• by Thom Forbes  @tforbes, May 6, 2016

With studies showing a large increase in vaping among teens, the Food and Drug Administration yesterday announced a ban on the sale of e-cigarettes, cigars, pipe and hookah tobacco to anyone under 18 in a heavily footnoted, 499-page document that makes clear it has established a connection between their use and “illnesses and premature deaths.” It also requires that e-cigarettes carry warnings that they contain nicotine.

“The rules promise to have a major impact on the $3.4 billion e-cigarette industry that has flourished in the absence of federal regulation, making the nicotine-delivery devices the most commonly used tobacco products for U.S. youngsters,” report Reuters’ Caroline Humer and Clarece Polke.

“Millions of kids are being introduced to nicotine every year, a new generation hooked on a highly addictive chemical,” U.S. Secretary of Health and Human Services Sylvia Burwell said during the press conference introducing the regulations.  

Hundreds of brands launched since 2007 — the vast majority of the market, according to a CBS/AP report — will have to undergo federal review “under new rules that have the potential to upend a multibillion-dollar industry attempting to position itself as an alternative to traditional cigarettes.” 

Under staggered timelines, the FDA expects that manufacturers will continue selling their products for up to two years while they submit — and an additional year while the FDA reviews — a new tobacco product application, according to the FDA’s press release.

The “sweeping new rules,” writes Sabrina Tavernise for the New York Times, “shifted the terms of the public debate over e-cigarettes, putting the federal government’s heft behind a more restrictive approach to the devices. Many health experts fear that e-cigarettes will eventually hook a new generation on traditional cigarettes, while others worry that a tougher approach will make it harder for addicted smokers to get access to devices that may be their best hope of quitting.” 

Indeed, the FDA itself call its action “a milestone in consumer protection — going forward, the FDA will be able to review new tobacco products not yet on the market, help prevent misleading claims by tobacco product manufacturers, evaluate the ingredients of tobacco products and how they are made, and communicate the potential risks of tobacco products,” reports CNN’s Jen Christensen. 

The new rules also require age verification by photo ID; ban the sale of the covered tobacco products in vending machines (unless in an adult-only facility) and forbid the distribution of free samples, among other restrictions.

“The Utah Department of Health praised the federal regulations Thursday, citing the skyrocketing rates of teen e-cigarette use in Utah, which have nearly tripled since 2011,” writes Daphne Chen of the Deseret News. Brittany Karzen, who works for the department’s tobacco prevention and control program tells Chen “e-cigarettes threaten to overturn decades of work spent wrestling the U.S. smoking rate to all-time lows, particularly among youths.” 

Vaping is a gateway to “combustible tobacco” use, its critics contend, and “some early studies in the U.S. suggest a link between e-cigarette experimentation and traditional tobacco use among teens,” Chen points out.

“Ending the tobacco epidemic is more urgent than ever, and can only happen if the FDA acts aggressively and broadly to protect all Americans from all tobacco products,” says Harold Wimmer, president of the American Lung Association.

But the vaping industry is gearing up for a fight, claiming it’s part of the solution.

“Today’s final rule pulls the rug out from the nine million smokers who have switched to vaping, putting them in jeopardy of returning back to smoking, which kills 480,000 Americans each year and costs the U.S. more than $300 billion in annual health care expenses,” says Cynthia Cabrera, president and executive director of the Smoke-Free Alternatives Trade Association (SFATA) in a statement. “These new regulations create an enormously cost-prohibitive regulatory process for manufacturers to market their products to adult smokers and vapers.”

SFATA also points to the U.K.’s Royal College of Physicians’ recently released report “endorsing vaping as a harm reduction option.” 

In an op-ed published by USA Today, Jeff Stier calls on Congress to “undo some of FDA’s damage” by including an amendment passed by the House appropriations committee in its final fiscal 2017 spending bill. It would dial back the more stringent provisions the FDA has decreed but still “institute vapor battery standards, marketing restrictions and a ban on sales to minors.”

“The FDA wasn’t wrong to regulate e-cigarettes. It was wrong to effectively ban, by its own estimate, up to 98.5% of the e-cigarettes on the market today,” writes Stier, a senior fellow at the National Center for Public Policy Research, which receives 1.4% of its support from the tobacco and e-cigarette industry.