Vape Manufacturers Must Submit PMTAs in 10 Months or Shut Down
Vaping manufacturers must submit premarket tobacco applications (PMTAs) within 10 months or remove their products from the market, according to an order issued today by federal District Court Judge Paul W. Grimm.
The judge struck down the FDA’s 2017 guidance in May, agreeing with plaintiffs that the agency’s 2022 PMTA deadline (which extended the due date for applications from 2018) was issued without following the rulemaking process mandated by the Administrative Procedures Act, and that the four-year delay the FDA granted vaping manufacturers was “so extreme as to amount to an abdication of its statutory responsibilities.”
In his 12-page order, the judge said manufacturers who submit an application within 10 months—by May 11, 2020—will be able to leave products on the market for up to one year while the FDA considers the application. He also said the FDA can exempt products from the application requirements “for good cause,” on a case-by-case basis.
The FDA now has 30 days to file a Notice of Appeal, and to ask the 4th Circuit Court of Appeals to stay (postpone) Grimm’s decision during the appeal. Many industry observers think the FDA and Department of Justice will challenge the ruling, because it usurps powers granted to the executive branch of government.
Others think the FDA will not appeal, because the judge’s decision will accomplish what the agency has sought all along: to reduce the vape industry to a few large companies (primarily tobacco companies).
In a statement, acting FDA Commissioner Ned Sharpless seemed to indicate the FDA may not appeal. “Today’s ruling is an important step forward for public health and validates FDA’s commitment to accelerate review of these products, particularly the ones that are most attractive to youth,” Sharpless said.
No vape manufacturer has submitted a PMTA, because of the excessive cost of the research and analysis required (estimated at more than $1 million per application). Additionally, FDA had not even published final guidance for manufacturers until last month, when it did so under pressure from Judge Grimm.
Nothing in the FDA guidance document offered any hope for small manufacturers. It would be a fool’s errand to gamble millions of dollars on applications that are unlikely to meet the high bar of proving that products are “appropriate for the protection of public health.”
The lawsuit against the FDA was filed in March 2018 by a group of plaintiffs that includes the American Academy of Pediatrics (AAP), American Cancer Society Cancer Action Network, American Heart Association, American Lung Association, Campaign for Tobacco-Free Kids, and Truth Initiative.
This is just another way to hurt the people we the people have no rights we are all slaves and we will never have a say in anything as long as the government keeps control over everything if the fda really gave a shit they would have banned cigarettes a long time ago but they are steadily making a mint
I don’t disagree with you, but FDA is prevented by the Tobacco Control Act from banning cigarettes. They don’t have that authority.
I’m curious as to how the FDA will regulate 0mg vape liquid. It is not a tobacco product. Granted, it is a vaping product but since it has no nicotine how can the FDA deem it a “tobacco product”. I understand that pod devices come with a manufactured pre-filled cartridge that contains nicotine so those devices should be included but strictly vape liquid that does not contain nicotine can not and should not be included. I have yet to see anything either in the 23 pages of guidelines the FDA published or in Judge Grimm’s ruling that takes 0mg vape… Read more »
If it is sold in a vape shop and the vape shop sells nicotine additives it will be classified as a nicotine product it does not have to contain nic just be sold where they sell the nicotine.
As someone who smoked two packs of Newport for over thirty years I am
The FDA Deeming Rule categorizes zero-nicotine e-liquid as a tobacco product, because it is used in conjunction with other “tobacco products” (vaping devices). Challenging that would be expensive, and what company would care enough about nicotine-free sales to spend the money on lawyers? That said, I doubt the FDA will bother to pursue enforcement of its rules for a product that occupies maybe 3-5% of the e-liquid market. Eliminating nicotine-containing e-liquid would destroy the vaping market, simply because very few people vape without nicotine. Vape shops would not survive selling only products that appeal to 5% of vapers, and manufacturers… Read more »
That’s not true at all. Many people that vape do not use nicotine. They just are not loud about. They did a study a bit back and found that most kids that vape do not use the nicotine they just really like the flavors and the smoking part. I got to 0% nic about 3 years ago and I still vape like crazy. If I don’t I get the urge to smoke or chew . There are still plenty of reasons to go without nic like the ritual part of it, the flavoring Ect. It also can really help with… Read more »
as a retailer,i 100% agree
I know very well that some vapers don’t use nicotine. I’ve written about it myself before. But if you ask vendors, they’ll tell you that zero nic e-liquids are a very small part of their business. The surveys (Monitoring the Future, National Institute of Drug Abuse/University of Michigan) that showed teens vaping without nicotine are from 2016 and 2015 — a whole different world from prefilled pods and salts. There is also the problem of many kids trying someone else’s vape and thinking it contains no nic, but being wrong. My point is that there isn’t enough zero-nic liquid sold… Read more »
“My point is that there isn’t enough zero-nic liquid sold to sustain a business. I’m confident that’s true.” You have a valid point. Still there is another angle to view it from. Once someone was telling me that there was no work for a place that ran contract work projects. They tried equating it to a farmer that had a bad run on a crop, livestock. Well, this is the same argument you’re presenting. When have you known a farmer to lash themselves to strictly one crop or type of livestock? My point here is that lots of shops would… Read more »
I don’t understand what you’re saying — that vape shops would sustain themselves selling OTHER unapproved vaping products? You have to understand that anything that is used in or with a “tobacco product” (so any component or accessory, like wick and wire, nicotine, any e-liquid, mods, atomizers, batteries, software, and every other vaping product) is considered a tobacco product too, according to the Deeming Rule. All of them will also require premarket approval from the FDA. Even if that weren’t the case, it is the profit margin of e-liquid that makes vape shops viable businesses. As far as a “negative… Read more »
In Russia, liquids with nicotine are subject to a huge tax that is not commensurate with their value. This led to the fact that manufacturers of liquids began to produce them with zero nicotine content. Ampoules with nicotine 100-200 mg / ml are sold separately. Since the amount of nicotine is small, then the tax is minimal. The same can be done in the United States, removing the liquid from the FDA’s control, while pure nicotine will be much easier to certify. From the point of view of the consumer, it is not difficult to pour the liquid from the… Read more »
It can’t be, because both the zero-nicotine e-liquid and the separate nicotine would be classed as tobacco products that require premarket approval. And proving that 100-200 mg/mL nicotine is “appropriate for the protection of public health” sounds a lot harder to me than doing the same for standard e-liquid. But, of course, anyone with a million dollars or so and the time to do the necessary research and testing can roll the dice.
What does public health have to do with anything nicotine in itself in relatively small doses is not bad for you. People only think it is because of the cigarettes it’s all the other crap in cigarettes that’s bad for you not the nicotine itself it’s even been proven to help with some people like my stepfather because when he was chewing nicorette gum it help relieve his stress It brought his blood pressure down the doctor told him if it’s working keep doing it. and why would it be necessary for the all this testing by the FDA when… Read more »
Hi all. Im not entirely sure as to how localised to the USA or universal will this ruling effect. By requesting manufacturers withdraw these products from the market, surely can only be enforced to manufacturers and vape shops based in America – and not globally. The FDA has no juristiction in other countries so surely the online/external market will continue as normal, but the localised industry will suffer!?
Yes, the FDA is an American agency, and this article applies to the U.S. only.
Would they not place restrictions on imports?
Importers are responsible for the products they bring in. All products sold in the United States must have a marketing order from the FDA. But I doubt if wholesalers will submit PMTA’s for products they don’t have an ownership stake in.
Thank God I am in the Philippines!