The efforts to stem the tsunami of nicotine product use by youth and young adults have suddenly been given substantial support. Many of the previously unregulated nicotine products will now fall under the regulatory body of the U.S. Food and Drug Administration (FDA).
The FDA recently finalized a rule that extends their authority to cover all tobacco-related products. The regulatory umbrella now covers vaporizers, vape pens, hookah pens, electronic cigarettes and electronic pipes — all electronic nicotine delivery systems (ENDS).
A major concern surrounding the electronic systems was the attraction of the products to youth. The products had flavorings, packaging and marketing that were appealing to younger consumers.
A company selling ENDS products will now have to submit applications to the FDA to obtain authorization to sell a new tobacco product. They will be required to register current products by Dec. 31, if manufactured domestically, and companies will have to submit a complete listing of ingredients as well as any known harmful or potentially harmful constituents.
Products that are sold exclusively for therapeutic purposes such as a smoke cessation aide are regulated by the FDA through the Center for Drug Evaluation and Research. Among the products coming under regulation are:
- E-liquids
- A glass or plastic vial container of e-liquid
- Cartridges
- Atomizers
- Certain batteries
- Cartomizers and clearomizers
- Digital display or lights to adjust settings
- Tank systems
- Drip tips
- Flavorings for ENDS
- Programmable software
Mitch Zeller, director of the Center for Tobacco Products at the FDA, recently spoke to Vox about the changes: "The main news here is that finally e-cigarettes, cigars, hookah and pipes will be regulated by the FDA, which is a milestone in consumer protection."
In 2014, Zeller testified before the U.S. Senate about the urgency of developing protections for youth: "Each day in the United States, more than 3,200 youth under age 18 try their first cigarette and more than 700 youth under age 18 become daily smokers. If we fail to reverse these trends, 5.6 million American children who are alive today, will die prematurely due to smoking later in life."
Zeller's testimony proposed means to further protect youth, including regulations forbidding the distribution of free samples, minimum age and identification restrictions, requirements for products to bear health warnings, and the prohibition of vending machine sales unless they are located in a facility that never admits youths.
The use of tobacco is the single largest preventable contributor to disease and death in the United States. For 90 percent of smokers, the age of use started before age 18, and 99 percent of smokers started by age 26. The appeal of ENDS to youth and young adults is contributing to the failure for the numbers of smokers to decline.
"Perhaps the greatest opportunity FDA has to overcome this pressing public health problem is to dramatically decrease the access and appeal of tobacco products to youth," Zeller concluded in his testimony to the Senate.
The expanded authority of the FDA over nicotine products will enable closer monitoring of products and hopefully stem the flow of nicotine products into the youth and young adult market.
