E-cigarettes are available in different strengths, with nicotine content ranging from 0 – 24 mg. Some believe them to be a better alternative to conventional cigarettes which contain tobacco, tar and carbon monoxide. However, the US Food and Drug Administration (FDA) has concerns about the safety of e-cigarettes, which have yet to be completely researched in a rigorous setting.
Among other things, it has not yet been established whether electronic cigarettes are safe for long term use. There is no definitive research on the amount of nicotine and other potentially harmful chemicals inhaled during vaping or whether those chemicals might even bring any benefit to the user. Some also have concerns that young people could first obtain e-cigs, and later become addicted to conventional tobacco cigarettes.
Due to the above mentioned issues, the FDA took the opportunity to extend its regulatory reach to electronic cigarettes manufacturers. Electronic cigarette regulation would theoretically be applied to those companies which claim their products have therapeutic use, regulated and monitored by the FDA Center for Drug Evaluation and Research (CDER). Another government agency, the Center for Tobacco Products (CTP) regulates cigarette tobacco, cigarette, and smokeless tobacco and roll–your-own tobacco could also get into the act; it is authorized to regulate other products containing nicotine like electronic cigarettes, even if in the future they do not claim to have therapeutic use.
A key decision by the FDA came in 2011, when they decided to only regulate e-cigs in the same way they regulate tobacco cigarettes, rather than under the stricter regulations they had been trying to apply, that govern the sale of drug delivery devices. That came after a court defeat, when the D.C. Court of Appeals ruled that the FDA cannot regulate electronic cigarettes under the same act as is used to regulate drugs and devices.
Under electronic cigarette regulations, warning letters have been issued by the FDA to a number of e-cigarette distributors for violating the federal Food, Drug and Cosmetic Act, for making controversial drug claims and for violations of proper manufacturing practices, and for using devices as delivery mechanisms for active pharmaceutical ingredients like tadalafil and rimonabant. The companies receiving these warning letters were E-Cig Technology Inc., E-Cigarette Direct LLC, Ruyan America Inc, Smokey Bayou Inc and Johnson’s Creek Enterprises LLC.
Electronic cigarette regulation was called into play for E-Cig Technology LLC because it allegedly marketed the weight loss drug rimonabant and the erectile dysfunction drug tadalafil in liquid form, such that it could be placed into the cartridges of electronic cigarettes and administered through vapor when inhaled. According to the FDA, Johnson’s Creek Enterprises failed to meet proper manufacturing standards with poor quality control and below average testing procedures.
There are also efforts underway in many states to regulate or ban the sale and use of e-cigs; those efforts range from bans on sale of the devices to people under the age of 18, to banning their use in public places, to complete bans on the sale or use of electronic cigarettes. So far, the attempts to legislate have mostly fallen short, but in states like New York, lawmakers continue their efforts.