Round 1: FDA takes enforcement action

The FDA announced its first enforcement actions since the deeming regulations went into effect


Five weeks. That’s how long it took for the FDA to send warning letters to vaping vendors who failed “compliance checks,” and sold newly deemed “tobacco products” to minors. The FDA has been ramping up its compliance check operation, and they’re out to catch as many lax retailers as possible.

The new federal regulations require retailers to check the ID of anyone under age 27, and makes sale to people under age 18 illegal. According to the FDA, it has conducted more than 660,000 inspections of tobacco retailers since 2009, issuing nearly 50,000 warning letters, and initiated 8,290 civil money penalty cases.

“During compliance checks at major national retail chains, tobacco specialty stores and online retailers, minors were able to purchase some of these newly regulated tobacco products in a variety of youth-appealing flavors, including bubble gum, cotton candy and gummy bear,” the FDA announced.

“Youth-appealing flavors”…of course. This is how the FDA justifies its regulations that amount to a complete ban of independent vapor products. And FDA Center for Tobacco Products director Mitch Zeller wasted no time using the issue to lobby for public approval of his ban.

“We’re helping protect the health of America’s youth by enforcing restrictions that make it illegal to sell tobacco products to minors – including e-cigarettes, e-liquids and cigars. Retailers play a vital role in keeping harmful and addictive tobacco products out of the hands of children and we urge them to take that responsibility seriously,” said Zeller. “It’s clear from these initial compliance checks that there’s a need for strong federal enforcement of these important youth access restrictions.”

Whatever age verification system you choose, it needs to work.

Warning letters are the first step in penalizing retailers who violate the FDA’s rules. Repeat offenders can be fined, and multiple offenses can earn a “no tobacco sale” order, preventing the retailer from selling any tobacco product.

The list of 55 violators includes many vapor businesses, but also gas stations, convenience stores, and pharmacies, including many national chains.

All of the vapor business violations appear to be online sales.

Businesses need to understand that the FDA will use these results to justify further regulations. Whatever age verification system you choose, it needs to work. Failing to prevent sales to minors will have an effect on the whole industry’s future.

Jim McDonald

I spend most of my time studying the regulatory, legislative and scientific challenges to vaping, advocating for our right to exist, and talking with others who do the same. Consider me a source for information, and feel free to agree or disagree with anything I say. I love good coffee and sweet Michigan cherries. My childhood hero was Gordie Howe.

  • Michael Abrams

    Would be interesting to see how many passed the test, so we can benchmark for improvement that will follow. Or, is that not even measured? Do we know how many of the 55 were vape shops and US based online vape shops?

    Also, did they try to buy cigs, cigars, dip, or even patches and nic gum? Need to keep it fair, which they have shown no signs of.

    I recall the deeming regs affected cigars and other tobacco, but cigs were grandfathered.

    • Jim McDonald

      The last link in the story names the vendors. All the dedicated vape businesses’ violations were online sales.

    • John Songer

      Pretty much any form of nicotine EXCEPT e cigs is grandfathered or exempt completely from the regs. Flavored cigars, flavored nic gum and lozenges (which by the way is stated to being made fully exempt from any regulations ever) will remain on market while they continue to push for a ecig flavor ban. FDA needs to turn tobacco back over to the agency partially created to regulate it. FDA needs regulations upon as they currently can say or do whatever they wish without answering to anyone. The president has no say over FDA even currently. Maybe, and it’s a huge maybe, if companies like Mad Hatter, One Hit Wonder and whoever is making the Pokemon e liquids would quit with the childish novelty packaging, they would ease up a bit.

      • Jim McDonald

        Cigars are subject to the deeming rule, if marketed after Feb. 2007. Gum and lozenges aren’t regulated as tobacco products. The Dept of HHS is run by a presidential cabinet appointee. The FDA is part of HHS. HHS follows the general policy principles of the president.

        • John Songer

          When I contacted the FDA with a list of questions they referred me back to the regs saying it was all in there and they would not comment. I finally got a phone number where I could contact someone and ask a few of the questions IF I agreed it was only for my personal information and was not to be recorded. When I asked them why nicotine gum and lozenges were exempt they said while the nicotine within them was not derived from tobacco and it was a smoking cessation device not a nicotine delivery system. When I asked who made those decisions, they answered as I quote “We do.” And when I asked who gave them the right to do so they replied we did, we are a stand alone agency that answers to only ourselves. The last answer is a paraphrase as they refused as I said to answer anything in text only on the phone and I was instructed I was not allowed to record the conversation. Shady shady shady. But as the saying goes “any government big and powerful enough to give you everything you want is also big and powerful enough to take everything you have”

  • Mirza

    Hypocrites. In the days of CETA TTIP they want to ban an flavors that “aim” youth. How many cigarettes are aiming women and youth with their advertisement in the vicinity of Burger King, McCrap and KFCs, how many advertisiments for Heineken or other beer on sport events aiming kids and youth on bus stations etc. I’m speaking for EU. Even this is has nothing direct with USA flavor ban and EU the pattern is similar and can I say, universal. They tone the melody being played. When they want they have it. Money does make difference and they have a lot f money.

    • John Songer

      Don’t forget Nicorette fruit and candy flavored lozenges that are in a Easy Open pop top container (even says easy open on it). If kids can open a child proof twist top, can’t they open a pop open top?

  • Notquiteright

    “The new federal regulations require retailers to check the ID of anyone
    under age 27, and makes sale to people under age 18 illegal.”

    The ID requirement is only for direct, face-to-face sales. The exception to requiring photo ID is §1140.16(c)(2)(i). It’s the same exception provided to online tobacco sales.

    Age verification is required for online sales, photo ID is not required for online sales.

  • Roy Stephens

    in my opinion any vendor that was or is sell to underaged kids should be shut down and I am an advocate for vaping, We don’t need to give the FDA and ammunition in the attempts to stop vaping. And certainly do not wish to add any form of underage nicotine addiction.

    • John Songer

      The Royal College Of Physicians has already proven nicotine, in actual nontobacco form is about as addictive as caffeine with extremely similar withdrawal symptoms. Its the other toxins in the tobacco combined with the nicotine that is so addictive.

      • Jim McDonald

        Actually, that is an FDA conclusion! Nicotine in NRT, they say, has “low potential for abuse” (abuse = addiction).

        • John Songer

          I dont know why I keep confusing the two. Maybe because I wish the FDA would take a page from the Royal College Of Physicians. It totally dumbfounding to me how 2 organizations that have, from what I understand, basically the same job and purpose can take two polar opposite approaches to the same issue. While Child Lock tanks and 3ml tank size limit may seem strict for UK, I would welcome and applaud such regs here state side. Fact of the matter is, they say it’s to protect the kids from nicotine addiction yet there are pharmaceutical drugs they give the youth that contain nicotine. I have even been prescribed antidepressants and anxiety drugs that contained them. Sure, it was a clinical trial, but, isn’t clinical trials just a step before the drugs go fully public?

  • John Songer

    So even if a kid steals dad’s ID and Credit Card you will be in trouble…… no time can the kid be in trouble. And send questions in? Well I did and all FDA replied with was a comment saying they would not respond to the questions as the regulations are clearly written and understandable by most if not all.

    • Jim McDonald

      Yeah, they’re really clear, sure.