Are the FDA's E-Cigarette Restrictions Legal?

The new rules arguably violate the law that gave the agency authority to regulate tobacco products.


Juul Labs

The e-cigarette restrictions that the Food and Drug Administration announced yesterday differ from the agency's rumored plans in one way that may be legally important. In addition to allowing sales of the targeted flavors (everything but menthol, mint, and tobacco) by vape shops, tobacconists, and online vendors that have age verification, the rules described by FDA Commissioner Scott Gottlieb allow other retailers to sell them in "a section" that "adequately prevents entry of persons under the age of 18," as long as the products "are not visible or accessible to persons under the age of 18 at any time."

That language seems to be aimed at getting around a limit on the FDA's power that was included in the Family Smoking Prevention and Tobacco Control Act, the 2009 law that gave the agency the authority to regulate tobacco products. It says the FDA may not "prohibit the sale of any tobacco product in face-to-face transactions by a specific category of retail outlets." Since the FDA officially is allowing all categories of retail outlets to continue selling flavored e-cigarettes, it arguably is complying with that limit.

Then again, the option of creating a segregated section, presumably with a separate cashier (since the products cannot be visible to minors at any point), probably will not be feasible for most retailers. "What we are envisioning is a separate room or a walled-off area," Gottlieb told The New York Times. "It needs to be a complete separate structure. A curtain won't cut it." Lyle Beckwith, senior vice president for government relations at the National Association of Convenience Stores (NACS), says that sort of arrangement is "not practical." Hence the rule arguably amounts to a de facto ban on sales of flavored e-cigarettes in convenience stores and any other businesses that admit minors, which the Tobacco Control Act does not allow.

"The Tobacco Control Act is clear that the FDA can't discriminate against one type of retail outlet, and that's what they're trying to do here," Doug Kantor, a NACS lawyer, told the Times. "There is a very good chance this will end up in litigation, and lawyers are looking at that right now."

It's not clear the FDA actually wants convenience stores to create adults-only sections, which would require the same ID checks that are already required for selling e-cigarettes. If store employees cannot be trusted to verify that customers buying e-cigarettes are at least 18 (which is the implicit justication for the new restrictions), how can they be trusted to make sure that customers entering the e-cigarette section are at least 18?

As described by Gottlieb, the FDA plan does not directly regulate merchants, telling them which products they may sell under what circumstances. Nor does it directly regulate e-cigarette manufacturers, telling them which products they may sell to which retailers. The FDA instead plans to make the flavored e-cigarettes themselves illegal, but only in certain contexts.

Gottlieb said the FDA will do that by selectively revisiting its 2017 decision to change the deadline for seeking regulatory approval of e-cigarettes from 2018 to 2022. "I'm directing the FDA's Center for Tobacco Products (CTP) to revisit this compliance policy as it applies to deemed ENDS products that are flavored, including all flavors other than tobacco, mint and menthol," Gottlieb said yesterday. "The changes I seek would protect kids by having all flavored ENDS [electronic nicotine delivery system] products (other than tobacco, mint and menthol flavors or non-flavored products) sold in age-restricted, in-person locations and, if sold online, under heightened practices for age verification."

Since the original deadline for submitting e-cigarette applications to the FDA has already passed, "revisit[ing] this compliance policy" for flavored e-cigarettes sold in places that minors can enter would make those products illegal in that context. But the very same products would remain legal when sold by age-restricted stores or websites. It's a pretty weird, roundabout way to accomplish what the FDA wants, but it has the advantage of avoiding the time-consuming process of formally issuing a new rule.

NEXT: An Act of Congress Could Bring Hemp to the Shelves of Your Local Grocery Store

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  1. ENDS [electronic nicotine delivery system]

    Huh. I wonder if something like strawberry-and-nicotine scented perfume in some sort of pneumatic-powered dosing device dispenser applicator would fall under this regulation?

  2. The question is NOT whether the FDA’s restrictions are legal or not. The question is can the FDA find the correctly “stacked” court to rule that they are in fact legal.

  3. Then again, the option of creating a segregated section, presumably with a separate cashier (since the products cannot be visible to minors at any point), probably will not be feasible for most retailers.

    This just in: your local gas station will just put this shit under the counter with a cardboard placard on the counter that shows a picture of the product.

    This regulation-with-the-force-of-law won’t have any appreciable effect other than being onerous and pointless at the same time.

    1. Being onerous is the point.

  4. I read/skimmed through the 84 pages of the Tobacco Control Act, and it is specific to Tobacco.
    How did water vapor get defined as a tobacco product in contradiction the act?

    1. Especially since it isn’t made from tobacco, which would be the fig leaf they normally hide behind.

    2. The “If it walks like a duck and looks like a duck, it must be a turkey” theory.

    3. By the reasoning of the FDA, e-cigarettes contain nicotine, therefore they are “tobacco”. By that same reasoning, they need to ban sales and consumption of tomatoes by anyone under 18 because tomatoes contain nicotine and therefore are “tobacco”.

      1. OMG!! End of the world if kids cannot have pizza (made from tomatoes) or ketchup on fries.

      2. An ecig that contains nicotine is a drug delivery device by any definition

        1. So is a cup of coffee (caffeine is a drug too). What’s that got to do with anything?

        2. An e-cig doesn’t contain anything by default. It’s a miniature heater. The FDA shouldn’t have any more control over it than it does over an electric toothbrush. Sure you could use toothpaste containing nicotine, but that doesn’t classify the toothbrush as a drug delivery device.

    4. nocotine = tobacco

      prostitution = trafficking

      marijuana = narcotic

  5. A few choice tidbits:
    (a) INTENDED EFFECT.?Nothing in this division (or an amendment
    made by this division) shall be construed to?
    (1) establish a precedent with regard to any other industry, [seems to me vaping is “any other industry”]
    situation, circumstance, or legal action; or
    (2) affect any action pending in Federal, State, or tribal
    court, or any agreement, consent decree, or contract of any
    From the definitions:
    ”(3) CIGARETTE.?The term ‘cigarette’?
    ”(A) means a product that?
    ”(i) is a tobacco product; and
    ”(ii) meets the definition of the term ‘cigarette’
    in section 3(1) of the Federal Cigarette Labeling and
    Advertising Act; and
    ”(B) includes tobacco, in any form, that is functional
    in the product, which, because of its appearance, the type
    of tobacco used in the filler, or its packaging and labeling,
    is likely to be offered to, or purchased by, consumers as
    a cigarette or as roll-your-own tobacco. [See anything about the letter “E”? Anything about non-tobacco?]

    1. Why do you want children to die?

      1. Because their existence is threatening my freedoms

  6. I live in a world where flavored vapes must be controlled at all costs. I wonder how many proponents of that measure agree that minors should be able to have sex changes or abortions without parental acknowledgment.

  7. I am still having trouble understanding the difference between illegal sales of ecigs to minors and illegal sales of alcohol to minors. If you can satisfactorily accomplish the second one why can’t you accomplish the first one. Possibly outlawing certain products seems to be an over reach. And convenience store seems to be able to control liquor sales while the product is on a shelf right behind the cashier.

    1. My guess: The proponents of these restrictions don’t use ecigs but they do use alcohol, and no one seems to care anymore if kids are getting their hands on fruit flavored liqueurs; but, yes, the hypocrisy is no less disappointing

  8. There is enough confusion in the language of the FDA regs and Tobacco Control Act that there could easily be litigation, which would delay any action to ban flavored vapes. Maybe this was Gottleib’s intent? Hard to say, but seems strange that a commissioner appointed by a president who wants to reign in regulations would make so much noise about micromanaging what kinds of e-cigs can be sold where.

    The menthol cigarette ban is a real head scratcher too. I guess the GOP really does not care about getting more African-Americans to vote for them.

    1. Are you kidding? The Big Companies do not want litigation. These onerous rules make their market locked in.

  9. the option of creating a segregated section, presumably with a separate cashier (since the products cannot be visible to minors at any point)

    Interesting requirement. This is more strict than required for cigarettes which are visible behind the counter at grocery stores.

    1. In Ontario, Canada, where the “sin tax” has pushed the price of a pack of cigarettes over $13, it is against the law for cigarettes to be visible from in front of the counter and must be kept in closed shelves accessible only to the clerk. There can also be no Brand Names visible on the front or back of a pack of cigarettes, only on the top and bottom.

  10. The Ladies Pearl Clutching Society at the FDA needs to demand the beer & wine and birth control sections be hidden too.

    Wouldn’t want all those minors getting turned onto e-cigs just by their mere sight. You’d think they were as titillating to the little gutter snipes as the cover of this month’s Hustler.

    Shit, just ban all minors from all retail establishments…that’ll fix it!

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