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March 11, 2022

Congress Gives FDA Authority Over Synthetic Nicotine

July 14 update

On July 13, the FDA announced that it had received PMTAs from more than 200 manufacturers for over 1 million synthetic nicotine-based products. Our article from July 14 should be your first read for an overview of synthetic nicotine product regulations.

June 28 update

On June 17, the American Vapor Manufacturers Association (AVM) filed an FDA citizen petition requesting the FDA use its enforcement discretion to allow small companies that make bottled e-liquid containing synthetic nicotine to continue selling beyond the July 13 deadline. AVM is asking vapers to support its effort, and CASAA has issued a call to action that makes it easy to register support.

March 15 update
President Biden signed the spending bill into law today, starting the regulatory clock for synthetic nicotine. The effective dates are as follows:

April 14 - the law takes effect
May 14 - deadline to submit PMTAs for existing synthetic products. Products without pending PMTAs are now subject to FDA enforcement
July 13 - products that haven't received FDA marketing authorization (or an extension) are subject to enforcement

The Senate voted 68-31 Thursday evening to pass the omnibus spending bill that includes a rider granting the FDA authority over synthetic nicotine. The bill was passed Wednesday by the House, and will now go to President Biden to be signed into law.

The $1.5 trillion spending bill funds major parts of the government through September (the end of the 2022 fiscal year), and also appropriates $13.6 billion for aid to Ukraine. Like most such bills, it is loaded with senators’ pet projects and completely unrelated legislation—like the nicotine law.

The language in the bill will make products that use synthetic nicotine (and all forms of nicotine) subject to the same FDA rules as tobacco-derived nicotine products. The nicotine rider received no hearings or debate in either the Senate or House. The law is based on language from a House bill introduced last December, which also was not debated.

The law will take effect 30 days after Biden signs it, which will probably happen early next week. Manufacturers then have 30 additional days to submit Premarket Tobacco Applications (PMTAs) for synthetic products already on the market. Those who submit applications must receive authorization from the FDA within 60 days or remove those products from the market (or be subject to enforcement).

The law prevents marketing (after the effective date in about 30 days) of products the FDA considers synthetic nicotine variations of products with previously denied PMTAs. In other words, the manufacturer of an e-liquid that differs only in the type of nicotine from an e-liquid that has already received a Marketing Denial Order (MDO) cannot submit a new PMTA. However, new products—with different ingredients and names—can be introduced until the effective date of the law, and PMTAs for those products may be submitted.

For those concerned that this means the end of the independent vaping industry, it doesn’t—but it will hurt. Some businesses may decide to close rather than continue fighting a system stacked against them, but others have said they will continue.

“I know that it is very hard not to panic, I would encourage everyone to please remember we have been on the cusp of eradication many times before,” wrote American Vapor Manufacturers Association (AVM) President Amanda Wheeler on Facebook. “We are a resilient bunch and we will always keep fighting.”

There are a variety of legal strategies manufacturers will employ in the coming weeks to challenge the synthetic law—and many still have legal and administrative challenges pending for previously issued MDOs. Expect this to be a major stream of vaping industry news in the near future.

As we explained earlier this week, the nicotine language was inserted in the bill by a bipartisan group of House and Senate members, representing the interests of both anti-vaping groups and the tobacco industry. Juul Labs and RJ Reynolds actively lobbied for the bill, claiming it closed a “loophole” that allowed bad actors to “target youth” and escape FDA regulation.

The real reason Reynolds and Juul supported the bill (and state-level bills to ban synthetic nicotine and create registries of FDA-authorized products) is to protect their profits. Disposables sold by manufacturers like synthetic nicotine bad boys Puff Bar are major convenience store competitors for Juul Labs and Reynolds’ Vuse brand. And open-system products sold in vape shops and online continue to make up a big chunk of the vaping market.

The law will force thousands of products off the market that were launched by small e-liquid manufacturers in the wake of last year’s FDA mass-denial of PMTAs for flavored products.

The synthetic nicotine language changes the wording of the 2009 Tobacco Control Act to read, “The term ‘tobacco product’ means any product made or derived from tobacco, or containing nicotine from any source, that is intended for human consumption, including any component, part, or accessory of a tobacco product (except for raw materials other than tobacco used in manufacturing a component, part, or accessory of a tobacco product).” (New wording in bold type.)

In addition to vapes, the law includes any product containing synthetic nicotine, including nicotine pouches and lozenges. The recently introduced hemp cigarettes with added synthetic nicotine will also have to leave the market, unless their manufacturer can prove they’re “appropriate for the protection of public health” (not bloody likely).

The Tobacco Control Act was originally intended to regulate tobacco—especially combustible cigarettes, which are responsible for almost all of the immense harm caused by tobacco. In 2016, the FDA’s Deeming Rule amended the Act to include vaping products that use tobacco-derived nicotine. Now Congress has given the agency authority over products that have no connection to tobacco at all.

Smokers created vaping without help from the tobacco industry or anti-smoking crusaders, and I believe vapers have the right to continue 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’m a member of 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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John Hastings
John Hastings
6 months ago

I saw Amanda and Greg on the Grimm Green livestream. They came really dangerously close to encouraging folks to continue selling siting weak enforcement. I would discourage people from breaking the law in any way. It is what it is, and if you’re selling unlicensed tobacco products it WILL catch up to you and make your life situation MUCH worse. They’re now using the IRS to catch businesses selling unlicensed tobacco products, so don’t think you’re in the clear because agent Smith doesn’t come nosing around the warehouse or shop. Be smart, it’s not worth the risk.

John Hastings
John Hastings
6 months ago
Reply to  Jim McDonald

Spoke with two agents from the FDA at the last Champs show in Las Vegas. I asked about lack of enforcement. They said they’re using taxes to find out who is still selling unlicensed tobacco products. They told me that by filing income from sales, they can determine if those sales were of unlicensed tobacco, at which point they hand off the lead to ATF. At the time of our conversation it wasn’t tax time yet, so they probably haven’t used it yet, but now it is tax time and I would be very worried if I filed my taxes… Read more »

John Hastings
John Hastings
6 months ago
Reply to  Jim McDonald

They explained that the IRS can and will break down income from reported sales claims from licensed wholesalers, distros, and retailers. Then investigate the paper trail from invoices, and hand that info over to the FDA. Once the FDA sees that the business is reporting income from selling unlicensed products they get the ATF involved and the enforcement/punative process begins. They even said the IRS has advanced AI to pour over income filings from sellers who previously sold tobacco products as well as those who have applied for PMTA looking at profits. It didn’t make much sense to me, because… Read more »

John Hastings
John Hastings
6 months ago
Reply to  Jim McDonald

Will do Jim, but I reckon you’d hear about it before I would.

Florist Shaman
Florist Shaman
6 months ago

Not allowed to vote here-
Civil disobedience such as going against an order handed down from a fascist regime is just as sufficient as voting
Bending over for a such government and stating fear of the state is an entirely different strategy one that allows such tyranny to flourish
Just pointing this out

Florist Shaman
Florist Shaman
6 months ago

What would really be something is if a big vape juice manufacturer who is making it right under clean conditions with researched flavors continues despite what the gerontocracy dictates. Unfortunately these bans will ultimately destroy what little progress nicotine and cannabis has made as well and this decade will be filled with yet another American war on its people all over again. My town alone is already suffering from this. People are switching back to dipping as well as cigarettes and cheap dangerous highs. No one is being made safer by this administration.

Trump2024
Trump2024
4 months ago
Reply to  Jim McDonald

This administration is the one that is more obsessed with controlling people’s lives than ANY we have ever had! Any past administration wouldn’t have had the nerve to try as much tyranny as the current bunch of lunatics who are controlling the senile old fart they prop up like Bernie from “Weekend at Bernies”.