Category: Regulation

  • Court Extends Deadline for Premarket Applications

    Court Extends Deadline for Premarket Applications

    Tobacco and vapor companies have an extra four months to file their premarket tobacco applications (PMTAs) for newly deemed tobacco products with the Food and Drug Administration (FDA) following a U.S. court ruling.

    On July 12, 2019, the United States District Court for the District of Maryland ordered the FDA to require manufacturers of e-cigarettes, cigars and other deemed new tobacco products that were on the market as of Aug. 8, 2016 to submit applications for premarket review by May 12, 2020.

    However, the coronavirus pandemic has drastically impaired the FDA’s ability to adhere to this timeline. As a result of the pandemic and these exceptional and unforeseen circumstances, the agency requested on March 30 a 120-day extension of the May 12 deadline. This request has now been granted.

    The court order means applications for premarket review for many e-cigarettes, cigars and other new tobacco products are now required to be filed by Sept. 9, 2020. Consistent with the original court order, for companies that submit timely applications, the agency may continue to exercise enforcement discretion, meaning their products would generally continue to be marketed without being subject to FDA enforcement actions, for up to one year from the deadline (up to Sept. 9, 2021), unless a negative action is taken by the FDA on an application during that time.

    Following the Covid-19 outbreak, the agency received numerous inquiries from the tobacco industry expressing concern they would be unable to complete premarket applications by the original May 12 deadline due to disruptions at all stages of preparation, including preventions or disruptions to in-person laboratory work and clinical studies or necessary foreign travel, or from the shuttering of manufacturing facilities abroad.

    In a statement, the FDA said it believes the public health is better protected by not having these firms compromise their employees’ health or take actions that would risk spreading Covid-19 to others by trying to meet the previous May 12 deadline. In the more than a dozen requests for an extension that the FDA received, this public health concern was mentioned repeatedly.

    Another consideration, according to the agency, was that a number of the FDA’s Center for Tobacco Products (CTP) personnel have been deployed to work on Covid-19 pandemic issues for the U.S. Public Health Service (PHS), leaving fewer staff to process applications. Many of those deployed are among the staff that had been playing a critical role as CTP prepared for this deadline.

    “Ultimately, a Sept. 9 deadline will better serve the public health by allowing manufacturers to prepare for, and the agency to conduct, the thorough scientific review of these products that is required under law and vital to our mission of protecting Americans while reducing or eliminating physical contact during this critical period,” the FDA wrote in its statement.

    “Importantly, this new deadline does not detract from our efforts to prioritize enforcement of certain e-cigarette products currently on the market. Although the FDA’s in-person compliance checks and vape shop inspections are currently on hold due to the pandemic, review of previous inspections continues, and we continue to monitor the online marketplace and will take action as appropriate.

    “Accordingly, the January 2020 enforcement priorities guidance, which independently prioritizes earlier enforcement against certain e-cigarette products that are widely used by youth, remains in effect regardless of whether an application is submitted, although we intend to update it for products for which the Sept. 9 date now applies.”

  • South Africa Cigarette Ban Challenged

    South Africa Cigarette Ban Challenged

    Photo: Taco Tuinstra

    The Fair-trade Independent Tobacco Association (FITA) plans to mount a legal challenge against South Africa’s temporary ban on cigarette sales, which was implemented to help prevent spread of the coronavirus.

    “The simple truth is that the current situation cannot be endured for much longer by the various role-players along the tobacco industry value chain without severe consequences for all,” said FITA Chairman Sinenhlanhla Mnguni. 

    “Allowing the current situation to continue indefinitely will in all likelihood lead to job losses and/or loss of income for many along the tobacco industry value chain,” he added.

    Mnguni pointed out that people had started being assaulted and murdered for cigarettes. “We are also seeing the illicit trade flourish whilst the legitimate tobacco industry is prevented from participating,” he said, adding that the government is missing out on some ZAR1.5 billion ($79.01 million) a month in excise tax revenue alone.

    “This at a time when we are already dealing with huge deficits as far as our tax collections are concerned with the recent announcement that the South Africa Revenue Service collected ZAR66.2 billion less than estimated for the last financial year,” said Mnguni.
     

  • Menthol Ban: Industry Asks More Time

    Menthol Ban: Industry Asks More Time

    Tobacco industry representatives are talking to the European Union about postponing the deadline to sell off stock that does not comply with the upcoming ban on menthol cigarettes and new track-and-trace requirements.

    On May 20, two new EU directives are set to come into effect. Article 7 bans the sale of cigarettes with “characterizing flavors” such as menthol. Article 15 requires all tobacco products sold in the EU to comply with track-and-trace rules such as carrying a “unique identifier” to cut down on illicit trade.

    The May 20 deadline was chosen to give suppliers a chance to sell off stock that does not comply with the new rules. Article 15 came into effect in May 2019 but offered a grace period for noncompliant products to be removed.

    The Covid-19 shutdown has left many retailers unable to sell off their noncompliant products and facing losses now that the lockdowns and travel restrictions in many EU countries have been extended into next month.

    The EU Parliament has not commented on a possible extension.
     

  • Comments Deadline Set for 22nd Century’s Modified-Risk Application

    Comments Deadline Set for 22nd Century’s Modified-Risk Application

    Photo: Eduin Escobar | PixaBay

    The U.S. Food and Drug Administration (FDA) has set May 18, 2020, as the deadline for the submission of public comments on 22nd Century Group’s Modified Risk Tobacco Product (MRTP) application.

    The application seeks authorization from the FDA to allow 22nd Century to market its reduced nicotine content cigarettes under the brand name VLN, with packs and advertising stating that the product contains 95 percent less nicotine than conventional tobacco cigarettes, as well as related claims regarding reduced nicotine exposure.  

    “We are very pleased with the progress our team continues to make towards receiving FDA authorization to market our VLN reduced nicotine content cigarettes,” said Michael Zercher, president and chief operating officer of 22nd Century Group. “With the imminent closing of the public comment period, we are hopeful that we will receive a positive decision from FDA allowing us to introduce our reduced nicotine content cigarettes to adult smokers looking to reduce their exposure to nicotine.”

    22nd Century’s reduced nicotine content cigarettes enable adult smokers to experience the same taste and smell as conventional cigarettes but with minimal exposure to nicotine. Numerous independent scientific studies funded by the National Institutes of Health and other U.S. federal government agencies using the company’s reduced nicotine content cigarettes studies show that smokers who use 22nd Century’s reduced nicotine content cigarettes reduce their nicotine exposure and dependence, smoke fewer cigarettes per day, experience reduced withdrawal symptoms, increase their number of smoke-free days, and double their quit attempts.

    The company believes that bringing its reduced nicotine content cigarettes to market will be an important step towards the implementation of the FDA’s proposed plan to require all cigarettes sold in the U.S. to be made “minimally or non-addictive.”

    By limiting the nicotine content of all combustible cigarettes to just 0.5 milligrams of nicotine per gram of tobacco, a level already achieved in VLN, FDA projects that 5 million adult smokers would quit one year after implementation and more than 8 million American lives would be saved by the end of the century.

  • RAI Submits New PMTAs for Vuse

    RAI Submits New PMTAs for Vuse

    Photo: RAI

    Reynolds American Inc. (RAI) has submitted two new premarket tobacco product applications (PMTAs) to the U.S. Food and Drug Administration (FDA). RAI is seeking marketing orders for its Vuse Vibe and Vuse Ciro vapor products, which would allow these products to remain on the market after the FDA’s deadline for PMTAs for electronic nicotine-delivery systems.

    The applications include a range of scientific studies for Vuse Vibe and Vuse Ciro using well-known methodologies, including the comparative assessment of cigarettes and associated health risks. Though the PMTAs themselves are considered commercially proprietary and are thus confidential, the data and information submitted to the FDA include the results of product analyses, nonclinical health risk information and human health and population information, including the impact to both users and nonusers of tobacco products.

    According to RAI, the results of these studies demonstrate that the continued marketing of the Vuse Vibe and Vuse Ciro products is appropriate for the protection of the public health.

    “I am incredibly proud of our diverse team of scientists, researchers and regulatory experts, who have worked tirelessly together to complete these applications well ahead of the FDA’s May deadline for ENDS products,” noted Reynolds’ executive vice president and head of scientific and regulatory afairs, James Figlar.

    The PMTAs for Vuse Vibe and Vuse Ciro are the second and third complete grouped PMTA applications submitted by Reynolds to the FDA for review, following the initial PMTA applications for Vuse Solo submitted in October 2019.
     

  • India Bans Tobacco Sales to Ensure Social Distancing

    India Bans Tobacco Sales to Ensure Social Distancing

    The government of India has banned the sale of tobacco, liquor and gutka (a form of chewing tobacco) to help prevent the spread of the coronavirus.

    The measures have been put in place in order to ensure social distancing, an important aspect of the fight against the coronavirus, is adhered to. The ban is part of a list of directives issued under the Disaster Management Act of 2005 and also prohibits acts such as spitting in public, which is now punishable by a fine.

    The lockdown in India began on March 25 and was extended on April 14 for another three weeks. India has reported more than 10,000 coronavirus cases and 377 deaths.

    Dominated by traditional tobacco products, such as bidis and chewing tobacco, India is one of the world’s largest tobacco markets.
     

  • BAT Investigated for Sanctions Busting

    BAT Investigated for Sanctions Busting

    British American Tobacco (BAT) is under investigation by the U.S. Department of Justice (DOJ) and the Office of Foreign Assets Control (OFAC) over suspected sanctions-busting. Britain’s Serious Fraud Office (SFO) is conducting a separate investigation relating to “suspicions of corruption in the conduct of business by group companies and associated persons.”

    BAT has operations in several countries that are subject to sanctions, including Iran and Cuba. In its 2019 annual report, the company acknowledged that operations in these countries expose the company to the risk of “significant financial cost.”

    BAT said that it is cooperating with the investigation.

    “As the investigations are ongoing, it would be inappropriate for us to provide further comment at this time,” BAT spokeswoman Anna Vickerstaff said.

    Shares in the company fell 5.5 percent after The Times first reported the news on Tuesday

    Financial services company Jefferies suspects the U.S. investigations may be linked to the SFO investigation. “If we are right, and it (the U.S. probe) does relate to the same accusations (as in SFO probe), the fact this has been ongoing in some form since 2017 with no apparent conclusion, we would not worry too much about it for now,” Jefferies analyst Owen Bennett wrote.

  • South Korea Revises Health Warnings

    South Korea Revises Health Warnings

    The South Korean health ministry is revising the images used on cigarette packs to discourage smoking.

    Nine of the 12 photos currently used will be replaced; “Warning images showcasing heightened risk of laryngeal cancer, sexual dysfunction and dangers posed by electronic cigarettes will be retained,” according to the Yonhap News Agency. “Images showing a greater chance of smokers contracting lung and oral cancer, heart disease, stroke and early death are set to be altered, along with images highlighting the dangers of secondhand smoking and smoking during pregnancy.”

    The new images will take effect on Dec. 23 and remain in place for two years.

    Under current regulations, 75 percent of a cigarette pack must be covered in warning images and text, and they must be revised every two years.  

  • FDA Extends Comment Period for Information on EVALI

    FDA Extends Comment Period for Information on EVALI

    Couleur | Pixabay

    In response to requests from the public, FDA is extending the comment period for a request for information (RFI) seeking data and information related to the use of vaping products that are associated with lung injuries. 

    The RFI, initially published in the Federal Register on Feb. 18, responds to direction from Congress to gather additional information that could help identify and evaluate additional steps that could be taken by the agency to “address the recent pulmonary illnesses reported to be associated with the use of e-cigarettes and vaping products.”

  • Opinion: Four-Month FDA Extension Not Sufficient

    Opinion: Four-Month FDA Extension Not Sufficient

    Photo: Nmedia | Dreamstime.com

    Consumers are staying home and spending less as COVID-19 and social distancing mandates sweep across the globe. The extreme, necessary steps to control the spread of the virus have already taken an economic toll, and there certainly will be a long-term impact on individual businesses and workers. One industry, in particular, will likely fail without swift federal action: e-cigarettes, according to Michelle Minton with the Competitive Enterprise Institute.

    Cigarettes may prove “pandemic-proof.” Since they are often sold at outlets deemed “essential” under the current lockdown, cigarettes continue to be available and big tobacco companies have so far remained financially unscathed. But the same is not true for their lower-risk competitors. Vape shops, which sell vapor products, like e-cigarettes, have not been universally recognized as essential businesses, so they have been forced to close.

    To maximize ways to fight the virus, many states have pressed pause on certain rules and regulations (leading many to wonder if they were #NeverNeeded in the first place.) For example, Vermont Governor Phil Scott signed an order lifting the state ban on home alcohol delivery. This was a pragmatic move, as Reason’s Guy Bentley aptly put it. Vermont lawmakers understand that people still want to imbibe, and at-home delivery discourages unnecessary booze runs.

    Yet that pragmatism hasn’t been extended to e-cigarettes, and Governor Scott’s online e-cigarette sales ban enacted last year remains in place. As a result, some adults now find themselves cut off from the products they rely on to stay smoke-free. Without swift federal action, they may be cut off permanently as vape shops go belly up, and many people will revert to smoking.

    The last year has already been difficult for those who sell and enjoy vapor products. Even as the evidence that e-cigarettes are relatively harmless for adults and highly effective for smoking cessation has become clearer, calls to ban or restrict e-cigarettes have only grown louder. Groups that oppose nicotine use, no matter how safe, ramped up attacks, spending millions to promote the idea that e-cigarettes are no different than cigarettes and to foment panic over the non-existent “epidemic” of youth vaping.

    Last summer, as scores of mostly young people fell ill with a mysterious lung ailment, anti-tobacco groups (with the aid of the CDC and news media) convinced people e-cigarettes were to blame, obfuscating the fact that the injuries were caused by black market THC vaping products, contaminated with vitamin E acetate (an oil that cannot be mixed into nicotine-containing e-cigarettes).

    By exploiting fear and confusion, e-cigarette opponents amassed support among the public and lawmakers for restrictions on e-cigarettes. Cities and states instituted onerous new rules, including banning all e-cigarette sales (but not traditional cigarettes), prohibiting flavored e-cigarettes, restricting sales to in-person transactions, and criminalizing possession of certain e-cigarettes.

    Some members of Congress tried to make these rules national, holding several hearings antagonistic toward vaping and considering a number of bills. Rep. Frank Pallone’s (D-NJ) bill, which bans all flavors except “tobacco,” prohibits online and mail-order sales and raises the national tobacco purchasing age limit to 21 (which it already is), passed the House. If enacted, it would make e-cigarettes less attractive, harder to get, and more expensive—leading some to label the bill a “win for cigarettes.”

    E-cigarette supporters battled threats to products they believe saved their lives. But unless federal regulators take immediate action there will be no industry left to save: By May 12, 2020 all vapor products must either submit a pre-market tobacco application (PMTA) to the Food and Drug Administration (FDA) for approval or exit the market. Filing a PMTA is an expensive and time-consuming task, which the FDA admitted would Eliminate 99 percent of the e-cigarette market. COVID-19 disruption could make that figure nearer to 100 percent.

    Last week, the FDA submitted a request to delay the PMTA deadline by four months, but even if granted, this would merely push the inevitable end of the e-cigarette industry to September 2020. The FDA should go further: Make the process, which vapor industry experts estimate takes over 1,700 hours and millions of dollars, quicker and cheaper for small companies. Although Health and Human Services Secretary Alex Azar announced plans in January to create a “streamlined” avenue for small businesses, that has yet to materialize.

    In the meantime, anti-nicotine advocates are still trying to spread misinformation, slip state-wide vaping bans around the normal legislative process, and, ludicrously, link COVID-19 deaths to e-cigarette use—for which there is zero evidence. Worse, some have even encouraged countries to reject critically needed medical equipment like ventilators if donated by Big Tobacco.

    The outbreak of COVID-19 should elevate the value of harm reduction—the idea that you can’t entirely stop people from engaging in risky behavior, but you can reduce harm by encouraging them to do so in the least risky way possible. E-cigarettes are the best way we know so far to reduce the harms related to nicotine use. They are vastly safer than smoking and more popular than most other forms of tobacco cessation. Lawmakers should do everything in their power to keep e-cigarettes a viable option for smoking cessation.