RICHMOND | The Food and Drug Administration said Monday it plans to regulate smokeless electronic cigarettes as tobacco products and won’t try to regulate them under stricter rules for drug-delivery devices.
The federal agency said in a letter to stakeholders Monday that it intends to propose rule changes to treat e-cigarettes the same as traditional cigarettes and other tobacco products.
The news is considered a victory for makers and distributors of the devices, which continue to gain popularity worldwide.
E-cigarettes are plastic and metal devices that heat a liquid nicotine solution in a disposable cartridge, creating vapor that the “smoker” inhales. A tiny light on the tip even glows like a real cigarette.
Users and distributors say e-cigarettes address both the nicotine addiction and the behavioral aspects of smoking — the holding of the cigarette, the puffing, seeing the smoke come out and the hand motion — without the more than 4,000 chemicals found in cigarettes.
First marketed overseas in 2002, e-cigarettes didn’t become easily available in the U.S. until late 2006. Now, the industry has grown from the thousands of users in 2006 to several million worldwide, with tens of thousands of new e-smokers every week.
No timeline has been set on the proposed rule changes.
The FDA said e-cigarettes could still be regulated as drugs or drug-delivery devices if they are “marketed for therapeutic purposes,” — for example, as a stop-smoking aid.
Jason Healy, president of e-cigarette maker Blu Cigs, called the news a good first step, but said the pending rule changes will be more beneficial for “weeding out the shady companies.”
Right now, “you can potentially sell snake oil,” Mr. Healy said.
Nearly 46 million Americans smoke cigarettes. About 40 percent try to quit each year, according to the Centers for Disease Control and Prevention. But unlike nicotine patches or gums, e-smokes have operated in a legal gray area.
The FDA lost a court case last year after trying to treat e-cigarettes as drug-delivery devices, rather than tobacco products, because e-cigarettes heat nicotine extracted from tobacco. It had until Monday to appeal to the U.S. Supreme Court.
In December, a federal appeals court ruled electronic cigarettes should be regulated as tobacco products by the FDA rather than as drug-delivery devices, which have more stringent requirements such as expensive clinical trials to prove the products are safe and effective as a stop-smoking aid.
Some sellers of e-cigarettes sued the FDA in 2009 after the agency told customs officials to refuse entry of shipments into the U.S. A federal judge ruled that the FDA can’t stop those shipments, saying the agency had overstepped its authority.
In September, the FDA issued warning letters to several makers of electronic cigarettes or its components, saying the companies are violating the law with unsubstantiated health claims and poor manufacturing practices.
The FDA also had said that its tests found the liquid in some electronic cigarettes contained toxic substances — besides nicotine, which is itself toxic in large doses — as well as carcinogens that occur naturally in tobacco. Most e-cigarettes are imported from overseas.
However, some public health experts say the level of those carcinogens was comparable to those found in nicotine replacement therapy, because the nicotine in all of the products is extracted from tobacco.
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