New regulations from the Food and Drug Administration ban the sale of all tobacco products – including e-cigarettes – to minors.

The final rule announced May 5 extends FDA regulatory authority to e-cigarettes, cigars, hookah tobacco, pipe tobacco, and other similar products. Prior to this, FDA regulated cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco under the Tobacco Control Act of 2009.

The new regulations requires manufacturers of all newly regulated products to show that their products meet applicable public health standards and that makers receive marketing authorization from the FDA. The agency now has the authority to evaluate ingredients, product design, and health risks of these products.

U.S. Department of Health & Human Services Secretary Sylvia Burwell said the move was critical to improve public health and protect future generations from the dangers of tobacco.

“As cigarette smoking among those under 18 has fallen, the use of other nicotine products, including e-cigarettes, has taken a drastic leap,” Secretary Burwell said in a statement. “All of this is creating a new generation of Americans who are at risk of addiction. 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.”

Before the rule, no federal law prohibited stores and websites from selling e-cigarettes, hookah tobacco, and cigars to minors, according to an FDA fact sheet. The new rule aims to deter youth access to the products by barring sales to persons under 18, requiring age verification of purchasers, preventing the selling of covered tobacco products in vending machines, and prohibiting the distribution of free samples.

In addition, manufacturers, importers, and retailers of newly regulated tobacco products must follow provisions, such as registering their manufacturing establishments and providing product listings to the FDA, reporting ingredients and potentially harmful constituents to the agency, and placing health warnings on packages and advertisements, among other guidelines. Manufacturers of newly regulated products must meet the applicable public health standards, unless the product was on the market as of Feb. 15, 2007.

FDA Commissioner Dr. Robert M. Califf said the rule marks a milestone in patient protection.

“As a physician, I’ve seen first hand the devastating health effects of tobacco use,” Dr. Califf said in a statement. “At the FDA, we must do our job under the Tobacco Control Act to reduce the harms caused by tobacco. That includes ensuring consumers have the information they need to make informed decisions about tobacco use and making sure that new tobacco products for purchase come under comprehensive FDA review.”

It’s about time that e-cigarettes are regulated like other tobacco products, said Dr. Roy Herbst, chief of medical oncology at Yale Cancer Center and Smilow Cancer Hospital at Yale-New Haven (Conn).

“It’s been quite some time that e-cigarettes have been gaining momentum in our communities and now to finally have them under the purview of the FDA is huge,” Dr. Herbst said in an interview. “It will force more science and research into these products. ... If these are so safe, they should go through clinical studies to prove that.”

Dr. Herbst noted that within 90 days of the published rule, retailers can no longer sell the products to minors, and that within 3 years, the products will be regulated like other tobacco products.

Manufacturers will be allowed to continue selling their products for up to 3 years while they submit a new tobacco product application and the FDA reviews the application, according to the FDA.

Physicians and other health advocates expressed support for the regulations.

“The AMA supports the FDA’s new rule and its efforts to ensure the public – especially young people – is aware of and protected from these harmful products,” AMA President Dr. Steven J. Stack said in a statement. “The new FDA rule, which fills the gap in federal regulations on purchasing, labeling, and packaging of e-cigarettes; cigars; and other tobacco products, is a notable and important step that will ban the sale of these products to minors and improve public health. However, we urge FDA to issue further regulations addressing marketing of these products and banning flavored e-cigarettes, which are particularly enticing to minors.”

The American Academy of Pediatrics also suggested more steps to curb tobacco use.

“The rule is a welcomed starting point, but it is only a framework upon which to build meaningful regulation to end the tobacco epidemic in the United States once and for all,” American Academy of Pediatrics President Dr. Benard P. Dreyer said in a statement. “Today’s action marks an historic step forward in helping to alleviate the threat of lifelong nicotine addiction for our youth, and should serve as a foundation for further progress when it comes to keeping children safe from dangerous tobacco products.”

The rule will be published in the Federal Register on May 10.

agallegos@frontlinemedcom.com

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FDA takes more steps to keep kids off tobacco products