E-cigarette manufacturers hoping to stay on the market must submit a premarket tobacco product application to the FDA as part of the agency’s evolving regulation of the vaping industry.
Kenzo Tribouillard/AFP/Getty Images
In recent weeks, there’s been a surge of reports about people ending up in the hospital because of lung issues, seizures and other health concerns after vaping — and seven people have died. It’s clear we’re just starting to understand all the dangers of vaping.
E-cigarettes hit the US market about a decade ago, touted as a safer alternative to traditional tobacco cigarettes. However, they didn’t really gain any traction until 2015, when Juul Labs (then part of Pax Labs) debuted its discreet USB-size vaporizer and quickly became the industry leader.
The result was a spike in e-cigarette use, especially among young adults, a segment of the population that, until then, had been using fewer tobacco products, according to the Centers for Disease Control and Prevention. In 2016, the Food and Drug Administration finalized a rule extending its authority to regulate all tobacco products, including e-cigarettes, the repercussions of which are still playing out today.
Below, we go through what’s happened over the past year as health officials and the vaping industry try to adapt within this rapidly changing regulatory landscape.
Watch this:
Marijuana tech is evolving
5:37
Sept. 12, 2018 — FDA calls teen vaping an “epidemic”
Dr. Scott Gottlieb, the FDA commissioner at the time, issues a statement calling teen vaping an “epidemic” and urges the e-cigarette industry to address the problem or risk having their flavored products pulled from the market.
Sept. 31, 2018 — FDA inspectors seize documents from Juul Labs HQ
The FDA conducted an unannounced inspection of Juul Labs’ San Francisco headquarters, seeking more information about the company’s sales and marketing practices. Inspectors collected “over a thousand pages of documents,” according to the agency.
Nov. 18, 2018 — Juul Labs shuts down social media accounts
After the FDA expresses concern that Juul is luring in underage users, the company shuts down Facebook and Instagram accounts, and limits its Twitter presence to “non-promotional communications only.”
The University of California, San Francisco, was ahead of the curve. It’s been a smoke- and tobacco-free campus since Aug. 1, 2017.
Getty Images
March 13, 2019 — FDA restricts sale of flavored tobacco products
FDA issues new guidelines restricting the sale of most flavored tobacco products, including e-cigarettes, at convenience stores, gas stations and pharmacies. The FDA also asks that all e-cigarette manufacturers submit applications showing their products meet current regulations by Aug. 8, 2021.
March 27, 2019 — Health experts sue FDA over delay of e-cigarette review
Seven public health and medical groups and several pediatricians file suit against the FDA for not following proper requirements when the agency gave e-cigarette companies more time to submit their products for review.
April 3, 2019 — FDA announces investigation into potential link between seizures and vaping
The FDA notifies the public that it has received reports of people experiencing a seizure following the use of e-cigarettes.
June 25, 2019 — San Francisco bans e-cigarettes
San Francisco, home to Juul’s headquarters, becomes the first city in the US to ban the sale of e-cigarettes.
July 12, 2019 —E-cigarette marketing application submission deadline set
A US District Court judge in Maryland gave e-cigarette companies until May 12, 2020, to submit premarket tobacco applications to the FDA for approval.
July 23, 2019 — FDA launches anti-vaping ads to combat teen vaping
The FDA launches new anti-vaping commercials as part of The Real Cost, the agency’s nearly $60 million smoking prevention campaign. In the TV ads, a street magician uses tricks to educate teens on the risks of using e-cigarettes.
July 24, 2019 — Facebook, Instagram restrict e-cigarette content
Facebook issues a new policy that will restrict sales of and limit content related to alcohol and tobacco products, including e-cigarettes, across Facebook and Instagram.
July 26, 2019 — WHO issues global tobacco epidemic report
In a report, the World Health Organization calls for more research and regulation of e-cigarettes and specifically names Juul as one of the new industry players that “continue to subvert tobacco control.”
Aug. 7, 2019 — FDA says it’s received 127 reports of vaping-related seizures
FDA releases a statement saying it’s now received a total of 127 reports of seizure or other neurological symptoms, such as fainting or tremors, that occurred after vaping between 2010 and 2019.
Aug. 14, 2019 — Vaping industry group sues FDA
The Vapor Technology Association, which represents hundreds of vaping companies, files suit against the FDA to delay regulators’ review of the e-cigarettes currently on the market.
Aug. 16, 2019 — Investors still bullish on Juul Labs
Juul Labs raised another $325 million from investors, despite growing health and legal concerns, according to regulatory filings.
Juul Labs was founded by former smokers with the goal of eliminating cigarettes, according to the company’s mission statement.
truthinitiative.org
Aug. 17, 2019 — CDC opens probe into vaping-related lung disease
State and federal health officials team up to explore whether e-cigarettes caused severe pulmonary issues in 153 people (and counting).
Aug. 19, 2019 — Juul Labs sued over marketing practices
A 19-year-old Juul user sues the company for targeting minors and using deceptive marketing practices, saying the practices led to his nicotine addiction. The lawsuit also names tobacco giant Philip Morris and its parent company Altria, a Juul investor.
Aug. 19, 2019 — Health officials report more than 150 people have been hospitalized
State and federal health officials report that 153 people — many of them young adults — across 16 states have been treated for respiratory issues that occurred after vaping.
Aug. 20, 2019 — Juul Labs leaves Vapor Technology Association
Six days after the VTA issued a lawsuit against the FDA, Juul Labs announces that it won’t renew its membership to the industry group, citing differences on “critical policy issues.”
The CDC says “e-cigarette products should not be used by youth, young adults, pregnant women, as well as adults who do not currently use tobacco products.”
John Keeble/ Getty Images
Aug. 23, 2019 — Illinois reports a patient dying after vaping
The Illinois Department of Public Health said a person who had “recently vaped and was hospitalized with severe respiratory illness” had died. The death may be the first tied to vaping in the US, according to the Associated Press.
Aug. 28, 2019 — Juul CEO says respiratory illness cases are ‘worrisome’
Juul CEO Kevin Burns calls the recent string of lung illnesses potentially linked to vaping “worrisome” and urges nonsmokers to avoid using Juul. “If there was any indication that there was an adverse health condition related to our product, I think we’d take very swift action,” Burns said in a CBS This Morning interview.
Aug. 29, 2019 — FTC launches an investigation into Juul’s marketing practices
The Federal Trade Commission has launched an investigation into whether Juul practiced deceptive marketing, including targeting minors and may seek monetary damages, according to a report from The Wall Street Journal.
Aug. 30, 2019 — CDC: Don’t buy vaping products off the street, and don’t modify them
The Centers for Disease Control and Prevention “took the unusual step” of issuing recommendations regarding vaping and e-cigarette products, The New York Times reported. The CDC’s vaping recommendations cover the general public, clinicians and public health officials. Among the advice for the public: “Anyone who uses e-cigarette products should not buy these products off the street (e.g., e-cigarette products with THC, other cannabinoids) and should not modify e-cigarette products or add any substances to these products that are not intended by the manufacturer.” The CDC also said, as it had done previously, that “e-cigarette products should not be used by youth, young adults, pregnant women, as well as adults who do not currently use tobacco products.”
In early September, the CDC released a statement about its investigations and said no single product is linked to all cases of lung disease.
Europa Press News
Sept. 4, 2019 — A second vaping-related death
Severe lung disease linked to vaping took another life, according to The New York Times. The unidentified person was hospitalized after vaping THC using a product bought at an Oregon recreational marijuana shop, the Times said. The patient was “otherwise healthy and quickly became very ill,” a public health physician and lead investigator in the case told the paper.
Sept. 5, 2019 — Indiana reports vaping-related death
A third life was claimed by severe lung injury related to vaping, The Wall Street Journal confirmed. After news of the individual’s death, federal health authorities urged people to stop using e-cigarette products while they investigate about 450 cases of the mysterious illness in 33 states.
Sept. 6, 2019 — Two more deaths and CDC warning
Health officials in Minnesota confirmed that a 65-year-old person died in August after a long hospitalization from severe lung injury. The person had a history of underlying lung disease, but the lung injury was associated with vaping illicit THC products. The lung injury progressed to other conditions, ABC 5 reported on Friday. The Minnesota Department of Health told the station that the state has had 17 patients to date who’ve been classified as confirmed or possible cases. An additional 15 cases are under investigation.
The first death in Los Angeles county related to vaping was also reported the same day by ABC 7. The county has reported 12 cases “of vaping-associated pulmonary injury” to date, according to its Department of Public Health.
The CDC also released a statement about its investigations and said no single product is linked to all cases of lung disease. Many of the patients reported recent use of products containing THC while some reported using products with both THC and nicotine. A smaller group said they used nicotine only.
Illinois Sen. Dick Durbin tweeted a letter to Ned Sharpless, acting commissioner for the US Food and Drug Administration, demanding action. Durbin said the FDA should send letters to all schools in America warning them of health consequences related to vaping. He also called on the agency to ban e-cigarette flavors other than tobacco and ban e-cigarette devices that haven’t been approved by the FDA.
“If Dr. Sharpless doesn’t take action in the next 10 days, I plan to call for his resignation. Enough is enough,” Durbin tweeted.
The vaping epidemic has now reached the point where multiple people have died and over 450 have been hospitalized, but @FDACommissioner is sitting on his hands. If Dr. Sharpless doesn’t take action in the next 10 days, I plan to call for his resignation. Enough is enough. pic.twitter.com/6yXbu3TxSn
— Senator Dick Durbin (@SenatorDurbin) September 6, 2019
Sept. 9, 2019 — FDA calls out Juul for claiming vaping is safer than other tobacco products
The FDA has raised more concerns about Juul over some questionable marketing that suggested that Juul’s vaporizer is safer than other tobacco products. What’s worse, high school students testified before Congress claiming that a company rep told them that Juul is “totally safe.”
Sept. 12, 2019 — Photos emerge revealing severe lung damage, Juul continues ads despite FDA warning
A collection of photos obtained by Business Insider from doctors and researchers illustrate what are believed to be the severe effects of vaping-related lung damage. The images include those of a California teen who underwent surgery to remove a blister that collapsed his lung after he used a cannabis vape he bought at a concert. Other photos illustrate patterns noted by researchers, including inflammation, damage to the alveoli (or the lungs’ air sacs), and particles of fat in lung tissues. The surgeons quoted in the article said they couldn’t confirm that the injuries and illnesses were definitely caused by vaping.
Despite a warning letter from the US Food and Drug Administration last week, a Juul spokesman told CNBC the company will continue to run its “Make the Switch” ad campaign, which positions vaping as a safer alternative to cigarettes. The company is required to obtain FDA approval before asserting that a product is safer than cigarettes but hasn’t submitted an application for such approval, CNBC said.
Sept. 16, 2019 — Three confirmed cases of severe lung disease related to vaping in Washington
The Washington State Department of Health confirmed two new cases of severe pulmonary disease related to vaping, bringing the total number of confirmed cases statewide to three. Of the two new cases, one patient is in their teens, and the other is in their 20s. All three confirmed cases reported vaping prior to the onset of their illness, but the department has not yet identified a common product, device or additive among the three, though investigations are ongoing.
“The symptoms of these patients match what the Centers for Disease Control and Prevention have asked all state and local health jurisdictions to be on the lookout for in regards to the nationwide investigation into this matter,” Washington State Health Officer Kathy Lofy said in a press release. “This is now a state-wide outbreak.”
Sept. 19, 2019 — Vaping criminal probe announced by FDA as illnesses rise to 530
Health officials from the Centers for Disease Control said that the number of cases of vaping-related lung illnesses has risen to 530 across 38 states. As reported by The Washington Post, the Food and Drug Administration revealed a criminal investigation into the outbreak. Seven people have died from the illness so far. The FDA has collected more than 150 samples from patients across the country and are now analyzing them for the presence of cutting agents and other substances.
Sept. 20, 2019 — Walmart discontinues the sale of e-cigarettes
Citing “regulatory complexity” and “uncertainty” around e-cigarettes, Walmart said it’ll stop selling the products, according to a new report from CNBC. Earlier this year, the company raised the required age to buy tobacco products to 21 and discontinued the sale of fruit and dessert nicotine flavors.
Sept. 24, 2019 — California warns of “sudden lung damage”
The California Department of Public Health released a health advisory that warns citizens of the “imminent public health risks posed by vaping any product.” It said it’s received reports of 90 people in California with a history of vaping being hospitalized “for severe breathing problems and lung damage.”
Two people have also died in California, the state’s public health department said. The advisory added that everyone should stop vaping “no matter the substance or source.” If people continue vaping, they should never modify a vaping product, or buy one off the street, it said.
Vaping appears to be causing “sudden lung damage,” the CDPH said. Symptoms that could be linked to vaping include coughing, chest pain, difficulty getting your breath, nausea, vomiting, diarrhea, abdominal pain, fatigue, fever and weight loss.
The state’s public health department said it’s working with the CDC, FDA, other health departments and healthcare providers on investigating what’s in vaping materials that’s making people ill.
Note: The information contained in this article is for educational and informational purposes only and is not intended as health or medical advice. Always consult a physician or other qualified health provider regarding any questions you may have about a medical condition or health objectives.
CNET’s Alison DeNisco Rayome, Rae Hodge and Corinne Reichert contributed to this report.