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FDA needs to do better at policing online tobacco retailers, new report says

E-cigs market to teens using big tobacco tactics


The US Food and Drug Administration is falling down on the job of policing online tobacco retailers, according to a highly critical new report from the US Department of Health and Human Services’ Office of Inspector General.

The report criticizes the FDA for its lack of oversight, saying that children’s use of tobacco remains of “high concern” and that online sales are a potentially easy way for kids to buy tobacco products without having to verify their ages.

In 2022, nearly 17% high school students – or more than 2.14 million high schoolers – reported that they currently used e-cigarettes, according to the US Centers for Disease Control and Prevention.

And research shows that almost all kids have easy access to the internet. About 95% of those ages 13 to 17 report having, or having access to, a smartphone. Close to half of those polled report using the internet on a “near-constant basis.”

The new report is based on summary data from 2010 through 2020 as well as interviews with officials, written responses from the agency and information available on its public website.

In a memo to the Inspector General’s Office in response to the report, Beethika Khan, the FDA associate commissioner for economics and analysis, wrote that her agency’s online tobacco surveillance program is “flexible” and has played “a major role in supporting FDA’s highest tobacco enforcement priorities.”

Of the 16,511 online tobacco websites that the FDA flagged for review between 2010 and 2020, the agency sent warning letters to 899 of them, yet the Inspector General’s report says that the agency took not a single enforcement action against those retailers. The FDA has the legal authority to fine retailers, among other punishments like criminal prosecution and seizing tobacco products.

The warning letters it sent most often cited retailers for advertising and labeling violations, the report says.

“It is unclear to what extent FDA conducted additional oversight of these online tobacco retailers at later dates and found subsequent violations that could result in FDA taking enforcement actions,” the report says.

In some cases, the FDA didn’t send warning letters when they may have been appropriate, the report says. For example, the FDA surveillance program took note of 400 online domestic retailers selling Ends products. There were 30 high-volume retailers that sold flavored cartridges, which are illegal, yet the FDA sent letters to only 19.

The report also notes that the FDA has failed to complete the rule-making process for online tobacco sales despite a deadline of 2011, more than a decade ago.

The Bureau of Alcohol, Tobacco, Firearms and Explosives, commonly known as ATF, requires tobacco product retailers to register with the agency, but the FDA has failed to work with ATF to get access to that information, according to the report. The FDA does share information on investigations, however.

While it can be difficult to police online retailers due to the sheer volume and the internet’s “wild West” nature, as one FDA official described it in the report, it says the FDA could do better by collaborating more closely with ATF on the oversight of these online retailers.

The report recommends that the FDA finish making rules about online sales, as it was supposed to do years ago, and collect data about its oversight of online retailers.

When the Inspector General asked, the FDA was not able to determine how many investigations of online retailers it’s done, saying that its investigations are just one tool that it uses to control kids’ access to tobacco.

The Inspector General’s report says the FDA should increase transparency of its investigations so parents and other interested parties can better understand what it’s doing to keep kids safe online.

In response to the report, the FDA agreed that there may be additional opportunities to collaborate with ATF and promised to explore them.

The FDA also agreed about the need for transparency and promised that by March, it will create a dedicated website to offer more information about its efforts.

The agency did not make any promises to develop rules about online tobacco sales but said that other laws and requirements may achieve the same ends.

The FDA also did not make any promises about data collection but said it would explore ways to “maximize transparency without jeopardizing investigations.”

Erika Sward, assistant vice president of national advocacy for the American Lung Association, said it is important to keep in mind that this report was done under a former director of the FDA’s tobacco program and that she has started to see positive changes in terms of enforcement under the program’s new leadership. Dr. Brian King was appointed director of the Center for Tobacco Products in July.

Also in July, FDA Commissioner Dr. Robert Califf announced that he had commissioned a review of the agency’s tobacco program, as well as its work regulating food. The independent review of the tobacco program is due to Califf by December 19.

What stood out to Sward in the report was the FDA’s lack of follow-up beyond warning letters to online retailers.

“The IG report underscores the significant and serious challenges that the Center for Tobacco Products has had with enforcement,” Sward said.

The tobacco industry is unlike any other in the FDA’s purview, Sward said. Although drug companies and other regulated industries may adhere to any sort of letter from the agency, it will probably take more aggressive action to move the tobacco industry.

“It’s not enough to send a letter. They have to be willing to follow up,” Sward said. “Unless FDA is willing to put some teeth behind it – and that could involve ATF or other parts of [the US Department of Justice] – we really need the law enforcement component to come in and pursue these manufacturers or retailers when they continue their illegal behaviors and actions.”

Supreme Court refuses request to block California flavored tobacco ban

WASHINGTON (AP) — The Supreme Court on Monday refused a request from tobacco companies to stop California from enforcing a ban on flavored tobacco products that was overwhelmingly approved by voters in November.

R.J. Reynolds and other tobacco companies sought the high court’s intervention to keep the ban from taking effect by Dec. 21.

There was no additional comment from the justices and no noted dissents.

The ban was first passed by the state legislature two years ago but it never took effect after tobacco companies gathered enough signatures to put it on the ballot. But nearly two-thirds of voters approved of banning the sale of everything from cotton-candy vaping juice to menthol cigarettes.

Supporters of the ban say the law was necessary to put a stop to a staggering rise in teen smoking.

R.J. Reynolds filed a federal lawsuit filed the day after the Nov. 8 vote, but lower courts refused to keep the law on hold while the suit proceeds.

Menthol cigarettes make up about a third of the market in California, the companies said in urging the Supreme Court to keep them from losing so much business in the nation’s largest state.

They argued that the authority to ban flavored products rests with the federal Food and Drug Administration.

California responded that federal law comfortably allows state and local governments to decide which tobacco products are to be sold in their jurisdictions. And the state noted that the companies only went to the Supreme Court after spending “tens of millions of dollars” in a losing cause at the polls.

California will be the second state in the nation, after Massachusetts, to enact a ban prohibiting the sale of all flavored tobacco products. A number of California cities, including Los Angeles and San Diego, have already enacted their own bans, and several states have outlawed flavored vaping products. So far no legal challenges to those bans have prevailed, but the companies have an appeal pending at the high court in their fight with Los Angeles.

It’s already illegal for retailers to sell tobacco to anyone under 21. But advocates of the ban said flavored cigarettes and vaping cartridges were still too easy for teens to obtain. The ban doesn’t make it a crime to possess such products but retailers who sell them could be fined up to $250.

In addition to menthol and other flavored cigarettes, the ban also prohibits the sale of flavored tobacco for vape pens, tank-based systems and chewing tobacco, with exceptions made for hookahs, some cigars and loose-leaf tobacco.

Yes on 31 Campaign Declares Victory for California over Big Tobacco

New Law Will Protect Kids from Candy-Flavored Tobacco, Reduce Smoking Rates, Save Taxpayer Money and Save Lives

Sacramento, CA – Shortly after polls closed on Tuesday evening, the YES on Prop 31 campaign declared victory over Big Tobacco in the fight to end the sale of candy-flavored products, including minty-menthol cigarettes. The California legislature overwhelmingly voted to support the end of flavored tobacco with Senate Bill 793 in 2020; and with voters now affirming that decision on the ballot, California is poised to save billions of dollars in future tobacco-related healthcare costs and save countless lives from a future of nicotine addiction and smoking-caused death.

The broad coalition of public health advocates, doctors, and parents supporting Prop 31 released the following statements:

“In California’s battle against Big Tobacco, voters have overwhelmingly decided to protect kids from being lured into a lifetime of addiction to nicotine,” said Lindsey Freitas, Regional Advocacy Director, Campaign for Tobacco-Free Kids. “By stopping tobacco companies from using candy flavors to hook another generation of kids, Proposition 31 will save countless lives in the years to come. And it sets a powerful example for other states and cities, as well as the FDA, which has proposed nationwide regulations prohibiting menthol cigarettes and flavored cigars.”

“California voters have sent a resounding message that Black lives matter,” said Carol McGruder, Co-Chair of the African American Tobacco Control Leadership Council. “Ending the sale of menthol cigarettes and flavored tobacco products will save countless Black lives in California in the decades to come.”

“Tobacco use remains the leading preventable cause of cancer and cancer deaths. And flavors are the main reason youth use tobacco products and mistakenly perceive them as less harmful,” said Jim Knox, Managing Director, American Cancer Society Cancer Action Network (ACS CAN). “With their vote, Californians have blocked Big Tobacco’s deplorable attempt to keep targeting kids and communities of color with fruit- and candy-flavored products; they have taken a critical step towards reducing tobacco use, promoting health equity and ending cancer as we know it, for everyone.”

“Proposition 31 is California’s antidote to the candy-flavored poison Big Tobacco has been peddling to our kids and communities of color,” said Fmr. Senator Jerry Hill, author of SB 793. “With the implementation of Prop 31 comes a strong layer of protection against tobacco companies’ ability to lure kids into smoking and a lifetime of addiction to nicotine; and Californians will live longer, healthier lives as a result.”

“California voters had their say, and they rejected Big Tobacco’s devious attempt to repeal a law that will protect public health and save lives,” said Kathy Rogers, executive vice president, American Heart Association, Western States. “We’re grateful for the strong coalition of organizations and volunteer advocates who came together to make this victory possible.”

“We are pleased California voters have voted in favor of Proposition 31, allowing a statewide ban on flavored tobacco to go into effect,” said Senior Vice President and Chief Health Officer Bechara Choucair, M.D. “Taking flavored e-cigarettes off the shelves will support the work Kaiser Permanente does every day to keep kids away from tobacco. It also marks the end of a decades-long, unjust targeting of African American communities in California with promotion of highly addictive mint and menthol cigarettes.”

“California’s parents are thrilled by this resounding win for our children, and this huge defeat for Big Tobacco,” said Meredith Berkman, Co-Founder, Parents Against Vaping e-Cigarettes (PAVe). “By ending the sales of all flavored tobacco products, California-only the second state to do so-sends a clear message to the tobacco industry that America’s parents will not allow the insidious use of flavors and other predatory marketing tactics to continue.”

“Once again, Californians resoundingly voted in support of protecting kids and standing up to Big Tobacco,” said Harold Wimmer, President and CEO of the American Lung Association. “With Yes on 31 passing, California will finally be able to implement its strong flavored tobacco law. We call on states and localities nationwide to continue to pass comprehensive laws to end the sales of all flavored tobacco products, including menthol cigarettes and e-cigarettes, and for the FDA to quickly move forward to finalize its rules on menthol cigarettes and flavored cigars.”

Evidence-Based Point-of-Sale Policies to Reduce Youth Tobacco Use in North Carolina

Sarah M. Halvorson-Fried, Alexandria E. Reimold, Sarah D. Mills, Kurt M. Ribisl

Many states and localities in the United States are implementing evidence-based tobacco control policies at the retail level, including Tobacco 21 laws, tobacco retailer licensing, restrictions on point-of-sale promotions, and bans on flavored tobacco products. With the passage of new point-of-sale tobacco control policies, North Carolina could reduce youth tobacco use rates.


While cigarette smoking among North Carolina youth has steadily decreased over time, e-cigarette use has increased dramatically [1]. According to the North Carolina Youth Tobacco Survey, self-reported e-cigarette use increased 510% for middle schoolers and 1129% for high schoolers from 2011 to 2019 [1]. Compared to 5.7% of high schoolers and 2.4% of middle schoolers reporting cigarette smoking, 20.9% of high schoolers and 6.1% of middle schoolers reported e-cigarette use in 2019 [1]. This rise in e-cigarette use offsets declines in smoking, stagnating progress in reducing youth tobacco use. As North Carolina continues to work to prevent youth tobacco use and eliminate tobacco-related health disparities, key state-level policy changes would bolster the effectiveness of tobacco control efforts. In this commentary we describe the evidence base for point- of-sale policies, including Tobacco 21 laws, restrictions on advertising and promotion, flavored tobacco product bans, tobacco retailer licensing, and repealing preemption.

Tobacco 21

Both projections and real-world studies show that raising the minimum legal age for tobacco sales from 18 to 21 (“Tobacco 21” or “T21”) reduces tobacco use among youth and young adults, with substantial long-term impacts expected for related health outcomes [2, 3]. Prior to the federal enactment of T21 in 2019, a 2015 Institute of Medicine (IOM) report estimated that a national T21 law would decrease cigarette smoking initiation by 25% for those aged 15-17 and by 15% for those younger than 15 or aged 18-20 [2]. Since adolescents frequently obtain tobacco products from social sources (e.g., classmates or older siblings), creating a larger distance between legal access and younger peer groups reduces opportunities for tobacco use initiation [2].

Because 95% of adults who use tobacco begin before age 21 [4], the IOM report predicted that T21 would reduce tobacco use not only in the short term but also over time [2]. Projections indicated that smoking prevalence would decrease by 12% by the time current teenagers became adults [2]. Decreased smoking prevalence would lead to “substantial reductions in smoking-related mortality” and long-term improvements in health outcomes related to other tobacco use, secondhand smoke, and pregnancy [2]. The IOM projected that enacting T21 nationwide in 2015 would have resulted in approximately 249,000 fewer premature deaths among people born between 2000 and 2019 [2].

A recent evaluation found that from 2009 to 2019, state-level T21 policies reduced cigarette smoking among young adults (aged 18–20 years) by 2.5%–3.9% [3]. Among 18-year-old high-school students, these policies reduced smoking by 3%–7% and e-cigarette use by 6%–12% [3]. The laws also had spillover effects, reducing cigarette use among youth (aged 16–17 years) and marijuana and alcohol use among young adults [3].

As of December 2019, it is illegal under federal law to sell nicotine or tobacco products to anyone under age 21 [5]. Although this law applies to all retailers in the United States, complementary state and local laws are important for policy implementation and enforcement [6]. Compliance with T21 is necessary for states to receive “Synar funding” from the Substance Abuse and Mental Health Services Administration [7]. North Carolina risks losing this federal funding for substance abuse prevention, treatment, and recovery efforts if 20% or more of randomly sampled tobacco retailers are found to be in violation of the T21 law [7]. Complementing the federal law, state-level T21 policies provide state agencies with greater control over enforcement activities to keep states in compliance with Synar provisions [7].

In addition, state and local policies are useful for codifying best practices. For example, a state-level law should ban retailers from selling tobacco products instead of criminalizing possession among underage youth, a key recommendation included in a model policy produced by the Campaign for Tobacco-Free Kids, American Heart Association, American Cancer Society, Public Health Law Center, American Lung Association, and others [6]. Other best practices include imposing a structure of civil rather than criminal penalties for retailers, and defining products covered by the T21 law to include all current and future tobacco products, including e-cigarettes [6]. A broad definition of tobacco products is important given the high prevalence of e-cigarette use among middle and high schoolers and the potential for new product development by the tobacco industry [1].

T21 policies have been among the most rapidly adopted tobacco retail control policies and have widespread public support [8], including from tobacco companies and retailers [9, 10]. Nineteen US states had T21 policies in place before federal enactment and 21 more states passed state policies after the nationwide law [11]. Should North Carolina follow the other 40 states in adopting T21, it is important that the new law follow the best practices noted here. In addition, the law should include provisions related to enforcement. Specific provisions include requiring age verification and signage indicating age regulations, designating authority for—and requiring a minimum number of—compliance checks, and creating a licensing agency for tobacco retailers [6].

Point-of-Sale Advertising and Promotion

Tobacco advertising is associated with increased tobacco initiation for youth and increased use for both adults and adolescents [12]. Existing policies prevent tobacco companies from advertising in outdoor settings, on billboards, on public transportation, and on television and radio. As a result, tobacco companies have funneled the majority of current advertising expenditures to the point of sale (POS) at retail outlets [13]. A recent analysis of tobacco advertising expenditures found that, in the United States, tobacco industry spending on POS advertising and promotions grew exponentially beginning in the 1990s and is now an astonishing 98% of the advertising budget [13]. Price promotions at the POS that lower the price of tobacco products, or give them away for free, supplement advertising as a marketing activity designed to stimulate purchasing behavior [14].

Exposure to tobacco advertising and promotions at the POS is associated with increased youth tobacco use [14]. Among adolescents who do not smoke, increased exposure to tobacco industry advertising and price promotions is associated with increased susceptibility to smoking during adolescence and increased smoking behavior later in life [14]. Furthermore, in a survey of young adult smokers, roughly one in three reported that frequent exposure to tobacco advertising made it difficult to quit [15]. Individuals who identified advertising as a barrier to quitting were also more likely to report purchasing cigarettes once they were in a store without planning to do so beforehand [15].

The tobacco industry targets advertising and promotional efforts toward historically marginalized groups. For example, neighborhoods with a higher percentage of Black residents are more likely to have tobacco retailers with advertising, price promotions, and cheaper prices for menthol cigarettes [16]. This may be due, in part, to predatory contracts designed to promote menthol products in predominantly Black neighborhoods in urban areas [17].

Localities and states are working to address POS tobacco advertising and promotion. For example, Providence, Rhode Island, passed a regulation in 2012 that restricted discounting of tobacco products and banned multipack offers (e.g., “buy-one-get-one”) [18]. In 2020, New York State barred tobacco retailers from offering or redeeming price discounts for tobacco and vapor products and prohibited exterior tobacco advertisements within 1500 feet of schools (500 feet in New York City) [19]. In 2021, St. Paul, Minnesota, also passed a regulation that comprehensively prohibits price discounting on all tobacco products, including vape products [20].

Menthol and Other Flavored Tobacco Bans

In 2021, 79.1% of youth tobacco users in the United States used a flavored product [21]. The United States Food and Drug Administration proposed rules in May 2022 to ban the sale of menthol cigarettes and flavored cigars in response to research demonstrating the public health benefits of banning flavored combustible tobacco products [22]. Among adults, approximately one-third of cigarette smokers use menthol cigarettes, the only remaining flavored cigarette on the market, and half of cigar users use flavored products [23, 24]. Flavors are added to tobacco products to improve their taste and reduce the harshness of smoke on the throat, which facilitates smoking initiation [25]. Studies indicate that flavored tobacco products also inhibit smoking cessation [25]. Banning flavored tobacco products would therefore not only reduce smoking initiation among youth but would also increase quit rates among smokers [25, 26]. A study simulating a ban on menthol cigarettes and flavored cigars in the United States projected a 15% decline in cigarette smoking in just five years [26].

As is typical in the field of public health, local communities have led the way in regulating flavored tobacco products [27]. To date, four states and more than 150 localities restrict the sale of menthol cigarettes or other flavored tobacco products [27]. Given that North Carolina’s rates of cigarette use among both youth and adults are higher than the national average, a ban on flavored tobacco products would have great public health benefits in the state [28].

Banning the sale of flavored tobacco products in North Carolina would also advance health equity. The tobacco industry’s targeted marketing of menthol cigarettes to Black communities increases appeal and accessibility of the product and contributes to the disproportionate burden of tobacco-related disease and mortality within Black populations [29]. In 2018, 85% of Black individuals, 50% of Hispanic individuals, 47% of Asian individuals, and 35% of American Indian, Alaska Native, Native Hawaiian, or Other Pacific Islander individuals who smoked preferred menthol cigarettes, compared to 29% of white individuals who smoked [30]. A menthol cigarette ban would help reduce the existing Black-white disparity in lung cancer, cardiovascular disease, diabetes, and other tobacco-related health outcomes in North Carolina by reducing smoking prevalence among Black individuals, who use menthol cigarettes at the highest rates [30–32].

Tobacco Retail Licensing

A tobacco retail license—a permit to lawfully sell tobacco products—requires the retailer to comply with conditions of operation or risk license suspension [33]. Tobacco products are the most lethal products sold in the United States, which is why most states license their tobacco product retailers. However, North Carolina does not require a retail license to sell tobacco products and even preempts, or bans, local communities from allowing local licensing regulations.

Retail licensing is sometimes called the “Swiss Army knife of tobacco control,” given its remarkable flexibility. Licensing typically includes the requirement to avoid selling tobacco products to those under the minimum legal age. If a store sells to a minor, the proprietor may be warned and reinspected [34]. If the store sells on a second or third inspection, their license may be revoked immediately or not renewed after the current license period. Bans on the sale of candy- and fruit-flavored tobacco products are often implemented through licensing restrictions, as are caps on the total number of retailers and bans on sales of tobacco products near schools [33].

Licensing provides a regular source of funding for enforcement efforts and a list of retailers to make it easier for enforcement officials to know where to visit for compliance inspections [33]. Currently, when local or state entities in North Carolina enforce youth access laws, they do so with their own resources. In other words, without funding provided by a licensing system, the government is subsidizing the costs associated with enforcing regulations governing the sale of tobacco products at private businesses.


Preemption laws in North Carolina make it difficult for local jurisdictions to make progress toward addressing youth tobacco use rates through the evidence-based policies described here. Preemption laws limit the power of local governments to pass local tobacco control policies sought by policy-makers and constituents. Preemption also releases potential pressure on the state government to adopt pervasive local policies [35]. Continuation of North Carolina’s 1993 preemption policy stifles tobacco control efforts by limiting localities’ ability to pass evidence-based tobacco regulations [36]. Without preemption, local governments can lead the way in future tobacco control and prevention efforts.


Progress in reducing youth tobacco use has stagnated due to the meteoric rise in e-cigarette use over the past decade. Reducing youth tobacco use would lead to lower rates of tobacco-related chronic disease and improvements in health on a population level. State and local T21 laws, point-of-sale advertising and promotion regulation, and regulation of flavored tobacco products can reduce youth tobacco use and enhance health equity in North Carolina. A tobacco retail licensing system is needed to help implement and properly enforce these policies. Finally, repealing preemption is necessary to allow local jurisdictions to pass new tobacco control laws as innovative policy solutions are developed. NCMJ


Disclosure of interests. Dr. Ribisl is a paid expert scientist in litigation against e-cigarette and tobacco companies. No further interests were disclosed.

©2022 by the North Carolina Institute of Medicine and The Duke Endowment.. All rights reserved.


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PTAF Statement About F.D.A. Tobacco Science Official Takes Job at Philip Morris

For those of you familiar with our five-year, frustrated effort to work with the FDA about enforcement against underage nicotine sales, including even a strongly worded letter from the unique pairing of Senators Mitch McConnell and Tim Kaine, it comes as no real surprise that the nicotine industry has deep reach into the agency.

The departure of FDA’s Center for Tobacco Products (CTP) second in command for an immediate job with Phillip Morris gives a more public perspective of the actual function of this powerful body, one that has oversight of the production, marketing and sales of all nicotine and tobacco products.

What many had believed to be mere bureaucratic ineptitude, fear of litigation and governmental foot-dragging that rendered the Agency so incredibly ineffective in controlling the epidemic of adolescent nicotine addiction, now takes on a more sinister aspect.

Matt Holman, the departing official, was largely responsible for pushing the industry’s debunked “harm reduction” narrative in support of continued sale of e-cigarettes and similar products.  Not only did the agency sit idly by while millions of American kids habituated to vaping, it even gave an FDA stamp of approval over several products of dubious value.

Yesterday’s New York Times article offers several insights.  Best of all is our board member, Micah Berman’s quote that was so spot-on that I simultaneously grimaced and chortled so loudly that it disturbed my son sleeping in the next room.

“It is embarrassing for the F.D.A., which sees itself as a public health agency, to have its employees go to a company that is a leading manufacturer of death,” said Micah Berman, an associate professor of public health and law at Ohio State University.

A more in-depth discussion of the history of the FDA’s flawed evaluations of e-cigarettes and “heat-not-burn” products is in yesterday’s excellent blog post by Stan Glantz.

An appropriate latin corruption: illegitimi non carborundum,

Rob Crane, MD

Board President, Preventing Tobacco Addiction Foundation