The US Food and Drug Administration (FDA) has issued marketing denial orders (MDOs) for several mint-flavored electronic cigarette products sold by Logic Technology Development. These products include Logic Pro Menthol e-cigarette liquid packaging and Logic Power Menthol e-cigarette liquid packaging. This marks the first time the FDA has issued MDOs against menthol products after undergoing scientific review.
This move appears to align with regulatory agencies' goals of banning the use of menthol flavoring in tobacco products. It is expected that the FDA will not approve any flavored electronic cigarette products other than tobacco.
Ensuring that new tobacco products undergo pre-market assessments is a key part of the FDA's efforts to reduce tobacco-related diseases and deaths," said Brian King, director of the FDA's Center for Tobacco Products (CTP) in a press release. "We remain committed to evaluating new tobacco products based on public health standards, which take into account the risks and benefits of these products for the entire population.
Gregory Conley, Director of Legislative and External Affairs at the American Vaping Association, told tobacco reporters that the FDA's recent ban on menthol-flavored e-cigarettes brings to mind their "fatal flaw" review of PMTAs, which resulted in millions of products being denied. The FDA uses the term "fatal flaw" to submit PMTAs without specific research, and it has been at the center of almost all lawsuits against the agency's PMTA process.
The dysfunction of the FDA is ongoing. Over the past year, the FDA has delayed making a decision on menthol-flavored e-cigarette products," said Conley. "To avoid giving the impression that the FDA is striving to find a balanced approach, they have revealed today that their grand plan for menthol-flavored e-cigarette products will follow the same 'fatal flaw' review process, which has led to dozens of lawsuits being filed against the agency.
After reviewing the premarket tobacco product application (PMTA) of the company, the FDA has determined that these applications "lack sufficient evidence to demonstrate that allowing the product to be marketed would be appropriate for protecting public health (APPH), the applicable standard required by the 2009 Family Smoking Prevention and Tobacco Control Act.
The FDA stated that the evidence provided in the PMTA refused by Logic did not prove that mint-flavored electronic cigarettes are more effective in promoting "complete conversion or significant reduction in cigarette use" than tobacco-flavored electronic cigarettes.
Logic is now faced with the decision to either resubmit their application or submit a new application in order to address the issues with their MDO-restricted products. However, these actions may be futile as the FDA has stated that for non-tobacco flavored e-cigarettes, including mint-flavored e-cigarettes, "existing evidence indicates known significant risks in terms of youth appeal, uptake, and use.
The FDA conducts a rigorous and scientific review of pre-market tobacco product applications, evaluating data for each product to determine if it meets public health standards," said King. "In this case, the applicant did not provide sufficient scientific evidence to demonstrate that the potential benefits for adult smokers outweigh the risks for youth.
A manuscript of an upcoming article on nicotine and tobacco research has recently been received, which found that California's flavored electronic cigarette and other tobacco sales restrictions have not affected the use of electronic cigarettes among youths.
According to the organization, the MDO letter received by Logic today is not limited to the two products mentioned above. Generally, the FDA only publicly discloses the names of products that the applicant is marketing to avoid potential disclosure of confidential business information. Any product bound by MDO cannot be sold or distributed in the United States, otherwise the FDA may take enforcement action. Without risking enforcement action by the FDA, these products cannot be legally introduced into interstate commerce in the United States. In March, the FDA authorized several tobacco-flavored electronic cigarette products, including devices, under the company's Logic Vapeleaf, Logic Power, and Logic Pro brands.
Apart from ensuring that Logic complies with the directive, the FDA intends to ensure compliance from distributors and retailers. Specifically, the FDA has stated that any new tobacco products sold on the market without prior authorization are considered illegally sold, and their distribution or sale will be subject to enforcement action.
Recently, the United States Department of Justice on behalf of the FDA filed a motion for a permanent injunction against six e-cigarette manufacturers in a federal district court. These cases mark the first time the FDA has initiated injunction proceedings to enforce premarket review requirements for new tobacco products under the Federal Food, Drug, and Cosmetic (FD&C) Act.
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