The warning from the Food and Drug Administration on Wednesday marks a stark shift in the agency's tone on e-cigarettes, including the popular Juul brand and others, which have become the most used tobacco product among teenagers.
Since 2017, FDA officials have discussed e-cigarettes as a potential tool to ween adult smokers off cigarettes.
The move comes in response to an "epidemic" of young people using e-cigarettes.
US health officials say teenage use of e-cigarettes has reached "epidemic" levels and are calling on the industry to address the problem or risk having their flavored products pulled off the market.
The proposal, announced on Wednesday, is part of a broader effort to curb teen use of the nicotine devices. The agency issued 12 warning letters to companies they declared have deceptive marketing labels on e-liquids. "We can not allow a whole new generation to become addicted to nicotine", he said.
The agency is now demanding plans to reign in youth-targeted marketing campaigns and control illegal sales of their products to minors from Juul and four other e-cigarette makers within 60 days.
Last year, the FDA announced that it would delay regulations that could have halted the sales of many e-cigarettes.
The owners of Vuse, MarkTen XL, Blu and Logic did not immediately respond to requests for comment.
"I have grown increasingly concerned around what we see as rising youth use in these products, and I'm disappointed in the actions the companies have taken to try to address this", Gottlieb said at a press briefing.
"By working together, we believe we can help adult smokers while preventing access to minors", the company said in a statement.
The FDA said it would consider requiring brands to remove flavored products, which could be contributing to the rise in youth e-cigarette use. Instead, the agency gave extensions to new and existing vaping products, giving them until August 2022 to submit information to support their products' safety and efficacy as switching devices.
He also notes that while many adults who use e-cigarettes report that these products helped them stop smoking combustible tobacco, "the benefits of vaping devices for cessation has not yet been borne out at the population level in clinical or observational studies".