Much to the displeasure of the burgeoning, multibillion-dollar electronic cigarette industry, the U.S. Food and Drug Administration has issued a ruling that prevents those under 18 from buying the battery-operated smokes, as well as cigars, hookah tobacco and pipe tobacco.
But a long list of additional restrictions on the manufacturers of these smoke-generating devices may ensure the safety of e-cigarette users of all ages.
Statistics show that the restrictions were needed. The use of other tobacco devices soared and the vaping industry flourished, with products being sold in malls, convenience stores and vape markets in most communities nationwide.The FDA and the Centers for Disease Control and Prevention reported that the use by high-school-age teens of flavored e-cigarettes and similar products has exploded from 1.5 percent in 2011 to 16 percent last year.
The federal investigators attribute much of that 900 percent increase to the availability of scores of appealing flavors used in the electronically generated smoke.
Most of the battery-operated products — promoted as smoking cessation devices — heat a liquid containing nicotine, flavoring and other chemicals that are atomized into a vapor, which can be inhaled and exhaled like cigarette smoke.
It was the flavorings and other chemicals that most concerned FDA investigators and other public health authorities. For years, the industry said only that the liquid nicotine in each e-cigarette is derived from natural tobacco plants. However, it remained silent on the other various chemical blends it used, insisting they were trade secrets and need not be disclosed.
There was little that the FDA could do about it. Yet bowing to industry is not unique in the FDA, as the agency has long permitted the food industry to self-designate thousands of additives as “Generally Regarded As Safe,” or GRAS, usually without the permission or even knowledge of the federal food-safety cops.
Frustrated by vape sellers’ continued stonewalling, in 2009 the FDA bought a handful of samples off the street and analyzed the smoke-generating liquids inside. It announced that its laboratory found carcinogens and toxic chemicals such as diethylene glycol — an ingredient used in antifreeze — and concluded that users could potentially be exposed.
Later that year, the agency began seizing e-cigarette products at the Mexican border and some West Coast ports, declaring them “adulterated, misbranded, or unapproved drug-delivery devices,” according to federal court documents. However, the border confiscations ended quickly when the well-funded vaping industry went to federal court to halt the FDA seizures. In December 2010, a court ordered the agency to stop blocking the import of the products. FDA appealed the decision, but the industry’s position was upheld in a higher court a month later.
FDA investigators say they continue to have serious concerns about the safety of the imported products, especially because the majority of the devices and flavoring liquids come from China, which has a lackluster safety record on exports of food and additives.
Calling its long-awaited action “historic,” the agency said it was ordered under the Family Smoking Prevention and Tobacco Control Act of 2009 to “improve public health and protect future generations from the dangers of tobacco use through a variety of steps.”
“We have more to do to help protect Americans from the dangers of tobacco and nicotine, especially our youth. 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,” said Health & Human Services Secretary Sylvia Burwell.
The FDA expects that e-cigarette makers will continue selling their products for as long as three years before these requirements will be imposed:
• All manufacturing operations and all the products they make must be registered.
• The FDA must be informed of all ingredients, especially harmful and potentially harmful chemicals and additives.
• All new products must undergo a premarket review and authorization by the FDA.
• Health warnings must appear on all product packages and advertisements.
The ban on sales to minors will go into effect in 90 days, said the agency.