The American Medical Association has signed onto a lawsuit filed in June trying to get the Food and Drug Administration (FDA) to ban menthol flavored tobacco products. The suit says menthol disproportionately affects people of color.

An October 13 article from Bloomberg Business further explains the suit and why the AMA decided to sign on as a co-defendant.

This release from the World Health Organization shows how tobacco use is responsible for one in five deaths from coronary heart disease. Below is the release, or you can read at the original link by clicking here.

 

“Every year, 1.9 million people die from tobacco-induced heart disease, according to a new brief released today by the World Health Organization, World Heart Federation and the University of Newcastle Australia ahead of World Heart Day, marked on 29 September.

This equates to one in five of all deaths from heart disease, warn the report’s authors, who urge all tobacco users to quit and avoid a heart attack, stressing that smokers  are more likely to experience an acute cardiovascular event at a younger age than non-smokers.

Just a few cigarettes a day, occasional smoking, or exposure to second-hand smoke increase the risk of heart disease. But if tobacco users take immediate action and quit, then their risk of heart disease will decrease by 50% after one year of not smoking.

“Given the current level of evidence on tobacco and cardiovascular health and the health benefits of quitting smoking, failing to offer cessation services to patients with heart disease could be considered clinical malpractice or negligence. Cardiology societies should train their members in smoking cessation, as well as to promote and even drive tobacco control advocacy efforts,” said Dr Eduardo Bianco, Chair of the World Heart Federation Tobacco Expert Group.

The brief also shows that smokeless tobacco is responsible for around 200 000 deaths from coronary heart disease per year. E-cigarettes also raise blood pressure increasing the risk of cardiovascular disease.

Moreover, high blood pressure and heart disease increase the risk of severe COVID-19. A recent WHO survey found that among people dying of COVID-19 in Italy, 67% had high blood pressure and in Spain, 43% of people who developed COVID-19 were living with heart disease.

“Governments have a responsibility to protect the health of their people and help reverse the tobacco epidemic. Making our communities smoke-free reduces the number of tobacco-related hospital admissions, which is more important than ever in the context of the current pandemic,” said Dr Vinayak Prasad, Unit Lead of the WHO No Tobacco Unit.

Tobacco control is a key element for reducing heart disease. Governments can help tobacco users quit by increasing tax on tobacco products, enforcing bans on tobacco advertising and offering services to help people give up tobacco.”

Big news from Bozeman, MT as the city commission voted in favor of a tobacco-free parks resolution. The legislation will prohibit “cigarettes, cigars, pipes, vapes, chewing tobacco and “alternative smoking devices””

To read the full article, click here.

A new study published in Tobacco Control shows how various e-cigarette companies used different stages of the COVID-19 pandemic to boost sales of their products, including using misleading language about the effects of their products.

To read the full study, click here

The FDA issued a letter to 10 companies on July 20, including Puff Bar, to “remove their flavored disposable e-cigarettes and youth-appealing e-liquid products from the market because they do not have the required premarket authorization.”

Puff Bar announced on July 13 they were suspending sales of their product in the United States, but not abroad. Below is the release from the FDA about today’s warning:

 

FDA Notifies Companies, Including Puff Bar, to Remove Flavored Disposable E-Cigarettes and Youth-Appealing E-Liquids from Market for Not Having Required Authorization

Companies Cited for Marketing Unauthorized Tobacco Products Based on Continued Internet Surveillance During COVID-19 Pandemic

Today, the U.S. Food and Drug Administration issued warning letters notifying ten companies, including Cool Clouds Distribution Inc. (doing business as Puff Bar), to remove their flavored disposable e-cigarettes and youth-appealing e-liquid products from the market because they do not have the required premarket authorization. These new actions are part of the FDA’s ongoing, aggressive effort to act against illegally marketed tobacco products amid the public health crisis of youth e-cigarette use in America. The agency is particularly concerned about the appeal of flavored, disposable e-cigarettes to youth and continues to monitor all available data.

“The FDA continues to prioritize enforcement against e-cigarette products, specifically those most appealing and accessible to youth,” said FDA Commissioner Stephen M. Hahn. “We are concerned about the popularity of these products among youth and want to make clear to all tobacco product manufacturers and retailers that, even during the ongoing pandemic, the FDA is keeping a close watch on the marketplace and will hold companies accountable.”

“Despite suspending in-person inspection activities—such as retail compliance checks and vape shop inspections—due to the COVID-19 pandemic, our enforcement against unauthorized e-cigarette products has endured,” said Mitch Zeller, J.D., director of the FDA’s Center for Tobacco Products. “These warning letters are the result of ongoing internet monitoring for violations of tobacco laws and regulations.”

Three firms are receiving warning letters for illegally marketing disposable e-cigarettes—Puff Bar, HQD Tech USA LLC and Myle Vape Inc. The FDA’s review of the companies’ websites revealed that each firm is selling or distributing unauthorized tobacco products that were first introduced or modified after Aug. 8, 2016—the effective date of the deeming rule that extended the FDA’s authority to all tobacco products. Any new tobacco product not in compliance with the premarket requirements of the Federal Food, Drug and Cosmetic Act (FD&C Act) is adulterated and misbranded and may not be marketed without FDA authorization. Puff Bar and HQD Tech USA LLC were also cited for an additional violation for marketing their products as modified risk tobacco products without an FDA order in effect that permits such marketing.

Additionally, FDA issued seven other warning letters to the following firms: Eleaf USA, Vape Deal LLC, Majestic Vapor LLC, E Cigarette Empire LLC, Ohm City Vapes Inc., Breazy Inc. and Hina Singh Enterprises (doing business as Just Eliquids Distro Inc.), who sell or distribute unauthorized electronic nicotine delivery system (ENDS) products targeted to youth or likely to promote use by youth. These firms were cited for marketing unauthorized e-liquids that imitate packaging for food products that often are marketed and appeal to youth, such as Cinnamon Toast Crunch cereal, Twinkies, Cherry Coke and popcorn, or feature cartoon characters.

The FDA has requested responses from each firm within 15 working days detailing how each company intends to address the agency’s concerns, including the dates on which each firm discontinued the sale and/or distribution of these tobacco products, and its plans for maintaining compliance. Failure to correct violations may result in further action such as a civil money penalty complaint, seizure or injunction. In addition, misbranded or adulterated products imported into the U.S. are subject to detention and refusal of admission.

The FDA’s actions during the COVID-19 pandemic also include a recent warning letter to e-liquid manufacturer StemStix Inc. for violations of the FD&C Act, including marketing new tobacco products without authorization, marketing tobacco products with false and misleading advertising and marketing unauthorized modified risk tobacco products.

Additionally, last month the agency issued letters to seven tobacco product manufacturers requesting information to help the FDA examine whether certain tobacco products were first marketed after the deeming rule’s effective date and therefore not subject to FDA’s policy on deferred enforcement of the premarket requirements for certain deemed products. Over the past four months, the agency has also refused admission into the U.S. of at least 74 entries of disposable ENDS products for violations of the FD&C Act.

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.

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