The Bureau of Investigative Journalism released a new report showing heated tobacco products from Philip Morris has significantly more nicotine than previously thought. The product claims to have 0.5 milligrams of nicotine per stick, but testing showed it has 4 mg of nicotine per stick. To read the full analysis, click here.
Here are the slideshows from the Badlands Symposium presentations. Each can be accessed by clicking on the name:
Badlands Symposium_Pharmacist Providers
Badlands Symposium_TFND_SmokeFreeAirLaw and This Is Quitting
News broke that big tobacco companies are trying to push a “Cash for Vape” program with Australian pharmacists to encourage them to prescribe and distribute vaping devices and product. This is an incredibly devious plan and further proves that vaping is big tobacco in digital form. To read the response from the Royal Australian College of General Practitioners (RACGP), click here.
New CDC data shows that the cost of smoking nationally was more than $184 billion, including costs of $465 million in North Dakota. This is a first of its kind study to provide a detailed estimate to the costs of smoking. To read the study and appendix, follow the links below.
Appendix_Cost of Smoking-Attributable Productivity Losses, U.S., 2018
Cost of Cigarette Smoking-Attributable Productivity Losses, U.S., 2018
It is exciting to see so many members of Congress taking the menthol ban actions seriously and standing with us. Attached are two letters sent from various members of Congress to the Food and Drug Administration (FDA). We strongly support the FDA moving forward with a ban on menthol flavored products. These products disproportionately affect minority communities and make quit attempts less likely to be successful.
TFND submitted a comment to the FDA during the public comment period for the proposed menthol flavor ban. TFND supports this action as more and more research is showing how menthol is making it harder for those smoking cigarettes to quit, as well as menthol having a long history of targeting the African-American community. Below is the comment we submitted for the FDA’s review.
“We thank the FDA for coming forward with this rule. Flavored tobacco products present a
monumental risk to the next generation of children. Tobacco Free North Dakota is a statewide
nonprofit based in Bismarck, North Dakota, with a mission of improving and protecting the
public health of all North Dakotans by reducing the serious health and economic consequences
of tobacco use, the state’s number one cause of preventable disease and death. The proposed
rule regarding menthol flavoring is a good start, but we believe it can be improved by changing
menthol restrictions from the “characterizing flavor” level to the “additive” level.
According to the Centers for Disease Control and Prevention, among other government
sources, menthol is an additive in almost every cigarette. Only 37 percent of the cigarettes sold
in the United States contained enough menthol to be designated at the “characterizing flavor”
level. Menthol flavoring adds a cooling sensation for the user and helps mask the harshness of
tobacco. By changing the rule to address menthol as an additive, it would affect nearly all
commercial cigarettes, significantly increasing the potential public health impact.
A 2020 study printed in Addictive Behaviors Reports analyzed the flavored-tobacco sales ban in
San Francisco, California and the effect of tobacco product use on 18-34 year-olds. The city
enacted this ban in 2019, which included menthol cigarettes. The analysis showed that the sales
ban on flavored products reduced the use of all flavored tobacco products, as well as e-
cigarettes and cigars. While this is encouraging, the study also showed 65 percent of
respondents didn’t feel the ban was being thoroughly enforced. Many respondents also
claimed they were able to access flavored products in multiple ways. The study concluded
flavor bans could be a potential tool, but shouldn’t be used as a sole action.
Again, we applaud this effort to protect against the harms caused by menthol in tobacco
products and we hope to see further steps forward for tobacco prevention and control in the
near future. Thank you.
Citation: Yang, Yong et al. “The impact of a comprehensive tobacco product flavor
ban in San Francisco among young adults.” Addictive behaviors reports vol. 11
100273. 1 Apr. 2020, doi:10.1016/j.abrep.2020.100273
Link: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7186365/
The FDA, on back-to-back days, has announced major tobacco control measures. On Thursday, June 23, the FDA ordered JUUL Labs to remove ALL of their products from the shelves. This is a huge win for tobacco control advocates against JUUL, who was a major catalyst in starting the youth vaping epidemic. The full FDA release is posted below:
Today, the U.S. Food and Drug Administration issued marketing denial orders (MDOs) to JUUL Labs Inc. for all of their products currently marketed in the United States. As a result, the company must stop selling and distributing these products. In addition, those currently on the U.S. market must be removed, or risk enforcement action. The products include the JUUL device and four types of JUULpods: Virginia tobacco flavored pods at nicotine concentrations of 5.0% and 3.0% and menthol flavored pods at nicotine concentrations of 5.0% and 3.0%. Retailers should contact JUUL with any questions about products in their inventory.
“Today’s action is further progress on the FDA’s commitment to ensuring that all e-cigarette and electronic nicotine delivery system products currently being marketed to consumers meet our public health standards,” said FDA Commissioner Robert M. Califf, M.D. “The agency has dedicated significant resources to review products from the companies that account for most of the U.S. market. We recognize these make up a significant part of the available products and many have played a disproportionate role in the rise in youth vaping.”
These MDOs only pertain to the commercial distribution, importation and retail sales of these products, and do not restrict individual consumer possession or use—the FDA cannot and will not enforce against individual consumer possession or use of JUUL products or any other tobacco products.
After reviewing the company’s premarket tobacco product applications (PMTAs), the FDA determined that the applications lacked sufficient evidence regarding the toxicological profile of the products to demonstrate that marketing of the products would be appropriate for the protection of the public health. In particular, some of the company’s study findings raised concerns due to insufficient and conflicting data – including regarding genotoxicity and potentially harmful chemicals leaching from the company’s proprietary e-liquid pods – that have not been adequately addressed and precluded the FDA from completing a full toxicological risk assessment of the products named in the company’s applications.
To date, the FDA has not received clinical information to suggest an immediate hazard associated with the use of the JUUL device or JUULpods. However, the MDOs issued today reflect FDA’s determination that there is insufficient evidence to assess the potential toxicological risks of using the JUUL products. There is also no way to know the potential harms from using other authorized or unauthorized third-party e-liquid pods with the JUUL device or using JUULpods with a non-JUUL device. The FDA recommends against modifying or adding substances to tobacco products. JUUL users are encouraged to report any unexpected health problems or product problems to the FDA through the Safety Reporting Portal and to seek medical attention as necessary.
“The FDA is tasked with ensuring that tobacco products sold in this country meet the standard set by the law, but the responsibility to demonstrate that a product meets those standards ultimately falls on the shoulders of the company,” said Michele Mital, acting director of the FDA’s Center for Tobacco Products. “As with all manufacturers, JUUL had the opportunity to provide evidence demonstrating that the marketing of their products meets these standards. However, the company did not provide that evidence and instead left us with significant questions. Without the data needed to determine relevant health risks, the FDA is issuing these marketing denial orders.”
Any products subject to an MDO may not be offered for sale or distributed in the United States, or the FDA may take enforcement action.
In addition to ensuring that JUUL complies with this order, as with unauthorized products generally, the FDA intends to ensure compliance by distributors and retailers. Specifically, the FDA notes that all new tobacco products on the market without the statutorily required premarket authorization are marketed unlawfully and are subject to enforcement action.
As the FDA has stated in the past, unauthorized electronic nicotine delivery system (ENDS) products for which no application is pending, including for example, those with an MDO, are among our highest enforcement priorities. Therefore, the FDA encourages retailers to discuss products in their inventory with their suppliers including the current status of any particular tobacco product’s marketing application or marketing authorization. Manufacturers will be the best source of that information and retailers should rely on manufacturers directly to inform decisions about which products to continue selling.
There are many resources to help smokers who want to quit. Quitting all tobacco products is the best possible path to good health. Some current JUUL users who will not have access to JUUL products following this action or current smokers who want to transition away from cigarettes and cigars may decide to switch to other ENDS products that have been reviewed and authorized by the FDA based on their potential to benefit adult smokers.
To date, the FDA has authorized 23 ENDS products. Under the PMTA pathway, applicants must demonstrate to the agency, among other things, that permitting the marketing of the new tobacco product would be appropriate for the protection of the public health.
The FDA continues to work to complete its review of the remaining pending applications for deemed products submitted by the Sept. 9, 2020, deadline.
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The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
This is massive news from the FDA and would have extraordinary, positive effects on public health and tobacco dependence. We are at least a few years away from any rule, but the move is very welcomed and we are excited to see the end product. We have pasted the full FDA release below:
Today, the Biden-Harris Administration published plans for future potential regulatory actions that include the U.S. Food and Drug Administration’s plans to develop a proposed product standard that would establish a maximum nicotine level to reduce the addictiveness of cigarettes and certain other combusted tobacco products. The goal of the potential rule would be to reduce youth use, addiction and death.
Each year, 480,000 people die prematurely from a smoking-attributed disease, making tobacco use the leading cause of preventable disease and death in the United States. Additionally, tobacco use costs nearly $300 billion a year in direct health care and lost productivity.
While nicotine is not what makes smoking cigarettes so toxic, it’s the ingredient that makes it very hard to quit smoking. Addiction to nicotine in combusted products is the main driver of sustained use of these products. In fact, more than half of adult cigarette smokers make a serious quit attempt each year (quitting for at least a day), but most do not succeed due to the addictive nature of cigarettes. Such a product standard, if proposed and then finalized after a thorough process, would make those products minimally- or non-addictive.
“Nicotine is powerfully addictive,” said FDA Commissioner Robert M. Califf, M.D. “Making cigarettes and other combusted tobacco products minimally addictive or non-addictive would help save lives. The U.S. Surgeon General has reported that 87 percent of adult smokers start smoking before age 18, and about two-thirds of adult daily smokers began smoking daily by 18 years of age. Lowering nicotine levels to minimally addictive or non-addictive levels would decrease the likelihood that future generations of young people become addicted to cigarettes and help more currently addicted smokers to quit.”
A paper published by the FDA in the New England Journal of MedicineExternal Link Disclaimer in 2018 projected that by year 2100, a potential nicotine product standard could result in more than 33 million people not becoming regular smokers, a smoking rate of only 1.4%, and more than 8 million fewer people dying from tobacco-related illnesses. The current smoking rate is 12.5%.
The Spring 2022 Unified Agenda of Regulatory and Deregulatory actions published today provides a report on the actions administrative agencies are considering issuing in the near and long term and currently lists several planned potential regulatory actions related to tobacco products; however, the dates in the Unified Agenda are not intended to be a precise estimate of when the work necessary to complete a proposed rule will be finished nor a final decision regarding whether a rule will be proposed.
The FDA also remains focused on its regulatory oversight of e-cigarettes and other electronic nicotine delivery systems (ENDS). Thus far, FDA has taken action on approximately 99% of the nearly 6.7 million products for which applications were received by the Sept. 9, 2020, deadline, including issuing marketing denial orders for more than 1 million ENDS products. The FDA has also issued warning letters to ENDS product manufacturers and retailers who continue to sell products that are illegally on the market.
The agency is focused on expeditiously completing the review of the remaining applications we received by the Sept. 9 deadline with a focus on those products with large market share. In addition, the FDA has made a significant investment in a multimedia e-cigarette public education campaign aimed at the nearly 10.7 million youth aged 12-17 who have ever used e-cigarettes or are open to trying them highlighting information about the potential risks of e-cigarette use.
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The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.