FDA – Smoke Master https://smoke.vmondeika.com The ultimate smoking source Tue, 08 Sep 2026 15:46:16 +0000 en-US hourly 1 https://wordpress.org/?v=7.1 https://smoke.vmondeika.com/wp-content/uploads/2026/01/cropped-SMG_logo_favicon-32x32.png FDA – Smoke Master https://smoke.vmondeika.com 32 32 Juul’s New JUUL2 Device Gets Hit With a Patent Lawsuit Days After FDA Clearance https://smoke.vmondeika.com/juuls-new-juul2-device-gets-hit-with-a-patent-lawsuit-days-after-fda-clearance/ Tue, 08 Sep 2026 15:46:16 +0000 https://smoke.vmondeika.com/juuls-new-juul2-device-gets-hit-with-a-patent-lawsuit-days-after-fda-clearance/

The lawsuit

Maine-based AJ Marketing LLC filed suit against Juul Labs on September 3, 2026, in the U.S. District Court for the District of Delaware (case No. 1:26-cv-01110). The complaint alleges that both the original JUUL and the newly authorized JUUL2 devices infringe U.S. Patent No. 8,851,068, titled “Personal Inhalation Devices.”

AJ Marketing is not a downstream licensing shell. It is the original assignee of the patent. The patent’s inventors, Scott A. Cohen and Michael J. Bedecs, assigned their rights to the company back in 2010, when the underlying application was filed. The patent issued on October 7, 2014.

According to the complaint, the technology traces back to an effort to deliver metered doses of caffeine to military pilots, pitched as a non impairing alternative to the amphetamines historically used to keep aircrews alert. But the patent’s claims are broader than caffeine delivery alone. It covers a personal inhalation device: an outer shell with an orifice, a reservoir holding a “medium,” and an atomizing unit that vaporizes the medium and doses it to the user on each puff. The patent explicitly lists nicotine, medications, vitamins and even THC (in permitting jurisdictions) as possible payloads alongside caffeine.

AJ Marketing alleges Juul’s heating and delivery system infringes those claims. The suit seeks a reasonable royalty covering the six years preceding the filing, plus an ongoing royalty through the patent’s expiration, estimated by Bloomberg Law at January 2031. Juul Labs has not yet responded in court.

The lawsuit lands exactly a week after the FDA authorized the JUUL2 device and two accompanying pods through the Premarket Tobacco Product Application (PMTA) pathway, clearing Juul’s second generation platform for legal U.S. marketing. AJ Marketing named JUUL2 explicitly in its infringement claims, meaning Juul’s newly cleared product enters the market already tangled in litigation.

Not Juul’s first patent fight

Juul has spent much of the past two years on both sides of the patent litigation table against rival Altria and its NJOY subsidiary.

In August 2025, Juul filed a complaint with the U.S. International Trade Commission seeking to block imports of Altria owned NJOY Ace devices, alongside a parallel infringement suit in Delaware federal court. Juul argued the NJOY Ace, the only pod based device with FDA marketing authorization at the time, infringed its patents, and pointed to a perfect record in three prior ITC cases against counterfeit and unauthorized compatible products.

Altria’s NJOY unit answered with its own ITC complaint and a companion Delaware lawsuit, accusing Juul’s flagship JUUL device and JUULpods of infringing two patents that NJOY had acquired from Fuma International as part of a separate patent settlement.

Juul separately sued NJOY and Altria in Arizona federal court, alleging NJOY Daily infringed a Juul nicotine salt patent. That case took an unusual turn: newly unsealed filings showed an ITC judge had found that vaping products sold by R.J. Reynolds back in 2013 already contained every element of Juul’s asserted nicotine salt claims, evidence Altria and NJOY are now using to argue the patent lacked novelty and should be invalidated.

The bigger picture

This pattern of litigation on multiple fronts, in multiple forums (ITC, Delaware, Arizona), often running in both directions at once, has defined Juul’s relationship with Altria/NJOY since Altria fully divested its Juul stake in 2023 and later acquired NJOY’s competing product line without licensing Juul’s patent portfolio.

The AJ Marketing case is a departure from that pattern in one respect. AJ Marketing is not a competing vaping company but appears to be a pure patent holder, asserting a decade old patent with no vaping product of its own on the market, a profile closer to what’s commonly termed a non practicing entity than to an operating rival like NJOY.

Whether Juul challenges the patent’s validity, given its 2010 priority date and broad “personal inhalation device” claim language that predates the pod vape category as it exists today.

Whether AJ Marketing seeks an injunction or settles for royalties; the complaint as reported asks only for damages, not a sales ban.

Whether this becomes a template for other legacy inhalation patent holders to test claims against the now much larger and more valuable pod vape market, especially as JUUL2 rolls out under fresh FDA authorization.



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FDA Authorizes Juul2 and Two New Juul Pods in the US https://smoke.vmondeika.com/fda-authorizes-juul2-and-two-new-juul-pods-in-the-us/ Mon, 31 Aug 2026 15:35:52 +0000 https://smoke.vmondeika.com/fda-authorizes-juul2-and-two-new-juul-pods-in-the-us/

The end of the saga, or just another twist?

It is a saga that began more than ten years ago. In 2015, Juul Labs launched its pod system in the United States. The device proved hugely successful, both among adult smokers and some minors with no previous history of smoking. Under regulatory and media pressure, Juul voluntarily withdrew several of its flavored pods from the U.S. market. Flavors such as mango and crème disappeared, leaving only tobacco and menthol.

As the years passed, lawsuits against Juul continued to pile up. Several states notably accused the manufacturer of being directly responsible for the large number of minors vaping in the United States. An “epidemic of e-cigarette use among teenagers”, as then-Food and Drug Administration (FDA) Commissioner Scott Gottlieb had described it a few years earlier.

In mid-2022, the FDA banned all Juul products in the United States, citing insufficient data on their health effects and conflicting data regarding their genotoxicity. But just twelve days later, the regulator itself reversed the decision, stating simply that certain scientific questions concerning Juul pods warranted further review. The products were allowed back onto the market in the meantime.

Between 2022 and 2024, the FDA conducted an in-depth review of all the data it held on Juul products. During those two years, the regulatory agency faced numerous lawsuits from manufacturers whose products had been denied authorization. The FDA lost several of these cases, with some rulings describing its actions as “arbitrary and capricious”, or finding that it had imposed certain evaluation criteria that were inconsistent with the guidance it had itself provided manufacturers on how to obtain authorization for their products.

In mid-2024, the FDA formally rescinded the bans imposed on Juul products two years earlier. It stressed, however, that this did not amount to an authorization, but simply meant that its review of the products for which Juul had applied for marketing authorization would resume. The agency also noted that its decision took into account several recent court rulings. Ironically, the January 2024 ruling that apparently influenced this reversal would itself be overturned a year later. On April 2, 2025, the U.S. Supreme Court unanimously sided with the FDA in the case, by nine votes to zero, finding that the agency had not acted arbitrarily when denying the marketing applications. The FDA had therefore softened its position under pressure from a legal precedent that, a year later, would no longer stand.

In 2025, the Food and Drug Administration finally authorized five Juul products for legal sale in the United States. Then, on August 28, 2026, it authorized three additional products: the Juul2 device and two tobacco- and menthol-flavored pods containing 18 mg/mL of nicotine. Juul had been seeking authorization to market these products since 2023.

Juul has already indicated that it intends to submit further marketing applications for pods containing higher nicotine concentrations and additional flavors.



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States Should Start Planning Now For FDA Approval Of Psychedelics, Federal Report Says https://smoke.vmondeika.com/states-should-start-planning-now-for-fda-approval-of-psychedelics-federal-report-says/ Wed, 26 Aug 2026 23:16:47 +0000 https://smoke.vmondeika.com/states-should-start-planning-now-for-fda-approval-of-psychedelics-federal-report-says/

A federal health agency has published a new report on recent advances in psychedelic medicine, along with recommendations for state policymakers on how to prepare for formal approval of drugs like psilocybin and MDMA. It also notes how the Schedule I status of many psychedelics has hampered scientific studies on their effects for decades.

“Psychedelic-assisted therapy is moving from research settings toward clinical practice faster than most observers anticipated even 5 years ago,” the report published on Wednesday by the Substance Abuse and Mental Health Services Administration (SAMHSA) says.

The document says that substances such as psilocybin, LSD and MDMA “show potential in clinical studies for treating depression, post-traumatic stress disorder, anxiety, and substance use disorders,” though it cautions that the evidence base “remains uneven and important methodological limitations persist.”

The SAMHSA report notes that President Donald Trump issued an executive order aimed at expanding and expediting research on the potential therapeutic benefits of psychedelics in April with an eye toward federal approval of psychedelic medications by the Food and Drug Administration (FDA).

State officials should “consider planning now for the fiscal, legal, and operational implications of potential FDA-approved psychedelic therapies, including any Medicaid coverage obligations,” it says.

They should also work toward “developing oversight frameworks, including credentialing standards, safety protocols, informed consent processes, and complaint mechanisms proactively, before psychedelic therapies are formally made available for state system service recipients,” the SAMHSA report recommends.

“States should engage with the federal regulatory process and coordinate across agencies so that relevant decision-makers in states are informed and prepared when psychedelic policy proposals arise.”

One methodological issue with most psychedelic research to date, the paper notes, is that clinical trials have largely excluded people with serious mental illness, low incomes and complex trauma histories—”precisely the populations that state mental health systems primarily serve.”

The SAMHSA paper provides an overview of the traditional and cultural use of psychedelics, as well as their legal status in the U.S., noting that their placement in Schedule I of the Controlled Substances Act (CSA) meant that “clinical research into psychedelics was substantially limited” for decades.

“This classification was viewed by many as a response to cultural panic surrounding recreational drug use in the 1960s rather than a science-based assessment,” it says.

Research has picked up in recent years, however, and FDA has granted “breakthrough therapy” status to several psychedelics, including psilocybin, MDMA and a 5-MeO-DMT formulation.

If any psychedelics are approved by FDA, key questions will arise about coverage through Medicaid and other programs—both for the drug itself as well as therapeutic sessions that can last for several hours.

“State Medicaid agencies could theoretically cover the drug but not the associated services. Such an arrangement would create a dilemma because the evidence for benefit appears inseparable from the therapeutic framework,” the report says. “Prescribing psilocybin or other psychedelics for unsupervised home use is not supported by the current evidence.”

But “if states are required to cover both the medication and therapeutic services, the budgetary implications are substantial,” the SAMHSA analysis notes.

In any case, the federal overview says that regardless of whether states approve or cover any psychedelic medicines or services, “access and use are already happening.”

“The question is not whether individuals in a particular state will use psychedelics, but whether they will do so in regulated, safe contexts or in underground networks,” it says. This has implications for what information to gather, what public health communications to develop, and what policies to put in place proactively.”

The report also says that an ongoing “fundamental legal tension is that federal and state laws may not align.”

“A state that permits psychedelic-assisted therapy outside of FDA-approval or authorized right-to-try expanded access creates a situation in which the state is facilitating conduct that remains federally criminal. This is not unprecedented (medical cannabis states face similar tensions), but it represents a real legal risk. State attorney general offices may be able to provide guidance on whether prescribers can legally administer Schedule I compounds under state law even when federal law prohibits them.”

Whatever happens at the federal level, psychedelics are unlikely to recede from public attention,” it says. “The science will continue to accumulate, and state agencies will face questions from service recipients, their families, providers, legislators, and others.”

“State mental health directors do not need to become advocates for psychedelic-assisted therapy, but they must be informed. The evidence base, the regulatory momentum, and the budget implications are all substantive enough to warrant serious attention now. The most prudent course is to stay informed, engage with the evidence critically, prepare for the possibility that FDA-approved psychedelic therapies may arrive soon, and think carefully about how these therapies might fit into the broader mission of serving people with mental health conditions and substance use disorders, including individuals with serious mental illness. These decisions are likely to come whether or not states are ready for them, and it will be easier to develop informed positions in advance than to react under pressure.”

Last month, the Department of Health and Human Services (HHS) and Department of Veterans Affairs (VA) announced a partnership to collaborate on research and development of psychedelic medicines to treat people struggling with serious mental health conditions.

Separately, FDA issued finalized guidance to help researchers studying the therapeutic benefits of psychedelics navigate the “unique challenges” of such investigations. The agency also announced it will be holding a public hearing on psychedelic therapy issues in September.

Previously, FDA and HHS in April announced steps that they say will help with “accelerating” therapeutic access to psychedelics for patients dealing with serious mental health conditions.

In May, a bipartisan coalition of 32 members of Congress sent a letter urging FDA to expedite ongoing reviews of psychedelic therapies.

Lawmakers recently filed a new bill that would require the Department of Defense (DOD) to evaluate how ongoing research on the therapeutic benefits of psilocybin could help members of the military.

A separate recently introduced bipartisan measure is intended to codify Trump’s psychedelics executive order into law.

An amendment adopted as part of the National Defense Authorization Act would extend a psychedelics research effort at DOD for an additional six years.

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The FDA Wants to Know How You Use Cannabis—Useful or Concerning? https://smoke.vmondeika.com/the-fda-wants-to-know-how-you-use-cannabis-useful-or-concerning/ Tue, 25 Aug 2026 17:43:37 +0000 https://smoke.vmondeika.com/the-fda-wants-to-know-how-you-use-cannabis-useful-or-concerning/

The FDA is seeking outside data and analytics services to better understand how people use cannabis, CBD, and other emerging products through public social-media conversations, consumer surveys, and market intelligence. The request does not establish access to private messages, but it does point to a much more systematic federal effort to analyze how cannabis consumers behave, what they buy, and what they say online.

There are like a trillion ways people use cannabis today, especially in the US, where medical weed is legal across much of the country and roughly half the states have given the green light to adult-use marijuana. That tricky patchwork of legalization has also created enormous differences in what people buy, where they buy it, and how they use it. 

And when we talk about “ways of using cannabis,” we’re not only talking about that new vape you didn’t even know existed, infused drinks, gummies, concentrates, topicals, or whatever new format showed up at the dispensary this month. We’re also talking about why people use weed, how often, what doses they use, what symptoms they’re trying to address, the effects they’re looking for, the circumstances in which they use it, and pretty much everything else that shapes a cannabis experience. 

That is exactly the kind of information the Food and Drug Administration now wants more of. 

The FDA Wants to Know the Whys, Wheres, and Hows 

With tens of millions of Americans using cannabis, it only makes sense to assume that they don’t all use it the same way, in the same places, or for the same reasons. Better information about those differences can be useful for everything from public-health research to product development, consumer education and a better understanding of emerging patterns of use. At least, that seems to be part of the FDA’s thinking. 

This is not some out-of-nowhere idea the agency dreamed up in 2026. The FDA has been talking about gaps in cannabis-related data for years. Back in 2022, it published a “Sources Sought” notice looking for small businesses capable of collecting and analyzing information about cannabis-derived products across social media, e-commerce platforms, specialized websites and even the dark web. The agency explicitly mentioned machine learning and natural-language processing as tools that could help identify emerging risks, adverse-event signals and online activity that conventional sources might miss. 

That effort came after the 2018 Farm Bill removed hemp containing no more than 0.3% delta-9 THC by dry weight from the federal definition of marijuana, setting off a rapid expansion of hemp-derived products. The FDA said at the time that the changing market had left significant gaps in its understanding of product quality, adverse events and misinformation. 

Fast-forward four years, and the idea has become much more specific. In August 2026, the FDA issued a new request for quotes for external data and analytics services related to cannabis, CBD and emerging products. Among the requested services are monitoring cannabis conversations on TikTok, Instagram and Reddit; surveying cannabis consumers; and providing detailed information on products, brands, behaviors and market trends.

So far, so good. Lovely, even. More data can mean better research, better policy and a clearer picture of what people are actually doing rather than what regulators think they’re doing. But things start to sound a little different when the data collection involves systematically monitoring public conversations among cannabis users online. 

Do you use TikTok, Instagram or Reddit? Then this might interest you. The FDA is looking for a contractor capable of capturing social-media data related to cannabis and hemp, including information about products, ingredients, claims, consumer conditions and sentiment. According to the agency’s request, the system should also allow information to be filtered by attributes such as age group, sex and consumer “persona” through the use of trained AI models, while also allowing users to click through to the underlying public posts.

According to Marijuana Moment, the agency says the broader purpose is to “address knowledge gaps on cannabis, cannabidiol (CBD), and emerging products and help inform work on policy and regulation, education and outreach, and compliance activities.”

Based on the procurement language reported so far, the FDA is asking for social listening and market intelligence, not access to people’s private messages. So while “the FDA is sneaking into your DMs” makes for a much creepier headline, that is not what the available documents show. 

What they do show is that a federal agency wants a much more granular view of how cannabis consumers behave and talk online.

It’s Not Just Your Posts They Want to Understand

Social media is only one piece of the project. The contractor is also expected to conduct a U.S. Cannabis Consumer Survey focused on dispensary shoppers. The questionnaire would collect information on symptoms, product preferences, desired effects, medical conditions, use occasions, frequency of use, use history, average purchase amounts, preferred doses and purchase journeys.

Another survey would look more broadly at consumer behavior around cannabis as well as kratom, psilocybin and other emerging products marketed with functional or wellness claims. A separate component would examine women’s purchasing and product-use patterns across different life stages, including fertility, perimenopause and postmenopause.

For CBD and other non-intoxicating cannabis products, meanwhile, the FDA wants market data such as market size, leading brands, product types, formats and claimed cannabinoid content.

Put together, this is considerably more ambitious than simply counting how many times someone says “weed” on Reddit.

It is an attempt to combine online conversations, consumer surveys and commercial market intelligence into a clearer picture of what people are using, why they use it, what they believe it does and how the market is evolving.

How Are They Going to Do It, Exactly?

The FDA’s request calls for technology capable of continuously collecting and organizing cannabis-related conversations from major social platforms and turning those conversations into structured data.

That means identifying the products people mention, the ingredients they discuss, the claims made about them, the conditions consumers associate with using those products and the sentiment surrounding those experiences. AI-assisted tools would then help sort those conversations into categories and identify different consumer profiles.

The request specifically points to services similar to those offered by Brightfield Group, a cannabis and wellness market research company that provides consumer intelligence and social-listening analytics. The planned contract would run from September 30, 2026, through September 29, 2027.

In other words, the FDA is not asking one employee to spend their afternoon doomscrolling r/trees. It wants an industrial-scale system that can turn the enormous amount of information that cannabis consumers voluntarily post online into data regulators can actually use.

Whether that sounds reassuring or unsettling probably depends on which part of that sentence you focus on.

Cover photo created with AI.

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FDA Wants Help Monitoring Marijuana And Hemp Posts On TikTok, Reddit And Instagram https://smoke.vmondeika.com/fda-wants-help-monitoring-marijuana-and-hemp-posts-on-tiktok-reddit-and-instagram/ Thu, 20 Aug 2026 13:04:26 +0000 https://smoke.vmondeika.com/fda-wants-help-monitoring-marijuana-and-hemp-posts-on-tiktok-reddit-and-instagram/

The Food and Drug Administration (FDA) is seeking a contractor to monitor social media sites like TikTok, Instagram and Reddit for conversations about marijuana and hemp products, and to conduct a survey of cannabis consumers, among other tasks.

The agency said in a request for quotes that it is seeking help to “address knowledge gaps on cannabis, cannabidiol (CBD), and emerging products and help inform work on policy and regulation, education and outreach, and compliance activities.”

The social media monitoring services will “capture data on products, ingredients, claims, consumer conditions, sentiments, and other attributes,” and FDA wants to be able to filter posts “by age-group, sex, persona, and other attributes…using trained artificial intelligence (AI) modeling, with click-through to verbatim conversation postings.”

FDA also wants the contractor to conduct a “US Cannabis Consumer Survey” focused on dispensary shoppers.

“The survey will collect data on consumer symptoms and paths to purchase, as well as product preferences, desired effects, medical conditions, occasions, frequency and history of use, average purchases, and preferred dosages,” the posting says.

A broader general population survey will also cover “consumer packaged goods adoption and needs, conditions, and behaviors, including use of cannabis, kratom, psilocybin, and emerging products in other categories with ingredients marketed as functional and/or other claims.”

Another survey will focus on women’s “usage and purchase behaviors and drivers across cannabis products and other consumer packaged goods categories by life-stage.”

“Life-stages will be defined as fertility/prime, perimenopause, and postmenopause, considered in core dimensions, such as physical, emotional, and financial, and by need states/drivers, such as hormonal, functional, lifestyle/behavioral, and others. Product coverage will include cannabis products, vitamins/minerals/supplements, functional consumer packaged goods and beverages, topicals, feminine health and hygiene, and others.”

With respect to CBD specifically, the contractor will need to provide data on both the market—”including size; top brands; product types, forms, claimed content; and other pertinent market attributes for CBD and emerging non-intoxicating cannabis products, including those that are state regulated”—as well as consumers of the products.

FDA specified in the posting that it requires “brand name or equal to Brightfield Group online data subscription and analytic services,” referring to a company that says it provides “predictive consumer intelligence and social listening for CPG brands in food, beverage, supplements, and wellness.”

The contract will cover September 30 of this year through September 29, 2027, FDA said. Quotes are due by Monday.

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