Food and Drug Administration Defends Refusal To Approve Flavored E-Cigarettes Before the Supreme Court

The Supreme Court heard the Food and Drug Administration’s (FDA) appeal in Food and Drug Administration v. Wages and White Lion Investments, LLC on Monday. The case concerns the FDA’s requirement for scientific studies to approve premarket tobacco applications (PMTAs) for flavored electronic cigarette (e-cigarette) manufacturers and distributors. The FDA’s requirement contradicts data and years of its own guidance for the end of reducing an exaggerated epidemic of underage nicotine use.

Concerns about rampant teen nicotine use are common. They are also commonly exaggerated. NPR originally claimed that “the percentage of high school kids who reported daily vaping of e-cigarettes jumped from 9.7% in 2014 to 30% in 2023.” (The outlet has since printed a correction.) What the FDA and CDC’s 2023 National Youth Tobacco Survey actually said was that 29.9 percent of high schoolers currently using e-cigarette were daily users; only 10 percent of all high schoolers were current users, (down from 14.1 percent in 2022), 90.3 percent of whom used flavored products. If “e-cigarettes have filled the vacuum” left by smoking, as former FDA deputy commissioner William Schultz says to NPR, the vacuum is not as large as people are led to believe.

The 2024 National Youth Tobacco Survey shows that this figure has fallen even further: from 10 percent to 7.8 percent. E-cigarettes have become increasingly unpopular with middle school and high school students despite sales increasing 47 percent from 2019 to 2023. More than 80 percent of this is attributable to flavored products, according to data from the CDC Foundation and Truth, a nonprofit public health organization committed to preventing youth nicotine addiction.

E-cigarettes are not the only product inappropriate for consumption by middle schoolers and high schoolers, alcohol is too. Despite the popularity of Pink Whitney, Fireball, Mike’s Hard Lemonade, and other sugary, colorful alcoholic drinks among high schoolers, federal regulators allow these products to be manufactured and distributed. The prohibition of such goods to adults would be unwarranted, not to mention infeasible. Nonetheless, the paternalistic Family Smoking Prevention and Tobacco Control Act of 2009, which grants the FDA the authority to regulate tobacco and nicotine products, restricts what kinds of tobacco products adults may consume.

The Act explicitly “prohibits a cigarette or any of its components from containing…any artificial or natural flavor (other than tobacco or menthol) or any herb or spice (including strawberry, grape, orange, clove, cinnamon, and vanilla.” The law also directs the Secretary of Health and Human Services of the FDA to establish the Center for Tobacco Products and to, among various responsibilities, “develop an action plan to enforce restrictions on the promotion and advertising of menthol and other cigarettes to youth.”

But the Act also “prohibits the secretary from: imposing unduly burdensome requirements” on manufacturers and importers. This provision is problematic for the FDA’s wholesale denial of PMTAs to flavored nicotine products. In the Fifth Circuit’s January 2024 opinionJudge Andrew Oldham explains that the FDA “sent manufacturers of flavored e-cigarette products on a wild goose chase” by imposing new testing requirements after “promulgat[ing] hundreds of pages of guidance documents” between 2018 and 2020.

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Iowa vaping bill draws opponents from retailers, health care groups

An Iowa bill that would add requirements to manufacturers of vaping and e-cigarette products has two surprising allies standing together in opposition: vape shops and health care organizations.

House Bill 682 and its companion legislation, Senate File 2402, would require vaping manufacturers who sell products in the state to include them on a new registry. The registration fee is $100 per product. Retailers could only sell products listed on the registry.

David Scott of Altria, a manufacturer of tobacco and related products, said the bill does not prohibit the sale of any legal product. What the bill does is prevent illegal products from overseas.

“China have over 50% of the (products) that are illegal,” Scott told a House Ways and Means subcommittee this week. “Three out of the five youth brands are illicit but they are still being brought in.”

The Food and Drug Administration created a similar registry on the federal level. In January, the 5th U.S. Circuit Court of Appeals ruled that the FDA’s decisions were made arbitrarily and capriciously and that the agency should reconsider its guidelines. Scott said the FDA admits it doesn’t have the resources to monitor the products.

“If you are not on the directory, the FDA has no idea what the ingredients are in your vape,” Scott said. “They have no control of your marketing and we have no idea of the manufacturing process.

Iowa is one of 23 states considering bills that would require a vaping product registry, according to Consumer Advocates for Smoke-free Alternatives Association, an organization opposing the bills.

Sarah Linden, owner of Generation V in Council Bluffs and Davenport, told the subcommittee that the bill would put a strain on her business.

“It would eliminate 99% of the vapor products on the market,” Linden said. Retailers said vape users will find other ways to get their product if it is unavailable in their stores.

Retailers have an unlikely ally in health care organizations. The American Cancer Society is listed as “against the bill” in lobbyist declarations. The American Heart Association is undecided. CAFE Iowa Citizens Action Network, an organization that advocates for tobacco control policies to reduce its use, is also against the bill.

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Remember the Teen Vaping ‘Epidemic’?

Remember the “epidemic” of underage nicotine vaping? For years, activists, politicians, and public health officials have been warning that a surge in e-cigarette use by teenagers would hook a generation of young people on nicotine and encourage them to smoke.

That never happened, as new federal survey data confirm. But policies adopted in response to that overblown threat continue to undermine the harm-reducing potential of vaping products by making them less attractive to current and former smokers.

According to the latest National Youth Tobacco Survey, which is overseen by the Centers for Disease Control and Prevention (CDC), 10 percent of high school students reported past-month e-cigarette use in 2023, down from 14 percent last year and more than 27 percent in 2019. Among middle school students, the 2023 rate was 4.6 percent, less than half the 2019 rate.

How many of those past-month vapers might reasonably be described as addicted to nicotine? A quarter of them—less than 2 percent of all respondents—reported vaping every day in the previous month, meaning that, as usual, the vast majority were occasional users.

This does not look like an epidemic of nicotine addiction. Nor did the fear that vaping would lead to smoking pan out.

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Sales Data Indicate That Restrictions on Flavored Vaping Products Encourage Smoking

Legal restrictions on the flavors of nicotine vaping products are associated with increased cigarette purchases, according to a new paper that analyzes retail sales data from 44 states. For each fewer 0.7-milliliter nicotine pod sold in jurisdictions with such policies, the analysis found, consumers bought 15 more cigarettes. “That tradeoff,” the authors note, “equates to over a pack more cigarettes per pod for the size of current leading products” such as the Vuse Alto, which uses 1.8-milliliter pods.

The substitution effect identified by this study underlines the folly of trying to protect public health by deterring the use of electronic nicotine delivery systems (ENDS), which are far less hazardous than combustible cigarettes. “We find that ENDS flavor policies reduce flavored ENDS sales as intended, but also increase cigarette sales across age groups,” Yale public health researcher Abigail Friedman and her collaborators report. “As cigarettes are much more lethal than ENDS, the high rate of substitution estimated here suggests that, on net, any population health benefits of ENDS flavor policies are likely small or even negative.”

Friedman et al. identified 15 state and 279 local flavor restrictions that took effect during the study period—January 7, 2018, through March 26, 2023. Those policies included both outright bans on ENDS flavors other than tobacco and laws that limited sales of such products to specialty stores such as vape shops and tobacconists. The study’s sales data came from Information Resources Incorporated, which collects checkout numbers from convenience stores, supermarkets, drug stores, discount stores, and gas stations.

“ENDS sales fall and cigarette sales rise as a greater percentage of state residents is subject to policies restricting flavored ENDS sales,” Friedman et al. report. “Effects are in the same direction for policies prohibiting all ENDS sales (i.e., flavored and unflavored), consistent with substitution.” These effects are “larger in the long-run; that is, for policies in effect a year or longer,” the researchers note. They add that “separating ENDS flavor prohibitions from less restrictive policies limiting flavored ENDS sales to particular types of retailers reveals that both policies yield reductions in ENDS sales and increases in cigarette sales once in effect for at least a year.”

The relationship between reduced ENDS sales and increased cigarette sales, the study found, “holds across cigarette product age profiles, including for brands disproportionately used by underage youth.” Menthol brands accounted for 29 percent of the increase in cigarette sales, while standard cigarettes accounted for 71 percent, which “indicates that the observed substitution response to ENDS flavor policies cannot be attributed to menthol cigarettes’ availability” or “fully counteracted by menthol cigarette sales prohibitions.”

These findings, Friedman et al. note, are consistent with “results from 16 of 18 other studies assessing cigarette use following adoptions of minimum legal sales age laws for ENDS, ENDS tax rate increases, and advertising restrictions.” They are also consistent with prior studies suggesting that ENDS flavor restrictions boost smoking rates. “In other words,” the authors say, “policies making ENDS more expensive, less accessible, or less appealing appear to incentivize substitution towards cigarettes.”

Who could have predicted that? Lots of people, starting with all the ex-smokers who have switched to vaping and overwhelmingly prefer the flavors that politicians portray as an intolerable threat to the youth of America. Savvy tobacco control experts likewise have been warning legislators and regulators for years that policies aimed at discouraging underage vaping could inadvertently lead to more smoking-related diseases and deaths.

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American Lung Association Demands the FDA Mislead the Public About Vaping

The Food and Drug Administration (FDA) should abandon any efforts to inform the public that vaping is safer than smoking, says the American Lung Association (ALA).  

Numerous public surveys show a consistent, widespread misperception that vaping nicotine is just as or more dangerous than smoking cigarettes. The problem is so extensive that correcting these false beliefs forms part of the FDA’s Center for Tobacco Products (CTP) 5-year strategic plan

Writing in the journal Addiction, Brian King, the head of CTP, stated: “Opportunities exist to educate adults who smoke cigarettes about the relative risks of tobacco products.” To that end, among the five goals listed as part of CTP’s plan is a commitment to inform the public that not all tobacco products are created equally, with cigarettes being the most dangerous and others, such as e-cigarettes, being far less harmful. 

The pledge to provide accurate information about the risks of different nicotine products is long overdue and in line with the public health communications of peer countries such as CanadaNew Zealand, and the U.K. (The U.K. even has vape shops in hospitals, and some smokers are offered free vapes to help them quit.)

But in their comments on CTP’s strategic plan, the ALA, which proclaims its commitment to a world free of lung disease, demands the FDA “remove language from the description for this goal that references informing adults about the relative risk of tobacco products” and that “CTP should have no part in the industry’s efforts to sustain addiction through the failed and flawed notion that adult smokers should switch to e-cigarettes.”

Despite ALA’s protestations, the idea that e-cigarettes are effective for smoking cessation is not a tobacco industry notion. According to the prestigious Cochrane Review, e-cigarettes are more effective than nicotine patches or gums in helping smokers quit. In essence, the ALA is asking the FDA to withhold accurate information from the public that could save lives. The recommendations sparked strong reactions from those who believe safer alternatives to cigarettes are a no-brainer from a public health perspective.

“This is highly ironic, given the extent to which the Lung Association and other tobacco control organizations went to punish the tobacco industry for lying to the public and hiding critical health information,” writes Michael Siegel, a visiting professor at the Tufts University School of Medicine. “It is also unethical because it violates the public health code of ethics, which calls for honesty and transparency in public health communications. We do not hide critical health information from the public.”

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Horrific Video Shows Teen Start Convulsing as Cop Tasers Him for Vaping Outside

“He was only vaping,” was the sentiment from eye-witnesses over the weekend who watched in horror as an Atlanta police officer tasered a 17-year-old boy, causing him to fall to the ground and start convulsing. The incident is now the subject of an internal investigation.

On Thursday, dozens of teens took to Atlanta’s Historic Fourth Ward Skate Park and were peacefully skating and hanging out when a female officer spotted one of the teens using a vape pen. Apparently, vaping is illegal at the park, despite the fact that it is outside, so the officer claimed the right to extort the teen for doing so.

In the brief video we see the teen, 17-year-old Terion Fortson, standing up talking to the officer as she demands he “Get on the ground now. Get on the ground.” Fortson was not seen in the video physically assaulting the officer or otherwise resisting in any way that would require the following use of force.

According to witnesses, the taser came out after Fortson didn’t get out his ID fast enough.

“I was scared, because you know, past events, of police officers and Black people, you expect him to be shot, but she didn’t,” witness, Brendon Aldridge told WSB-TV.

“He was only vaping. She asked him for his ID. He was being calm, he wasn’t being like, ‘No, I’m not going to show you my ID.’ She tased him. It was crazy, because while he was on the ground, shaking, she was like, ‘Get down, get down,’ like he wasn’t already on the ground. It was even crazier, like six other police officers pulled up and they were all dapping each other up, saying, ‘What’s up?’, hugging. I’m like, what is this? That was just crazy. It made no sense.”

As the video shows, the officer tasers Fortson but it didn’t have much of an effect. The teen just stood there before the officer fired a second time. The second time, it definitely penetrated his skin, causing him to collapse to the ground.

Once he was on the ground, he was no longer a threat but the officer deployed the taser once more causing the teen to start convulsing uncontrollably on the ground. The video is hard to watch which is why local news refused to air it.

When reached for comment, the department claimed Fortson was resisting and said this was the reason the taser was used. However, according to the videos below and witnesses, Fortson was not physically resisting at all.

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To Protect ‘Children’ From E-Cigarettes, Congress Imposes New Restrictions on Everything Related to Vaping of Any Kind

Buried in the enormous spending/COVID-19 relief package that Congress approved this week is a bill that imposes new restrictions on the distribution of all vaping equipment, parts, and supplies, including a ban on mailing them. The provision illustrates not only how utterly irrelevant legislation can be slipped into unread, must-pass bills but also how Congress redefines reality through legal fictions and uses save-the-children rhetoric to justify restricting adults’ choices.

Title VI of the 2021 Consolidated Appropriations Act, which appears on page 5,136 of the 5,593-page bill, is called the Preventing Online Sales of E-Cigarettes to Children Act. The bill was introduced last April by Sen. Dianne Feinstein (D–Calif.), joined by seven original cosponsors: six Democrats plus Sen. John Cornyn (R–Texas). It includes two changes aimed at complicating and obstructing online sales of vapes and e-liquid.

Feinstein’s bill amends the Jenkins Act of 1949, which requires that vendors who sell cigarettes to customers in other states register with the tax administrators in those states and notify them of all such sales so they can collect the taxes that the buyers are officially obligated to pay. In 2002, the General Accounting Office (now the Government Accountability Office) found that online cigarette sellers routinely flouted the Jenkins Act and that the federal government had done virtually nothing to enforce it. Nine years later, Congress amended the law, beefing up its reporting requirements and extending it to cover roll-your-own tobacco.

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