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Federal regulators have finalized new, long-anticipated rules designed to govern electronic cigarettes in the United States, focusing on the importance of keeping e-cigs and the chemicals they release out of the mouths and lungs of children and teens.
On May 5, the FDA announced that it has finalized a rule that extends its authority to all tobacco products. While most of the attention has been on how the agency will regulate the rapidly growing electronic cigarette, or vaping, industry, the new rule also affects cigars, hookahs and pipes. The final rule was published in a Federal Register notice (PDF).
At their core, the new regulations are focused on preventing sales to, and use by, youths, making it illegal to sell e-cigarettes, hookah tobacco and cigars to those under the age of 18. It also puts into place regulations on marketing and manufacturing in order to add safety and quality control measures to the industry, which has come under scrutiny following a string of recent e-cigarette explosions.
“We have more to do to help protect Americans from the dangers of tobacco and nicotine, especially our youth,” said Health and Human Services Secretary Sylvia Burwell in a press release. “As cigarette smoking among those under 18 has fallen, the use of other nicotine products, including e-cigarettes, has taken a drastic leap. All of this is creating a new generation of Americans who are at risk of addiction.”
The rules come following growing pressure on the FDA to take action to prevent youth electronic cigarette use.
The FDA noted that a recent survey conducted with the U.S. Centers for Disease Control and Prevention (CDC) which found that the percentage of high school students who admit to vaping jumped from 1.5% in 2011 to 16% in 2015, an increase of more than 900%.
The new rules that focus on preventing minors from getting access to e-cigarettes and other tobacco products go into effect in 90 days and include a prohibition against sales to minors both in stores and online, and requiring age verification through photo I.D. It also makes it illegal to sell tobacco products affected by the new rules in vending machines unless they are located in an adults-only facility and prohibits the distribution of free samples.
The rules also include a requirement that manufacturers prove that their products meet applicable public health standards detailed in the regulation and requires FDA approval for any of the products to be sold in the U.S. unless it was already for sale before February 15, 2007.
Manufacturers will also have to register manufacturing facilities, provide a list of ingredients and detail which are harmful or potentially harmful, place warning labels on packages and advertisements and agree not to sell tobacco products that suggest a modified risk, such as “light”, “low”, or “mild” without FDA approval.
The FDA has provided a staggered timeline over the next two years for manufacturers to comply with the new rules.