Bidi vapor announced PMTA acceptance, including 11 flavors

According to foreign reports, bidi vapor, the manufacturer of bidi stick closed system, announced yesterday that it had received the PMTA acceptance letter from the regulatory agency after submitting the PMTA application to FDA on September 8, 2020.

Bidi Stick

Niraj Patel, President and CEO of bidi vapor and kaival brands, said: ‘it has always been our goal to provide an option for traditional combustible tobacco to meet the needs of every adult smoker aged 21 and over. “We are very pleased that we have taken another step towards this goal.

The company is now waiting for a filing letter from the FDA. Bidi stick PMTA will then enter the substantive review phase, where it will analyze scientific data.

Bidi stick is the fastest growing closed-end e-cigarette product in the United States, according to Goldman Sachs’ Stock Research Report on Nielsen data of total nicotine in 2020.

According to Nielsen data, bidi stick is the second largest disposable electronic nicotine product, mainly based on the retail volume based delivery system (ends) during the first 52 cycles.

The acceptance covers all 11 flavors in the bidi stick range.

As we move into the filing phase of the PMTA, we expect that as we move into the substantive review phase of the PMTA process, we will spend months of massive data collection, investment and hard work to collect 285000 pages of science based evidence, Patel said. Receiving the acceptance letter is an important step as we wait for the FDA’s filing letter and then conduct a substantive review of our products.

Bidi stick is also the only e-cigarette product on the market with an eco-friendly, large-scale recycling program for adults, the press release said.

Kaival brands also recently launched bidi vapor’s bidi pouch, a smokeless nicotine bag.

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Hemp producers: USDA preparing for 2022 Census of Agriculture with sample content tests

Hemp farmers may have seen something new in their mailboxes this winter, as federal agriculture officials prepare for the 2022 Census of Agriculture, which will include hemp farmers for the first time.

Over the last two months, the U.S. Department of Agriculture’s National Agricultural Statistics Service sent “content tests” to a sample of 36,000 producers from various agriculture segments across the country.

The content tests are brief surveys to help the agency market projections for the larger census.

The NASS conducts the Census of Agriculture once every five years, giving the USDA a complete count of U.S. farms and the people who operate them.

The ag census looks at land use and ownership, operator characteristics, production practices, income and expenditures, and is a source of uniform, comprehensive agricultural data for every county in the nation.

Through the census, agricultural producers provide information that can influence decisions that shape their industry segment and the future of U.S. agriculture.

According to USDA-NASS, there will be several tests running concurrently through this spring to address producer requests and technological trends, including the inclusion of previously reported data.

NASS is also testing the way it collects its data. The content test is a short survey that includes a handful of screening questions to determine if operations meet the definition of a farm, helping to fine-tune the accuracy of the sample list for the upcoming census.

Most important for hemp producers, the NASS is testing questions for the new commodity, which will be included for the first time in the 2022 Census of Agriculture.

All content test results will be considered for incorporation in the upcoming census, and in accordance with federal law, USDA-NASS will keep all responses confidential and uses them only for statistical purposes.

Farmers who received a content test can get assistance for completing it by calling 888-424-7828.

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West Hollywood Bans Flavored Tobacco and Menthols

The sale of flavored tobacco products, including the sale of menthol cigarettes, was banned in the city of West Hollywood, Calif.

The city council of West Hollywood, Calif., recently passed legislation banning the sale of menthol-flavored cigarettes and other flavored tobacco products. According to the council, the ban cover flavored electronic cigarettes and other non-combustibles as well.

The ban overall covers any flavored tobacco products. Products under this legal definition emulate state and federal definitions that characterize tobacco products as cigarettes, cigars, chewing tobacco, pipe tobacco, and “electronic smoking devices.”

Menthol is also now an outlawed flavor. Coupons or other sorts of retail discounts on regular tobacco products are also banned. Shisha is still permitted under the new law.

“The sooner [tobacco companies] get you addicted, the longer they’re going to have a customer and the more profit they’re going to make off of you,” West Hollywood Mayor Lindsey Horvath said in an interview, published on Feb. 18 by The Los Angeles Times.

“What that also means is many more chronic health impacts, and perhaps not being aware or being exposed to education or information about the impacts of early tobacco use. We’re doing what we can to have both an education campaign but also restricting access to those products, which make becoming addicted that much easier,” Hovarth added in the interview.

Council members were lobbied by vape and tobacco shop owners, claiming that such an ordinance was overreaching and directly harmful to their bottom lines.

West Hollywood’s ordinance, observers note, is a similar bill passed by the California voters last year.

Thanks to political campaigning by large tobacco and vape brands, the law’s implementation was put on hold due to a referendum that was triggered for the ballots in 2022.

The reasons why shisha was exempted from the council’s flavored tobacco ban stems from lobbying from hookah shop business groups claiming the importance of the tobacco blend in Middle Eastern culture.

“Ultimately, hookah itself is a completely different subject than Marlboro selling some bubblegum cigarette to a 16-year-old who wants the taste and feel, and then they’re living a life of horrible health results of something they thought was fun and cool at the time,” said council member John Erickson in a statement.

US: Over 60 Organizations Urge The FDA to Ban Menthol Cigarettes

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When Biden took office, the PMTA and Se principles promulgated by FDA were frozen?

On January 19, 2021, according to a news circular issued by the U.S. Food and drug administration, the agency has set two key principles for companies seeking to be able to market new tobacco products.

According to the introduction, both of the two principles include the content, format and minimum requirements for review of tobacco pre marketing application (PMTA) and substantial equivalence (SE) reports. PMTA and Se are two ways that manufacturers can choose when they need to apply to FDA for new tobacco product marketing license.

However, recently, according to the news from the US tobacco network, with the new US President Biden taking office, all regulations issued by the former president trump administration have been temporarily suspended, including the provisions of the US Food and Drug Administration on the pre marketing application (PMTA) for new tobacco products.

According to reports, all regulations that have not yet come into effect during the trump administration have been temporarily suspended by the White House Office of management and budget. This means that the FDA’s previous provisions on the application for new tobacco products before marketing (PMTA) and the principle of substantial equivalence (SE) will also be suspended.

After Biden took office, all new regulations proposed by trump will be frozen, and the thawing time will depend on the situation, until Biden’s government confirms which regulations can be allowed. Although the application for new tobacco products (PMTA) and the principle of substantial equivalence (SE) have been temporarily frozen, the implementation time can not be determined, but it is only a matter of time.

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US Study: Switching From Smoking to Vaping Reduced Carcinogen Presence

Titled, “Effect of Pod e-Cigarettes vs Cigarettes on Carcinogen Exposure Among African American and Latinx Smokers,” the study consisted of a six-week-long randomized trial comparing e-cigarette use to traditional cigarette use, amongst African American and Latin smokers.

“The primary outcome was reduction in urinary 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL) concentration at week 6. Secondary outcomes were change in urinary cotinine, expired carbon monoxide (CO), respiratory symptoms, lung function, blood pressure.”

Co-program leader of KU Cancer Center’s Cancer Prevention and Control research program, Nikki Nollen, PhD, acted as site principal investigator.

“Fourth generation e-cigarettes contain high concentrations of nicotine and other appealing features that may support switching and reduce potential health risks among those who smoke combustible cigarettes,” Dr. Nollen said. “We wanted to examine the biomarkers of exposure in both groups and determine the risk-benefit tradeoff of e-cigarettes.”

The participants were adult smokers who consumed at least 5 cigarettes/d on at least 25 of the past 30 days for at least 6 months and were interested in switching to e-cigarettes. Data were analyzed and collected between September 18th, 2019, and September 4th, 2020.

According to the study Abstract, the study subjects were offered a 6 week supply of vaping products in their preferred flavours (at 5% nicotine) along with brief education, training, and action planning to completely switch to e-cigarettes from combustible cigarettes. While the control group were instructed to keep smoking as usual.

A reduction in the analysed biomarkers was measured

The compiled data indicated a reduction in the analysed biomarkers. “The primary outcome was reduction in urinary 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL) concentration at week 6. Secondary outcomes were change in urinary cotinine, expired carbon monoxide (CO), respiratory symptoms, lung function, blood pressure, past 7-day consumption of combustible cigarettes, and switching rates (e-cigarette group only) at weeks 2 and 6.”

Nollen pointed out that the level of reduction in certain biomarkers was surprising. “What was most surprising was the magnitude of change experienced by those in the e-cigarette group,” Dr. Nollen said. “They reduced their NNAL by 64%, carbon monoxide by 47% and respiratory symptoms by 37% compared to those in the control group who continued to smoke cigarettes as usual.”

Dual users experienced benefits aswell

Moreover, reported the study, the benefits were not only experienced by those who switched completely, but also by dual users, even though to a lesser degree than those who made a complete switch. “The e-cigarette trajectory subgroups differed significantly for NNAL and CO levels. Exclusive e-cigarette users had the most pronounced changes, followed by dual users, and then exclusive cigarette smokers. At week 6, exclusive e-cigarette users had significantly greater reductions in NNAL and CO levels than dual users and cigarette smokers. Dual users also had greater reduction of CO levels compared with exclusive cigarette smokers.”

CVA Quotes Study Indicating That Vaping Could Prevent 6.6 Million Deaths

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President of the Canadian Vaping Association calls on decision makers to include e-cigarettes in harm reduction strategies

On February 16, Darryl Tempest, chairman of the Canadian Vaping Association, issued an open letter calling on the government to use electronic cigarettes in tobacco harm reduction strategies.

He said that in Canada, the number of deaths caused by smoking has exceeded the combined number of deaths from drug overdose and the covid-19 pandemics, making it the first enemy of public health. E-cigarettes have been proven to have significant harm reduction effects and are the most effective tool to solve this public health crisis.

An open letter from Darryl Tempest – Executive Director of the Canadian Vaping Association

Beamsville, ON, Feb. 16, 2021 — For the better part of the last decade, advocates have fought for vaping to be recognised as a harm reduction tool for adult smokers. In the time since, science has caught up with the industry’s message and vaping has been recognized by all health organizations as far less harmful than smoking. Yet, despite the overwhelming evidence concluding that vaping is less harmful, smokers and society at large are still being sent mixed messages by the government and misleading information by media to support a sensationalistic narrative.

Canada has a strong history of supporting other types of harm reduction, with the response to the opioid crisis being a great example. Opioid overdoses were responsible for 16,364 deaths in Canada over a 4-year period. The government responded by creating safe injection sites and are now considering decriminalizing heroine, fentanyl and cocaine. These measures were designed to provide safe spaces for addicts and to connect them with needed resources. While safe injection sites and the decriminalization of hard drugs are controversial, the government continues to address the problem through a science-based harm reduction lens.

This harm reduction lens is again applied to COVID-19, with Canada’s implementation of a highly controversial response. The country has shut down businesses, closed schools, mandated safety plans for employers and restricted travel. These measures while extreme and controversial were implemented following a thorough scientific review which determined they were necessary for public health. To date, COVID-19 has taken the lives of 21,311 Canadians.

These are just two of many examples of Canada leading effective harm reduction policies regardless of the controversy surrounding them for the betterment of public health. Vaping has been scientifically proven to be the most effective cessation method for smoking; an addiction that claims the lives of 45,000 Canadians each year. Despite smoking being Canada’s leading cause of preventable illness and premature death, the government’s response to vaping has been dangerously inadequate.

While Health Canada’s website does state that smokers who switch completely to vaping reduce their exposure to harmful chemicals, their campaigns warning of the dangers of vaping, without mention of the immense harm reduction opportunity for our country’s 4.5 million smokers have confused the public. This is made clear by polling which found more than half of Canadian’s believe vaping is at least as harmful as smoking. This polling data is dreadfully low for a product that could save millions of lives, save our health care system billions of dollars, and prevent millions of Canadian families from experiencing the emotional toll of smoking related deaths.

In large part, the confusion surrounding vaping stems from legitimate concerns regarding increased youth vaping rates. Instead of focusing on educating youth and restricting access, media and anti-vape organizations continue to run harmful campaigns discrediting vaping as a harm reduction solution while targeting flavours. These campaigns are contrary to the fact that vaping is the most successful tool in history to address smoking rates. To meet our national smoking reduction goal, policy makers must support vaping as a harm reduction strategy. We only need to look to the results in the United Kingdom to see the incredibly positive impact vaping has had on their nation. If the Government of Canada is serious about smoking rates being at 5% by 2035, their current policies will need to catch up with the plethora of science supporting vaping as the most powerful tool for harm reduction and acknowledge that flavours are the key to vaping’s success.

Youth vaping is a real concern, but it can be addressed through proper enforcement, education, and restricting access to adult environments, rather than further regulation at the expense of the lives of millions of adult smokers. Smoking is our country’s greatest threat to public health, with a death toll greater than both overdoses and COVID-19 fatalities combined. The government must use the same scientific approach to solving this health crisis as would be applied to any other.

While my message is addressing the systematic change needed to save millions of lives, personally I have lost family members to smoking related disease, as many of us have. If our leaders in government, public health and journalism continue to ignore the research, the only message I could share with those that our families have lost, is that because of stigma their lives didn’t matter to our society.

We will continue the fight for those that can change their health outcomes and for those that we have already lost.

Empire brand Canada opposes the government’s proposal to reduce nicotine consumption in e-cigarettes

According to the information from regulation tobacco control, recently, imperial brand Canada has publicly expressed its opposition to a government health department’s proposal on reducing nicotine content in steam electronic cigarettes.

Empire brand Canada opposes the government's proposal to reduce nicotine consumption in e-cigarettes

Prior to this, the health department of the Canadian government has proposed to reduce the maximum nicotine content of steam electronic cigarette products to 20 mg / ml. But imperial Canada points out that such measures will undermine the government’s goal of tobacco control, that is, to reduce the national smoking rate to less than 5% by 2035.

In response, a person in charge of imperial brand Canada pointed out that limiting the nicotine content in e-cigarettes to 20 mg / ml would mean that current smokers would not be able to find their own substitutes for tobacco products, which might eventually lead to a large number of e-cigarette consumers to start smoking again. The official believes that the 20 mg / ml nicotine amount proposed by the government is too low to meet the needs of current smokers in Canada, let alone those who are looking for low hazard alternatives.

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Indiana House signs off on smokable hemp

The Indiana state House has overwhelmingly voted to reverse a smokable hemp ban being challenged in federal court.

A bill approved 69-28 last week would remove references to “smokable hemp” from the state’s 2019 law setting up hemp regulations. Those regulations banned the production and sale of hemp flower products.

The bill also repeals a law that requires that a hemp bud or a hemp flower be sold only to a processor licensed in Indiana.

The measure now heads to the Indiana Senate.

The Midwest Hemp Council and several businesses have challenged Indiana’s smokable hemp ban; the matter is pending in a federal court.  California and New York are currently considering smokable hemp bans.

Smokable hemp is one of the fastest-growing sectors in the hemp industry.

Analytics firm Nielsen Global Connect predicts that by 2025, the market cold to reach $300 million to $400 million, representing roughly 5% of the potential $6 billion to $7 billion hemp-derived CBD consumer products category.

Read more about the U.S. smokable hemp market in this free report, “Sector Snapshot: Opportunities & Challenges in Smokable Hemp.”

smokable hemp map

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Leaked Plans For “Europe’s Beating Cancer Plan” Indicate Threat to Vapers

The plan is due for launch on the 3rd of February, and leaked drafts of the plan are causing major concern amongst Europe’s Vaping groups. “Europe’s Beating Cancer Plan is a historic chance to beat cancer and the Commission is about to botch it. Vaping is not the same as smoking and treating the two as the same is a mistake that could prevent thousands of smokers from quitting. What we have seen in the leaked plan is very concerning and I hope that the version announced will correct this flawed approach,” said WVA Director, Michael Landl.

A press release by the WVA, explained that the EC Europe Beating Cancer Plan looks to:

  • extend taxation to “novel tobacco products”, including vaping
  • extend the coverage of the smoking bans indoor and outdoor to e-cigarettes
  • ban flavours.

“We should be led by science and not by ideology on this issue. Europe’s Beating Cancer plan must acknowledge vaping is not smoking, and actively encourage smokers who are not willing or not able to quit to switch to e-cigarettes. Otherwise the goal of eradicating cancer in Europe cannot be achieved. I truly hope that what the Commission publishes on vaping will look very different to what we see in this leaked document or the future for vaping in Europe looks pretty bleak. If this is what we get from the Commission, then I hope we see Members of the European Parliament push back against these misguided proposals,” added Landl.

Back Vaping Beat Cancer

Meanwhile, the WVA’s own anti-cancer campaign, BACK VAPING. BEAT CANCER campaign, has been ongoing for 6 months now. The initiative encourages European vapers to #backvapingbeatcancer, by sharing their success stories related to how vaping helped them quit smoking. European vapers are also being encouraged to get in touch with their elected representatives, in the hope that they can influence policy changes.

“Smoking is the leading cause of cancer in Europe and vaping has helped hundreds of thousands of smokers to quit smoking once and for all. We want to see policymakers introduce vaping in the EU Beating Cancer Plan to ensure millions of Europeans can benefit from a successful and efficient method of quitting smoking for good,” said Landl, upon launching the WVA campaign.

Europe’s Beating Cancer Plan

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