FDA Makes E-Cigs Off-Limits to Minors Under New Regulations

Disclosures

May 05, 2016

E-cigarettes will be off-limits to people younger than 18 years under new regulations issued today by the US Food and Drug Administration (FDA) that bring all tobacco products under the agency's authority.

Long in the making, the FDA regulations reflect a worry over a lack of progress in curtailing tobacco use among the nation's youth, who are switching from traditional cigarettes to e-cigarettes, cigars, pipes, and hookah bars.

"All of this is creating a new generation of Americans who are at risk of addiction," Sylvia Burwell, secretary of the US Department of Health and Human Services, said in a news release. "Today's announcement is an important step in the fight for a tobacco-free generation — it will help us catch up with changes in the marketplace, put into place rules that protect our kids, and give adults information they need to make informed decisions."

Under the new regulations, retailers must not sell any tobacco product, including e-cigarettes, to anyone younger than 18 years. As with traditional cigarettes, retailers must require age verification by photo ID from tobacco seekers.

The FDA also has banned covered tobacco products in vending machines unless they are in an adult-only facility, as well as the distribution of free samples.

The new requirements go into effect August 8.

New Regs Will Force Manufacturers to Report Ingredients

Makers of e-cigarettes and other newly regulated tobacco products have their own set of rules to follow. They must:

  • Register their manufacturing establishments along with their products

  • Obtain premarket authorization — which involves an agency review — for any tobacco product introduced after February 15, 2007

  • Report ingredients and any harmful or potentially harmful constituents

  • Add health warnings to product packages and advertisements

  • Refrain from selling so-called modified-risk products — often described as "light," "low," or "mild," — without FDA clearance.

The FDA said in its proposed regulations that these requirements will improve its ability to reduce the morbidity and mortality linked to tobacco use. An ingredients list, for example, will help the agency better assess a product's health risk. The FDA also will take into account a given product's appeal to children.

Manufacturers have more lead time than retailers to comply with the new regulations. The FDA will allow them to sell their tobacco products for up to 2 years while they apply for market authorization, and they get another year of sales while the FDA reviews the application.

FDA Backs Off From Banning Flavored E-Cigarettes

Medical societies such as the American Medical Association and the American Academy of Pediatrics, along with patient advocacy groups such as the American Cancer Society, were quick to praise the FDA's move to regulate all forms of tobacco. However, they encouraged the agency to go one step further and ban flavored e-cigarettes, which they view as come-ons for kids.

In the regulations released today, the FDA said it intends to propose a ban on flavored cigars down the line, but that it is holding off on e-cigarettes for now. "Emerging evidence" indicates that some smokers may be trying to break their habit by switching to flavored e-cigarettes and other types of electronic nicotine delivery systems, or ENDS, the agency said.

Some physicians view e-cigarettes as a promising form of tobacco cessation. The Royal College of Physicians in the United Kingdom took that position in a report it issued last month, calling e-cigarettes safer than smoking.

Here in the United States, the American Society of Clinical Oncology (ASCO) said that the new FDA regulations will protect children from e-cigarettes "without undermining their potential to reduce harm as a smoking cessation tool."

Right now, the jury is still out on that question, said ASCO President Julie Vose, MD, in a news release. "E-cigarettes may reduce smoking rates and other adverse health risks, but we will not know for sure until these products are researched and regulated."

More information on today's announcement by the FDA is available on the agency's website.

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