The FDA evoked the sale of four cigarette products manufactured by R.J. Reynolds.

The FDA, recently tightening its regulatory grip on cigarette manufactures, banned the sale of four kinds of cigarettes on Sept. 15.

Manufactured by R.J. Reynolds, the banned brands include Camel Crush Bold, Pall Mall Deep Set Recessed Filter, Pall Mall Deep Set Recessed Filter Menthol and Vantage Tech 13. The action was taken because the manufacturer failed to prove the cigarettes were not more harmful than comparable tobacco products.

The FDA Pulls Cigarettes Off The Shelves

The FDA ordered that four cigarette brands be removed from retails stores because they failed to achieve substantial equivalence status.
Image: Pipes Magazine

The Family Smoking Prevention and Tobacco Control Act of 2009 was passed to allow the FDA to deny cigarettes and other tobacco products that may pose a greater public health risk than comparable products on the market.

R.J. Reynolds released new products that were commercially marketed as of Feb. 15, 2007. In 2011, the company applied for substantial equivalence status.

To receive that status, R.J. Reynolds would have to provide evidence that the products didn’t raise new questions for public health. The company could also receive the status by proving the new products had the same characteristics as an existing product.

The FDA found that the four banned brands were not the same as their predecessors and questioned if the newer versions could be more harmful.

In the announcement, the FDA said that ingredients, engineering and chemistry of the products were analyzed. The agency also measured how these factors could influence cigarette toxicity, addictiveness and appeal to smokers.

For example, Camel Crush Bold cigarettes have a small menthol capsule in the filter, which might make the cigarette more appealing to consumers.

Matthew Myers, the president of Campaign for Tobacco-Free Kids, said the products “deliver menthol differently and at higher levels, have added sugars and other sweeteners, new filters, and tested differently for harmful and potentially harmful constituents.”

Retailers have been told to immediately stop the sale of banned brands and dispose of them within 30 days. The consequence of noncompliance is financial penalties or criminal prosecution.

“These decisions were based on a rigorous, science-based review designed to protect the public from the harms caused by tobacco use,” Mitch Zeller, the director of the Center for Tobacco Products at the agency, said in statement.

A Response From R.J. Reynolds

R.J. Reynolds claims that the FDA ban is unjust because the company successfully proved the substantial equivalence of their products.
Image: CBS News

The company gave a statement that asserted a strong disagreement with the decision.

“Our submissions to the agency on these brands were comprehensive, and we believe we effectively demonstrated substantial equivalence,” according to Jeffery S. Gentry, the company’s executive vice president for operations and chief scientific officer.

R.J. Reynolds is currently examining options for moving forward.

Financial services firm Cowen and Company said in a research note that the four banned products accounted for less than 1 percent of the company’s sales. It’s not likely that the action will have a serious impact on R.J. Reynolds.

The firm predicts that the company will file a legal injunction to suspend the action. The other option would be to pull the products before legally contesting the findings.

As the FDA increasingly wields its power, it’s interesting to reflect on the nation’s tobacco history. Gone are the days when cigarette companies could alter existing products and introduce new ones as they pleased.

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A new study confirms that youths who use electronic cigarettes are more likely to switch to traditional tobacco cigarettes.

Vaping is a relatively new fad, and researchers all over the world are trying to figure out how it will impact the population.

Because so many scientists are gathering data on vaping, the studies often conflict. Some support e-cigarettes as smoking cessation therapies, while others reject them as gateway products.

As the FDA grapples with how to regulate e-cigarettes, a new study sponsored by the National Cancer Institute shows that teens who vape are more likely to move on to traditional tobacco cigarettes.

The Study

Researchers surveyed approximately 700 e-cigarette users and non-users and tracked the amount who begun using traditional cigarettes one year later.
Image: West Texas News

The study will be published in the November edition of the journal JAMA Pediatrics. It’s one of many that attempts to discern the benefits from the negative effects of e-cigarettes.

Researchers at the University of Pittsburgh and Dartmouth-Hitchcock Norris Cotton Cancer Center conducted a study that tracked 694 people between the ages of 16 to 26. The majority of participants were considered to be “non-susceptible” and had no intention of smoking cigarettes. Only 16 people, or 2.3 percent of participants, were already using e-cigarettes at the start of the study in 2012.

One year later, 37.5 percent of e-cigarette users had transitioned to cigarettes, compared to only 10 percent of youths who were not already using e-cigarettes.

About 31 percent of e-cigarette users changed their mind about intending to smoke cigarettes, compared to 9.3 percent who were not using e-cigarettes at the beginning.

The authors took additional factors that could have influenced e-cigarette users into account. The study did not focus on the frequency of e-cigarette use, intention to experiment or if e-cigarettes and cigarettes were being used simultaneously.

Results And Regulation

The FDA is in the process of deciding how heavily e-cigarettes will be regulated.
Image: Electronic Cigarette Consumer Reviews

The study was limited by the small sample size of people already using e-cigarettes at the beginning of the trial. The small sample size made it difficult to prove the results would be easily replicated.

The results are based on the idea that e-cigarette users are becoming conditioned to enjoy sensation-seeking behavior, which could make them more likely to smoke traditional cigarettes. Some also argue that vaping is more attractive to younger generations.

“E-cigarettes are not subject to many laws that regulate traditional cigarettes, such as age limits on sales, taxation and labeling requirements,” said lead author Brian A. Primack, MD, PhD, director of CRMTH and assistant vice chancellor for health and society in Pitt’s Schools of the Health Sciences.

“They also come in youth-oriented flavorings that laws have limited in traditional cigarettes, such as apple bubble gum and chocolate candy cane.”

These individuals may have transitioned to smoking tobacco cigarettes regardless. But when the authors adjusted the study to include additional factors and sensation-seeking tendencies, there was still a link between e-cigarette use and a transition to traditional cigarettes.

The study authors cite three main reasons that e-cigarettes might be a gateway to traditional smoking:

• E-cigarettes deliver nicotine more slowly than traditional cigarettes, allowing a new user to advance to cigarette smoking as he or she becomes tolerant of nicotine side effects.

• Unlike other forms of nicotine, such as smokeless tobacco, e-cigarettes are designed to mimic the behavioral and sensory act of cigarette smoking, allowing the user to become accustomed to the act of smoking.

• E-cigarettes are not subject to the same regulations as traditional cigarettes, potentially renormalizing the act of smoking after decades of public health efforts to shift public norms around smoking.

The FDA is in the process of analyzing data from various studies to make decisions on how to regulate e-cigarettes. Some hope that e-cigarettes could be a healthier alternative to traditional cigarettes, whereas others believe the products could create a new generation of nicotine addicts.

“It will be important to continue surveillance among youth of both e-cigarette use and overlap with use of other tobacco products,” according to the study authors.

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The annual Monitoring the Future study, which tracks trends in drug and alcohol use, shows that college students prefer marijuana over tobacco cigarettes.

When college students take a smoke break, it’s more than likely that they aren’t smoking a cigarette. In fact, they’re probably picking up a pipe.

Studies show more teens and young adults regularly smoke marijuana instead of cigarettes, which illustrates a new trend in the adolescent and undergraduate age group.

The Survey

For 40 years, the study has tracked and reported on the popularity and use of various substances in American adolescents, college students, young adults, and adults up to age 55.
Image: Monitoring The Future

The University of Michigan Institute for Social Research conducts an annual Monitoring the Future study, which has collected data about full-time college student’s drug and alcohol use since 1980. The study is meant to be a nationally representative sample.

“Monitoring the Future is an ongoing study of the behaviors, attitudes, and values of American secondary school students, college students, and young adults.

In addition, annual follow-up questionnaires are mailed to a sample of each graduating class for a number of years after their initial participation,” according to the Monitoring The Future website.

The survey asks students if they smoke marijuana every day or if they have used the drug for a minimum of 20 times in the last 30 days. Results show that almost 6 percent of full-time students used marijuana regularly, whereas only 5 percent identified themselves as heavy cigarette smokers.

Out of the students surveyed, 21 percent said they used marijuana at least once during the previous month and 34 percent said they had used it in the past year. But what do the study’s findings mean?

Results Show A Changing Trend

The most recent results mark first time the study has found more students are smoking marijuana than cigarettes.
Image: NYU Local

Researchers believe that teenagers and young adults have paid attention to public health warnings about cigarettes, but have regarded marijuana as a much safer alternative, according to lead investigator Lloyd Johnston.

This year’s results are important: this is the first time that more young adults have admitted to regularly using marijuana more than cigarettes. The number of daily and near-daily pot users from the 2014 survey was the highest ever recorded.

“It’s clear that for the past seven or eight years there has been an increase in marijuana use among the nation’s college students,” Johnston said. “And this largely parallels an increase we have been seeing among high school seniors.”

The survey includes information about other substances as well. In terms of alcohol use, only 5 percent of students said they engaged in extreme binge drinking, which researchers defined as having 15 or more drinks in one sitting at least once in the last two weeks.

However, the amount of students using cocaine has increased from 2.7 percent in 2013 to 4.4 percent in 2014. It’s too early to know if cocaine is making a comeback on college campuses, but Johnston said the increase was statistically significant.

As far as sober students go, half of survey respondents had not used any illicit drugs in the past year.

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The FDA has issued letters to three tobacco manufactures urging them to alter the advertising tactics used on natural and additive-free cigarettes. The FDA believes the wording will lead consumers to believe that some kinds of cigarettes are safer than others.

You’re a dedicated cigarette smoker, but this year you want to make an effort to be more health conscious. When shopping for cigarettes, you may see a product that has the words ‘natural’ or ‘additive-free’ written on the label. You compare the packaging and choose the brand that seems the healthiest.

In a recent crackdown, the FDA has demanded three tobacco companies stop advertising their cigarettes with wording that may be misleading to consumers.

This is the first time the FDA has taken action to enforce a law that was created six years ago. The historic move will change the way tobacco products are labeled.

Steps For Stricter Regulation

American spirit cigarette advertisements feature the standard surgeon general’s warning and an additional warning for cigarettes with no additives.
Via: Flickr

An FDA ruling in 2000 compelled cigarette companies that claimed their products use natural tobacco had to include “no additives in our tobacco does NOT mean a safer cigarette” on the labeling, along with the standard surgeon general’s warning.

But in 2009, legislators passed the Tobacco Control Act, which gave the FDA the authority to “regulate the manufacture, distribution, and marketing of tobacco products to help all Americans, especially young people, live longer, healthier lives.”

The law allowed the FDA to:

• Require new and more effective warning labels on tobacco products
• Establish and enforce restrictions on tobacco advertising and promotions
• Require tobacco companies to disclose what is in their products
• Review tobacco manufacturers’ claims of “modified risk” products to prevent misleading claims
• Educate consumers about the dangers of tobacco use, among other powers

The FDA first exercised the law by sending a warning to Santa Fe Natural Tobacco Co.,  ITG Brands and Sherman’s 1400 Broadway N.Y.C. about the advertising tactics used to sell their cigarettes. The brands sell American Spirits, Winston cigarettes and Nat Sherman cigarettes, respectively.

The warning letters discuss violations of section 911 of the Federal Food, Drug, and Cosmetic Act, urging the companies to alter their labeling to make sure that it doesn’t present “a lower risk of tobacco-related disease” that makes their product appear “less harmful than one or more other commercially marketed tobacco products.”

Setting An Example

The FDA is waiting for a response from three companies that have been asked to alter the advertising on their cigarette packages.
Via: Viral Sneak

The press release detailing the offense was issued on August 27. The three companies were contacted by the FDA and must respond to the letters in no more than 15 business days with an explanation of how they plan to remedy the issue.

The FDA believes these companies are not in compliance with the law. The companies have the option to give an explanation and  provide evidence if they believe they are not in violation of the law. If they fail to respond, the FDA may initiate civil financial penalties, criminal prosecution, seizure and/or injunctions.

ITG has responded in a statement that its product complies with the state and federal regulations. According to the representatives, “while we disagree with the FDA’s position on this issue, we intend to engage with the FDA and respond to their letter in the coming days.”

According to a statement from Mitch Zeller, director of the FDA’s Center for Tobacco Products, the agency is just doing its job.

“The FDA’s job is to ensure tobacco products are not marketed in a way that leads consumers to believe cigarettes with descriptors like ‘additive-free’ and ‘natural’ pose fewer health risks than other cigarettes, unless the claims have been scientifically supported,” he said.

“This action is a milestone, and a reminder of how we use the tools of science-based regulation to protect the U.S. public from the harmful effects of tobacco use.”

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