FDA: E-Cigarette Makers Juul, Altria Failing to Reduce Youth Vaping

Juul and Altria, both makers of e-cigarettes and vape products, are in trouble with the U.S. Food and Drug Administration (FDA) again, this time for reneging on a promise the companies made to the government to help curb the epidemic of youth vaping.

FDA Commissioner Scott Gottlieb said he is drafting letters to both companies that will criticize them for publicly vowing to remove flavored liquid nicotine pods from store shelves, while quietly working on a financial partnership that will, in fact, place even more nicotine pods on shelves.

Top executives from Juul and Altria will eventually be confronted in person at FDA headquarters, where Gottlieb said they will have to explain to agency officials how they plan to keep their promise in light of the new agreement.

On December 19, 2018, Altria, the nation’s largest traditional cigarette producer and the maker of Marlboro tobacco cigarettes, agreed to purchase a 35% stake in Juul, the rapidly-growing e-cigarette maker that has exploded in popularity among teens. Juul currently dominates more than 70% of the e-cigarette market. The deal is worth about $13 billion.

When e-cigarettes first hit the market, the products were touted as effective smoking-cessation tools. But vaping became highly attractive to teenagers and young adults in large part due to the flavored nicotine pods used in the devices. Juul, in particular, is a favorite among younger people.

Source: Vox.com

Vaping has helped many people quit smoking, but a number of studies in recent years show that vaping may be creating a new generation of nicotine addicts. In fact, research indicates that a large percentage of teenagers who start vaping eventually graduate to traditional – and more dangerous – tobacco cigarettes.

Altria and Juul acknowledged this link and vowed to do their best to curb kids’ access to their products.

Gottlieb said:

“Juul and Altria made very specific assertions in their letters and statements to the FDA about the drivers of the youth epidemic. Their recent actions and statements appear to be inconsistent with those commitments.”

Back in October, Altria agreed to stop selling pod-based e-cigarettes until the FDA gave the company permission to start up again, or until the youth problem was otherwise addressed. In a letter to the agency, Howard A. Willard III, Altria’s chief executive, agreed that pod-based vaping products significantly contribute to the rise in youth vaping. It also said at the time that it would support federal legislation to increase the legal age to purchase any tobacco or vaping product to 21.

But the new deal between Juul and Altria will give Juul access to shelf space in 230,000 retail outlets where Marlboro cigarettes and other Altria tobacco products are sold. (Juul products are currently sold in 90,000 stores.) The FDA could ask Altria to restrict sales of flavored nicotine pods on its shelf space, but it is unlikely the company will comply with that request.

In September, the FDA warned Altria, Juul and 3 other e-cigarette companies that they had 2 months to figure out how they would prove to the agency that they’d taken steps to prevent the sale of their products to young people. At the time, Gottlieb threatened that failure to do so would result in the companies’ products being pulled from store shelves and worse.

Read: FDA Raid Seizes Thousands of Documents from E-Cigarette Maker Juul

Shortly after the announcement, Altria, Juul, and the other companies laid out to the FDA detailed plans for how they would comply with the agency’s requirements. But if there is one thing the tobacco industry has taught us, it’s that money is more important than human health.

Gottlieb said:

“I’m reaching out to both companies to ask them to come in and explain to me why they seem to be deviating from the representation that they already made to the agency about steps they are taking to restrict their products in a way that will decrease access to kids.”

The deal between Juul and Altria increased Juul’s value to about $38 billion, but even the company’s own employees argued that the deal contradicted Juul’s mission statement. [2]

Sources:

[1] The New York Times

[2] Gizmodo

Vox

SeekingAlpha

Time

FDA Takes “Historic Action” Against E-Cigarette Makers and Sellers

The U.S. Food and Drug Administration (FDA) on September 12 warned 5 e-cigarette manufacturers, including Juul, that they have 2 months to figure out how they’ll prove to the agency that they’ve taken steps to prevent the sale of their products to young people. [1]

Experts say there has been an “epidemic” rise in teen use of e-cigarettes, which are typically sold with liquid nicotine that comes in a variety of tantalizing flavors that appeal to young people.

FDA Commissioner Scott Gottlieb warned the FDA could take the step of requiring companies to:

  • Change their sales and marketing practices
  • Stop distributing products to retailers who sell to kids
  • Remove flavored e-cigarettes – and nicotine products – from the market
Source: National Institute on Drug Abuse for Teens

Gottlieb said:

“I use the word epidemic with great care. E-cigs have become an almost ubiquitous – and dangerous – trend among teens. The disturbing and accelerating trajectory of use we’re seeing in youth, and the resulting path to addiction, must end. It’s simply not tolerable.”

Read: Nearly Half of U.S. Teens Will See an E-cigarette Ad This Year

About 97% of the e-cigarette market is dominated by Juul, MarkTen, Vuse, Blu, and Logic, according to the FDA. Over the next 60 days, the 5 companies’ marketing and sales practices will be under intense scrutiny by the health regulator, and they could face “boots on the ground inspections,” Gottlieb said.

The commissioner said the FDA will also increase federal enforcement actions on e-cigarette sales to minors in convenience stores and other retail sites.

A Historic Crackdown

On September 12, the FDA announced “historic action” against upwards of 1,300 retailers who illegally sold Juul and other e-cigarettes to kids over the summer months of 2018. According to Gottlieb, it was the largest coordinated enforcement effort in the agency’s history.

The agency will closely investigate “straw purchases” in which adults purchase e-cigarettes in bulk from online stores and resell them to minors. It is illegal to sell tobacco products to youths under 18.

Gottlieb said:

“If young adults go online and buy 100 units of a product to sell to teens, that activity ought to be easy for a product manufacturer to identify.”

Manufacturers who choose not to investigate these bulk purchases will face “appropriate consequences,” according to the FDA commissioner.

“Let me be clear: Everything is on the table. This includes the resources of our civil and criminal enforcement tools.”

He added: [2]

“Industry must step up to this challenge. They say they’ve changed from the days of Joe Camel. But look at what’s happening right now, on our watch and on their watch. They must demonstrate that they’re truly committed to keeping these new products out of the hands of kids and they must find a way to reverse this trend.”

Read: 30 Minutes of Vaping Equals 5 Minutes of Cigarette Smoking?

The e-cigarette manufacturers say they will comply with the new rules and that they are working with the FDA to ensure young people don’t get their hands on their products.

JUUL CEO Kevin Burns said in a statement:

“We are committed to preventing underage use of our product, and we want to be part of the solution in keeping e-cigarettes out of the hands of young people. Our mission is to improve the lives of adult smokers by providing them a true alternative to combustible cigarettes.”

Risky Business

A report released in January by the National Academy of Sciences, Engineering, and Medicine suggests that e-cigarettes pose health risks, though they may be less risky than traditional cigarettes. Health experts are more concerned that e-cigarette use could lead to the use of traditional tobacco cigarettes, however.

Source: Daily Mail

Read: Vaping May be Overriding Efforts to Get Kids to Quit Smoking

In the report, a national panel of public health experts state that e-cigarette use may prompt teens and young adults to try regular cigarettes, thus increasing their risk for addiction. There is no scientific proof that vaping is a gateway to smoking tobacco cigarettes, however, and the authors were unable to determine whether young people were simply trying cigarettes or becoming regular smokers. [3]

Sources:

[1] CNN

[2] NPR

[3] The New York Times

National Institute on Drug Abuse for Teens

Daily Mail

Study Links THIS Cancer with Alcoholic Consumption in Teen Boys

There are a plethora of reasons why you should talk to your teens about the dangers of underage drinking. One study even shows that teen boys, in particular, may experience an increased risk of developing aggressive prostate cancer later in life. [1]

In a recent study, men who reported consuming at least 1 alcoholic beverage a day between the ages of 15 and 19 had more than triple the odds of developing aggressive prostate cancer in adulthood, compared to non-drinkers.

The study doesn’t prove that drinking during adolescence causes prostate cancer; however, it may be a marker of other risky behavior, including heavy drinking in adulthood.

Read: Drinking Soda Every Day can Significantly Increase a Man’s Risk of Prostate Cancer

Yet, senior researcher Emma Allott said that because the prostate grows more quickly during adolescence, it’s possible the organ is more vulnerable to cancer-causing agents during adolescence.

She said:

“We are still at the point where there isn’t really convincing evidence linking alcohol and prostate cancer risk. But potentially, there could be a role for alcohol early in life.”

Allott said she hopes the study will lead to more research into prostate cancer risk factors over a man’s lifetime, instead of just a focus on a man’s risk in adulthood.

Study Details

For the study, Allott and her colleagues questioned 650 ex-servicemen aged 49 to 89 who were having their prostate biopsied for possible cancer about their weekly alcohol consumption during each decade of life. [2]

Men who reported drinking 7 “standard” U.S. drinks – each the equivalent of a bottle of beer or a glass of wine – during their teen years were 3.2 times more likely to develop aggressive prostate cancer than men who said they never drank during adolescence.

Read: Eating 10 Portion of Tomatoes Every Week Reduces Cancer Risk “Significantly”

Men who drank largely the same level of alcohol during their 20’s and 40’s were found to have a similar risk. But once they reached their 60’s, their alcohol consumption appeared to have no impact on whether or not they developed prostate cancer.

Because of the self-reported nature of the study, however, the research had its limits.

Dr. Matthew Hobbs of Prostate Cancer UK said:

“As highlighted by the researchers, these studies are tricky to interpret as they rely on participants’ accurately reporting their drinking and eating habits from a significantly long time ago.

It is also very difficult to single out the impact of drinking alcohol from other factors. We do know that alcohol plays a role in the development of some cancers and should be consumed in moderation.”

Read: How Eating Certain Beans Cuts the Risk of Prostate Cancer

In fact, alcohol is linked to at least 7 different types of cancer: [3]

  • 1.Mouth and throat
  • 2. Esophagus
  • 3. Larynx (voice box)
  • 4. Liver
  • 5. Colon
  • 6. Rectum
  • 7. Breast

That info comes from a study published in July 2016 in the journal Addiction. The authors of the report say these are the 7 cancers caused by alcohol that we know of.

Professor Jennie Connor, PhD, of the University of Otago in Dunedin, New Zealand, said at the time:

“There is strong evidence that alcohol causes cancer at 7 sites, and probably others.”

Therefore, it is entirely possible that boys who drink alcohol during their teen years face a greater risk of aggressive prostate cancer later in life.

Sources:

[1] HealthDay

[2] Daily Mail

[3] WebMD