E-cigarettes, a form of Electronic Nicotine Delivery System (ENDS), are now regulated by the Food and Drug Administration (FDA).
The FDA has classified e-cigarettes, hookahs and other ENDS products as now subjected to regulation, like other tobacco products, regarding their manufacture, import, packaging, labeling, advertising, promotion, sale, and distribution.
Manufacturers of e-cigarettes are required to immediately submit an application and obtain authorization for marketing their product. The FDA requires a listing of ingredients, as well as information about harmful and potentially harmful constituents (HPHCs). E-cigarettes and their liquids also now must have a warning statement on packaging and advertisements.
The FDA was pushed toward regulation based on striking statistics, such as the increase in e-cigarette usage by youth. The agency’s website states “More than 3 million middle and high school students were current users of e-cigarettes in 2015, up from an estimated 2.46 million in 2014”.
For the second year in a row, e-cigarettes are the most commonly used tobacco product among youth, with an astounding 16 percent of high schoolers and 5.3 percent of middle schoolers using them in 2015 alone. Before 2011, the percentage of high schoolers using e-cigarettes was only 1.5 percent, and only .6 percent of middle schoolers.
The agency now has the authority to help prevent misleading claims by makers of tobacco products and evaluate the ingredients that go into tobacco products, as well as how they are made.
Health and Human Services (HHS) Secretary Sylvia Burwell said of the new regulation, “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.” Burwell described the decision to regulate e-cigarettes as “an important step in the fight for a tobacco-free generation.”
Diacetyl exposure is a major risk of e-cigarette usage, and has been a health concern for years. Diacetyl and 2,3 pentanedione (a diacetyl substitute) are chemicals that produce a buttery or creamy flavoring.
When diacetyl is inhaled, the person is at risk for developing obliterative bronchiolitis, or “popcorn lung,” a disease where the smallest airways of the lungs become scarred and restricted. The symptoms include difficulty breathing, and are very similar to the symptoms of COPD, asthma, or chronic bronchitis. Obliterative bronchiolitis is a disease that is only treatable by lung transplant.