FDA Issues Warning to 10 Companies for Illegal Marketing

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

For Immediate Release:
July 20, 2020

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 BarHQD 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 USAVape Deal LLCMajestic Vapor LLCE Cigarette Empire LLCOhm 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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Puff Bar Suspends Sales in United States

Puff Bar is Suspending US Sales- Full Article

This article appeared on FairWarning.org,  a website which is part of the Institute for Nonprofit News collaborative. The July 13 article describes some background into the owners of Puff Bar and how the company is entangled in two different US lawsuits.

 

Colorado Sun: Colorado to Put Tobacco and Vaping Tax on Ballot

This story appeared in the Colorado Sun on June 11, 2020. Colorado lawmakers are looking at adding a measure to the November ballot to increase taxes on tobacco and vaping products. A full version of the story can be found here

Tobacco Free North Dakota Announces Video Essay Scholarship Contest Winners

We tried to narrow it down to one winner, but one is a lonely number. For the first time, Tobacco Free North Dakota (TFND) is awarding two $1,000 scholarships for the Video Essay Scholarship Contest. The two winners are Sidney Anderson of Lisbon and Amy Moylan of Bismarck. Anderson will be attending Northern State University in South Dakota. Moylan will be attending the University of Mary in Bismarck.

“These two submissions were two of the best we’ve had since we started this contest three years ago,” said Heather Austin, Executive Director of TFND. “After discussion with the board, we decided both Sidney and Amy submitted award-winning videos.”

Usually,TFND hosts an in-person ceremony for the winner. This year, we opted for a socially-distanced video call with each winner.

“I’m really passionate about helping people quit smoking and this contest was the best way for me to spread that message,” said Moylan.
“Living life is important and finding alternatives to drugs and alcohol is best not only for you, but everyone around you,” said Anderson.

CNN: The fight against Covid-19 should also be the fight against tobacco

This story was posted on CNN’s website on June 3. The opinion piece was written by Kelly Henning, the director of public health at Bloomberg Philanthropies. She’s also a former professor of infectious disease at the University of Pennsylvania School of Medicine and served as director of the Division of Epidemiology at the New York City Health Department.

 

Study: People with Diabetes who Smoke Have Higher Risk of Unplanned Medical Visits

TFND’s former president Dr. Eric Johnson was among the authors published in a study showing adult patients with diabetes who smoke have a higher risk of unplanned medical visits. Dr. Johnson says the study was a “Collaboration between University of North Dakota School of Medicine and Health Sciences Department of Family and Community Medicine, UND Masters of Public Health Program, and Sanford Health recently published.”

To read the study, click here

Community Readiness Survey Shows Startling Concerns About Tobacco in North Dakota

The 2019 Community Readiness Survey of North Dakota is showing adults across the state are deeply worried about tobacco use, particularly among youth.

Just a few numbers in the survey show:

  • 3 out of 4 (75 percent) of ND adults believe tobacco use is a moderate or serious problem among youth.
  • Nearly 92 percent of adults don’t believe kids should be using e-cigarette products
  • Nearly 57 percent of adults say the tobacco taxes in North Dakota should be increased, something that hasn’t happened since 1993.
  • 82 percent of people say e-cigarettes should be taxed at the same rate as other tobacco products

To read the full survey, click here

NY Ban on Flavored Tobacco Now Active

New York state’s law banning the sale of flavored tobacco went into effect on Monday, May 18. Below is a  statement from Matthew L. Myers, President, Campaign for Tobacco-Free Kids:

“New York’s historic law prohibiting the sale of all flavored e-cigarettes takes effect today. This action is the right move to reverse skyrocketing youth use of e-cigarettes and couldn’t come at a better time as health experts are warning that smoking and vaping can worsen the effects of COVID-19. It’s more critical than ever to keep our lungs healthy. This measure is necessary to prevent e-cigarettes from addicting a new generation of kids and reversing the enormous progress we have made in reducing youth tobacco use.

Also going into effect is a statewide ban on the sale of all tobacco products at pharmacies. New York follows Massachusetts in taking this important action, and the city of Oakland did the same just last week. We applaud Gov. Andrew Cuomo for his strong leadership in pushing for these measures.

Especially during the COVID-19 pandemic, we urge Governor Cuomo and state lawmakers to continue and step up the state’s efforts to prevent kids from using any tobacco products and help current tobacco users quit. That includes providing robust funding for the state’s tobacco prevention and cessation programs.

The New York legislature should also tackle the serious problem of other flavored tobacco products – especially menthol cigarettes and flavored cigars – when they next return to session. It’s time to stop tobacco companies from targeting and addicting kids with flavored products once and for all and put an end to the tobacco industry’s long and harmful history of targeting kids and African Americans with menthol cigarettes. The coronavirus pandemic should serve as a wakeup call to make our lungs healthier now and for the future.

New York is one of four states that have prohibited the sale of flavored e-cigarettes, along with Massachusetts, New Jersey and Rhode Island (Massachusetts prohibited the sale of all flavored tobacco products). We strongly urge other states – including neighboring Connecticut and Vermont – to join in protecting the health of our kids by ending the sale of flavored tobacco products.

There is no time to waste as the youth e-cigarette epidemic has gone from bad to worse. According to the 2019 National Youth Tobacco Survey (2019 NYTS), e-cigarette use among high school students nationwide increased to 27.5% in 2019 compared to 11.7% in 2017. Altogether, more than 5.3 million middle and high school students now use e-cigarettes. In New York, 27.4% of high school students use e-cigarettes, compared to 4.8% who smoke cigarettes. The evidence is clear that flavored e-cigarettes have fueled this epidemic – 97% of youth e-cigarette users report using a flavored product in the past month, and 70% cite flavors as the reason for their use.”

WHO Statement on Tobacco Use and Covid-19

WHO statement: Tobacco use and COVID-19

Tobacco kills more than 8 million people globally every year. More than 7 million of these deaths are from direct tobacco use and around 1.2 million are due to non-smokers being exposed to second-hand smoke.

Tobacco smoking is a known risk factor for many respiratory infections and increases the severity of respiratory diseases. A review of studies by public health experts convened by WHO on 29 April 2020 found that smokers are more likely to develop severe disease with COVID-19, compared to non-smokers.

COVID-19 is an infectious disease that primarily attacks the lungs. Smoking impairs lung function making it harder for the body to fight off coronaviruses and other diseases. Tobacco is also a major risk factor for noncommunicable diseases like cardiovascular disease, cancer, respiratory disease and diabetes which put people with these conditions at higher risk for developing severe illness when affected by COVID-19. Available research suggests that smokers are at higher risk of developing severe disease and death.

WHO is constantly evaluating new research, including research that examines the link between tobacco use, nicotine use, and COVID-19. WHO urges researchers, scientists and the media to be cautious about amplifying unproven claims that tobacco or nicotine could reduce the risk of COVID-19.  There is currently insufficient information to confirm any link between tobacco or nicotine in the prevention or treatment of COVID-19.

Nicotine replacement therapies, such as gum and patches are designed to help smokers quit tobacco. WHO recommends that smokers take immediate steps to quit by using proven methods such as toll-free quit lines, mobile text-messaging programs, and nicotine replacement therapies.

Within 20 minutes of quitting, elevated heart rate and blood pressure drop. After 12 hours, the carbon monoxide level in the bloodstream drops to normal. Within 2-12 weeks, circulation improves and lung function increases. After 1-9 months, coughing and shortness of breath decrease.

WHO stresses the importance of ethically approved, high-quality, systematic research that will contribute to advancing individual and public health, emphasizing that promotion of unproven interventions could have a negative effect on health.

Oakland Bans Sale of Flavored Tobacco

The City of Oakland (CA) unanimously approved a measure to bans the sale of all flavored tobacco products at all locations within the city. Matthew L. Myers, President, Campaign for Tobacco-Free Kids, posted this statement about the decision:

“Oakland’s City Council today took an important step to protect the health of its kids by unanimously (8-0) ending the sale of all flavored tobacco products at all locations with no exemptions. This action – which covers flavored e-cigarettes, cigars and menthol cigarettes – is the right move to reverse skyrocketing youth use of e-cigarettes and stop tobacco companies from targeting and addicting kids with flavored products. It also couldn’t come at a better time as health experts are warning that smoking and vaping can worsen the effects of COVID-19. It’s more critical than ever to keep our lungs healthy. This measure is necessary to prevent flavored tobacco products from addicting a new generation of kids and reversing the enormous progress we have made in reducing youth tobacco use.

Oakland was one of the first cities to prohibit most sales of flavored tobacco products when it acted in 2017. But its exemption for so-called adult-only tobacco stores created a loophole that the tobacco industry has shamelessly exploited. While just a handful of such shops existed before the law, more than 55 currently operate in the city, with some of these “adult-only tobacco stores” simply being walled-off areas in a store or gas station.

There is no time to waste as the youth e-cigarette epidemic has gone from bad to worse. According to the 2019 National Youth Tobacco Survey (2019 NYTS), e-cigarette use among high school students nationwide increased to 27.5% in 2019 compared to 11.7% in 2017. Altogether, more than 5.3 million middle and high school students now use e-cigarettes. The evidence is clear that flavored e-cigarettes have fueled this epidemic – 97% of youth e-cigarette users report using a flavored product in the past month, and 70% cite flavors as the reason for their use.

Flavored products have long been a favorite tobacco industry strategy for targeting kids. In addition to e-cigarettes, flavored cigars have proliferated in recent years and become popular with kids, while more than half of youth smokers – including seven out of ten African-American youth smokers – smoke menthol cigarettes. The evidence shows that menthol makes it easier for kids to start smoking and harder for smokers to quit. Oakland’s law helps put an end once and for all to the tobacco industry’s long and harmful history of targeting kids and African Americans with menthol cigarettes. The city of Los Angeles, the state of California and others should follow suit by also ending the sale of all flavored tobacco products with no exemptions.

The Oakland City Council also voted to prohibit the sale of tobacco products at pharmacies, provide stronger compliance and enforcement of the law prohibiting the sale of flavored tobacco products, and clarify that the law penalizes retailers who violate the law and does not penalize youth for possession, use or purchase of tobacco products.”