Sixteen percent of U.S. high school students used electronic cigarettes last year, up from 1.5 percent in 2011, and the Food and Drug Administration is responding by bringing the devices under federal tobacco authority for the first time.

The final rule announced Thursday covers e-cigarettes, vape pens, cigars, hookah tobacco, pipe tobacco, nicotine gels and future products made or derived from tobacco. Beginning in 90 days, retailers may not sell newly covered products to anyone younger than 18, must check photo identification for buyers under 27, may not distribute free samples and may use vending machines only in adult-only facilities.

The regulation also subjects manufacturers to ingredient reporting, product registration, health-warning and premarket-review requirements. The action closes a gap left by the 2009 Tobacco Control Act, which immediately gave the FDA authority over cigarettes, cigarette tobacco, roll-your-own tobacco and smokeless tobacco but allowed the agency to “deem” other tobacco products subject to the law through rulemaking.

That process took more than two years after the proposed rule and produced a framework that public-health groups call overdue and vapor companies warn could eliminate much of a young industry.

A nationwide floor for youth access

The most immediate provisions concern sales. There has been no uniform federal minimum age for e-cigarettes, cigars and hookah tobacco, leaving access rules to a patchwork of states and municipalities. The new regulation establishes 18 as the national floor while preserving stricter state and local laws.

A CDC survey of middle and high school students found that e-cigarettes remained the most commonly used tobacco product among high school students in 2015. Middle-school use rose from 3.9 percent in 2014 to 5.3 percent in 2015. The agency estimated that 4.7 million middle and high school students currently used at least one tobacco product.

Exposure to promotion is widespread. A separate CDC analysis of e-cigarette advertising estimated that about seven in 10 middle and high school students—18.3 million young people—encountered advertising in retail stores, online, in newspapers and magazines or on television and in movies.

The rule does not ban flavors or restrict advertising as comprehensively as cigarette rules do. But it gives the FDA authority to inspect manufacturing, require disclosures, evaluate claims and take additional action. The American Academy of Pediatrics’ May 5 account emphasized the age limit, identity checks and restrictions on vending machines and samples, while urging stronger protections against flavors and promotion that appeal to children.

Premarket review reaches backward to 2007

The rule’s most consequential business provision applies the Tobacco Control Act’s premarket standard to products introduced after February 15, 2007. That date predates nearly the entire current e-cigarette market. Manufacturers of affected products will have two years to submit applications and may continue selling for an additional year while the FDA reviews them.

To receive authorization, a company must show that marketing a product is appropriate for protecting public health, considering both users and people who do not use tobacco. The agency can examine ingredients, toxicological evidence, manufacturing methods, patterns of use and the likelihood that a product will lead people to begin or stop using tobacco.

The mechanism is not equivalent to declaring every product safe. It creates regulatory gates that previously did not exist. A contemporaneous legal analysis by Venable noted that the rule treats vape shops that mix liquids or modify devices as manufacturers, exposing many small retailers to requirements designed for product makers.

Companies must register establishments, submit product lists and ingredients, report harmful or potentially harmful constituents, and obtain authorization for new products. Packages and advertisements for covered tobacco products will eventually carry a nicotine warning, unless a manufacturer can document that the product contains no nicotine.

Public health and harm reduction collide

Health advocates argue that nicotine exposure during adolescence can create addiction and that the rapid rise in youth use justifies federal control even while long-term evidence about vaping develops. Cigars and hookah also expose users to toxic chemicals produced by combustion, while nicotine liquids create poisoning risks for small children.

The Public Health Law Center’s response called federal oversight necessary because the e-cigarette market had expanded rapidly while youth use reached unprecedented levels. The organization nevertheless said it would examine how the rule interacts with state and local authority, which remains important for flavor, price and smoke-free-air policies.

Vapor businesses and some adult users make a different case. They argue that e-cigarettes can substitute for combustible cigarettes and may reduce exposure to many products of burning tobacco. They fear application costs will be manageable only for large tobacco companies, shrinking product variety and removing smaller competitors.

The scientific and regulatory questions are related but distinct. A product could expose an individual smoker to fewer toxicants than cigarettes while still increasing population harm if it attracts adolescents who would not otherwise use nicotine or if adults use both products instead of switching completely. The FDA’s public-health standard is designed to consider both sides of that equation.

PBS NewsHour’s report on the rule described the ban on sales to minors and the 90-day effective date, while noting industry concern about compliance. The measure regulates who may sell and market products; it does not settle whether e-cigarettes are effective smoking-cessation devices, and none has been approved by the FDA for that purpose.

An industry moves from invention to evidence

The e-cigarette market has evolved through frequent changes in batteries, heating coils, liquids, nicotine strengths and flavors. That pace conflicts with a premarket system that expects evidence before each new product is sold. The regulation will force the agency to decide how much variation constitutes a new tobacco product and what studies are adequate for authorization.

A May 5 summary of the FDA action highlighted the February 2007 grandfather date and the concern that few current vapor products existed then. The rule therefore shifts the burden from regulators proving a product dangerous after sale to manufacturers demonstrating that continued marketing meets the statutory standard.

The final requirements extend beyond e-cigarettes. All cigars, including premium cigars, fall under FDA authority, as do hookah and pipe tobacco. The agency rejected an option that would have exempted some premium cigars, concluding that regulating all cigars better protects public health.

Healthcare Dive’s contemporaneous analysis described the action as a major expansion of the agency’s jurisdiction and a foundation for reviewing future products. Implementation will now determine how quickly that authority changes what remains on shelves.

The rule creates a national minimum where none existed and places a fast-moving market inside a slow, evidence-based regulatory system. Its success will depend on whether the FDA can protect adolescents, evaluate product differences and preserve genuinely lower-risk options for adult smokers without allowing claims to outrun science.