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.
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In recent weeks, there’s been a surge of reports about people ending up in the hospital with lung issues, seizures and other health concerns after vaping. These issues — which are affecting many teenagers and young adults — are troubling, and we are just starting to understand all of 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-sized vaporizer, quickly becoming 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 (CDC). In 2016, the Food and Drug Administration (FDA) 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 last year as health officials and the vaping industry try to adapt within this rapidly changing regulatory landscape.
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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.
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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 has 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.
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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 will not renew its membership to the industry group, citing differences on “critical policy issues.”
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.
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.
