Category Archives: Uncategorized

Teens Are Being Hospitalized After Vaping: Here’s What We Know So Far

Parents, Yahoo! Lifestyle: August 27, 2019.


Last month, a 17-year-old from Texas named Tryston Zohfeld‘s lungs suddenly failed. He was rushed to Cook Children’s Hospital in Fort Worth, Texas and put into a medically-induced coma while the situation only worsened. X-rays found that the teen had a total blockage of his lungs. Ruling out diseases like pneumonia, doctors finally concluded that the lung inflammation and inability to exchange oxygen and carbon dioxide Zohfeld was experiencing had been brought on by chemicals the teen had been inhaling from his vape pen, which he had been regularly using since 8th grade.

While Zohfeld was grateful to be released from the hospital after an 18-day stay, his story is just one of several cautionary tales related to vaping and e-cigarettes that are making headlines nationwide. A 20-year-old from Utah named Alexander Mitchell was recently “on death’s door” after his lungs failed. The young man had been using e-cigarettes. Also this summer, 18-year-old Chance Ammirata’s lung collapsed. The Miami student admitted to vaping about one Juul pod every two days (roughly the equivalent of 10 cigarettes-worth of nicotine a day) for a year.

Now, the U.S. Centers for Disease Control and Prevention (CDC) is conducting an ongoing investigation into cases like these. Here’s what you need to know.

[…]

The Dangers of Vaping for Teens

With hope, the ongoing CDC and FDA investigations will offer parents more answers about the link between e-cigarette use and lung disease, but in the meantime, experts are noting that teens are an especially vulnerable group.

Diana Zuckerman, PhD, president of the National Center for Health Research told CBS News, “It seems some kids are having very measurable damage in a very short period of time than what we’ve seen from [cigarette] smoke.” She explained that a young person’s size might be a factor in how they experience the effects of the chemicals, noting, “The same amount of vaping for a child that weighs, say, 100 pounds, is a bigger issue than for somebody who weighs 200 pounds.”

At the same time, e-cigarettes that include nicotine put teens at risk of addiction, which amplifies their risk of illness. Teens who use nicotine can become addicted in just days. Yale Medicine pediatrician Deepa Camenga, M.D., says that nicotine affects teens differently than adults because “teens are just more vulnerable than adults are to developing an addiction to nicotine. As a result, it may be harder for teens to stop because their brain is still growing and developing.”

Potential Lung Damage Symptoms from Vaping

The CDC notes that “in many cases, patients reported a gradual start of symptoms” including:

  • breathing difficulty
  • shortness of breath
  • and/or chest pain before hospitalization
  • in some cases, mild to moderate gastrointestinal illness including vomiting and diarrhea and fatigue

People who experience illnesses after vaping are encouraged to report the incident to the FDA here.

 

Read the original article here.

Sample Vaping Letter

If you’re concerned about the epidemic of e-cigarettes and vaping, contact your two U.S. Senators to let them know how you feel!  A sample letter is below.  Here is a link to find the names and contact info for your senators.


Dear Senator_____:

I am very concerned about the dangers of e-cigarettes and I am writing to ask you to require that Congress address this serious epidemic.  Action is urgently needed since the Centers for Disease Control and Prevention (CDC) is investigating reports that more than 250 people, including many teenagers and young adults, have suffered harm and in some cases, hospitalization because of lung injuries from vaping.

One man in Illinois has died and vaping is strongly suspected as the cause of his fatal illness.

Scientists are studying whether certain brands of e-cigarettes are most likely to be harmful, and whether the lung damage is caused by the chemicals, contamination or other causes.  Meanwhile a range of vaping products are widely sold and teens and adults are being seriously harmed.

In 2016, the Food and Drug Administration’s (FDA’s) Center for Tobacco Products (CTP) issued regulations aimed at restricting access to e-cigarettes and requiring studies of their risk.  The regulations were supposed to go into effect in 2018, but were delayed.  Meanwhile, the FDA has failed to require the companies to prove that their products are safe.

The industry and the scientists they have hired claim that vaping helps people to quit smoking, but that has not been proven.  Meanwhile, we now know that vaping can cause serious lung damage in just a year or two.  That’s faster than cigarettes, which generally take decades to cause serious harm.

After initially delaying the regulation of e-cigarettes for 4 years, the former FDA Commissioner, Dr. Scott Gottlieb, modified his views, calling vaping an epidemic, and vowed that the agency would take appropriate action.

Please become a co-sponsor of the SAFE Kids Act (S. 655), which would ban most flavoring from e-cigarettes.  These flavors are a major reason why children like to vape.  In addition, please contact the FDA and urge the agency to immediately restrict the marketing of e-cigarettes and require that these devices be drastically restricted until the companies submit conclusive safety data through the PMTA process.  The current delay is harming unknown numbers of teens and adults.

  Sincerely,

Teens Are Being Hospitalized With Lung Damage From Vaping At An Alarming Rate

Emily Reily, Yahoo! Entertainment: August 14, 2019.


A surprising number of teens are suffering from lung damage, and it appears to stem from vaping.

Young Adults Getting Lung Damage

Several cases of severe lung damage were reported in Wisconsin last month, and it’s got medical professionals talking.

“It’s mind-boggling. I’ve never heard of a smoker ending up in the hospital in their teens,” says Dr. Diana Zuckerman, president of the National Center for Health Research.

We Have Evidence Now

And we have real, concrete examples of lung damage in young people.

A teen who said he vaped one Juul pod every two days for a year eventually suffered a collapsed lung.

“He didn’t have the symptoms that might have warned him that something was wrong — until something was really terribly wrong,” added Zuckerman.

[…]

Studies Confirm E-Cigs Are a Bad Idea

The journal “Pediatrics” published a study last year on e-cigarettes, noting that there is a slew of toxic chemicals in them. Some of those chemicals are linked to cancer.

“It seems some kids are having very measurable damage in a very short period of time than what we’ve seen from [cigarette] smoke,” adds Zuckerman.

Read the original story here.

Allergan Breast Implants Linked To Cancer Recalled After FDA Request

Lauren Dunn, NBC News: July 24, 2019.


Following a request from the Food and Drug Administration, Allergan is recalling its textured breast implants worldwide, the company said Wednesday.

The move comes after 38 countries already recalled the implant because of the higher risk of anaplastic large cell lymphoma, or BIA-ALCL, a cancer of the immune system.

[…]

The recall is “a very important step” toward reducing this type of lymphoma, women’s health advocate Diana Zuckerman said.

“When women decide to get breast implants for reconstruction after mastectomy or for breast augmentation, they should not be putting their lives at risk for lymphoma,” Zuckerman, president of the National Center for Health Research, said in a statement. “This recall will reduce that risk but it won’t eliminate it, because not all women with BIA-ALCL had these specific types of implants.”

Last November, NBC News, along with its partner, the International Consortium of Investigative Journalists, found that BIA-ALCL is an emerging risk for women with textured implants.

In March, the FDA said BIA-ALCL is most likely caused by textured breast implants, which have a suede-like coating. But the agency stopped short of taking the implants off the market, noting it wanted to continue studying the disease and tracking cases. It’s estimated that of the 400,000 women in the United States who get breast implants each year, about 1 in 10 has textured implants.

Read the full story here.

More Than Half Of Surgical Stapler Malfunctions Went To Hidden FDA Database

Sydney Lupkin and Christina Jewett, KHN; May 30, 2019


UNITED STATES – NOVEMBER 9 – The outside of the Food and Drug Administration headquarters is seen in White Oak, Md., on Monday, November 9, 2015. The FDA is a federal agency of the United States Department of Health and Human Services and has been in commission since 1906. (Photo By Al Drago/CQ Roll Call)

The Food and Drug Administration has acknowledged that more than 56,000 never-before-disclosed surgical stapler malfunctions were quietly reported to the agency from 2011 through 2018.

The newly acknowledged reports were detailed in an executive summary for FDA advisers. The agency convened a meeting of experts this week to help it determine whether surgical staplers should be moved out of its lowest-risk category — reserved for simple devices like tongue depressors and bandages — to a higher grade that may require testing and additional oversight. Surgical staplers are used to cut and seal vessels and tissues inside the body.

When the FDA initially announced the meeting in March, it acknowledged in a letter to doctorsthat “many more device malfunction reports” were reported to the agency than it had publicly disclosed. The FDA executive summary published this week shows that the total reports more than doubled when the agency took nonpublic reports into account, totaling nearly 110,000 malfunctions or injuries from 2011 through 2018.

“It shocks the conscience,” said Chad Tuschman, a lawyer representing Mark Levering, 62, of Toledo, Ohio, who suffered a serious brain injury after a stapler malfunction caused massive bleeding in 2018. The surgeon, hospital and device maker Covidien, a division of Medtronic, have all denied allegations of wrongdoing in an ongoing legal case.

Surgical staplers have a unique ability to harm patients if they malfunction. Often used in minimally invasive surgeries, they are meant to both cut tissue and vessels and then quickly seal them. Patients have been gravely harmed when staplers have failed to fire or seal tissue, suffering from massive bleeding or infections if stomachs or intestines aren’t sealed properly.

The nonpublic reports were sent to the FDA as “alternative summary” reports, the topic of a recent Kaiser Health News investigation that focused on the agency accepting millions of hidden reports related to medical devices — including for surgical staplers.

The agency had previously acknowledged that in 2016, even as it posted fewer than 100 stapler-related injuries in a public database called MAUDE, it accepted nearly 10,000 reports into its little-known internal alternative summary reporting database. (The data in the FDA’s executive summary contains reports for staplers and staples, which experts have said were just different names for the same problem.)

Tuschman said he was stunned that there were more hidden reports than public ones in the executive summary. “The first question should be ‘Why?’ Why would they have the right to submit to a hidden database?”

Leading surgical stapler makers include divisions of Medtronic and Johnson & Johnson. Medtronic has said the FDA granted it exemptions for stapler-related malfunctions; Johnson & Johnson said it has not. (Ethicon is the name of its subsidiary medical devices company.)

On Thursday, the advisory panel recommended switching surgical staplers to a higher-risk classification with additional safety requirements, according to meeting attendee Jack Mitchell, director of health policy for the nonprofit National Center for Health Research. FDA spokeswoman Stephanie Caccomo declined to confirm this, citing a media office policy against telling reporters what happens at advisory committee meetings, which are open to the public.

“Every surgeon that I have ever worked with has had stapler failures,” said Dr. Doug Kwazneski, a Michigan surgeon who authored a survey in 2013 about “unacknowledged” stapler problems after searching the FDA’s public database of device incidents and coming up empty-handed.

“Going into something without data is dangerous,” Kwazneski said. “If the information exists, we should have access to it.”

More than 400 deaths have been reported since 2011 in the FDA’s public MAUDE database; fatalities can’t be reported to the alternative summary reporting database. Deaths were associated with Ethicon and Covidien products.

In recent communications about stapler safety to doctors, the FDA has advised against using the staplers on large blood vessels.

Kwazneski said surgical staplers are a time-saving tool, which lessens the risk of anesthesia complications during surgery, for example. But it’s important for physicians to remember they can fail.

Diana Zuckerman, president of the National Center for Health Research, said that alternative summary reports are “a well-kept secret” and that any reports related to their existence were “done in a way that was not understood as a repository for hundreds of thousands of serious adverse event reports.” […]

See the original story here.

To fund projects like the Cancer Moonshot, Congress had to strip away some of the FDA’s most important regulatory powers

Katherine Ellen Foley, Quartz: December 1, 2016

Late on Nov. 30, the US House of Representatives voted in sweeping favor across both sides of the aisle (392-26) on a $6.8 billion medical research bill. It’s expected to pass in the Senate, and it has support from the Obama administration.

The 21st Century Cures Act is great for medical research.[…]

All of this medical research spending, though, came with a regulatory compromise. Tucked in the folds of the bill were a number of new laws that allow the US Food and Drug Administration (FDA) to speed up the approval process for a range of treatments.

For example, the Cures Act allows for the expedited approval of new uses of drugs that had been approved previously for other conditions with just anecdotal case studies providing evidence that they work, instead of the usual randomized clinical trials. On the one hand, this means that treatments could reach patients more quickly, and save more lives. But on the other, it means that patients could be exposed to therapies whose risks aren’t completely understood.

There’s also a section of the Act that “expedite[s] the development and availability of treatments for serious or life-threatening bacterial or fungal infections in patients with unmet needs.” That sounds great in theory, but in practice, these drugs might be approved for use in specific patient populations without ever being tested in those people.

According to NPR, some 1,445 lobbyists from 400 organizations worked to sway lawmakers on this bill. Over 1,300 were from groups in favor of the bill, including deep-pocketed pharmaceutical companies in favor of the expedited approval process.“It really is a David and Goliath issue of where the money is,” Diana Zuckerman, the president of the nonprofit National Center for Health Research (which did not lobby for the bill), told NPR.

The Act will go to the Senate next week, where it is expected to pass. Notably, though, Democratic senators Elizabeth Warren from Massachusetts and Bernie Sanders from Vermont have vocally opposed it because of the softened regulations. On Nov. 28, Warren called the bill “extortion,” implying the benefits to the patients with additional medical research would be greatly outweighed by the risks of diminished regulation. The same week, Sanders said in a statement, “This is a bad bill which should not be passed in its current form. It’s time for Congress to stand up to the world’s biggest pharmaceutical companies, not give them more handouts.”

Read original posting here.

Does the FDA Have a High Enough Standard for Drug Approvals?

Shayla Love, STAT News: September 28, 2015

Is the FDA ’s approval process broken? […] Here are some excerpts of the conversation, edited for clarity.

Let me start off by asking: What do you think needs to be improved in the FDA approval process?

Zuckerman: I am increasingly concerned when the standards and criteria for what’s safe and what’s effective is moving more from the pre-market stage, before approval decisions are made, to the post-market stage. More drugs and devices are being approved on a basis of preliminary data, smaller samples, shorter time frames, and sometimes lacking control groups, as what recently happened with Duchenne muscular dystrophy. When that happens, it has a chilling effect on those who are trying to develop treatments and cures. Why would a company spend all of its energy working to do the best possible research if they can get an approval based on a shorter-term study, less definitive data, as long as they encourage patient groups to advocate and lobby for them?

What about the notion that patients and parents living with the disease are really the only ones who can understand what that’s like, and they should be in a position to assess the benefit and risk?

Zuckerman: I think patient perspectives absolutely should be factored in. And they should be factored in at every level. It’s not just important for patients who are wanting a treatment, it’s also equally important for the patients who get harmed. There are some folks in this room who have been harmed by unsafe medical products. They feel like FDA doesn’t listen to them. It’s really important to listen to patients, both the patients who can talk about the benefits of the drugs, or devices, but also the patients who can talk about the risks and the complications.

[…]

Going forward, why wouldn’t we be concerned that other companies won’t be emboldened to try and put an application in, and then force the issue? What we saw with this Duchenne episode is that when you have an effective pressure campaign, that can have an effect. And I’m not saying that’s necessarily a bad thing, that introduces a very human element into the discussion, and it can provide additional information.

[…]

Zuckerman: I want to get into the specifics of why this particular decision concerned us so much. The scientists all said this drug isn’t proven to work, we don’t know if it works, and therefore it doesn’t meet the legal standards that FDA is supposed to use to make a drug approval decision.

The company said they didn’t have a control group because it would be unethical to have a control group. That is a very frightening statement. If you think that it is not ethical to have a control group to study a drug that you don’t know whether it works or not, then you will never be able to find out if the drug works. You have to have a control group, particularly if you have a small sample like that.

Another big issue is the company announced the same day of the approval that this drug is going to cost $300,000 a year. This is a drug that has to be taken every year for the rest of these boy’s lives. It’s not a cure, it’s management. Now, these patients who have been getting this drug, presumably, for free as part of a clinical trial will somehow have to come up with $300,000 a year to continue to get the drug. I don’t know if insurance companies are going to pay for it, considering that the data show there’s not evidence that it works.

[…]

To see the original article, click here

Women’s Health Bills Are Now in Committee


Are E-Cigarettes Safer Than Regular Cigarettes?

Brandel France De Bravo, MPH, Sarah Miller, Jessica Becker, and Laura Gottschalk, PhD, Cancer Prevention & Treatment Fund

Electronic cigarettes, or e-cigarettes, are being marketed as the “safe” new alternative to conventional cigarettes. But are e-cigarettes safe?  What does the FDA think about them?  Are e-cigarettes going to reverse the decline in smoking—giving new life to an old habit—or can they help people quit smoking? Here is what you need to know before picking up an e-cigarette.

What Are E-Cigarettes?

E-cigarettes are battery-operated devices shaped like cigarettes that provide a way to get nicotine. Nicotine is an addictive drug (it stimulates and relaxes) that is naturally found in tobacco. The most popular way for people to take in nicotine is to inhale it by smoking cigarettes. E-cigarettes also allow nicotine to be inhaled, but they work by heating a liquid cartridge containing nicotine, flavors, and other chemicals into a vapor. Because e-cigarettes heat a liquid instead of tobacco, what is released is considered smokeless.[1]

Are E-Cigarettes Safer Than Traditional Cigarettes?

The key difference between traditional cigarettes and e-cigarettes is that e-cigarettes don’t contain tobacco.  But, it isn’t just the tobacco in cigarettes that causes cancer. Traditional cigarettes contain a laundry list of chemicals that are proven harmful, and e-cigarettes have some of these same chemicals.

Since 2009, FDA has pointed out that e-cigarettes contain “detectable levels of known carcinogens and toxic chemicals to which users could be exposed.”[2] For example, in e-cigarette cartridges marketed as “tobacco-free,” the FDA detected a toxic compound found in antifreeze, tobacco-specific compounds that have been shown to cause cancer in humans, and other toxic tobacco-specific impurities.[3] Another study looked at 42 of these liquid cartridges and determined that they contained formaldehyde,  a chemical known to cause cancer in humans.[4] Formaldehyde was found in several of the cartridges at levels much higher than the maximum EPA recommends for humans.

The body’s reaction to many of the chemicals in traditional cigarette smoke causes long-lasting inflammation, which in turn leads to chronic diseases like bronchitis, emphysema, and heart disease.[5f] Since e-cigarettes also contain many of the same toxic chemicals, there is no reason to believe that they will significantly reduce the risks for these diseases.

There are no long-term studies to back up claims that the vapor from e-cigarettes is less harmful than conventional smoke. Cancer takes years to develop, and e-cigarettes were only very recently introduced to the United States. It is almost impossible to determine if a product increases a person’s risk of cancer or not until the product has been around for at least 15-20 years. Despite positive reviews from e-cigarette users who enjoy being able to smoke them where regular cigarettes are prohibited, very little is known about their safety and long-term health effects.

Can E-Cigarettes Be Used to Cut down or Quit Smoking Regular Cigarettes?

If a company makes a claim that its product can be used to treat a disease or addiction, like nicotine addiction, it must provide studies to the FDA showing that its product is safe and effective for that use. On the basis of those studies, the FDA approves or doesn’t approve the product. So far, there are no large, high-quality studies looking at whether e-cigarettes can be used to cut down or quit smoking long-term. Most of the studies have been either very short term (6 months or less) or the participants were not randomly assigned to different methods to quit smoking, including e-cigarettes. Many of the studies are based on self-reported use of e-cigarettes. For example, a study done in four countries found that e-cigarette users were no more likely to quit than regular smokers even though 85% of them said they were using them to quit.[6] Another year-long study, this one in the U.S., had similar findings.[7] People may believe they are smoking e-cigarettes to help them quit,  but 6-12 months after being first interviewed, nearly all of them are still smoking regular cigarettes.

Until there are results from well-conducted studies, the FDA has not approved e-cigarettes for use in quitting smoking.[8]

Teenagers, Children, and E-Cigarettes

The percentage of teenagers who have tried e-cigarettes has almost quadrupled in just four years, from 5% in 2011 to 19% in 2015.  Three million U.S. students in middle school and high school tried e-cigarettes in 2015, according to the National Youth Tobacco Survey.  And, 1 in 5 middle schoolers who said they had tried e-cigarettes also said they had never smoked conventional cigarettes.[9]

E-cigarette use by young people is worrisome for a number of reasons:

1) The younger people are when they begin smoking, the more likely it is they will develop the habit: nearly 9 out of 10 smokers started before they were 18.[10]

2) Nicotine and other chemicals found in e-cigarettes might harm brain development in younger people.[11]

3) E-cigarettes may introduce many more young people to smoking who might otherwise never have tried it, and once they are addicted to nicotine, some may decide to get their “fix” from regular cigarettes. Whether e-cigarettes end up being a “gateway” to regular cigarettes or not, young people who use them risk becoming addicted to nicotine and exposing their lungs to harmful chemicals.

The sharp rise in young e-cigarette users highlights the need to stop manufacturers from targeting teenagers with candy-like flavors and advertising campaigns.

Even children who are too young to smoke have been harmed by e-cigarettes. The liquid used in e-cigarettes is highly concentrated, so absorbing it through the skin or swallowing it is far more likely to require an emergency room visit than eating or swallowing regular cigarettes. In 2012, less than 50 kids under the age of six were reported to poison control hotlines per month because of e-cigarettes. In 2015, that number had skyrocketed to about 200 children a month, almost half of which were under the age of two![12]

How Are E-Cigarettes Regulated?

The FDA was given the power to regulate the manufacturing, labeling, distribution and marketing of all tobacco products in 2009 when President Obama signed into law the Family Smoking Prevention and Tobacco Control Act and in 2010 a court ruled that the FDA could regulate e-cigarettes as tobacco products.[13]

It wasn’t until 2016 that the FDA finally announced a rule to regulate e-cigarettes.[14] Under the final rule, the FDA plans to ban the sale of e-cigarettes to anyone under the age of 18.  The rule also requires all makers of e-cigarettes sold after February 15, 2007 to go through a “premarket review.” This is the process that the FDA uses to determine whether potentially risky products are safe. However, companies are allowed to have anywhere from 18 months to two years to prepare their applications. And it will take another year for the FDA to actually approve these applications. So don’t expect e-cigarettes currently on the market to be officially allowed to be sold by the FDA for another couple of years.

In the meantime, individual states have always had the power to pass laws restricting the sale and use of e-cigarettes. For example, in May 2013, the California state senate proposed a law making all e-cigarettes subject to the same regulations and restrictions as traditional cigarettes and tobacco products.  However, that did not become law.

The Bottom Line

E-cigarettes have not been around long enough to determine if they are harmful to users in the long run.  Unfortunately, many people, including teenagers, are under the impression that e-cigarettes are safe or that they are effective in helping people quit smoking regular cigarettes.  Neither of these assumptions has yet been proven. Studies by the FDA show that e-cigarettes contain some of the same toxic chemicals as regular cigarettes, even though they don’t have tobacco.  The big three tobacco companies—Lorillard, Reynolds American, and Altria Group—all have their own e-cigarette brands, so it’s not surprising that e-cigarettes are being marketed and advertised much the way regular cigarettes used to be.  Here are the 7 Ways E-Cigarette Companies Are Copying Big Tobacco’s Playbook.

Unless you want to be a guinea pig, hold off on e-cigarettes until more safety information is available.  And if you need help quitting or reducing the number of cigarettes you are smoking, check out the smokefree.gov website.

Related Content:

Quitting smoking: women and men may do it differently
Third-hand smoke
Smoking cessation products

All articles on our website have been approved by Dr. Diana Zuckerman and other senior staff. 

References

  1. Richard J. O’Connor Non-cigarette tobacco products: What have we learned and where are we headed? Tob Control. Author manuscript; available in PMC 2013 July 19. Published in final edited form as: Tob Control. 2012 March; 21(2): 181–190. doi: 10.1136/tobaccocontrol-2011-050281.
  2. “Summary of Results: Laboratory Analysis of Electronic Cigarettes Conducted By FDA.” FDA News & Events. FDA, 22 July 2009. http://www.fda.gov/NewsEvents/PublicHealthFocus/ucm173146.htm.
  3. “Summary of Results: Laboratory Analysis of Electronic Cigarettes Conducted By FDA.” FDA News & Events. FDA, 22 July 2009. Web. 09 Aug. 2013. http://www.fda.gov/NewsEvents/PublicHealthFocus/ucm173146.htm.
  4. Varlet et al. (2015) Toxicity of refill liquids for electronic cigarettes. International Journal for Environmental Research and Public Health. 12:4796-4815.
  5. Stoller, JK & Juvelekian, G; Chronic Obstructive Pulmonary Disease; 2010 Cleveland Clinic Center for Continuing Education. https://my.clevelandclinic.org/departments/respiratory/depts/chronic-obstructive-pulmonary-disease.
  6. Adkison SE, O’Connor RJ, Bansal-Travers M, et al. Electronic nicotine delivery systems: international tobacco control four-country survey. Am J Prev Med. 2013;44(3):207-215.
  7. Grana RA, Popova L, Ling PM. A Longitudinal Analysis of Electronic Cigarette Use and Smoking Cessation. JAMA Internal Medicine, published online March 24, 2014
  8. “Electronic Cigarettes” FDA News & Events. FDA, 25 July 2013. http://www.fda.gov/newsevents/publichealthfocus/ucm172906.htm
  9. Singh T, Arrazola RA, Corey CG, et al. Tobacco Use Among Middle and High School Students – United States, 2011-2015. CDC Morbidity and Mortality Weekly Report. April 15, 2016. 65(14);361-367.
  10. Centers for Disease Control and Prevention. Fact sheets: Youth and tobacco use.  http://www.cdc.gov/tobacco/data_statistics/fact_sheets/youth_data/tobacco_use/.
  11. US Department of Health and Human Services. Preventing tobacco use among youth and young adults. Atlanta, GA: US Department of Health and Human Services, CDC; 2012. http://www.cdc.gov/tobacco/data_statistics/sgr/2012/index.htm.
  12. Kamboj A, Spiller HA, Casavant MJ, et al. Pediatric Exposure to E-Cigarettes, Nicotine, and Tobacco Products in the United States. Pediatrics. May 2016. In Press.
  13. “Regulation of E-Cigarettes and Other Tobacco Products.” FDA News & Events. FDA, April 25, 2011. http://www.fda.gov/newsevents/publichealthfocus/ucm252360.htm.
  14. Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act; Restrictions on the Sale and Distribution of Tobacco Products and Required Warning Statements for Tobacco Products. 21 CFR Parts 1100, 1140, and 1143 (2016).