Category Archives: Vaping

Although news about vaping industry legal actions against the FDA has focused mostly on Turning Point Brands successful challenge, at least 27 other manufacturers and distributors have also filed petitions asking federal circuit courts to review their Marketing Denial Orders (MDOs).

None of the companies on the list of MDO recipients received their denials after Sept. 17, which means those on the list that have not already filed a petition for review are beyond the 30-day window for appeal. However, several of the companies that have filed actions in court are not included on the FDAs list, so its possible other unlisted companies are still within the 30-day time limit. (The FDA also hasnt updated its official list since Sept. 23.)

We have created a list of manufacturers that have filed petitions for review of MDOs, and in some cases motions for a stay of FDA enforcement. Theyre listed alphabetically, and next to the company name is the date of the legal action, the circuit court hearing the petition, and other applicable information. If we have covered the case in an article, the most recent coverage is linked. (For those companies whose names are known only from a list created by the Public Health Law Center we have no filing dates.)

This list will be updated if additional court filings become available.

7 Daze LLC Petition for review filed 10/7 9th Circuit Court of Appeals

AVAIL Vapor, LLC Petition for review filed 9/30 4th Circuit Court of Appeals

Bad Modder Fogger (BMF Labs) Petition for review filed 10/4 4th Circuit Court of Appeals

Bidi Vapor LLC Petition for review filed 9/29 11th Circuit Court of Appeals. Bidi also filed a motion for expedited consideration by the court

Breeze Smoke, LLC Petition for review filed 10/4 6th Circuit Court of Appeals. Breeze Smoke also filed an emergency motion for a stay on 10/13

Cloud House Petition for review filed 10/8 5th Circuit Court of Appeals

Cloud Nine Vapor Products Petition for review filed 10/8 10th Circuit Court of Appeals

Diamond Vapor LLC Petition for review filed 10/1 11th Circuit Court of Appeals

E-Liquid Brands, LLC Petition for review filed 10/7 4th Circuit Court of Appeals

ECS Global LLC Petition for review filed 10/12 District of Columbia Circuit Court of Appeals. ECS Global received MDOs for Phix pod-vape devices and prefilled Phix pods

Electric Clouds Petition for review filed 10/8 10th Circuit Court of Appeals

Fresh Farms E-Liquid Date of filing unknown 7th Circuit Court of Appeals. Public Health Law Center says this legal action challenges a Refuse to Accept (RTA) determinationnot an MDO

Fumizer, LLC Petition for review filed 10/6 9th Circuit Court of Appeals

Gripum LLC Petition for review filed 10/8 7th Circuit Court of Appeals. Gripum also filed an emergency motion for a stay on 10/17. UPDATE: On Oct. 19, the court temporarily stayed Gripums MDO while its motion for a longer-term stay is considered

Johnny Copper LLC Petition for review filed 10/7 11th Circuit Court of Appeals

Liquid Labs LLC Petition for review filed 10/12 3rd Circuit Court of Appeals

Magellan Technology, Inc. Petition for review filed 9/24 2nd Circuit Court of Appeals

My Vape Order, Inc. Petition for review filed 9/30 9th Circuit Court of Appeals. UPDATE: The FDA announced Oct. 18 that it has stayed My Vape Orders MDO while it completes an administrative review of the order

New World Wholesale, Inc. & Shenzhen Goldreams Technology Co., Ltd. Petition for review filed 10/11 5th Circuit Court of Appeals

Nude Nicotine, Inc. Petition for review filed 10/6 9th Circuit Court of Appeals

Paradigm Distribution Petition for review filed 10/11 5th Circuit Court of Appeals

Prohibition Juice Co. Petition for review filed 10/13 District of Columbia Circuit Court of Appeals

Simple Vapor Company Petition for review filed 10/12 6th Circuit Court of Appeals

SV Packaging Date of filing unknown 5th Circuit Court of Appeals

SWT Global Supply, Inc. Petition for review filed 10/1 5th Circuit Court of Appeals

Turning Point Brands, Inc. Petition for review filed 9/23 6th Circuit Court of Appeals. Turning Point Brands withdrew its petition for review after the FDA reinstated to review the TPB products that had received MDOs. TPB was the first company to file a petition for review, and the first to ask the court for a stay preventing FDA enforcement while the companys appeal was considered

Vapor Unlimited LLC Petition for review filed 10/8 11th Circuit Court of Appeals

Vaporized, Inc. Petition for review filed 10/11 5th Circuit Court of Appeals

Wages and White Lion Investments (Triton Distribution) Petition for review filed 10/6 5th Circuit Court of Appeals. Triton also filed a motion for a stay and for expedited consideration. UPDATE: On Oct. 15, the court temporarily stayed Tritons MDO while its motion for a longer-term stay is considered

Originally posted here:

At Least 28 Vape Companies Have Challenged MDOs in Court - Vaping360 News

After being on the U.S. market for around 15 years, an e-cigarette has, for the first time, been authorized for sale by the Food and Drug Administration.

The government agency announced on Oct. 12, 2021, that three products from the vaping company Vuse had been given the green light to be marketed, along with one device in which the approved cartridges are placed.

Although limited in scope the authorization only relates to tobacco-flavored e-cigarettes and not the wider range of flavors that critics say are aimed at younger consumers the move by the FDA is seen as a major development for the vaping industry. Many manufacturers of e-cigarettes are currently in a state of limbo, with their products still awaiting official authorization.

The FDA said that its decision on the Vuse products came after data showed e-cigarettes helped addicted adult smokers switch to vaping. But the move follows arguments over the merits, or harms, of e-cigarettes that have dragged on for years. It is a debate that The Conversations authors has followed carefully.

The FDA highlighted the role that e-cigarettes can play in weening nicotine-addicted smokers off harmful cigarettes. This concurs, to a degree, with recent research.

Reviewing evidence from 50 studies that included more than 12,000 participants, Jamie Hartmann-Boyce and Nicola Lindson at the University of Oxford found that the findings provided more confidence that e-cigarettes with nicotine such as those now approved by the FDA can help people quit smoking better than other replacement aids such as gum or patches. The review also found no evidence of serious harm of e-cigarettes with nicotine. Hartmann-Boyce and Lindon note that the data was limited, meaning that such harms cannot be ruled out.

The two Oxford scholars conclude that e-cigarettes with nicotine are not risk free but are considerably less harmful than smoking. When translated into action, this means: If you dont smoke, dont start to use e-cigarettes. If you do smoke, consider switching.

Read more: New evidence shows e-cigarettes can help people quit smoking

But it is the concern over nonsmokers especially teenagers taking up e-cigarettes for the first time that has fueled the debate. University of Michigans Tammy Chang and Marika Waselewski note that between 2011 and 2019, e-cigarette use among high-schoolers skyrocketed from 1.5% to 27.5%.

The pair surveyed over 1,000 people between the ages of 14 and 24 to discover what was behind the surge. Asked why they thought people their own age vaped, respondents gave answers like social pressures, the desire to experiment and the buzz from the product. Most were aware of the dangers.

Although the majority of young vapers go for flavored e-cigarettes, among them fruit, menthol, mint, candy and dessert, Chang and Waselewski found that just 5% of young respondents mentioned the taste as a reason for vaping.

Read more: Juuling among US youth is about the cool factor, new study suggests

Even if not that many young people mentioned taste as a reason to start vaping, having flavors that appeal to a younger audience has been a key strategy of the e-cigarette business.

Leah Ranney, director of tobacco prevention and evaluation at University of North Carolina at Chapel Hill, argues that companies have deliberately used flavoring, alongside other youth-targeting strategies, to lure younger nonsmokers into vaping.

The use of appealing packages and flavors has a significant impact on young people, causing them to perceive these tobacco products as less harmful and, in turn, making them more likely to experiment and continue using tobacco products, she concludes.

Read more: Flavored e-cigarettes sweetly lure kids into vaping and also mislead them to dismiss danger, studies suggest

Concerns over e-cigarettes are not restricted to how it may be leading teenagers to nicotine products. As Ilona Jaspers, also at University of North Carolina at Chapel Hill, notes, e-cigarettes have only been popular for a decade or so too early to say for sure what the long-term health risks will be to users. Jaspers studies how inhaled chemicals and particles affect human health and is far from convinced that scientists are fully aware of the extent of the dangers of vaping as yet.

It took decades for epidemiologists to discover that regularly inhaling the smoke from burning plant material, tobacco, caused lung cancer. Why would the scientific community be so quick to assume e-cigarettes would not have hidden dangers that might take years to manifest too? Jaspers writes.

She notes that there are hundreds of recorded cases of lung injuries that are associated with vaping and that the onset of these significant health problems is much faster than with smoking-related diseases. In short, she argues, a comparison with regular cigarette smoking is missing the point: Vaping in itself has health risks.

Read more: Vaping likely has dangers that could take years for scientists to even know about

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Whether comparisons to regular old smoking is appropriate for the relatively new e-cigarette sector is part of the reason it took the FDA so long to get around to regulating vaping products.

Michael P. Eriksen, of Georgia State University, explained in an article in 2016 that the federal government had been slow in casting a regulatory eye over e-cigarettes because the courts ruled that e-cigarettes were tobacco products and not drug-device combinations, which would have required FDA oversight. Things were further muddied when President Barack Obamas Family Smoking Prevention and Tobacco Control Act allowed the FDA to regulate some tobacco products, but did not explicitly include e-cigarettes, Eriksen notes.

As a result, the e-cigarette industry was basically unfettered for a period of time. That changed in August 2016 when the FDAs Center for Tobacco Products was handed regulatory authority over all electronic nicotine delivery systems, including e-cigarettes, a move that led to this weeks announcement that a trio of e-cigarette products had become the first to get authorizations for sale in the U.S.

Read more: Could FDA e-cigarette regulations help more people quit smoking?

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E-cigarettes get FDA approval: 5 essential reads on the harms and benefits of vaping - The Conversation US

Researchers at Johns Hopkins University analyzed popular vaping products and found nearly 2,000 chemicals not disclosed by manufacturers, as well as six potentially harmful compounds, including a pesticide. Will Kirk of Johns Hopkins University

When vaping first became popular, proponents were quick to claim it was safer than smoking cigarettes. New research suggests that might be a fallacy, reports Tiffany Kary of Bloomberg.

Scientists at Johns Hopkins University (JHU) discovered that vaping aerosols contain thousands of unknown chemicals and substances not disclosed by manufacturers, including industrial chemicals and caffeine. Their study appears in Chemical Research in Toxicology, a peer-reviewed journal produced by American Chemical Society.

Existing research that compared e-cigarettes with normal cigarettes found that cigarette contaminants are much lower in e-cigarettes, senior author Carsten Prasse, an assistant professor of environmental health and engineering at the Whiting School of Engineering and the Johns Hopkins Bloomberg School of Public Health, says in a statement.

The problem is that e-cigarette aerosols contain other completely uncharacterized chemicals that might have health risks that we dont yet know about," Prasse adds."More and more young people are using these e-cigarettes and they need to know what theyre being exposed to.

The study found traces of nearly 2,000 unknown chemicals in electronic cigarette vaping liquid and aerosols. Scientists also detected several known and potentially harmful compounds, reports Richard Haridy of New Atlas.

Researchers in Australia came up with similar results in a recent examination of 65 vape liquids. Every sample contained at least one potentially harmful chemical, including benzaldehyde, an airway irritant, and trans-cinnamaldehyde, an immunosuppressive agent, New Atlas reports.

In addition, their analysis detected trace amounts of nicotine in six samples, even though the products were marketed as nicotine free.

People just need to know that theyre inhaling a very complex mixture of chemicals when they vape, Prasse says in the JHU statement. And for a lot of these compounds we have no idea what they actually are.

For the JHU study, researchers analyzed four common tobacco vape flavors, as well as aerosols used in four e-cigarette devices, including a tank, disposable unit and two pods. In addition to the hundreds of unidentified chemicals, they discovered compounds linked to respiratory problems, a pesticide, industrial chemicals and caffeine, a known addictive substance.

That might be giving smokers an extra kick that is not disclosed, lead author Mina Tehrani, a postdoctoral fellow at the JHU School of Public Health, says in the statement. We wonder if they are adding it intentionally.

Study co-author Ana M. Rule, an expert in metals exposures from vaping at the Johns Hopkins Bloomberg School of Public Health,is concerned about the impact on the large numbers of young people taking up vaping believing they are making a healthier choice.

There are millions of middle school and high school students vaping that would not otherwise think of smoking, Rule says. For them there is no risk reduction, only increased risk.

JHU researchers became interested in the safety of vaping after the new smoking trend became popular. Prasse says he was convinced to look at this issue after his cousin, a former smoker, started vaping, claiming it was safe.

I have a problem with how vaping is being marketed as more healthy than smoking cigarettes, he says in the statement. In my opinion, we are just not at the point when we can really say that.

Read more here:

Nearly 2000 ChemicalsSome Potentially HarmfulFound in Vaping Aerosols - Smithsonian

The word vaping can be deceptive, since the single word can represent different behaviors. Vaping refers to a method of substance inhalation that delivers anything from blueberry-flavored vitamin D to delta-9-tetrahydrocannabinol (THC) into the body. Although health professionals often refer to electronic cigarettes (e-cigarettes) and vaping synonymously, e-cigarettes represent only a small fraction of the growing market for vaping products available to consumers of all ages.

Why All the Fuss?

We know that breathing in tar and asbestos is risky, but what about zinc, lead, chromium, manganese, and copper?1 All have been identified as components of various vaping products (eg, e-liquids, vape juice), although the long-term health consequences of these ingredients are not well defined. Although some e-liquid ingredients are considered to be safe to be ingested and processed in the gut and may thus be benign in that regard (eg, vegetable glycerin and propylene glycol), they may cause harm in the lungs.2 And, beyond the lung damage it can cause, aerosol inhalation may increase cardiovascular risk.3

In addition, nicotine vaping products increase the risk for the same health consequences as any other nicotine exposures, including: subsequent development of a nicotine addiction; priming for use of other substances; changes in attention, cognition, and impulse control; and increased risk of developing mood disorders.2 The risk is compounded by the ready availability of vape juices and e-liquids that have high concentrations of nicotine, beyond what are found in traditional tobacco products.4

Young children and developing fetuses may also be prone to indirect health consequences of vaping products. For instance, there are reports of vaping liquids being swallowed and absorbed through the skin and eyes in young children, resulting in poisoning. Fetal exposure can result in multiple adverse health consequences, including sudden infant death syndrome.3

So Why Vape?

Given the potential for harm, why do individuals vape nicotine and other harmful chemicals for purposes other than smoking cessation? Among youth, curiosity is the most common reason for vaping.5 Vaping may be seen an act that brings social benefit: Friends use what their friends use.6 Available online and in neighborhood stores, vaping products may be perceived as both fashionable and convenient.5 Plus, vape systems can be discreet (ie, no visible aerosol) or flashy (ie, production of large vape clouds). With advanced features such as voice control, accent lighting, and Bluetooth compatibility, there is a vaping device to appeal to almost any subculture and customer.

The ability to customize vape systems and liquids carries additional risks. Most samples obtained from the e-cigarette liquid of individuals being treated for e-cigarette or vaping product useassociated lung injury (EVALI) contained THC. Vitamin E acetate was identified in all samples, and glycerin, propylene glycol, diacetyl, aldehydes, formaldehyde, terpenes, organic compounds, and trace metals may have contributed to the more than 2800 EVALI cases and 68 associated deaths.7,8 In our investigation of college students vaping data collected from the 2018 to 2019 Health Minds Study survey, we found that almost 1 in 4 students who vaped used THC,9 and an analysis of 2018 National Youth Tobacco Survey data found that about 1 in 4 of the middle and high school student sample had vaped marijuana.10

Is This Behavior Legal?

The short answer is yes. A few US states and tribal governments, and some countries, have broadened prohibitions against smoking in public places to include vaping, but most have not. The US Food and Drug Administration (FDA) regulates flavors, predominantly when marketed to children and youth and when sold without age verification or without limiting number.11 Menthol, previously considered an adult flavor, is now banned per the FDA.12

How About Smoking Cessation?

Although vaping products are being used by nonsmokers, vaping has utility as a smoking cessation aid for adult consumers.13,14 Given the undeniable harms of smoking, vaping provides an option for people who are ready to quit smoking.13,14

Among youth, however, vaping is more often initiated as an addition or gateway to smoking. According to the results of one study, only 7.3% of high school seniors who vaped did so for smoking cessation.15 Furthermore, individuals with dual use (smoking and vaping) are exposed to increased harms.16

Clinical Implications

Paul, aged 35 with no history of psychiatric disorders, was a smoker for more than 30 years. Despite his use of numerous quit methods, Pauls frequent attempts to stop smoking were curtailed by his anxiety and disrupted concentration. Finally, his primary care provider convinced him to give vaping a 2-week try. Although cynical at first, Paul was relieved when he discovered vaping worked for him. In addition, he was thrilled to find products that were within his budget.

Unfortunately, vaping was not a 100% panacea. One day while working at his computer, Paul felt a sudden flash of pain and his pant leg burst into fire. A visit to the emergency department and a skin graft were required after his battery exploded in his pocket. Nevertheless, he is still vaping.

Paul says he will never return to smoking cigarettes, although he misses it. He is scheduled to see a pulmonologist; he is certain that vaping has been better for his health than the 2 packs a day he used to smoke. However, family and friends are concerned, he reports. They have pointed out that he is never without his vape pen, and he has realized he uses it with no conscious knowledge of doing so, regardless of where he is.

ASSESSING THE CLINICAL SIGNIFICANCE OF VAPING. Talking to a patient about vaping may require some investigation (Table). Frequency of use and the types of products used influence the safety and clinical significance of the behavior. If the patient is distressed by their behavior, experiences functional impairment, or reports poor health outcomes including symptoms of tobacco or cannabis use disorders, you may decide to provide assistance and help your client quit, or reduce, vaping behavior.

RESOURCES TO HELP YOUR PATIENT QUIT VAPING. The US Department of Health and Human Services17,18 and the FDA19 have online and printed resources to assist with smoking cessation, as have most US states.20 In-person and online classes and/or support groups, tailored text messaging services, a free QuitGuide app, and information related to nicotine replacement products are available. Patients can consult and access these resources when they want to quit smoking or vaping. While vaping cessation research is scant21-23 and is primarily limited to nicotine vaping, methods used to quit are likely amenable to those used in smoking cessation.16 US Preventive Services Task Force recommendations for clinicians are to ask about use, advise quitting, and provide behavioral interventions and pharmacotherapy.24

SPECIAL POPULATIONS. Teens and adolescents may require niched interventions, whether they are consuming nicotine via vaping or other methods.21-23 To this end, the Truth Initiative25 funded the development of a text-to-quit mobile application as an addition to their quit program for teens. This program is based on research of vaping patterns, quit attempts, and cessation motivation; interventions should be tailored to address social influences, outcome expectancies, and intentions to quit.21 Women who are pregnant also need a tailored approach to quit vaping; counseling techniques, including relaxation activities,26 and monetary incentives improve outcomes.27 Nicotine replacement therapy may also be helpful.28

Dr Striley is an associate professor and director of psychiatric epidemiology at the University of Florida. Ms Nuttey is a PhD student in epidemiology at the University of Florida.

References

1. National Academies of Science, Engineering, and Medicine; Health and Medicine Division; Board on Population Health and Public Health Practice; Committee on the Review of the Health Effects of Electronic Nicotine Delivery Systems; Eaton DL, Kwan LY, Stratton K, eds. Public Health Consequences of E-Cigarettes. National Academies Press (US); 2018.

2. E-cigarette use among youth and young adults. a report of the surgeon general. US Department of Health and Human Services. 2016. Accessed August 31, 2001. e-cigarettes.surgeongeneral.gov/documents/2016_SGR_Full_Report_non-508.pdf

3. Buchanan ND, Grimmer JA, Tanwar V, et al. Cardiovascular risk of electronic cigarettes: a review of preclinical and clinical studies. Cardiovascul Res. 2020;116(1):40-50.

4. Goniewicz ML, Boykan R, Messina CR et al. High exposure to nicotine among adolescents who use Juul and other vape pod systems (pods). Tob Control. 2019;28(6):676-677.

5. Romijnders KAGJ, van Osch L, de Vries H, Talhout R. Perceptions and reasons regarding e-cigarette use among users and non-users: a narrative literature review. Int J Environ Res Public Health. 2018;15(6):1190.

6. Jarmul S, Aherrera A, Rule A, et al. Lost in e-cigarette clouds: a culture on the rise. Am J Public Health. 2017;107(2):265-266.

7. Outbreak of lung injury associated with the use of e-cigarette, or vaping, products. CDC. Updated August 3, 2021. Accessed August 31, 2021. http://www.cdc.gov/tobacco/basic_information/e-cigarettes/severe-lung-disease.html

8. Griffiths A, Rauzi A, Stadheim K, Wheeler W. Lung injury associated with e-cigarette or vaping product use. Pediatr Ann. 2020;49(2):e93-e98.

9. Striley CW, Nutley SK. World vaping update. Curr Opin Psychiatry. 2020;33(4):360-368.

10. Ben Taleb Z, Kalan ME, Bahelah R, et al. Vaping while high: factors associated with vaping marijuana among youth in the United States. Drug Alcohol Depend. 2020;217:108290.

11. FDA finalizes enforcement policy on unauthorized flavored cartridge-based e-cigarettes that appeal to children, including fruit and mint. News release. FDA; January 2, 2020. Accessed May 11, 2021. http://www.fda.gov/news-events/press-announcements/fda-finalizes-enforcement-policy-unauthorized-flavored-cartridge-based-e-cigarettes-appeal-children

12. FDA commits to evidence-based actions aimed at saving lives and preventing future generations of smokers. News release. FDA; April 29, 2021. Accessed May 11, 2021. http://www.fda.gov/news-events/press-announcements/fda-commits-evidence-based-actions-aimed-saving-lives-and-preventing-future-generations-smokers

13. Hartmann-Boyce J, McRobbie H, Lindson N, et al. Electronic cigarettes for smoking cessation. Cochrane Database Syst Rev. 2021;4(4):CD010216.

14. Wang RJ, Bhadriraju S, Glantz SA. E-cigarette use and adult cigarette smoking cessation: a meta-analysis. Am J Public Health. 2020;111(2):230-246.

15. Evans-Polce RJ, Patrick ME, Lanza ST, Miech RA, OMalley PM, Johnston LD. Reasons for vaping among U.S. 12th graders.J Adolesc Health. 2018;62(4):457-462.

16. Prochaska JJ, Benowitz NL. Current advances in research in treatment and recovery: nicotine addiction. Sci Adv. 2019;5(10):eaay9763.

17. QuitGuide. Smokefree.gov. Accessed May 11, 2021. smokefree.gov/tools-tips/apps/quitguide

18. Tobacco information and tips for quitting smoking. BeTobaccoFree.gov. Accessed May 11, 2021. betobaccofree.hhs.gov/home

19. Smoking medicines to help you quit. FDA. Updated September 25, 2018. Accessed May 11, 2021. http://www.fda.gov/consumers/free-publications-women/smoking-medicines-help-you-quit

20. Smoking cessation information & programs. Tobacco Free Florida. Accessed May 11, 2021.

21. Berg CJ, Krishnan N, Graham AL, Abroms LC. A synthesis of the literature to inform vaping cessation interventions for young adults. Addict Behav. 2021;119:106898.

22. Cuccia AF, Patel M, Amato MS, et al. Quitting e-cigarettes: quit attempts and quit intentions among youth and young adults. Prev Med Rep. 2021;21:101287.

23. Amato MS, Bottcher MM, Cha S, et al. Its really addictive and Im trapped: a qualitative analysis of the reasons for quitting vaping among treatment-seeking young people. Addict Behav. 2021;112:106599.

24. US Preventive Services Task Force; Krist AH, Davidson KW, Mangione CM, et al. Interventions for tobacco smoking cessation in adults, including pregnant persons: US Preventive Services Task Force recommendation statement. JAMA. 2021;325(3):265-279.

25. Vaping: this is quitting. a 24/7 support network. The Truth Initiative. Accessed May 11, 2021. http://www.thetruth.com/article/this-is-quitting

26. Chamberlain C, OMara-Eves A, Oliver S, et al. Psychosocial interventions for supporting women to stop smoking in pregnancy. Cochrane Database Syst Rev. 2013;10(10):CD001055.

27. Notley C, Gentry S, Livingstone-Banks J, et al. Incentives for smoking cessation. Cochrane Database Syst Rev. 2019;7(7):CD004307.

28. Livingstone-Banks J, Norris E, Hartmann-Boyce J, et al. Relapse prevention interventions for smoking cessation. Cochrane Database Syst Rev. 2019;(10):CD003999.

Read more here:

The ABCs of Vaping - Psychiatric Times

After years of debate, research, and data accumulation, the FDA finally approved a vape for commercial use. With the debate continuing, children are becoming the new battlefield.

On Oct. 12, the Federal Drug Administration (FDA) announced the first vape authorized for mass marketing and distribution in the United States.

In a press release, the federal agency declared they granted orders to R.J. Reynolds (RJR) Vapor Company for its Vuse Solo closed ENDS device and accompanying tobacco-flavored e-liquid pods.

The authorization comes after several vape companies handed over samples to the FDA for testing and potential regulation. Only the Vuse product from the Reynolds Company met the requirements that the FDA demanded.

Not all of the flavors were approved only the nicotine flavor which lacks the other additives that provide an extra taste.

The main reason for approving the product is the potential assistance it can provide for people who are addicted to nicotine products. Other alternatives like nicotine gum do not provide the same physiological connection of inhaling and exhaling.

Todays authorizations are an important step toward ensuring all new tobacco products undergo the FDAs robust, scientific premarket evaluation, Mitch Zeller, J.D., director of the FDAs Center for Tobacco Products, said in the press release. The manufacturers data demonstrates its tobacco-flavored products could benefit addicted adult smokers who switch to these products either completely or with a significant reduction in cigarette consumption by reducing their exposure to harmful chemicals.

The Vuse vape is available at various gas stations, smoke shops, and other convenience stores. Their large availability plays an important role in the Reynolds Companys overall success.

Like many traditional vapes, the Vuse has a refillable cartridge that relies on a liquid, commonly referred to as juice, to provide the inhalable vapor. This liquid is found in replaceable pods. The device features a battery that allows for greater portability as well.

The three flavors offered by the company are menthol, golden tobacco, and rich tobacco. The pods are placed magnetically into the device. All of the flavors offer a contrast from the fruity flavors other companies use to market towards younger audiences.

Currently, Vuse owns 33 percent of the market share while Juul owns 40 percent. With a shift towards flavorless pods, the market share that Vuse acquired without appealing to a younger audience played a role in the product becoming authorized.

For these products, the FDA determined that the potential benefit to smokers who switch completely or significantly reduce their cigarette use, would outweigh the risk to youth, provided the applicant follows post-marketing requirements aimed at reducing youth exposure and access to the products, the FDA stated in a press release.

While the FDA felt the device would not lead to the youth gravitating towards the Vuse product, certain health experts are concerned with the adverse consequences of authorizing a vape product.

Ryan Barrlett of Utahs Department of Health, felt as if a green light was given to people to consume and use vape products. Young adults, one group of concern for the FDA, may misinterpret the authorization.

When it comes to e-cigarettes, were most concerned about youth, people who are in high school, middle school and even into the young adult range, Bartlett said to Deseret News. Because thats the age where if you start using this, theres a fairly good chance youre going to use for the rest of your life.

Apart from the confusion caused by the authorization, the Vuse device is only authorized for people who are attempting to quit smoking, not someone who is starting to vape. There is still the likelihood that a person who uses Vuse will emerge addicted to nicotine and could then start smoking cigarettes.

Eric Lindlom, a former official at the FDA, mentioned the specific use for the device is the only one tolerated. Any other uses pose risk for the user.

The only way Vuse [products] could be used to reduce health harms relating to tobacco are if smokers switch entirely or near-completely from smoking to using the Vuse e-cigarette instead, Eric Lindblom, a former official at FDAs Center for Tobacco Products who is now a senior scholar at the Georgetown University Law Center, wrote in an email to POLITICO. Any other use will increase the health harms and risks to the users.

Compliance with the FDA requires multiple checks on a product to make sure it is consistently meeting the requirements. For the Vuse device, the amount of aerosols the device produces is the key aspect. As long as the amount is low enough to warrant the use for addicts, the regulation could continue.

These products were found to meet this standard because, among several key considerations, the agency determined that study participants who used only the authorized products were exposed to fewer harmful and potentially harmful constituents (HPHCs) from aerosols compared to users of combusted cigarettes, the FDA stated in their press release.

Going forward, the FDA still needs to rule on other companies products. The decision on Juul products was delayed with a ruling that should be executed within the near future.

With the FDA establishing that youth deterrence is a priority, they stated more actions are still needed to fully regulate vaping. After several products were ruled to be removed for marketing and sales, other potential actions loomed on the horizon.

Jody Sindelar, in the New England Journal of Medicine, addressed one of the potential actions which may follow regulation rulings: taxation.

With taxes rising on cigarettes to make them more expensive than vapes, nicotine addicts could transition to vaping rather than smoking cigarettes.

Also, if taxes are high enough, the high price of vaping could result in fewer young people becoming inclined to spend so much money. The next regulation could be higher taxes along with banning flavored vapes.

Young people could end up being deterred from even starting to vape with a higher entry cost and less attractive flavors.

The future of vaping regulation remains up in the air, and multiple avenues can develop according to how many more devices are FDA approved.

Depending on how the market develops, other actions like Dr. Sindelar proposed could be instituted as a means of achieving youth deterrence. As more research is done, increasingly strict or loose regulation could be coming soon.

Photo by Sarah Silbiger/Getty Images.

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The FDA exhales a vape approval - The UCSD Guardian Online

Health professionals claim that vaping is better for you than smoking cigarettes, but that doesn't mean it isn't harmful.

According to the U.S. Food and Drug Administration (FDA), cigarette smoke contains more than 7,000 chemicals, and 70 of them are linked to cancer. People who have turned to vape pens may think that they're dodging these potentially toxic chemicals. A recent study shows that's not necessarily the case.

RELATED:The #1 Reason You Gain Weight After Quitting Smoking, Says New Study

In the study, which was published in the journal Chemical Research in Toxicology, researchers at Johns Hopkins University uncovered nearly 2,000 chemicals in the aerosols produced by an e-cigarette. Even more concerning, at least six were identified as "potentially harmful."

"Existing research that compared e-cigarettes with normal cigarettes found that cigarette contaminants are much lower in e-cigarettes. The problem is that e-cigarette aerosols contain other completely uncharacterized chemicals that might have health risks that we don't yet know about," senior author Carsten Prasse, an assistant professor of environmental health and engineering at the Whiting School of Engineering and the Bloomberg School of Public Health said in a statement."More and more young people are using these e-cigarettes and they need to know what they're being exposed to."

Previous studies have demonstrated an association between e-cigarette use and increased odds of asthma and chronic obstructive pulmonary disease (COPD). In fact, the data suggest that the odds of developing COPD are nearly six times greater in those who both vape and smoke tobacco regularly, compared to those who don't vape or smoke at all.

What's confusing is that the FDA just approved three vaping products under the brand name Vuse, making them the first e-cigarettes authorized to be sold in the U.S. The agency said it was a move to help offer smokers a way to quit traditional cigarettes, despite the fact that it could also inspire younger generations to get hooked on them.

"The authorized products' aerosols are significantly less toxic than combusted cigarettes based on available data," the FDA said in a statement.

Later in the statement, it reads: "The FDA determined that the potential benefit to smokers who switch completely or significantly reduce their cigarette use, would outweigh the risk to youth."

The question is, why would the FDA approve of a product that allegedly has thousands of chemicals in it? From what the latest research indicates, there's a lot of unknown ingredients in e-cigarettes that could pose a threat to our bodiesespecially if inhaled excessively.

For more, be sure to check outThe #1 Reason to Smoke Medical Marijuana, Say Doctors. Then, don't forget to sign up for our newsletter!

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Vaping Can Expose You to Nearly 2,000 Chemicals, Says New Study | Eat This Not That - Eat This, Not That

For the first time, the U.S. Food and Drug Administration has authorized the sale of a group of e-cigarette products. In the process, it has held the industry to serving only the purported valid purpose of the devices to help people quit smoking.

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FDA hits mark on vaping | Letters to the Editor | standardspeaker.com - Standard Speaker

Original post (published September 29, 2021):

On Thursday, Sept. 23, the Food and Drug Administration (FDA) announced that since Aug. 26 it had issued 323 orders denying applications by companies seeking to keep their vaping products in the market. These denials affect more than 1,167,000 flavored vape products. The FDA said previously it was denying applications that lacked sufficient evidence that they [vape products] have a benefit to adult smokers sufficient to overcome the public health threat posed by the well-documented, alarming levels of youth use of such products.

This comes after a Sept. 9 announcement that the agency would not meet a Sept. 9 deadline to make decisions on applications by vaping companies. All manufacturers of e-cigarettes and related products were required under a court order in 2019 to submit applications for FDA review by Sept. 9, 2020. However, the companies were allowed to keep these products on the market for one year while the FDA reviewed the applications.

Despite the progress reported by the FDA in reviewing and taking action on about 93% of applications, the majority of the denials are for flavored vape products from small and medium-sized companies and do not include large companies like Juul, which has a 40% market share.

The Centers for Disease Control and Prevention reported a decline in high school students who reported current use of e-cigarettes down from 27.5% in 2019 to 19.6% in 2020. However, an overwhelming majority, 84.7%, of high school students who used e-cigarettes in 2020 reported they use flavored e-cigarettes. The 2020 Arkansas Prevention Needs Assessment Survey found that among Arkansas public school students, the average age of first-time e-cigarette users is 13.5 years. The survey also showed that 3.2% of sixth graders, 9.8% of eighth graders, 16.9% of 10th graders, and 19.8% of 12th graders reported using a vaping product within the last 30 days.

States, including Arkansas, have acted to protect young people from the health hazards of vaping products. Arkansas legislation in 2019increased the minimum purchasing agefor vaping products from 18 to 21, shortly prior to federal legislation that increased the minimum purchasing age to 21 and became effective in January 2020.

Additional steps that states could take to curb youth use of vaping products include:

For more information about this evolving issue that continues to impact Arkansans, visit ourVaping Updates and Insightspage.

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UPDATE: FDA Authorizes 3 Vape Products After Rejecting 323 Other Applications From Vape Companies - Arkansas Center for Health Improvement

LAGUNA BEACH According to local news media reports, the city council for Laguna Beach (a small coastal city in Orange County) is considering a proposal to ban tobacco products in the city.

A city council staff report viewed by Vaping Post indicates that the elected governing body will decide to ban such sales and consider an assignment of staff to study the potential impact of such a plan and what this would mean for city revenue.

The nonprofit news outfit Voice of OC reports that the council voted to prohibit the use of smoking products (tobacco, nicotine, and marijuana) in public. The ordinance expanded smoking regulations to include all public places, including the outdoors.

The staff report suggests that councilmember George Weiss has requested a discussion on ending all retail sales of tobacco and vaping products within the city limits of Laguna Beach.

The document states that the policy consideration of the request, a majority of the City Council must first vote to direct staff to research and analyze the issue, and draft a proposed ordinance for the city council to review and take action at a future meeting.

Weiss told Voice of OC reporters that his move to adopt such an initiative comes from his personal beliefs and his campaigning.

Reportedly, he asked why people supported something that kills people, alluding to electronic cigarettes. Weiss also emphasized in the interview that the advantages of a potential ban could boost health and safety for individuals and the whole community.

Weiss, however, cited no further information to support the claims. This includes a lack of evidence consideration from entities like Public Health England in the United Kingdom, which says that vaping is 95 percent safer than smoking.

Legislative action is expected in the coming weeks.

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Laguna Beach Considering Banning The Sale of All Tobacco and Vapes - Vaping Post

The Canadian government recently consulted on its proposals for regulatingread:banningflavors used in vaping products. Its supposed justifications include a perceived increase in youth vaping exposing young people to harm, and the notion that vaping is a gateway into cigarette smoking.

Both concerns are flawed to say the least, as is Health Canadas claim that banning all flavors except tobacco and menthol is any kind of solution.

According to Statistics Canada, teen smoking has been falling more rapidly than in previous years and is now at a record low. If vapes were driving cigarette use, surely smoking rates would be increasing? When it comes to teen vaping, research suggests that youth who vape would be smoking at higher rates if vapes werent available. Data from more than one country have shown that most daily teen vapers have previously tried smoking. And research has also shown that vaping is a gateway out ofnot intosmoking.

By eradicating flavors, Health Canada risks ridding vaping of one of its most prominent attractions.

Health Canadas consultation document suggests that existing smoking cessation methods like traditional nicotine replacement therapy and medications work, while vaping is an unproven way to quit smoking. This entirely contradicts evidence which repeatedly shows vaping to be more effective in helping smokers to quit than NRT.

The consultation document also claims that young people are being exposed to vaping-related harms, yet Health Canada admits that There is currently no data on the long-term health consequences of vaping due to the relatively recent use of these products in Canada. When we know that vapes are vastly safer than cigarettesand that millions of people have used them as an effective route away from the established deadly long-term harms of smokingit is not proportionate to take such a strong precautionary stance.

Regarding flavors, Health Canada says that tobacco and unsweetened menthol should be adequate for vapers. This ignores the fact that many adult smokers find vape flavors essential to their efforts to quit. Governments simply should not be creating barriers for switching to safer products.

There is also a lot of evidence that flavors prevent people from returning to smoking. In a study published in July 2021 by George Washington University, 33.2 percent of vapers aged 18-34 said that without flavors they were likely to switch back to cigarettes. By eradicating flavors, Health Canada risks ridding vaping of one of its most prominent attractions.

Health Canada also attaches no value to dual use This is a fundamental misunderstanding of the process by which safer alternatives attract and keep smokers.

Health Canada also attaches no value to dual use of vapes and cigarettes, and therefore cares little if dual users revert to only smoking. It is anticipated that certain dual users would relapse to smoking only as a result of the proposal, reads the document. However, benefits of vaping by people who smoke are only accrued if they completely switch to vaping.

This is a fundamental misunderstanding of the process by which safer alternatives attract smokers and keep them as reduced-risk consumers instead. Unless a smoking cessation method is 100 percent effective immediately, there will be continued smoking in the period between attempting to quit and successfully quitting smoking. Dual use should be understood as a transitional phase in the migration from smoking to vaping.

Health Canada is admitting defeat by saying there is no value in dual users. It is the heaviest smokers and therefore the hardest to reachwho stay in the dual use phase longest before switching entirely.

Most damning of all, the Health Canada justifies its proposed policies in part with the contention that businesses which sell vaping products will benefit from an increase in tobacco sales instead as a result. This may be correct, but how can it be what any responsible government wants to achieve?

Canada should not be trying to re-invent the wheel on vaping regulations when they could just look across the Atlantic and replicate an environment which addresses their concerns and is working admirably.

Here in the United Kingdom, vaping is widely encouraged as an option for smokers looking to quit. The National Health Service recommends them to smokers and the government and Royal College of Physicians advocate for promoting e-cigarettes widely as a substitute for smoking.

Canada would be well-advised to replicate regulation that works in the UK.

Despite a wealth of flavors being readily available, UK tobacco control organization Action on Smoking and Health (ASH) reports that young never-smokers do not take up vaping because they find flavors and packaging attractive. Only 0.7 percent of 1118-year-olds who regularly use e-cigarettes were not former smokers.

Annual surveys by ASH have also charted the progress of how dual use leads to full switching to safer products. This year, the UK has 3.6m vapers, two-thirds of whom are ex-smokers who have fully switched. This proportion has increased steadily from 33 percent in 2014. Denying the benefit of dual use as part of a journey is to throw away a big prize for public health.

The UKs liberal regulation of alternative nicotine products has not led to a wild west of nicotine use, nor has it led to a rampant youth vaping epidemic. Instead, it has served to demystify vaping products and place them squarely in the category of smoking cessation tools.

Canada would be well-advised to replicate regulation that works in the UK rather than wasting taxpayer money on proposals that would be disastrous for public health.

Photograph via Pixabay

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Health Canada Is Poised to Take a Disastrous Wrong Turn on Vaping - Filter