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Halted - US Licensing Deal... GL
Exposure to smoke from high- but not low-nicotine cigarettes leads to signs of dependence in male rats and potentiates the effects of nicotine in female rats
https://www.sciencedirect.com/science/article/pii/S0091305720302264
Not that I want to see us going back to animal studies LOL... but there you ago.. MRTP already
Tipping point please... coming soon? WHO Launching Initiative To Help Over 1Bln People To Quit Smoking Amid COVID-19 - Tedros
https://www.urdupoint.com/en/world/who-launching-initiative-to-help-over-1bln-pe-971222.html
HMMM... is THIS what we were waiting for? Approval imminent? NPRM back on table?
Court Upholds FDA Authority to Regulate E-Cigarettes, Nicotine Vapor Products
https://www.cspdailynews.com/tobacco/court-upholds-fda-authority-regulate-e-cigarettes-nicotine-vapor-products
FDA Completes Scientific Review, Authorizes Reduced Exposure Marketing for IQOS Heated Tobacco System
On July 7, FDA authorized the marketing of “IQOS Tobacco Heating System,” which includes the IQOS device, Marlboro Heatsticks, Marlboro Smooth Menthol Heatsticks, and Marlboro Fresh Menthol Heatsticks as modified risk tobacco products (MRTPs).
FDA previously authorized the marketing of these products in April 2019 via the premarket tobacco application (PMTA) pathway. To limit youth access to the products and to limit youth exposure to IQOS advertising and promotion, the PMTA authorization placed stringent restrictions on how the products are marketed – particularly via websites and through social media platforms – by including requirements that advertising be targeted to adults of legal age to purchase tobacco products.
With today’s action, FDA issued exposure modification orders authorizing Philip Morris Products S.A. to use the following information in their advertising and marketing of the products:
“AVAILABLE EVIDENCE TO DATE:
The IQOS system heats tobacco but does not burn it.
This significantly reduces the production of harmful and potentially harmful chemicals.
Scientific studies have shown that switching completely from conventional cigarettes to the IQOS system significantly reduces your body’s exposure to harmful or potentially harmful chemicals.”
Even with this action, these products are not safe nor "FDA approved"—there are no safe tobacco products. The exposure modification orders do not permit the company to make express or implied statements that convey or could mislead consumers into believing that the product is endorsed or approved by FDA, or that FDA deems the product to be safe for use by consumers.
The company must request and receive authorization from FDA to continue marketing the products with the same modified exposure information after the initial order expires in 4 years. FDA also may withdraw the initial and any potential subsequent exposure modification orders if the agency determines that, among other things, the orders are no longer expected to benefit the health of the population as a whole, for example as a result of an uptake in use of the products by youth or former smokers, or a decrease in the number of current smokers who completely switch to the products.
More information about modified risk tobacco products (MRTPs), including the application process and a summary of past MRTP application actions, is available on the FDA website.
How do you know for certain?
Will the July 1 vaping ban push people back to cigarettes?
https://www.abc.net.au/triplej/programs/hack/will-the-july-1-vaping-ban-push-people-back-to-cigarettes/12385698
This is the mindset that'll get us to the promised land...
https://www.insidesources.com/are-state-budgets-ready-for-a-cigarette-free-world/
LOL would be awesome if you were right, for a change. Rooting for you (us).
Old news? Who cares. Nice conclusion: Effectiveness of Switching to Very Low Nicotine Content Cigarettes Plus Nicotine Patch Versus Reducing Daily Cigarette Consumption Plus Nicotine Patch to Decrease Dependence: An Exploratory Randomized Trial
https://pubmed.ncbi.nlm.nih.gov/31106492/
If we're not at 30 cents by end-of-yr I'd be surprised... looking for an unusual run to .50 / $1
Good luck to all
PMI sees switch to smoke-free, ‘better’ nicotine alternatives
https://business.inquirer.net/299907/pmi-sees-switch-to-smoke-free-better-nicotine-alternatives
I've always said PM will be the first adopter... a back dealing... to get MRTP for IQOS... if it happens you can buy me a beer.
"NICOTINE, INCLUDING IN PATCHES AND GUMS, COULD HELP LUNG CANCER SPREAD TO THE BRAIN"
https://bestlifeonline.com/nicotine-brain-cancer/
Who? 22nd Century Group Appoints James A. Mish as Chief Executive Officer and John Franzino as Chief Financial Officer
WILLIAMSVILLE, N.Y., June 03, 2020 (GLOBE NEWSWIRE) -- 22nd Century Group, Inc. (NYSE American: XXII) (“22nd Century” or “the Company”), a leading plant biotechnology company primarily focused on reduced nicotine tobacco and also hemp/cannabis plant genetics research and development, announced today that James A. Mish has been appointed Chief Executive Officer, effective June 22, 2020. The Company also announced that John Franzino has been appointed Chief Financial Officer, effective immediately.
Mish brings extensive global executive leadership experience in science-driven organizations with a recent focus on the development, manufacturing and commercialization of active pharmaceutical ingredients (“API”), including cannabinoids, and related consumer products. He has an outstanding track record of delivering profitable growth at both privately held and publicly traded companies. Prior to joining 22nd Century, Mish served as Chief Executive Officer of Noramco, a global leader in the production of controlled substances for the pharmaceutical industry, and Purisys, a synthetic cannabinoid API, ingredients and solutions provider to pharmaceutical and consumer products companies. Mish led the creation and spinoff of Purisys from Noramco during his tenure.
“We are very pleased to welcome Jim as our new Chief Executive Officer at this critical juncture in our Company’s history,” said Nora B. Sullivan, Chairperson of the Board of Directors of 22nd Century. “Jim’s extensive and proven executive leadership capabilities, substantial science-based industry background and deep experience with pharmaceutical and consumer products make him an outstanding candidate to successfully execute on the Company’s initiatives and strategic plan going forward. We are confident that under Jim’s demonstrated leadership capabilities, 22nd Century will continue to build its portfolio of assets and create value for the benefit of our shareholders. We expect that with Jim’s direction and guidance, 22nd Century will achieve meaningful growth as the Company looks towards the anticipated authorization of our MRTP application for our proprietary, reduced nicotine cigarettes, and as we work to develop new hemp/cannabis intellectual property and proprietary plants with valuable cannabinoid profiles.”
“I am delighted to join 22nd Century Group at this pivotal time in the Company’s growth as it looks to deliver on its primary mission to reduce smoking-related harm and also bring new and valuable hemp-derived cannabinoid products to market,” said Mish. “22nd Century is an innovative, plant-based biotech company with an extensive and growing intellectual property portfolio that is poised to disrupt both the tobacco and hemp/cannabis industries. I look forward to partnering with 22nd Century’s Board and management team to drive the business forward to deliver value to our customers and shareholders.”
Sullivan continued, “We are also pleased to welcome John Franzino into the role of Chief Financial Officer. John is an accomplished strategic financial executive with a track record of successful leadership in high-growth, highly regulated, consumer-facing industries including tobacco and alcoholic beverages. We are excited to have a CFO of his caliber on the executive management team to help lead the Company through the next chapter of its growth.”
Prior to joining 22nd Century Group, Franzino served as Chief Financial Officer of the West Point Association of Graduates. Additionally, he has extensive strategic financial leadership experience serving as Vice President of Finance and Controller at Bard College; as Chief Financial Officer of Santa Fe Natural Tobacco Company, a subsidiary of Reynolds American, Inc.; and as Chief Financial Officer of Labatt USA. Franzino is a Certified Public Accountant (CPA) and holds a Master of Business Administration degree from Farleigh Dickinson University.
“Also, on behalf of the Company’s Board of Directors, I would like to thank Andrea Jentsch, who has resigned as Chief Financial Officer due to personal reasons, for her service and significant contributions to the Company. Despite the challenges presented by COVID-19, Andrea has built a very strong team critical to advancing the Company’s accounting, finance, information technology and human resources activities, and she has made a number of significant improvements to the Company’s processes, internal reporting and IT resources that will be important enablers for the commercialization of the Company’s proprietary plants and products. We wish Andrea the best in her future endeavors,” Sullivan added.
This is an interesting date: Oct. 16, 2021
POSTPONED: Cigarette Health Warnings Effective Date
Due to the COVID-19 pandemic and its disruptive impacts on both regulated industry and FDA, on May 8 the U.S. District Court for the Eastern District of Texas granted a joint motion in the case of R.J. Reynolds Tobacco Co. et al. v. United States Food and Drug Administration et al. to govern proceedings in that case and postpone the effective date of the “Required Warnings for Cigarette Packages and Advertisements ” final rule by 120 days. FDA remains fully committed to the rule and would not agree to postpone its effective date but for the extraordinary disruptions caused by the COVID-19 pandemic.
The new effective date of the final rule is Oct. 16, 2021. Pursuant to the court order, any obligation to comply with a deadline tied to the effective date is similarly postponed. FDA has updated the “Required Warnings for Cigarette Packages and Advertisements” small entity compliance guide and the “Submission of Plans for Cigarette Packages and Cigarette Advertisements” guidance to include the rule’s new effective date and update the recommended timing for submission of cigarette plans.
FDA strongly encourages entities to submit cigarette plans as soon as possible, and in any event by Dec. 16, 2020. Early submission will facilitate timely FDA review of plans prior to the effective date of the required warnings, encourage dialogue with entities regarding any implementation concerns, and provide time to consider proposals by entities in a timely manner.
Regulated industry may contact CTP with questions about the effective date.
Altria Submits PMTAs for Oral Nicotine Products for FDA Review
https://csnews.com/altria-submits-pmtas-oral-nicotine-products-fda-review
Zelira Therapeutics in discussions to license medicinal cannabis products in US
https://www.proactiveinvestors.com.au/companies/news/918457/zelira-therapeutics-in-discussions-to-license-medicinal-cannabis-products-in-us-918457.html
You're not numb to it by now?
Is what it is... need MRTP, next step... it will happen. The meeting was preplanned... everything found with conclusive evidence for...
After that, we're free of FDA... we can at least sell/market properly... and then hope for NPRM for the endgame measure, but might not be necessary.
22nd Century Group Completes Successful Non-GMO Very Low Nicotine Content Tobacco Research Field Trials
https://www.businesswire.com/news/home/20200430005757/en/
22nd Century has earlier filed a patent application with the U.S. Patent and Trademark Office to secure intellectual property rights for this non-GMO genetic approach that achieves very low nicotine content (VLNC) levels in tobacco plants using non-GMO methodologies.
How much are you down? Not more than me.
I still believe a PM partnership is in the works... let's see...
Let's see if some good comes out of COVID-19... our tech/IP/nicotine/virus symptoms related...?
This pop may be too soon to be MRTP related...
Neither would surprise me
Say it ain't so!
Say it ain't so
FDA Establishes Closing Date for Public Comments on VLN King & VLN Menthol King MRTP Applications
https://www.fda.gov/tobacco-products/advertising-and-promotion/22nd-century-group-inc-modified-risk-tobacco-product-mrtp-applications?utm_source=Eloqua&utm_medium=email&utm_term=Stratcomms&utm_content=landingpage&utm_campaign=CTP%20News%26MRTP%3A%2022nd%20Century%20MRTP%20Comment%20Closing%20-%2041720
FDA is announcing the closing date of the public comment period on 22nd Century Group Inc.’s modified risk tobacco product (MRTP) applications for VLNTM King & VLNTM Menthol King cigarettes. Public comments on these applications must be submitted to the docket by May 18, 2020 to ensure they receive consideration by FDA.
The application materials, redacted in accordance with applicable laws, can be read on the CTP website. FDA takes into consideration all information available to the agency, including public comments and recommendations from the Tobacco Products Scientific Advisory Committee, before making a final determination on an MRTP application.
Please sign up to receive email alerts when materials from any MRTP applications under scientific review have been posted or check the 22nd Century Group Inc. MRTP Application webpage regularly for updates specific to those applications.
The Impact of Exclusive Use of Very Low Nicotine Cigarettes on Compensatory Smoking: An Inpatient Crossover Clinical Trial
https://cebp.aacrjournals.org/content/29/4/880
Conclusions: Among current smokers who exclusively used VLNC cigarettes for 4 days, there was no significant compensatory smoking behavior.
Impact: These data, combined with the larger body of work, suggest that a mandated reduction in nicotine content is unlikely to result in an increase in smoking behavior to obtain more nicotine.
Oversight Committee urges FDA to ban e-cigarettes, vaping over coronavirus risks
https://www.foxnews.com/politics/oversight-committee-fda-ban-e-cigarettes-vaping-coronavirus-risks
DA Finally Sends Overdue CBD Enforcement Update To Congress
https://www.marijuanamoment.net/fda-finally-sends-overdue-cbd-enforcement-update-to-congress/
"...while FDA takes potential steps to establish a clear regulatory pathway."
I believe what I've always said:
- PMI will be the first adoptors... they will get MRTP on IQOS only if...
- MRTP def. coming for XXII
- Small, real-world study, then argument for NPRM
Only interesting bone here is Congressman Pallone calling for FDA to provide answers as to why NPRM was shelved by the next couple weeks or so...
Let's see...
"PMI is undergoing a period of intensive change as we transition away from cigarettes to our science-based smoke-free products-products that are much better alternatives than continued cigarette smoking," says CEO André Calantzopoulos.
https://seekingalpha.com/news/3547391-philip-morris-names-new-cfo
I can't see acquisition until they can prove value with their IP (e.g. sales)... more importantly, as I believed, their value will skyrocket if FDA begins to regulate CBD and calls for clinical validation of products...
I think we need both or the latter to see acquisition... then, .50-$1+ is possible...
Need the end of this year to see what'll come
Hopefully something because I'm getting smashed with XXII
The CHOP/Autism collaboration is big IMO... CHOP being renowned...
Was this last study what we needed to reopen NPRM? MRTP around the corner? Is the congressman who was seeking answers to timeline questions in-the-know? Does he and others just want to look like heroes?
GLTA
FDA considering lowering nicotine levels in cigarettes
https://www.whec.com/news/low-nicotine-cigarettes/5658174/
Zelira is worshipping at the FDA altar hoping it will smite enemies
https://stockhead.com.au/health/zelira-is-worshipping-at-the-fda-altar-hoping-it-will-smite-enemies/
Nicotine Cap for Cigarettes Needed as FDA Waffles, Democrat Says
https://news.bloomberglaw.com/pharma-and-life-sciences/nicotine-cap-for-cigarettes-needed-as-fda-waffles-democrat-says