The FDA outlined its concerns over e-cigarette use in minors and its plans to respond to flavored e-cigarette products in a statement issued on September 12, 2018.
The statement reaffirmed the organization's goal of reducing the deaths and diseases caused by smoking, while also addressing its concern over the growing use of e-cigarettes, particularly among minors. Though its focus in the past has been on mitigating the use of tobacco due to its health risks and nicotine content, the FDA is now evaluating e-cigarettes due to the nicotine content in the vaping liquid.
In response to the FDA's statement regarding the use of flavors in electronic nicotine delivery systems, the Flavor and Extract Manufacturers Association of the United States (FEMA) clarified that FEMA GRAS-approved flavors are evaluated only for human food. The statement said, “None of the primary safety assessment programs for flavors, including the GRAS program sponsored by the Flavor and Extract Manufacturers Association of the United States (FEMA), evaluate flavor ingredients for use in products other than human food. FEMA GRAS status for the use of flavor ingredients in food does not provide regulatory authority to use flavor ingredients in [Electronic nicotine delivery systems], or any tobacco products in the U.S.”
Related: FEMA GRAS and U.S. Regulatory Authority: U.S. Flavor and Food Labeling Implications
The FDA intends to address these concerns through the evaluation of flavored e-cigarette products, which appeal to young consumers. Upon evaluation, the organization is looking to curtail the marketing and selling of flavored products or make a policy change that would lead to the immediate removal of these products.
The FDA issued 12 warning letters to companies that sold or advertised kid-friendly flavors (cookies, juice boxes, candy). This is in addition to 1,100 warning letters that were sent to stores that were participating in illegal sales of e-cigarettes to minors and 56 warning letters and six civil monetary penalties issued against e-cigarette provider JUUL in 2018.