#premarket tobacco product application

[tehalchemists-blog]

https://www.vice.com/en/article/vape-bust-counterfeit-china-geek-bars/

They got 11500 differnt devices apparently west mart says ware house isn't gonna sell no more there's only technically 23 legal devices https://www.fda.gov/tobacco-products/premarket-tobacco-product-applications/premarket-tobacco-product-marketing-granted-orders

Yeah anywhere selling couldla got hit in a FDA sting smh this posting link of what we will have left gonna sell https://www.fda.gov/-

logic dafaq is that shit and guess njoy is the way to go so anyway stock up on your vapes cuz there gonna be gone apparently

https://www.fda.gov/tobacco-products/premarket-tobacco-product-applications/premarket-tobacco-product-marketing-granted-orders

[vapehk1]

The Impact of PMTA Regulations on Small Vape Companies in the US Market

The US vape market is currently facing significant challenges due to the Premarket Tobacco Product Application (PMTA) process, implemented by the Food and Drug Administration (FDA). This regulatory pathway is crucial for new tobacco products aiming to enter or remain on the market, demanding a high level of scientific evidence to demonstrate that these products are a fit for public health protection. The Costly Affair of Compliance The PMTA process is not only rigorous but also costly, with average expenses amounting to $466,563 per application. Depending on the depth of original research and analysis required, these costs can soar even higher. This financial burden is split across clinical studies, non-clinical (toxicology) investigations, and manufacturing costs—each demanding a significant financial commitment. A Barrier for the Small Players These steep costs pose a daunting barrier, primarily affecting smaller vape companies. The financial demands of the PMTA process have sparked concerns that only well-established tobacco giants can endure this financial hit, potentially stifling innovation and limiting choices for vape enthusiasts. Smaller entities struggle to navigate through this costly and complex regulatory maze, which could lead to a less diverse market. Success Amidst Struggle Despite these hurdles, there are success stories within the PMTA framework. To date, the FDA has green-lit the marketing of 45 tobacco-related products, including devices and tobacco-flavored e-cigarettes. Noteworthy approvals include products from big names like Philip Morris Products S.A. and NJOY LLC’s NJOY DAILY and NJOY DAILY EXTRA Rich Tobacco. Meanwhile, R.J. Reynolds Vapor Company's VUSE is making strides with its Vuse Vibe ( but awaits approval on its pods range) and the phased-out Vuse Ciro Power Units. The Double-Edged Sword of PMTA The PMTA process serves a dual role. It ensures that each new tobacco product undergoes a thorough public health impact assessment. However, it also imposes a significant financial strain on manufacturers, potentially curbing competition and innovation within the market. While larger companies can manage these rigorous requirements, smaller vape businesses are at a serious disadvantage, potentially reshaping the market landscape to favor the financially robust. Final Thoughts: Looking to the Future of Vaping The PMTA process is pivotal in ensuring that vape products adhere to strict health standards, yet the complexity and cost associated with it could favor larger corporations at the expense of smaller enterprises and consumer choice. The limited number of approved brands and products highlights the challenging nature of this pathway. As the vape industry evolves, it's crucial to keep an eye on how these regulations will affect market dynamics and public health outcomes. Stay tuned, follow our blog for more updates, and discover how you can engage in meaningful advocacy for a diverse and innovative vape market. Remember, every puff counts towards shaping the future of vaping! Read the full article

[shenzhenmicrowell]

How to identify compliant vape products

To identify compliant vape products, you should look for the following:

Age verification: Reputable vape retailers will have strict age verification policies in place to prevent underage access to vaping products. This may include requiring customers to upload a government-issued ID to verify their age before purchasing.

Proper labeling: Compliant vape products will have clear labeling that includes the name of the product, the manufacturer, the ingredients, and any warnings or instructions for use.

Third-party testing: Look for vape products that have been third-party tested for quality and safety. Reputable manufacturers will typically list the results of these tests on their website or packaging.

Compliance with regulations: In the United States, vape products are regulated by the Food and Drug Administration (FDA). Look for products that comply with FDA regulations, such as those that have been authorized through the premarket tobacco product application (PMTA) process.

Brand reputation: Do some research on the brand of vape product you're considering. Look for reviews and testimonials from other users, and make sure the brand has a good reputation for quality and safety.

vaporesso.com

[csures]

Discover how research agencies can assist manufacturers with a premarket tobacco product application to comply with government legislation

A Premarket Tobacco Product Application (PMTA) can be submitted by any product manufacturer of a new tobacco product, who seeks an FDA marketing order. The purpose is to provide regulatory bodies such as the Food and Drug Administration with scientific proof that the product is appropriate, in order to comply with the public health protection bill.

However, the process of premarket tobacco product application can be very complicated, and for most manufacturers, it remains a challenging task, especially when all they want to do is introduce their new product to the market and see if flying off the shelves. For this reason, manufacturers of tobacco products sometimes enlist the services of reputable, internationally recognised research agencies to assist them in the application process.

Research agencies and leaders in the field of behavioural science in tobacco harm reduction and usually work in close relation with tobacco companies like British American Tobacco (BAT) to ensure approval of their Premarket Tobacco Product Applications. Through extensive research, these companies are able to not only obtain relevant to ensure that quality and control is brought to the tobacco industry but also advocate harm reduction of tobacco products.

For the general public, especially users of tobacco products, it can be easy to mistakenly think that regulatory requirements are just a means to make money, but no amount of money can be placed on the life of a human being and the fact remains that tobacco products, including tobacco cigarettes, e-cigarettes and vapes, are detrimental to one’s health.

The principal aim of PMTA is to encourage tobacco manufacturers to comply with regulation and keep their products, as well as consumers safe. Consumers need to be protected and in countries like the UK, legislation (the Tobacco Regulation Act of 2003) prohibits the sale of single cigarettes or small packs of cigarettes, tobacco for oral use and tobacco products via vending machines. Tobacco products can also not be sold to any person under the age of 18 years.

Under the same omnibus law as mentioned above, the advertising of tobacco cigarettes, sponsorship and promotion thereof, and smoking in public places is also prohibited. Consumers sometimes wonder why such legislation even exists, but based on extensive research and scientific evidence, these rules have been created to create a healthier future for British citizens and to protect the public against tobacco harm.

Despite public health campaigns and various forms of legislation, smoking of tobacco products remains the top avoidable cause of worldwide deaths, and currently, it is costing the world economy millions every year in healthcare expenses and loss of productivity. The burden of tobacco-related costs also puts heavier pressure on those who can least afford it, yet the consumption of tobacco products continues to rise every year, including the sales of c-cigarettes and vaping devices. This can be largely attributed to the aggressive marketing by tobacco companies.

The use of and exposure to tobacco is a public health issue that should in fact receive more attention (this remains a debatable topic for many) and had it not been for legislation and the valuable, weight-bearing substance research by leading research agencies, perhaps half of the world's population would have been wiped out from lung and heart diseases by this time.

Tobacco giants like BAT are some of the largest cigarette manufacturers in the world and yet they work closely with research agencies to promote and even encourage tobacco harm reduction and good health in general. Perhaps now you will better understand the words of warnings like ‘smoking is dangerous’ and ‘Smoking kills’, which are often printed on the packaging of tobacco products.

About us: CSUR is a Global Leader on Behavioural Science in Tobacco Harm Reduction, operating from their base at the Centre for Substance Use Research Ltd in Glasgow. CSUR opened in 1994 linked initially to the University of Glasgow, and in 2011 CSUR became a wholly independent research centre focussing on a wider range of substance use issues and developing a large programme of behaviourally focussed regulatory science research assessing the contribution of ENDS in reducing tobacco-related health harm. Our team comprises post-doctoral researchers in behavioural science, experts in marketing, cybersecurity, and media. Our focus is on furthering the goals of tobacco-related harm reduction and assessing the public health impact of Electronic Nicotine Delivery Systems and our goal is to ensure that those working within these industries have access to high-quality behavioural research that can further their owns goals of reducing the harms associated with the use of combustible tobacco products. Find out more by visiting our website at https://www.csures.com

[diyvapor]

Vaping Prohibition is On the Table in Congress!

While all eyes are on the White House this week, we are reminding members that several bills in Congress could do more harm to consumers and be enacted faster than FDA can take enforcement action against the vapor industry. In July, a US District Court judge, Paul Grimm, produced a remedy order that requires the FDA to enforce the premarket tobacco application (PMTA) requirement starting in May of 2020. This effectively moves up this particular compliance deadline by more than a year. While a small handful of companies might be in a position to attempt compliance with this new deadline, the rest of the vapor industry is not.

Take Action - Send a Message!

Strict enforcement of this deadline will force most US manufacturers to shut down. Even though the FDA will retain enforcement discretion with regard to certain compliance deadlines on a case-by-case basis, it is not clear how (or even if) the agency will apply it. In other words, there is no guarantee that companies will be allowed to keep their products on the market. At the same time, several bills are active in Congress that would undermine FDA’s authority over new tobacco products. These bills propose to raise taxes, ban flavors, limit online sales, and one bill even goes as far as requiring vapor products to be approved for market only as medical drugs/devices. CASAA is asking our members to take action by sending a message to your federal lawmakers urging them to reject this legislation and prevent a massive underground market from taking the place of our current legal, regulated marketplace. We will start delivering your messages one week from now to coincide with a lobby day organized by the Vapor Technology Association.

Take Action - Send a Message!---

The long version: By way of background, In July, Judge Paul Grimm, US District Court District of Maryland, ruled that the FDA has until May 2020 to enforce the premarket tobacco application (PMTA) requirement for new tobacco and vapor products. The initial compliance deadline for PMTA was August 8, 2018. But in July 2017, the FDA delayed the PMTA deadline to 2022--for non-combustible products--citing a need to give vapor manufacturers more time to prepare and submit meaningful applications that would be more likely to be accepted by the agency. Within a year, the FDA changed course after reviewing national survey data showing a sharp uptick in youth use of vapor products. The updated guidance would require applications to market vapor products in flavors other than tobacco to be submitted and accepted by the FDA by August of 2021. Although never finalized, the draft guidance would have also limited sales of flavored vapor products to adult-only specialty vapor/tobacco stores. In 2018, the American Academy of Pediatricians (AAP) sued the FDA with the goal of reinstating the original August 8, 2018 PMTA compliance deadline. Following an exchange of proposed remedy briefs by both parties, Judge Grimm ruled that FDA’s suggestion of no less than ten months from the date of the court’s decision would be necessary for companies to finalize and submit acceptable applications. Judge Grimm granted FDA’s request. The ten-month deadline is one of four points detailed in Judge Grimm’s remedy order. The remaining provisions of the order are as follows:

New products for which applications have not been filed within this period shall be subject to FDA enforcement actions, in the FDA’s discretion;

New products for which applications have been timely filed may remain on the market without being subject to FDA enforcement actions for a period not to exceed one year from the date of application while FDA considers the application;

The FDA shall have the ability to exempt New Products from filing requirements for good cause on a case-by-case basis.

While the one-year “grace period” for a manufacturer to keep a product on the market during FDA’s review of their application is nothing new, the points regarding the agency’s enforcement discretion and ability to exempt new products from the filing requirements are significant.

It may be hard to believe, but FDA specifically asked the court to preserve the agency’s enforcement discretion citing negative consequences of a mass exodus from the vapor market and an extreme and sudden decrease in access to safer alternatives to smoking. The FDA expressed strong concern that such an event would cause thousands of people who vape to return to smoking.

Preserving FDA’s enforcement discretion is not a free pass for the vapor industry and consumers should be very concerned about what this remedy order means for our access to vapor shops, vapor products, and other resources. The FDA and Congress are still facing tremendous pressure from anti-nicotine activists to ban flavors, enact taxes on vapor products, ban online sales, and raise the purchase age to 21. Additionally, we are monitoring a budding movement by local governments in California to take matters into their own hands by requiring that a vapor company has a marketing order from the FDA in order to sell their product in their city.

Take Action - Send a Message!

Thank you,

CASAA Legislative Team

[vapebiz]

Vape manufacturers must submit PMTAs in 10 months or shut down

Vape manufacturers must submit PMTAs in 10 months or shut down

Vaping manufacturers must submit premarket tobacco applications (PMTAs) within 10 months or remove their products from the market, according to an order issued today by federal District Court Judge Paul W. Grimm.

The judge struck down the FDA’s 2017 guidance in May, agreeing with plaintiffs that the agency’s 2022 PMTA deadline (which extended the due date for applications from 2018) was issued…

[biotechresearch-blog]

Beat FDA 510k Consultants And Their Services

What does the FDA approve?

The FDA can regulate a wide range of products, including foods, which are regulated by the U.S department the human and veterinary drugs, vaccines and other biological protects, the medical devices intended for human use, radiation-emitting electronic products, cosmetics, dietary supplements, and the tobacco products.

The FDA of medical device and the requirement that the FDA verifies/ enforce at the time they are offered for the import into the United States. The center for devices and radiological is the FDA center responsible for overseeing the medical device program.

What medical device requirement at the time of importation

At the time of importation, the FDA will verify compliance the following requirement

The central medical device may need to comply with premarket submission requirements

The FDA conducts the field examination and analyses samples of medical devices to ensure all applicable standards and label requirements.

The FDA checks the import alert database to ensure the product is not subject to detention without the physical exam and listed on an import alert. Read More

[uwelltech]

Disadvantages of e-cigarettes?

1. Too many choices: 

To a new vaper, or a smoker considering a change, the endless options presented by the vaping market can be overwhelming. With cigarettes, you choose a brand and light up, but with vaping there are literally millions of possible choices. That’s why it’s best to point the vape-curious toward easy-to-use products with simple instructions to get started, and then to good sources of further information (vape shops, forums, experienced vapers) as new vapers learn the finer points.

2. The vape learning curve: 

Maybe the biggest danger for a new vaper is buying a product that requires specialized knowledge. Often they wind up confused and frustrated, and regret trying to switch to vaping. Again, there is no need for a long learning curve! Simple starter products are almost always the best first choice.

3. Potential health risks: 

It’s true that vaping is too new for us to understand every potential risk it could pose. But if you’re using vaping to stay off cigarettes, you can rest easier knowing that you’ve distanced yourself from the well-documented dangers of smoking. The substances in cigarette smoke that make it uniquely harmful are either entirely absent from e-cig vapor or only present in tiny amounts. That makes it much safer for vapers, and also for bystanders subject to “secondhand vapor.”

4. Vapers face smoking stigma: 

For almost 60 years, tobacco control has focused on smoking “denormalization,” which is just a fancy word for stigmatizing smoking and smokers. Now the same drug war-style campaign to dehumanize people who smoke is being turned against vapers too. Because vaping looks like smoking to people who do neither, smokers who switch to safer vaping products are often disheartened to discover they face the same stigmatization, rooted in ignorance, fear and intolerance.

5. Vaping is perceived as a youth problem: 

Because of the endless news stories about a “teen vaping epidemic,” older smokers may shy away from vaping as a way to quit smoking. The fact is that adults of every age vape—and the legal age to buy vapes is 21—but for those coming to e-cigarettes now, soon after the “JUUL panic” era, it may not be easy to separate the harm reduction benefits of vaping from the adolescent fad perception.

6. Nicotine misinformation: 

Nicotine is probably as misunderstood as any drug in the world. It’s really just a mild stimulant that has effects similar to caffeine. But because its history is inevitably tied to smoking—a highly dangerous delivery mechanism—nicotine has a terrible reputation. Nicotine doesn’t cause cancer or heart disease, but many people mix up the effects of nicotine and smoking, including doctors that regularly treat lifelong smokers. Nicotine actually can offer health benefits for many users.

7. Restrictive laws and rules: 

Based mostly on the vaping “epidemic” promoted by anti-vaping organizations, vaping has become a ripe target for laws and regulations that reduce vaping choices, availability and cost. More than half of American states have taxes on vaping products, and Congress recently passed a law banning U.S. Postal Service delivery of vaping products. Some states have banned vape products in flavors other than tobacco.

8. FDA regulations may eliminate vaping choices: 

The biggest government threat to vaping may be the Food and Drug Administration’s Premarket Tobacco Application (PMTA) process. Manufacturers wishing to keep their products on the market were forced last fall to submit complex applications to prove the products are “appropriate for the protection of public health.” Experts believe the FDA will use the PMTA process to wipe many of the best vaping products off the market. (Cigarettes were grandfathered onto the market without having to submit PMTAs, by the way.)

9. Finding the truth about vaping isn’t easy: 

Vaping is a disruptive technology that threatens the tobacco industry, but it also threatens the powerful anti-smoking industry. It can be very hard for a smoker or new vaper to separate the lies from the truth about vaping, since these powerful foes advance their narratives in every kind of news outlet and even through allied federal agencies. Because there are lots of frightening stories about vaping. It’s easy to get scared away.

Read more e-cigarette news👉vape news

[burningpainterface]

RELX - A Global Leader in Information-Based Analytics

RELX is a world leader in information, risk management, and business analytics. Its principal brands include Elsevier and LexisNexis (legal and scientific information), as well as the Reed exhibition brand, which holds 500 events annually in over 30 countries. The company serves over 40 million people worldwide and has a $1.4 billion market cap. While it's unclear whether RELX will be able to receive a 510(k) from the FDA, its rapid growth strategy shows that it will be able to meet the deadline.

RELX International, the company that distributes RLX vapes outside of China, is a separate entity that employs about 35,000 people. Wang, who has a net worth of $370 million, serves as CEO of the brand and heads RELX International, which distributes its products internationally. Yang Yangzi, the co-founder of RELX International, is a co-founder of the company and the head of its marketing and sales department.

Relx is a global provider of information-based analytics that provides decision tools for professional customers. The company has offices in more than 40 countries and employs more than 33,000 people. Almost half of these workers live in North America. The company has a reputation for being transparent about its products and procedures. For more information on RELX, visit www.relx.com. relx - a Global Leader in Information-Based Analytics

Relx's leadership has been busy building a global presence, and is looking forward to submitting its Premarket Tobacco Product Application to the U.S. Food and Drug Administration by the end of 2021. The approval process could take 180 days, and Relx has repeatedly denied rumors of an IPO. This is a crucial step for the company, and a successful launch in China could bring in billions of dollars in revenue.

RELX shares trade on the New York Stock Exchange and Amsterdam Stock Exchange. The company is part of the FTSE 100 Index and is listed on the Euronext 100. Its shares are traded on three major markets: the New York Stock Exchange, and the London. Its stocks are listed on the FTSE. The company is a member of the Financial Times Global 500 and Euronext 100. Its profits are reported quarterly.

RELX is a world leader in information and analytics. Its four business segments include Scientific, Technical, and Medical. The Scientific, Technology, and Medicine segment is an information analytics company that helps advance healthcare and improve performance. The Risk & Business Analytics segment delivers decision tools that use public content, advanced technology, and innovative research. All these solutions and tools help the company make better decisions. Its goal is to deliver value to its customers through advanced analytics, information and tools.

In addition to its global presence, Relx has offices in more than 40 countries around the world. With a global presence, RELX serves professionals in more than 180 countries. Its headquarters in Shenzhen employs over 33,000 people, with almost half of them located in North America. Its name, 'Relx', is an acronym for 'Relx'. The brand is headquartered in the city of Shenzhen, China.

The Chinese word RELX translates to 'Responsibility.' It's a shortened version of the word "empathy." And 'Responsibility.' The company aims to build trust among its users by developing a range of products that appeal to different demographics. The company's mission is to be a global leader in the health industry. Its goal is to improve the lives of individuals by offering quality e-cigarettes.

Like other RELX products, RELX is available in a wide variety of flavors. These beverages are often delicious and palatable, and the drinks themselves are often a must-have. The company's mission statement is "to empower individuals." The company is also a leading global company in the medical field. Its shares trade on the New York Stock Exchange. If you're interested in learning about RELX, consider reading the following article.

The company provides a range of information services and publishing products. Its products include business information, consumer information, trade books, and computer information software. Its customers include individuals and companies in every country. Although RELX has not received a 510(k) from the FDA, it's still an impressive product that is able to compete with giants in the industry. Its reputation is a testament to its innovation and its ability to meet the needs of the masses.

[vapehk1]

SMOK's Legal Challenge Against FDA: Navigating the Complex Intersection of Vaping Innovation and Public Health Regulations

Chinese Vape Brand SMOK Appeals Against US FDA's Marketing Denial Order On January 18, Shenzhen IVPS Technology Co., Ltd., the parent company of the SMOK brand, announced that it has filed an appeal with the United States Fifth Circuit Court of Appeals against the US Food and Drug Administration (FDA)’s marketing denial order for its SMOK open system e-cigarette kits and related replacement parts. Previously, on January 16, the FDA issued a press release stating that it had issued marketing denial orders (MDOs) for 22 SMOK open system products, citing that the premarket tobacco product applications (PMTAs) for these products "failed to provide sufficient data to characterize constituent delivery, product stability, and product abuse liability." Shenzhen IVPS Technology strongly questioned the FDA's assertions. The company disclosed that it had invested over $30 million in its PMTA submission, producing more than 600,000 pages of data. This included extensive testing for harmful and potentially harmful constituents in aerosols, in vitro toxicology tests, toxicological analysis, accelerated and 24-month storage and stability tests, as well as rigorous clinical pharmacokinetic studies, in collaboration with leading global laboratories. The company also highlighted that the FDA’s press release misleadingly portrayed the expected level of youth usage of SMOK products. While the FDA claimed that the 2023 National Youth Tobacco Survey showed "11.3% of middle and high school students reported using SMOK products in the past 30 days," Shenzhen IVPS pointed out that, according to The New York Times, only 7.7% of middle and high school students reported using nicotine vaping products for more than 30 days, and of those, only 11.3% reported using SMOK products. What Happened Previously On January 16, the FDA issued marketing denial orders to Shenzhen IVPS Technology Co., Ltd for 22 SMOK brand e-cigarette products. These products, including devices, pods, atomizers, and cartridges, are part of an e-cigarette system marketed without an e-liquid, meaning consumers can add their own choice of e-liquid. The FDA determined that the company's PMTAs lacked sufficient evidence to demonstrate that permitting marketing of these products would be appropriate for the protection of public health, a standard set by the 2009 Family Smoking Prevention and Tobacco Control Act. Specifically, the applications were found lacking in data to characterize constituent delivery, product stability, and product abuse liability. The denied products are not sold with an e-liquid, which means they can be used with any e-liquid available to consumers, including tobacco-flavored and non-tobacco flavored e-liquids. Following the FDA's rigorous scientific review, products receiving an MDO cannot be introduced or delivered for introduction into interstate commerce and must be removed from the market if they are currently marketed. However, the company may submit new applications for the products subject to these MDOs. This action is part of the FDA’s ongoing efforts to ensure that all new tobacco products undergo a science-based review and receive marketing authorization before being legally marketed. To date, the FDA has authorized 23 tobacco-flavored e-cigarette products and devices but has denied marketing applications for millions of products that did not meet the necessary public health standard. Balancing Innovation and Regulation: A Closer Look at the SMOK vs. FDA Dispute The clash between Shenzhen IVPS Technology (SMOK) and the FDA represents a significant moment in the vaping industry. The FDA's strict stance is a clear signal of their commitment to public health and rigorous scientific standards. The denial of SMOK's products, based on insufficient data regarding safety and abuse potential, underscores the challenges vape companies face in navigating regulatory landscapes. However, Shenzhen IVPS's decision to appeal and their substantial investment in research and testing suggest that vape manufacturers are willing to engage deeply with regulatory processes. This could be seen as a positive sign, indicating that companies are taking scientific scrutiny and public health concerns seriously. The discrepancy in youth usage statistics between the FDA and external sources like The New York Times raises questions about the portrayal and perception of vaping among young people. It's a complex issue, with the need to balance public health concerns, especially among youth, against the rights of businesses to market their products. Overall, this situation illustrates the ongoing tension between innovation in the vaping industry and public health priorities. As vaping technology evolves and becomes more popular, especially among younger demographics, the role of regulatory bodies like the FDA becomes increasingly crucial. The outcome of this appeal could set a precedent for how similar cases are handled in the future, potentially shaping the vaping landscape for years to come. Read the full article

[shenzhenmicrowell]

How to identify compliant vape products

To identify compliant vape products, you should look for the following:

Age verification: Reputable vape retailers will have strict age verification policies in place to prevent underage access to vaping products. This may include requiring customers to upload a government-issued ID to verify their age before purchasing.

Proper labeling: Compliant vape products will have clear labeling that includes the name of the product, the manufacturer, the ingredients, and any warnings or instructions for use.

Third-party testing: Look for vape products that have been third-party tested for quality and safety. Reputable manufacturers will typically list the results of these tests on their website or packaging.

Compliance with regulations: In the United States, vape products are regulated by the Food and Drug Administration (FDA). Look for products that comply with FDA regulations, such as those that have been authorized through the premarket tobacco product application (PMTA) process.

Brand reputation: Do some research on the brand of vape product you're considering. Look for reviews and testimonials from other users, and make sure the brand has a good reputation for quality and safety.

vaporesso.com

[themfp1]

After Years of WHO Approval, Combustible Cigarettes Just Got a Christmas Present from the FDA

After Years of WHO Approval, Combustible Cigarettes Just Got a Christmas Present from the FDA

By: Lindsey Stroud On December 23 (and just in time for the holidays) the U.S. Food and Drug Administration (FDA) bizarrely gave a Christmas present to combustible cigarettes in the form of a modified risk tobacco product (MRTP) order for 22nd Century Group, Inc.’s VLN cigarettes. The MRTP order is an enhancement to the already-authorized premarket tobacco product application (PMTA), which the…

[reportwire]

Fifth Circuit Rebukes FDA for Regulatory "Switcheroo" in Denying Vaping Product Applications

Fifth Circuit Rebukes FDA for Regulatory “Switcheroo” in Denying Vaping Product Applications

In 2016 the Food & Drug Administration “deemed” electronic cigarettes, vaping pens, and other electronic Nicotine delivery systems (“ENDS”) to be “tobacco products” under the Family Smoking Prevention and Tobacco Control Act. As a consequence, all ENDS manufacturers were required to submit premarket tobacco applications (PMTAs) in order to continue selling their wares. Under the Tobacco Act, the…

[1truhealth]

Some Vaping Companies Are Turning to Synthetic Nicotine to Outsmart the FDA

Some Vaping Companies Are Turning to Synthetic Nicotine to Outsmart the FDA

Troy Johnston swears he wanted to play by the rules. Johnston, who owns the Texas-based vaping company VaporSalon, tried to follow the U.S. Food and Drug Administration’s (FDA) guidelines for selling e-cigarette products, which required all manufacturers to file paperwork known as premarket tobacco product applications (PMTAs) by Sept. 9, 2020. In these applications, companies were tasked with…