Probably no single event has rocked the vaping world like the announcement of the FDA Deeming Rule on May 5, 2016. The Deeming Rule is the regulation that gives the FDA authority over vapor products.
The first version was a long document — 499 double-spaced pages — and as readers made their way through it, what had only been rumored became reality: the FDA would impose a hard stop on the independent vaping industry two years after the rule took effect on Aug. 8, 2016. The agency would require submission of complex and expensive applications to prove that existing products are “appropriate for the protection on public health.” And there was no assurance that those applications would be approved.
The only products that would be spared the process of “premarket approval” were those that had been on the market unchanged since Feb. 15, 2007, the so-called predicate date named in the 2009 Family Smoking Prevention and Tobacco Control Act. And no such products existed. The agency also didn’t offer specific standards for manufacturers to meet, or a list of harmful ingredients that would be prohibited, or nicotine limits, or rules that would make products safer for consumers.
The FDA admitted that the regulations would cause more than 99 percent of vaping manufacturers to “exit the market,” and that the cost of a premarket tobacco application (PMTA) would be higher than all but a few companies (almost exclusively Big Tobacco companies) could bear.
In this article, we’re going to examine the origins of the FDA’s vaping regulations, then bring the story up to the present. We’ll look at the forces that have shaped the Deeming Rule, and how it’s still changing. At the end of the article we’ve included an updated timeline of all the compliance deadlines manufacturers have had to meet, and those that still lie ahead.
The Food and Drug Administration’s mandate to regulate vapor products had its origin in the Family Smoking Prevention and Tobacco Control Act (usually called the Tobacco Control Act, or TCA). The legislation — which was created with the cooperation of tobacco company Philip Morris and Campaign for Tobacco-Free Kids president Matthew Myers — easily passed Congress with bipartisan support and was signed into law on June 22, 2009 by President Obama.
The act gave the FDA regulatory authority over tobacco products like cigarettes and smokeless tobacco. It also created a new FDA office, the Center for Tobacco Products (CTP), which would be completely funded by user fees from tobacco companies. (Recently, the CTP has collected more than $600 million a year in user fees in both 2017 and 2018.)
The Tobacco Control Act “grandfathered” all cigarettes already available for sale, but created difficult barriers to any new products that might attempt to enter the market. The act effectively protected existing cigarette brands from future competition — not just from other cigarettes, but also from low-risk nicotine products that might threaten the tobacco companies down the road. One skeptical senator called it the “Marlboro Protection Act.”
In addition to existing products, the act gave the FDA the power to “deem” any new product containing “nicotine made or derived from tobacco” to be a tobacco product. That meant that the FDA could grant itself the power to regulate any product it decided met the standards laid out in the TCA without further oversight from Congress.
Although the FDA Center for Tobacco Products received its mandate to regulate tobacco products in 2009, it would be another seven years before the agency granted itself authority over e-cigarettes. However, the FDA had begun going after the new products even before the Tobacco Control Act became law.
It was the FDA Center for Drug Evaluation and Research (CDER), that struck first at the tiny industry that was just beginning to build a U.S. vaping market in early 2009. According to CASAA’s historical timeline, the agency directed customs officials to turn away shipments of e-cigarettes from China, on the basis that they were unapproved drug delivery devices.
In April of 2009, e-cig manufacturer Smoking Everywhere filed a lawsuit against the FDA, and soon after Sottera (maker of NJOY products) joined the suit. The companies claimed the FDA had no jurisdiction over the products because they were tobacco products, not drug delivery devices.
Even after the Tobacco Control Act was passed in June 2009 and the agency could have regulated e-cigs as tobacco products, the FDA stuck with its original legal strategy. As it turned out, that was a mistake, because in January 2010 U.S. District Court Judge Richard Leon issued an opinion in favor of the vaping manufacturers, and an injunction preventing the FDA from seizing their imported products.
Eleven months later, the federal appeals court upheld Judge Leon’s decision, ruling that unless therapeutic claims were being made, the FDA could only regulate e-cigarettes as tobacco products. The FDA did not appeal further, and in April 2011 announced it would regulate e-cigs as tobacco products.
It would be three more years before the FDA explained how it intended to implement vaping regulations. During that time, the industry experienced explosive growth and rapid innovation, as millions of smokers discovered that these devices could be a viable alternative to cigarettes.
Between 2011 and 2014, the FDA was pushed hard to issue deeming regulations. Pressure came from Democratic members of Congress, and from private special interest groups like the American Cancer Society, Campaign for Tobacco-Free Kids, the American Academy of Family Physicians, and the heart and lung associations.
E-liquid flavors were the primary target of the anti-vaping activists. Banning “characterizing flavors” in cigarettes had been one of the new Center for Tobacco Products’ first regulatory acts, and — despite the tiny market share held by “candy-flavored” cigarettes — anti-tobacco advocates thought fruit and candy flavors should be prohibited in combustion-free vaping products too.
Also weighing in on the call for regulation was Marlboro manufacturer Altria (formerly Philip Morris, which had helped write the Tobacco Control Act). Altria told the FDA that manufacturers of vaping products should be subject to the same rules and restrictions that cigarette producers were.
On April 24, 2014 the FDA released its proposed regulations. They were as bad as most vaping supporters had feared. The proposed rule would eliminate almost all of the vaping industry (aside from some products made by Big Tobacco), by requiring manufacturers to submit premarket tobacco applications (PMTA’s) for all existing products within two years after the final rule was issued.
The regulations also required separate applications for every “component or part,” extensive studies and toxicological testing that would possibly cost millions for each product submitted, and offered no guidance for standards the agency expected from manufacturers. The FDA said each product would have to show that it benefited public health — the health of the whole U.S. population, not just individual vapers and smokers — which requires studies on uptake by non-smokers and ex-smokers too. The FDA expressed no concerns about a black market being created.
The FDA gave the public 75 days (later extended) to make comments, and then set about creating a final rule. The comment period is often a formality, with the agency winding up right back where it intended to be all along. But in this case the FDA got at least one comment that was truly helpful.
The comment from RAI Services (owner of RJ Reynolds, manufacturer of Camel cigarettes) essentially was a blueprint for the FDA to eliminate the entire messy independent vaping industry. The cigarette maker suggested that the FDA should ban outright so-called “open-system” vaping products (the separate components that fit together in different combinations, like bottled e-liquid, mods, atomizers, and coils).
“Unlike closed-system products,” said Reynolds, “open-system products are highly customizable. As a result, there is no way to adequately evaluate how such a product will work or to establish whether consistency of product composition and quality can be maintained.”
The cigarette manufacturer then went on to explain how vape shops could be defined as manufacturers, since many mixed e-liquids on site, and assembled hardware components into finished products. RJ Reynolds, whose cigarettes were grandfathered onto the market by the Tobacco Control Act, patiently instructed the regulatory agency how to eliminate the tobacco industry competitor with burdensome regulations.
On May 5, 2016 the FDA announced the finalized Deeming Rule. It was a shocking day for vapers, who realized that the FDA hadn’t listened to their heartfelt pleas to preserve these products, but instead delivered a systematic attack on the independent vaping industry that seemed legally airtight.
The agency had constructed a maze of regulatory hoops for small business owners. And the FDA assured it wouldn’t have to deal with a mountain of PMTA’s for hardware by demanding that all components and parts applications would have to show how each device might work with any other component it could be combined with. For example, if your company wants to sell an atomizer with a 510 connection, you would have to test the device with every other product it could be attached to, and every e-liquid it could possibly be used to vaporize. Each separate combination of thousands of devices would have to be proven “appropriate for the protection of public health.”
The FDA’s “Guidance for Industry” was 58 pages long. That document was intended as an instruction manual for preparing PMTA’s, but it didn’t suggest a single technical standard that would be required, or explain what would make a product acceptable or unacceptable to regulators. Business owners were left wondering just what they had to do to assure marketing approval from the agency.
In fact, the FDA suggested that closed-system devices would be more likely to win approval. The agency so feared the confusing and probably impossible-to-regulate market of tanks, mods and bottled e-liquid that it unknowingly walked itself right into the situation it now faces, with at least half the market consisting of small and inexpensive pod vapes.
There was no immediate flavor ban, but the agency left open the possibility that it could come at any time. The Deeming Rule, CTP director Mitch Zeller explained, was a foundational regulation. It was just the beginning. Restrictions on flavors might be added any time in the future. (As it turned out, the FDA had intended to ban flavors, but was prevented by the White House.)
Among the newly deemed products — which included not just vapor products, but also cigars, hookah, pipes and pipe tobacco — only manufacturers of pipe tobacco and cigars would be required to pay tobacco company “user fees” to the FDA. But the agency still considered makers of tobacco- and combustion-free vaping products to be “tobacco manufacturers.”
The deeming regulations would take effect on Aug. 8, 2016, and some of the provisions would be enacted immediately. Those included a federal minimum age of 18 to purchase vaping products (of course, 48 states already had their own minimum age laws), a ban on free samples in shops, and the requirement for premarket approval of any product introduced after Aug. 8. Other parts of the Deeming Rule would be rolled out over a two-year schedule. The final requirement — the submission of PMTA’s for existing products — would be due by Aug. 8, 2018.
Even before the FDA’s vaping regulations had been announced, there was a U.S. House bill, introduced by Oklahoma Republican Tom Cole, that would grandfather existing vaping products onto the market without premarket approval. HR 2058 would have preserved the vaping devices and e-liquids that were on the market when the Deeming Rule went live. The bill didn’t go anywhere, but Cole kept at it, promoting variations on his bill for the next two years.
Immediately after the announcement of the Deeming Rule in May, Republican Sen. Ron Johnson of Wisconsin sent a letter to FDA Commissioner Robert Califf, demanding answers about the regulations. He sent follow-ups too, although he never received a substantial reply. After his re-election in November 2016, aside from one more letter Johnson’s interest seemed to wane. He never sponsored Senate legislation to help the vaping industry.
In 2017, Rep. Cole co-sponsored a bill with Georgia Democrat Sanford Bishop, a moderate with a large e-liquid manufacturer in his district. The “Cole-Bishop bill” was supported by vaping industry and consumer advocates as a vital first step to undoing the damage of the Deeming Rule. However, despite Republican majorities in both houses of Congress and a Republican president, Cole-Bishop was unsuccessful.
California Republican Rep. Duncan Hunter — like Sen. Johnson, an early Trump supporter — also introduced a bill in 2017 that would have mandated reasonable FDA regulation of the vapor industry. However its supporters (mainly e-liquid standards organization AEMSA) decided to announce that they wouldn’t back Cole-Bishop, and instead went all in for the Hunter bill. That caused friction with longtime advocates that thought the industry disunity confused legislators. In any case, Hunter didn’t seem interested in promoting his own legislation or recruiting co-sponsors, and the bill died quietly.
Immediately after the May deeming announcement, several lawsuits were filed against the FDA. The two best known actions were initiated by Halo e-liquid manufacturer Nicopure Labs and the Right to be Smoke-Free Coalition, a group of state and national vaping industry groups. The Nicopure and R2BSF suits were combined by the court, and in July 2017 U.S. District Court Judge Amy Jackson Berman ruled against the vapor industry plaintiffs. The decision was appealed, and the plaintiffs are still awaiting the result.
Three lawsuits were filed in federal courts around the country in January 2018 by the conservative/libertarian Pacific Legal Foundation, on behalf of several small vaping businesses. These suits are still pending, as are a couple lesser-known actions. There have also been lawsuits brought by cigar manufacturers and cigar trade organizations challenging the Deeming Rule.
In a bizarre twist, several anti-vaping groups — including Tobacco-Free Kids, the American Academy of Pediatrics, and the American Cancer Society Cancer Action Network — petitioned two federal courts, asking to take over the defense of the Deeming Rule in two lawsuits.
After the surprise election of Donald Trump in November 2016, the vaping industry saw a glimmer of hope for the future. And when Trump named former Bush FDA official and venture capitalist Scott Gottlieb, M.D., to head the FDA, the glimmer of hope became a broad beam.
Gottlieb took office barely a year after the announcement of the Deeming Rule. He had worked at the conservative American Enterprise Institute, which is generally supportive of vaping, and also served on the board of a vaping company (Kure, a vape shop franchiser), which had earned him some skeptical questions during his Senate confirmation hearing.
In a speech to FDA employees on his first day, he spoke words vapers never expected to hear from the leader of the FDA. “We need to redouble efforts to help more smokers become tobacco-free,” said the new commissioner. “And, we need to have the science base to explore the potential to move current smokers – unable or unwilling to quit – to less harmful products, if they can’t quit altogether. At all times, we must protect kids from the dangers of tobacco use.”
Then in a speech on July 28, 2017, Gottlieb announced a major initiative to completely remake the American nicotine product landscape. Gottlieb said the FDA would begin rulemaking to reduce nicotine in cigarettes below addictive levels. And because millions of smokers would need safer nicotine products to replace their cigarettes, Gottlieb said that e-cigarettes were an important part of his “comprehensive plan.”
Gottlieb said that the FDA would postpone the 2018 PMTA submission deadline for four years, until Aug. 8, 2022. That would allow time for the FDA to create workable premarket review standards. He also said that while applications were being reviewed, products could remain on the market indefinitely (previously they were only allowed to be sold for one year, even if the FDA had not determined their eligibility).
The commissioner also announced that the agency would begin the rulemaking process to address “kid-appealing flavors” in tobacco products, including in e-liquids. And he promised foundational rules that would make the premarket review process transparent and predictable, and guidance on “known risks” in vapor products like batteries.
The vaping industry was mostly giddy, and Gottlieb looked like the savior that manufacturers and retailers had hoped for — at least temporarily.
The opponents of vapor products had long beaten the drum of “child-appealing” flavors. In fact, the accusation that flavors (other than tobacco) were especially attractive to youth had been with vaping almost since the beginning, well before Lorillard Tobacco bought Blu in 2012 — Big Tobacco’s entry into the e-cigarette business.
Since the Deeming Rule had punted on an outright flavor ban, groups like the Campaign for Tobacco-Free Kids made flavors the tip of the anti-vaping spear. They frequently sent letters to Congress (and issued press releases), and even created dedicated websites to push the anti-flavor narrative. For TFK and the other tobacco control groups, “candy-flavored tobacco” allowed them to tie vaping to combustible tobacco products (like “little cigars”) in a way nothing else could. Because the FDA had banned flavored cigarettes (except menthol), they argued that “characterizing flavors” should also be prohibited for other tobacco products, including in bottled e-liquid.
The independent vaping industry — manufacturers of the products found in thousands of vape shops — fears flavor restrictions above all other regulation, since flavored e-liquid is the primary driver of their sales. The anti-vaping activists know that the vapor industry would crumble without the almost endless variety of e-liquid flavors. It’s not an exaggeration to say that flavors are the vaping industry.
There were attempts to create additional vaping bogeymen too, as the groups aligned against vaping threw ideas at the wall to see what would stick. Dripping had its moment in the spotlight, with an alarming study portraying it as a dangerous fringe practice, and newspaper stories to drive the public panic that activist researchers hoped would follow. Battery explosions made the news regularly, although an FDA study of battery mishaps showed that such events were easily avoidable and not especially common. And old rodent studies were brought out of mothballs to show a potential link between adolescent nicotine use and compromised brain development.
But in mid-2017 anecdotal stories of high schools students using the JUUL — a tiny pod device that uses high-strength e-liquid — started bubbling in the northeast, especially in Massachusetts. By October, New York Sen. Chuck Schumer became the first national politician to use JUUL as a pretext to ask the FDA to enforce the Deeming Rule’s PMTA requirement immediately. Schumer issued an alarming press release, held a news conference, and sent a letter to Commissioner Gottlieb.
Schumer used talking points that would become very familiar over the next year. JUUL is small and easy to hide, he said. Kids are using it in school, and teachers don’t notice because it looks like a USB flash drive. One JUUL pod contains as much nicotine as a whole pack of cigarettes. And JUUL has flavors — including “child-appealing” flavors like Fruit Medley, Mango, and Creme Brulee.
Tobacco control groups leapt onto the JUUL train. Newspaper articles and TV spots began appearing regularly, often using as examples the same few New England schools the earliest articles had used, and the same handful of drug treatment specialists as experts. The panic spread and multiplied. By March 2018, when the FDA issued its advanced notice of proposed rulemaking for flavors, JUUL fever had overtaken the vaping conversation. And since flavors were supposedly a big part of JUUL’s appeal to youth, the anti-vaping experts managed to fit both issues into the stories. The talking points Sen. Schumer had used in October were now ubiquitous. Teen nicotine use had become a national emergency!
On April 19, the major non-profit groups aligned against vaping launched a coordinated maneuver to grab headlines and mark JUUL as the target of what they hoped would be a national demand for action. On that day, Truth Initiative published a study that purported to prove the threat JUUL posed to children; six tobacco control organizations sent a letter demanding that the FDA take action against JUUL and reverse its delay of the premarket review process; and 11 Democratic senators sent letters to the FDA and to JUUL Labs with similar demands.
Under pressure, Commissioner Gottlieb began shifting his focus to teen nicotine use. By summer, he was using the word “epidemic,” and in September the FDA chief threatened to ban flavors and possibly remove products from the market, based on unpublished preliminary data from a 2018 CDC survey. The agency announced a $60 million ad campaign featuring a video titled “Epidemic,” that showed teenagers infested with bugs crawling under their skin while they vaped.
Gottlieb now owned the epidemic. On Nov. 15, the commissioner announced a ban on vape flavors (other than tobacco, menthol and mint) except in adult-only stores, like vape or tobacco shops. That meant that adults who don’t live near a vape shop would have no retail access to the most popular vaping products. Gottlieb reminded the public that the FDA was still planning rules for flavors too. He also promised new guidelines for online sales that would require “heightened” age verification standards.
Since his November 2018 announcement, Commissioner Gottlieb has threatened further FDA action if the epidemic doesn’t reverse course quickly. But despite his promise of tough actions, the FDA still hasn’t issued any written guidance for retailers and manufacturers.
Because the postponement of the final deeming deadline was a matter of FDA regulatory discretion, Gottlieb could choose to reverse himself and impose the PMTA requirement sooner than 2022. That’s what the anti-vaping groups have been demanding since the delay was announced. The new Democratic-majority House will almost certainly hold hearings and otherwise support the tobacco control groups’ position.
The FDA still hasn’t issued the transparent, standards-based guidelines for vaping manufacturers that were promised in Gottlieb’s July 2017 speech. Vaping businesses that hope to remain in this industry long-term are still guessing what a successful PMTA might look like. And until there is some kind of assurance that any PMTA could pass muster with the agency, no company is willing to take the plunge. It’s been nearly three years since the Deeming Rule was announced, and no vaping industry PMTA’s have been submitted.
During the 10 years since Congress gave the FDA regulatory authority over tobacco products, the agency has never stated clearly that vaping is safer than smoking. However, vaping has grown rapidly, despite the cold shoulder from American public health authorities. And it has expanded around the world. While some countries like India are still trying to ban vaping products, others like the U.K. and Canada have allowed and even encouraged vaping as a safer choice for smokers.
Whether the FDA quietly admits its error in attempting to prohibit and restrict products that could save millions of lives, or goes down kicking and screaming like drug warriors in their fight against decriminalizing marijuana, the vaping genie is out of the bottle. It will be almost impossible to put it back, and to save its own credibility the FDA will have to acknowledge that fact soon, or preside over an ineffective prohibition and a large black market.
This list applies to vapor products only, not to other deemed products like cigars or pipe tobacco. Each compliance deadline is listed in chronological order by its most-recently revised date. We have noted the original compliance date in brackets for those deadlines that have changed. (Note: some deadlines have changed multiple times. We have not listed all the changes, just the final and original dates.)
The official FDA document describing compliance deadlines is the source for this list. Manufacturers should consult the actual FDA document when making business decisions.