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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Meta Pushes for a Digital ID Revolution

Meta is coming out as a supporter of age verification, and the proposal the giant is putting forward exposes and sums up many of the points critics have been consistently making.

blog post by Meta VP and Global Head of Safety Antigone Davis proposes to implement age verification at the operating system/app stores level.

Although the narrative around child safety and difficulties of parenting “in the digital age” dominates the article, “the meat of it” are the implications that this approach brings with it: namely, it creates a situation where, down the line, people would be forced to link real-world identity to their phone’s operating system (OS).

And everything they do using the phone is exposed to that OS.

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Push to Pass KOSA Spurs Fears Over Privacy and Free Speech

Attorneys general from 32 jurisdictions — including 31 states and the District of Columbia — have signed an open letter urging Congress to pass the Kids Online Safety Act (KOSA) before the looming conclusion of the current session early next year. This legislation, although primarily aimed at protecting minors from digital harms, introduces significant implications for online privacy and freedom of speech through proposed mechanisms for age verification and potential censorship.

We obtained a copy of the letter for you here.

KOSA itself doesn’t mandate direct implementation of online age verification but tasks the Secretary of Commerce, along with the FTC and FCC, with exploring “options for developing systems to verify age at the device or operating system level.” This move toward digital identification could fundamentally alter the landscape of internet privacy, linking social media accounts and other online activities directly to real-world identities.

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Senate Passes Kids’ “Safety” Bills Despite Privacy, Digital ID, and Censorship Concerns

Two bills combined – the Kids Online Safety Act (KOSA) and the Children and Teens’ Online Privacy Protection Act (COPPA 2.0) – have passed in the US Senate in a 91-3 vote, and will now be considered by the House.

Criticism of the bills focuses mainly on the likelihood that, if and when they become law, they will help expand online digital ID verification, as well as around issues like censorship (removal and blocking of content).

Related: The 2024 Digital ID and Online Age Verification Agenda

The effort to make KOSA and COPA 2.0 happen was spearheaded by a parent group that was pushing lawmakers and tech companies’ executives to move in this direction, and their main demand was to enact new rules that would prevent cyberbullying and other harms.

And now the main sponsors, senators Richard Blumenthal, a Democrat, and Republican Marsha Blackburn are trying to dispel these concerns, suggesting these are not “speech bills” and do not (directly) impose age verification.

Further defending the bills, they say that the legislation does not mandate that internet platforms start collecting even more user data, and reject the notion it is invasive of people’s privacy.

But the problem is that although technically true, this interpretation of the bills’ impact is ultimately incorrect, as some of their provisions do encourage censorship, facilitate the introduction of digital ID for age verification, and leave the door open for mass collection of online users’ data – under specific circumstances – and end ending anonymity online.

The bills are hailed by supporters as “landmark” legislation that is the first to focus on protecting children on the internet in the last 20 years, with some lawmakers in the Senate, like majority leader, Democrat Chuck Schumer, describing the result of the vote as “a momentous day.”

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Biden-Harris Task Force Urges Online Age Verification Digital ID Tool Development

The online digital ID age verification creep in the US continues from a number of directions, through “recommendations” and “studies” – essentially, the government is nudging the industry to move in the direction of implementing digital ID age verification tools.

At this point, it is happening via various initiatives and legislation, still, without being formally mandated.

One instance is a recommendation coming from the Biden-Harris Administration’s Kids Online Health and Safety Task Force, which is telling online service providers they should “develop and inform parents about age verification tools built into the app or available at the device level.”

The task force is led by the Department of Health and Human Services, HHS (its Substance Abuse and Mental Health Service Administration, SAMHSA,) in what is referred to in official statements as “close partnership” with the Department of Commerce.

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Senate Passes Kids’ “Safety” Bills Despite Privacy, Digital ID, and Censorship Concerns

Two bills combined – the Kids Online Safety Act (KOSA) and the Children and Teens’ Online Privacy Protection Act (COPPA 2.0) – have passed in the US Senate in a 91-3 vote, and will now be considered by the House.

Criticism of the bills focuses mainly on the likelihood that, if and when they become law, they will help expand online digital ID verification, as well as around issues like censorship (removal and blocking of content).

The effort to make KOSA and COPA 2.0 happen was spearheaded by a parent group that was pushing lawmakers and tech companies’ executives to move in this direction, and their main demand was to enact new rules that would prevent cyberbullying and other harms.

And now the main sponsors, senators Richard Blumenthal, a Democrat, and Republican Marsha Blackburn are trying to dispel these concerns, suggesting these are not “speech bills” and do not (directly) impose age verification.

Further defending the bills, they say that the legislation does not mandate that internet platforms start collecting even more user data, and reject the notion it is invasive of people’s privacy.

But the problem is that although technically true, this interpretation of the bills’ impact is ultimately incorrect, as some of their provisions do encourage censorship, facilitate the introduction of digital ID for age verification, and leave the door open for mass collection of online users’ data – under specific circumstances – and end ending anonymity online.

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Surgeon General Murthy Advocates for Digital ID to Combat Online “Misinformation” and Protect Youth

These days, as the saying goes – you can’t swing a cat without hitting a “paper of record” giving prominent op-ed space to some current US administration official – and this is happening very close to the presidential election.

This time, the New York Times and US Surgeon General Vivek Murthy got together, with Murthy’s own slant on what opponents might see as another push to muzzle social media ahead of the November vote, under any pretext.

A pretext is, as per Murthy: new legislation that would “shield young people from online harassment, abuse and exploitation,” and there’s disinformation and such, of course.

Coming from Murthy, this is inevitably branded as “health disinformation.” But the way digital rights group EFF sees it – requiring “a surgeon general’s warning label on social media platforms, stating that social media is associated with significant mental health harms for adolescents” – is just unconstitutional.

Whenever minors are mentioned in this context, the obvious question is – how do platforms know somebody’s a minor? And that’s where the privacy and security nightmare known as age verification, or “assurance” comes in.

Critics think this is no more than a thinly veiled campaign to unmask internet users under what the authorities believe is the platitude that cannot be argued against – “thinking of the children.”

Yet in reality, while it can harm children, the overall target is everybody else. Basically – in a just and open internet, every adult who might think using this digital town square, and expressing an opinion, would not have to come with them producing a government-issued photo ID.

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Big Brother in Training? How Proposed Legislation Might Pave the Way for Online Age Verification and Digital ID

Bipartisan legislative efforts are underway in the US House of Representatives to adopt new versions of two laws originally drawn up to deal with the safety of youth online.

But the fear is that the bills introduced now – H.R.7891, the Kids Online Safety Act (KOSA), and H.R. 7890, the Children and Teens Online Privacy Protection Act (COPPA) 2.0 – will facilitate implementation of a future sweeping age verification and digital ID push.

These concerns are raised because KOSA is directing the secretary of commerce, together with the Federal Communications Commission (FCC) and the Federal Trade Commission (FTC) to conduct a study “evaluating the most technologically feasible methods and options for developing systems to verify age at the device or operating system level.”

At this stage of the proceedings, the study will not be used to mandate that platforms implement “an age gating or age verification functionality” – however, once the authorities have at their disposal the technical solutions to do it, some observers expect it could be used for a more aggressive legislative push at the federal level later on.

The key difference between the existing Senate version of KOSA and the proposed House bill is found under the “care of duty” component, with the House text now defining that to apply to “high impact online companies” with $2.5 billion or more annual revenue, and 150+ million global monthly active users over at least three months of the preceding year.

The Senate version refers to platforms “reasonably likely to be used by a minor” (employing 500 or more people, with gross annual revenue of $50 million or more).

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Legalizing Marijuana For Adults Does Not Drive Increases In Youth Use, New Federally Funded Study Finds

New federally funded research into the impacts of marijuana legalization on youth use found no association between legal adult-use cannabis sales and the prevalence of consumption among middle-school students.

To test whether legal sales led to an uptick in youth use, authors compared middle-school use rates in Nevada and New Mexico, looking at 2017 and 2019 data from two state-run surveys. At the time, adult-use marijuana sales were legal in Nevada, while New Mexico allowed only medical marijuana.

In both states, researchers found increases in the proportions of students that had ever consumed cannabis as well as those who had consumed within the past 30 days.

In Nevada, the share of middle-school students who said they’d ever consumed cannabis rose during the study period, from 9.7 percent in 2017 to 13.3 percent in 2019. Past 30 day (P30D) use also rose, from 6.3 percent to 8.9 percent.

New Mexico, where recreational marijuana remained illegal, saw lifetime use rise from 14.1 percent to 17.4 percent over the same period. Past 30 day use rose from 8.9 percent to 10.5 percent.

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Pennsylvania Officials Won’t Give Medical Marijuana Patients Access To Edibles—For Now

Officials tasked with monitoring the state’s medical marijuana program said this week edibles don’t belong in Pennsylvania’s marketplace.

Concerns about safety, efficacy and legal enforcement gave members of the Medical Marijuana Advisory Board pause. Six abstained from voting on the recommendation at all during its Wednesday meeting. Only two members supported the proposal, while two more rejected it.

The vote came after a discussion about the growing popularity of “troches,” an ingestible form of THC that resembles a cough drop. Dispensaries market the product alongside tinctures, which users absorb sublingually.

Supporters say some patients dislike the respiratory and digestive side effects that come from other forms of medical marijuana, including vaping cartridges, flowers, pills, and concentrates. Edibles offer a viable alternative.

Critics argue, however, that traditional edibles offered in other states come with a higher risk of poisoning, particularly in children, because of deceptive packaging and underestimated potency.

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