Gottlieb says the five largest e-cigarette manufacturers will have 60 days to produce plans to immediately reverse underage use of their products.
But Gottlieb acknowledged Wednesday that the agency failed to predict an "epidemic of addiction" among youth, mainly driven by flavored products.
Several other manufacturers targeted by the FDA - MarkTen, Vuse, Blu and Logic - also issued statements agreeing with the need to limit access to minors and announcing their willingness to work with the FDA to reach a solution. Appropriate flavors play an important role in helping adult smokers switch.
Gottlieb's action drew immediate praise from a major tobacco-control organization, the Campaign for Tobacco-Free Kids.
The commissioner has repeatedly agreed that e-cigarettes can be an effective tool for adults trying to quit smoking, so his harsh words for the industry on Wednesday were all the more remarkable.
FDA commissioner Scott Gottlieb said the agency will soon release data that show a "substantial increase" in youth vaping this year compared with 2017. But "the youth risk is paramount", he said.
Makers argue that e-cigarettes can help adult smokers transition away from burnt tobacco products. They included chains such as 7-Eleven, Casey's General Store, Circle K, Cumberland Farms, Kwik Trip, Sheetz, Speedway, Tom Thumb and Wawa, as well as gas station banners like BP, Chevron, Citgo, Conoco, Exxon, Marathon, Mobil, Murphy USA, Phillips, RaceTrac, Shell, Sunoco, Texaco and Valero. BPS prohibits smoking on school property, including the use of electronic devices.
Tobacco investors have grown increasingly concerned that the widespread popularity of e-cigarettes is having a negative impact on the old-school industry, a headwind expected to grow as its products from companies like Juul continue gaining traction with consumers.
The FDA's regulation of tobacco products has always been marked by twists and turns and years of debate.
Congress gave the FDA the authority to regulate tobacco products in 2009. Additionally, 12 online retailers were found to be selling vaping products that were "misleadingly labeled and/or advertised e-liquids resembling kid-friendly food products", in violation of an earlier order from the FDA, and were also slapped with warning letters, according to the announcement. Sales were allowed to continue in the interim.
"Today we can see that this epidemic of addiction was emerging when we first announced our plan last summer", said Gottlieb.
The FDA has also been revamping its regulation on tobacco, including lowering the amount of nicotine in conventional cigarettes. In addition, the agency pushed back until 2022 a deadline for electronic-cigarette companies to submit applications to the FDA. The delay was denounced by public-health groups, which have sued to restore the tighter timeline.
Wells Fargo analyst Bonnie Herzog, in a research note, said Juul appears "most at risk" from the crackdown because of its "strong appeal to youth and the FDA's comments on flavors".
Much of the FDA's sharp change in course is a result of the phenomenal success of Juul, which looks like a USB flash drive. In just three years, it has captured about 70 percent of the e-cigarette market, according to Bloomberg.
"Juul was a game changer", Myers said in an interview.
The company has stressed that the device was created for adults who want to transition from regular cigarettes.
Organizations from around the country have been looking into whether the marketing tactics used by these companies lure teens specifically.
Originally, e-cigarettes were created to help those who already smoked by providing options to get nicotine without tar and other cancer-causing chemicals. No flavors now are restricted from other tobacco products.