On 12 October the US Food and Drug Administration said it had sent letters to 21 e-cigarette companies questioning the legality of 41 of their products – the latest in a series of actions to thwart e-cigarette sales to youth. Earlier, the FDA sent some 1,300 warning letters and fines to retailers who sold e-cigarettes to minors, and letters to five major manufacturers demanding they submit plans within 60 days outlining how they would tackle widespread youth access to and use of their products.
The FDA statement said that moving forward it was “indefinitely stepping up enforcement actions with a sustained campaign to monitor, penalise and prevent e-cigarette sales to minors in retail locations including manufacturers’ own internet storefronts.
“The agency is currently exploring action under both its civil and criminal enforcement tools to target potentially violative sales and marketing practices by manufacturers as well as retailers.”
The action prompted a flurry to media coverage, some of it presented below.
FDA investigates if dozens of e-cigarette products are being illegally marketed
The US Food and Drug Administration, in its latest effort to curb youth vaping, is investigating whether dozens of e-cigarette products are being sold illegally, the agency announced, reports Laurie McGinley in the Washington Poston 12 October,
The FDA said it asked 21 manufacturers and importers to provide information about whether more than 40 products were on the market before 8 August 2016. Products introduced or changed after that date must receive FDA clearance before going on sale.
If the FDA determines that the products are being sold illegally, the companies could face fines, seizures or a court order to take them off the market. The move is the agency’s first large-scale action to enforce the requirement that products introduced after the August 2016 date get advance agency clearance, officials said.
In September, FDA Commissioner Scott Gottlieb said youth use of e-cigarettes has become an “epidemic”, and he ratcheted up enforcement actions against retailers.
He also directed leading manufacturers of e-cigarettes to come up with detailed plans for reducing underage use and warned that the agency would consider a possible ban on flavoured e-cigarette products or a prohibition on online-sales of e-cigarettes.
Public health groups urged FDA action
Public health groups have repeatedly urged the agency to take action against what they say are new products that have not received FDA clearance.
In a letter to Gottlieb in August, six health and tobacco-control organisations said that “manufacturers of e-cigarette products have introduced new products at an alarming pace in total defiance of law, with no apparent concern for FDA enforcement”. It noted that one vaping website said that so many new products were being introduced that it was hard to keep up with them.
The letter, whose signers included the American Academy of Pediatrics and the Campaign for Tobacco-Free Kids, added that many of the new products appeared to be trying to capitalise on the success of Juul Labs, whose e-cigarettes have boomed in popularity among young people.
Products under scrutiny
Among the products under scrutiny by the FDA action are Vuse Alto, manufactured by RJ Reynolds Vapor Co; myblu Starter Kit by Fontem US; and Rubi by Kandypens.
The agency said that Juul did not receive a request for information because the FDA recently conducted an unannounced inspection of the company’s corporate headquarters to learn more about its marketing practices.
A spokesman for Reynolds said that the company notified the FDA in May “that we would be making VUSE Alto nationally available and that it was a repackaged and rebranded version of a vapor product that was lawfully marketed in the US as of 8 August 8 2016.”
The agency said that there may be situations in which an e-cigarette product did not appear to be on the market as of 8 Aug 2016, but actually was commercially available and in compliance with the law. For example, a product might have been available but not publicly announced or advertised, or might have had a different name.
In cases where products are being sold illegally, however, “we will take swift action when companies are skirting the law,” Gottlieb said in a statement.FDA investigating whether dozens of e-cigarette products are being illegally marketed
In crackdown, US FDA seeks details on new electronic cigarettes
Faced with a proliferation of new electronic cigarettes and a sharp rise in teen vaping, the US Food and Drug Administration has sent letters to 21 electronic cigarette manufacturers seeking information to assess whether the products are being marketed illegally, wrote Chris Kirkham for Reuterson 12 October.
An FDA rule banned the sale of new e-cigarette products after August 2016 without regulatory approval. In September, Reuters reported that startups and big tobacco firms launched more than a dozen new high-nicotine e-cigarette products mimicking the popular Juul devices after the FDA imposed the deadline.
The agency sent letters to companies including Reynolds American Inc, a unit of British American Tobacco Plc, which makes the Vuse Alto device, asking for evidence that the products were on the market before the August 2016 cutoff.
FDA Commissioner Scott Gottlieb said the agency “will not allow the proliferation of e-cigarettes” being sold without proper approval.
The agency also sent letters to Fontem Ventures, a unit of Imperial Brands Plc, seeking information about its myblu e-cigarettes, as well as smaller companies including Kandypens, Myle Vapor and VGOD.
Shares of British American Tobacco on Friday were down 3.9% and Imperial Brands fell 6% in London.
A spokesman for British American Tobacco said the company will provide to the FDA information to show it is in compliance with the rule. He said the company notified the FDA in May that the product was a “repackaged and re-branded” version of a product that was on the market before August 2016.
A spokesman for Imperial Brands said the myblu products are in compliance with FDA rules, adding that the company will provide the requested documentation soon. Representatives for the other companies did not respond to requests for comment.
If the FDA determines the e-cigarettes were introduced after the August 2016 deadline, companies could face fines or have their products seized from store shelves. Gottlieb said the agency was concerned about sweet flavours in several of the products, which he said are “one of the principal drivers of the youth appeal of e-cigarettes”.
Popular among teens
The FDA has faced increased pressure to act as the sleek Juul e-cigarettes have surged in popularity among US teenagers. Juul Labs Inc’s share of the e-cigarette market rose to more than 70%, up from 13.6% in early 2017, according to a Wells Fargo analysis of Nielsen retail data that does not include online sales.
Juul sales grew from 2.2 million devices sold in 2016 to 16.2 million devices last year, according to the US Centers for Disease Control and Prevention. Many high schools have resorted to locking bathrooms – jokingly called “Juul rooms” by students.
The Juul design mimics a flash drive – with plug-in cartridges of concentrated nicotine juice. It is far more compact than earlier vaping devices and produces less vapor, making it easy to use without being detected – an attribute some health advocates say attracts teenagers.
Juul was on the market before the August 2016 FDA deadline, but other companies have introduced new copycat devices after the cutoff date without regulatory consequences.
Anti-smoking advocates including the Campaign for Tobacco-Free Kids complained about the Juul lookalikes in an August letter to the FDA, saying the companies that had “evaded the review process”.
The FDA has recently cracked down on what it calls an “epidemic” of youth e-cigarette use, threatening last month to ban Juul and four other leading e-cigarette products unless their makers take steps to prevent use by minors.In crackdown, US FDA seeks details on new electronic cigarettes
FDA threatens to ban sales of some new e-cigarette products
Nathaniel Wexel of The Hill wrote that FDA Commissioner Scott Gottlieb has changed his stance on e-cigarettes in recent months. Last spring, the agency loosened regulations on the products. Gottlieb said he wanted to promote innovation of products that were key to helping adults quit smoking traditional cigarettes.
But as vaping among teenagers has skyrocketed, Gottlieb has clamped down. He recently launched a major push to stop e-cigarette sales to minors, accusing manufacturers and retailers of contributing to an “epidemic” of use among kids and teenagers.
Gottlieb has also said he is considering a possible ban on flavoured e-liquids if five of the largest manufacturers can’t come up with adequate steps on their own to keep e-cigarettes out of the hands of those under the age of 18.
“The FDA remains committed to the potential opportunity for e-cigarettes to help adult smokers transition away from combustible cigarettes. But we cannot allow that opportunity to come at the expense of addicting a whole new generation of kids to nicotine,” Gottlieb said in a statement on Friday.
“We’ll take forceful steps to stem the youth use, even if our actions have the unwelcome effect of impeding some opportunities for adults,” he added.
The FDA began regulating e-cigarettes in 2016. The agency’s exemption lets the devices remain on the market until 2022, so long as the companies don’t introduce any new features or flavours.
FDA said it’s received complaints that some companies may be ignoring this, and the letters specifically targeted those companies.
“Given the explosive growth of e-cigarette use by kids, we’re committed to taking whatever measures are appropriate to stem these troubling use trends. We’re going to address issues related to the access kids have to e-cigarettes, as well as the youth appeal of these products,” Gottlieb said.
Juul Labs was not sent a warning letter, as the company was separately subject to a recent unannounced inspection of its corporate headquarters, which sought similar information about its marketing practices. Sales of Juul’s e-cigarette account for nearly one in every three purchases nationwide.FDA threatens to ban sales of some new e-cigarette products
Some e-cigarettes may need to halt sales after latest FDA move
US health officials dialed up their efforts to halt an epidemic of underage electronic-cigarette use, warning tobacco companies including British American Tobacco Plc that their products may be violating the law and could need to come off the market, writes Anna Edney for Bloomberg.
The Food and Drug Administration on Friday sent warning letters regarding 40 e-cigarette products to 21 companies, asking them to prove that they haven’t run afoul of an exemption that let the industry continue selling vaping devices after the agency began regulating them in 2016.
Vaping among teenagers has increased dramatically over the past year, prompting FDA Commissioner Scott Gottlieb to change his stance on devices he has viewed as tools that could help adults quit smoking cigarettes. Last month, Gottlieb told e-cigarette makers to find ways to clamp downon youth use of their products or face curbs on sales of flavored tobacco pods that appeal to children. He has also said he could explore banning online e-cigarette sales.
“Through these actions — and with more to come in the weeks and months ahead — we’re committed to doing all we can to reverse the disturbing trends of youth tobacco use, especially e-cigarettes,” Gottlieb said. “I’ll do everything I can to curb the epidemic of youth use.”
Congress gave the FDA the authority to regulate tobacco products in 2009, and the agency extended that oversight to e-cigarettes in 2016. The agency has permitted companies to continue selling only vape devices that were on the market prior to Aug. 8, 2016, while preparing applications for the agency to review the products by 2022. The FDA is concerned that some may have new features, flavours or formulations that disqualify them from the carve-out.
The letters sent on Friday target companies that may have introduced new flavours or altered their product in ways that violate the exemption. They include Logic Technology Development and Fontem US Inc.
Juul Labs Inc, the maker of the most popular vaping product among teens, didn’t receive a letter. The FDA conducted a surprise inspection of Juul’s headquarters in San Francisco last month and seized documents that could help determine whether the company violated the exemption.
Anti-tobacco and health-advocacy groups including the American Heart Association and the Campaign for Tobacco-Free Kids sent Gottlieb a letter in April accusing Juul of introducing its mango and cool cucumber flavors in 2017.
The FDA confirmed that youth vaping jumped 75% in the past year as teens were increasingly drawn to Juul. In 2017, more than 2 million middle- and high-school students used e-cigarettes, according to the Centers for Disease Control and Prevention.Some E-Cigarettes May Need to Halt Sales After Latest FDA Move
FDA SATEMENT: FDA advances investigation into whether more than 40 e-cigarette products are being illegally marketed and outside agency’s compliance policy
In a press release on 12 October, the FDA said it sought more information from companies as it continued to pursue its Youth Tobacco Prevention Plan amid evidence of sharply rising e-cigarette use among kids. The release carried by PRNewswire said:
The FDA sent letters to 21 e-cigarette companies, including the manufacturers and importers of Vuse Alto, myblu, Myle, Rubi and STIG, seeking information about whether more than 40 products – including some flavored e-cigarette products – are being illegally marketed and outside the agency’s current compliance policy, the FDA said in a press release on Friday 12 October.
These new actions build on those taken by the FDA in recent weeks as part of its Youth Tobacco Prevention Plan to address the epidemic of youth e-cigarette use, including cracking down on the sale and marketing of e-cigarettes to kids and educating youth about the dangers of using these products.
“Companies are on notice – the FDA will not allow the proliferation of e-cigarettes or other tobacco products potentially being marketed illegally and outside of the agency’s compliance policy, and we will take swift action when companies are skirting the law,” said FDA Commissioner Scott Gottlieb, MD.
“Given the explosive growth of e-cigarette use by kids, we’re committed to taking whatever measures are appropriate to stem these troubling use trends. We’re going to address issues related to the access kids have to e-cigarettes, as well as the youth appeal of these products.
“If products are being unlawfully marketed and outside the FDA’s compliance policy, we’ll act to remove them. This includes revisiting our compliance policy that has resulted in certain e-cigarettes, including flavored e-cigarettes, remaining on the market until 2022 while their manufacturers submit applications for premarket authorization.
“Further, many of these products pose particular concerns given their use of flavors. We know flavors are one of the principal drivers of the youth appeal of e-cigarettes and we’re looking carefully at this,” said Gottlieb.
“The FDA remains committed to the potential opportunity for e-cigarettes to help adult smokers transition away from combustible cigarettes. But we cannot allow that opportunity to come at the expense of addicting a whole new generation of kids to nicotine.
“We’ll take forceful steps to stem the youth use, even if our actions have the unwelcome effect of impeding some opportunities for adults. These are the hard tradeoffs we now need to make.
“We’ve been warning the e-cigarette manufacturers for more than a year that they need to do more to stem the youth use. No reasonable person wants to see these products reaching epidemic use among kids.
“Retailers and manufacturers of e-cigarettes know that the FDA is aggressively enforcing the law to ensure they are complying with prohibitions against marketing and selling to kids. “Through these actions – and with more to come in the weeks and months ahead – we’re committed to doing all we can to reverse the disturbing trends of youth tobacco use, especially e-cigarettes. I’ll do everything I can to curb the epidemic of youth use.”
As part of the FDA’s comprehensive plan on tobacco and nicotine regulation, the agency implemented a new compliance policy related to the deadline for companies to submit tobacco product review applications for “deemed” tobacco products that were on the market as of 8 August 2016 – the effective date of the final deeming rule that extended the FDA’s authority to additional tobacco products such as e-cigarettes.
The compliance policy provided manufacturers additional time to develop higher quality, more complete applications. The extension of the compliance date also aimed to give the agency more time to explore clear and meaningful measures to make tobacco products less toxic, appealing and addictive. These measures, which will focus on protecting youth, could include an examination of flavors/designs that appeal to children, child-resistant packaging and product labeling to prevent accidental child exposure to liquid nicotine.
Since this extension, the FDA has received complaints that some companies may be marketing new products that do not meet the Food Drug and Cosmetic Act’s (FD&C Act) premarket requirements and that were introduced or modified after the deeming rule’s 8 August 2016, effective date. Such modifications could include the introduction of new product features, formulations or flavors.
The letters issued today ask companies to provide information about the products in question, including evidence that the product is a deemed product that was on the market as of 8 August 2016 and has not been modified since that date.
JUUL Labs Inc. did not receive such a letter, as the company was separately subject to a recent unannounced on-site inspection of its corporate headquarters, which sought similar information about its marketing practices.
Any product that does not comply with the premarket requirements of the FD&C Act is adulterated and misbranded and may not be marketed without authorization from the FDA. The agency has several tools to enforce the requirements of the FD&C Act and regulations, including pursuing administrative actions such as civil money penalty complaints (fines) or judicial actions such as seizures or injunctions.
Although it may appear that a deemed tobacco product, such as an e-cigarette, was not on the market as of 8 August 2016, there are situations where this may not be the case. In some instances, it could be that products are, in fact, in compliance with the FDA’s current policy. For example, a product may have been commercially available and on the market as of 8 August 2016, but the company may not have publicly announced or advertised its product until recently. Additionally, a company may have been selling the same tobacco product under a different name as of 8 August 2016, but is now promoting it as “new” because of its re-branding, or it may have been purchased from another company and re-released with a different name by the new company.
In order to more easily clarify these situations, manufacturers may want to consider maintaining easily accessible evidence on the marketing status of each of their products at their facility. Doing so would benefit all parties at the time of an inspection and could also be included in future correspondence with the FDA.
FDA actions crack down on illegal e-cigarettes sales to youth
The 21 letters announced today are part of series of actions over the past several months to target the illegal sales of e-cigarettes to youth more immediately, as well as to target the kid-friendly marketing and appeal of these products.
In particular, the FDA recently announced a series of critical and historic enforcement actions that included issuing more than 1,300 warning letters and fines to retailers who illegally sold JUUL and other e-cigarette products to minors during a nationwide, undercover blitz of brick-and-mortar and online stores this summer – the largest coordinated enforcement effort in the FDA’s history.
Moving forward, the FDA is indefinitely stepping up enforcement actions with a sustained campaign to monitor, penalize and prevent e-cigarette sales to minors in retail locations including manufacturers’ own internet storefronts. The agency is currently exploring action under both its civil and criminal enforcement tools to target potentially violative sales and marketing practices by manufacturers as well as retailers.
The agency also recently issued letters to five major e-cigarette manufacturers whose products – JUUL, Vuse, MarkTen, blu e-cigs and Logic – comprise more than 97% of the market share for closed system ENDS products. These letters asked the firms to submit to the FDA within 60 days plans describing how each firm will address the widespread youth access and use of its products.
In addition, the FDA also recently stated it will consider whether it would be appropriate to revisit the current policy that results in certain deemed products remaining on the market without a marketing order from the agency. This could mean requiring companies to remove some or all of their flavored products, which may be contributing to the rise in youth use, from the market, until they receive premarket authorization and otherwise meet all of their obligations under the law.
“The Real Cost” campaign
The agency also recently launched “The Real Cost” Youth E-Cigarette Prevention Campaign. This is a new, comprehensive effort targeting nearly 10.7 million youth, aged 12-17, who have used e-cigarettes or are open to trying them. The new campaign features hard-hitting advertising on digital and social media sites popular among teens, as well as posters with e-cigarette prevention messages in high schools across the nation.
As part of the FDA’s comprehensive plan on tobacco and nicotine regulation, the agency also issued an advance notice of proposed rulemaking in March to seek public comment on the role that flavors in tobacco products play in attracting youth.
The FDA intends to expedite the review and analysis of the comments so it can leverage the information into policy as quickly as possible, should the science support further action. Additionally, the agency plans to explore additional restrictions on the sale and promotion of electronic nicotine delivery systems to further reduce youth exposure and access to these products.FDA advances investigation into whether more than 40 e-cigarette products are being illegally marketed and outside agency’s compliance policy
Media reports and statementsFDA investigating whether dozens of e-cigarette products are being illegally marketed
In crackdown, U.S. FDA seeks details on new electronic cigarettes
In crackdown, US FDA seeks details on new electronic cigarettes
FDA threatens to ban sales of some new e-cigarette products
FDA advances investigation into whether more than 40 e-cigarette products are being illegally marketed and outside agency’s compliance policy
See alsoFDA seizes Juul e-cigarette documents in surprise inspection of headquarters