E-cigarettes and other tobacco products like premium cigars and hookahs will be regulated in the same way the government regulates traditional cigarettes and smokeless tobacco.
Secretary of Health and Human Services Sylvia Burwell and the commissioner of the Food and Drug Administration, Dr. Robert Califf, made the announcement about their final rule Thursday (PDF).
The rule broadens the definition of tobacco products to include e-cigarettes, hookahs, pipe tobacco, premium cigars, little cigars and other products.
“This action is 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,” the agency said in announcing the extension of its authority.
The new rule will not go into effect immediately, since companies will need time to comply.
The FDA held three public workshops to gather information about the devices and the potential impact on public health. The public comment period closed July 2, at which point the agency began a review of approximately 130,000 comments that informed the final rule.
The purpose of those workshops was to figure out what the risks of e-cigarettes are when used properly and how many chemicals and nicotine are inhaled when someone uses them. The FDA also wanted to know about any potential health benefit.
Some studies have showed that using e-cigarettes would be a good way to help a person quit smoking. In 2014, the Royal College of Physicians published a statement that suggested they were an effective and affordable alternative to conventional cigarettes and could “make harm reduction a reality for smokers.”
The American Lung Association heralded the news as a “long-awaited step to protect public health.”
“At last the Food and Drug Administration will have basic authority to make science-based decisions that will protect our nation’s youth and the public health from all tobacco products, including e-cigarettes, cigars and hookah,” Harold Wimmer, president and CEO of the association, said in a statement.
E-cigarette use among adults has gone up about 12.6%, according to Centers for Disease Control and Prevention (PDF) data from 2014. Among the adults who tried to quit smoking that year, more than a half had tried e-cigarettes as an alternative, and more than 20% started using them. Only a little more than 3% of people who had never smoked tried them, but what has troubled public health leaders is the news that people between ages 18 and 24 had the highest number of new users.
With the new regulations, people under the age of 18 won’t be able to buy these products. Currently, not all states forbid sales to minors.
Research has showed that e-cigarettes have become a problem for children. This year, the CDC found that e-cigarette use had tripled among teens in just one year, and recent research found that teens who used them were more than three times as likely to smoke traditional cigarettes a year later. It’s a phenomenon CDC Director Dr. Tom Frieden characterized as “deeply troubling.”
The American Academy of Pediatrics also said it welcomed the rule. “Today’s action marks an historic step forward in helping to alleviate the threat of lifelong nicotine addiction for our youth,” said its president, Dr. Benard Dreyer.
The products will also have to come in child-resistant packaging. In 2014, the CDC found that the number of calls to poison centers about e-cigarettes had skyrocketed. Most of those calls involved children under the age of 5 ingesting the liquid or getting it into their eyes or on their skin.
E-cigarettes come in kid-friendly flavors like gummy bear, atomic fireball candy, and cookies and cream.
The new regulations also mean that the government can have a say in what goes into the products.
Until now, there was no law mandating that manufacturers tell you what you are inhaling when you try one of their products. The market has been called a “complete unregulated Wild Wild West.”
“This important final regulation puts several strong provisions in place that will serve to protect the public health and rein in an unscrupulous industry,” said Chris Hansen, president of the American Cancer Society Cancer Action Network. “There are thousands of products on the market.”
The new rule will require companies to show what is in their products, excluding those that have been on the market since before 2007. Legislation in Congress would move that to a later date, since there were few if any e-cigarettes on the market prior to 2007.
That FDA made its first big move to regulate e-cigarettes in 2009, when an FDA test on a small number of e-cigarette samples found “detectable levels of known carcinogens and toxic chemicals to which users could potentially be exposed.” Diethylene glycol was found in one cartridge at a 1% level; an ingredient used in antifreeze, it can be toxic to humans in large quantities. Diethylene glycol is also found in some dental products and in some pharmaceuticals.
After that study, the FDA banned the sale of e-cigarettes. It warned e-cigarette users that they were inhaling “toxic” and “harmful” chemicals. However, in 2010, a court ruled that “the FDA had cited no evidence to show that electronic cigarettes harmed anyone” and that stores could continue selling them.
The new rules will also require companies to register with the FDA and put health warnings on their packages and in their ads. It gives the agency the authority to evaluate the potential health impact of these ingredients on users.
Ray Story, the founder and CEO of the Tobacco Vapor Electronic Cigarette Association, called the ruling “a complete disaster.” Since 2009, his association has advocated for a change in the law that would require age verification and restrict sales to minors.
“No children should have access to these products. Just like with alcohol, these are adult products,” he said.
What he takes issue with is the FDA requirement for approval on the products, down to the batteries. He said the rule “essentially bans the product across the land.”
He believes that all the former cigarette smokers who switched to e-cigarettes will now have to go back.
“This is a big blow to public health,” he said. “When you see everyone switching back to conventional tobacco, the pharmaceutical industry will be happy, since they will now have an endless supply of new customers.”
Companies will probably file lawsuits that could delay implementation of parts of the law for decades. Story said he will be meeting with his group’s lawyers today to discuss options.
The FDA said it has been preparing to enforce the law with state- and local-level experts and will add inspectors to be sure retail stores are not selling to minors.