stores to specifically purchase tobbacco products? Hmmm ….

#6 Vaper Vixen on 11.29.11 at 11:07 PM

Pretty absurd when you think about it! How in the world does this make any sense. I mean your clerk may not even work for you now? Absurdity! FDA=F’ing Dumb Asses

Leave a Comment