August 10th: New Labeling and Ad Requirements

    August 10th new labeling Fda rule ads

    No e-liquid manufacturer has ever tried to hide the nicotine content of its products. Vapers are fairly obsessed with how much nic they’re ingesting, and buy liquid in varying levels depending on the delivery device, their mood, or whether they’re trying to reduce or quit nicotine.

    But on Aug.10 it will be mandatory to place a bold, black-and-white warning on every nicotine-containing e-liquid and closed-system product and advertisement that warns consumers that nicotine is present, and that it is “addictive.” The changes are part of the still-unfolding Deeming Rule’s countdown to extinction.

    The exact warning reads, “WARNING: This product contains nicotine. Nicotine is an addictive chemical.” Get ready, you’ll be seeing it a lot in the near future — and forever. There is a one-month grace period to sell product already on the market, but after Sept. 10, you should see no more packages without the warning.

    In keeping with the sheer idiocy of the deeming regulations, the FDA will allow manufacturers of zero-nicotine e-liquid to use an alternative warning: “This product is made from tobacco.” Yes, if there is no nicotine, there is certainly no tobacco — but that’s the rule. Of course, to use the alternative warning, the manufacturer must submit “a confirmation statement certifying to be true and accurate that the product does not contain nicotine (e.g., no nicotine at detectable levels) and that the tobacco product manufacturer has data to support that assertion.”

    There are specific requirements for size and placement of the warning on packages and advertisements, and some exceptions for small packages and other unusual circumstances. You can read all the details in the FDA’s “Guidance for Industry: Small Entity Compliance Guide.

    There are other labeling requirements that go into effect on Aug. 10. All labels must contain this information:

    • The name and place of business of the manufacturer, packer, or distributor
    • Quantity of the contents (by weight, measure, or quantity)
    • The statement: “Sale only allowed in the United States” on labels, packaging, and shipping containers of tobacco products

    Manufacturers looking for an easy way to instantly convert existing images to compliant advertisements (but not labels, which have different proportion requirements) need look no further than the Mountain Oak Vapors “Warnizer” app. Vaping360 featured this cool software in a recent article, but we might have had too much fun with the app’s novelty value, and downplayed its real utility as a tool for manufacturers. You can find it in the Google Play Store or Apple App Store by searching “MOV Warnizer.” And it’s free, thanks to MOV owners Brandy and Steve Nair.

    Let this be your periodic reminder that we now have four years until the final deeming deadline on Aug. 8, 2022, which will result in almost complete prohibition of vapor products. On that date, every product whose manufacturer has not submitted a premarket tobacco application (PMTA) will be illegal to sell. And unless we are successful getting Congress to change the law or the FDA to reverse itself, that day will come.

    Jim McDonald
    Smokers created vaping without any help from the tobacco industry or anti-smoking crusaders, and vapers have the right to keep innovating to help themselves. My goal is to provide clear, honest information about the challenges vaping faces from lawmakers, regulators, and brokers of disinformation. I recently joined the CASAA board, but my opinions aren’t necessarily CASAA’s, and vice versa. You can find me on Twitter @whycherrywhy

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