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Federal health officials are taking new regulatory steps to prevent teenagers and adolescents from using e-cigarette products, amid increasing popularity of vaping and mounting evidence of health risks.
FDA Commissioner, Scott, Gottlieb, M.D. released a plan for tobacco regulation on September 12, outlining a new framework developed to create regulatory processes for the proper evaluation the safety and addictiveness of electronic cigarette devices prior to being given marketing authorization from the FDA.
The move comes as the agency warns that nicotine addiction among youth has become an epidemic since the growth in popularity of electronic nicotine delivery systems (ENDS).
The framework was developed after several recent studies identified the increased use of e-cigarette devices such as vape pens and pods, which can have significantly higher levels of nicotine released from them in comparison to traditional cigarettes.
In what the FDA says is the largest coordinated enforcement effort in history, the agency sent 1,100 warning letters to stores nationwide, warning them to stop the illegal sale of e-cigarettes to minors under the age of 18, and issued 131 fines to stores that violated the restrictions on sales to minors.
The FDA also took action against several of the larger manufactures of e-cigarette products, including Juul and four others, ordering them to provide plans to mitigate youth sales within 60 days or face potential criminal or civil actions.
Companies have been asked to change their sales and marketing practices and to stop distributing the products to those who are known to resell to kids, known as “straw purchases”. In these situations, adults will buy the products in bulk and turn around and resell them to children that cannot purchase them outright in stores due to age limitations.
Although electronic forms of nicotine delivery systems have been marketed as an alternative to traditional cigarette smoking, the products have become a particular favorite of teenagers and adolescents, sparking an increased risk of youth nicotine addiction. Gottlieb states the FDA did not anticipate the introduction of e-cigarette devices would cause the epidemic of teenage users that has evolved over the last several years.
While nicotine is ultimately the driving addiction among all tobacco products, the FDA has stated if users could transition away from the act or burning tobacco to free the drug for inhalation, it could prevent thousands of harmful constituents from entering the body.
The FDA believes e-cigarettes may present an important opportunity for adult smokers to transition off combustible tobacco products and onto nicotine delivery products that could prevent a large degree of risk from burning of tobacco.
Several months ago, the FDA and the Federal Trade Commission (FTC) jointly sent 13 warning letters to manufacturers, distributors, and retailers of e-liquid products used in e-cigarettes that closely resemble candy or other food products intended for children.