FDA Issues MDO For 55,000 Flavoured E-Cigarette For Failing To Assure Protection Of Public Health

On 26th August, 2021 the US Food and Drug Administration (FDA) issued the first Marketing Denial Orders (MDOs) for electronic nicotine delivery system (ENDS) products after assessing the applications for over 55,000 flavoured ENDS or e-cigarette products from three applicants, due to the paucity of evidence regarding the  benefit it has on adult smokers which is adequate to overcome the public health menaces posed by the well-documented, disturbing  levels of youth use of these products. This move is subjected to non-tobacco-flavoured ENDS from JD Nova Group LLC, Great American Vapes, and Vapor Salon, including flavours including Apple Crumble, Dr Cola and Cinnamon Toast Cereal. Products receiving such orders would require the companies to pull out them from the market until proper evidence is presented before FDA.

Marketing Application is required to get legal authorization for marketing and commercialization of a product, which is yet to be approved by the FDA or any other regulatory authority. Products that are  subjected  to an MDO for a premarket application cannot be delivered for  interstate commerce. And If the product is already out in the market, it is supposed to be removed from the market or face legal actions. Mitch Zeller, JD, director of the FDA’s Center for Tobacco Products said, “Companies who want to continue to market their flavored ENDS products must have robust and reliable evidence showing that their products’ potential benefit for adult smokers outweighs the significant known risk to youth.”

“Ensuring new tobacco products undergo an evaluation by the FDA is a critical part of our aim to reduce tobacco-related disease and death. We know that flavored tobacco products are very appealing to young people, therefore assessing the impact of potential or actual youth use is a critical factor in our decision-making about which products may be marketed,” said Acting FDA Commissioner Janet Woodcock, MD.

What are e-cigarettes?

Before going into further details, one must clearly understand what e-cigarettes actually are and how is it different from the conventional cigarettes. As the name suggests, e-cigarette is an electronic device that allows the users to inhale nicotine in the form of vapour, along with various available flavours. In this device the tobacco electronically creates vapour out of the nicotine contained liquid instead of burning the tobacco in the usual cigarettes.  It is also addressed as vaping, like it is smoking for cigarettes.

According to Centers for Disease Control and Prevention  (CDC), e-cigarettes often contain nicotine which is highly addictive and can adversely affect adolescent brain development. E-cigarettes can contain other harmful substances besides nicotine and young people who are addicted to e-cigarettes are more likely to smoke cigarettes in the future.

E-cigarettes in India and other countries

On 18th September, 2019 the Indian government announced that it has decided to ban e-cigarettes consumption, including its production, import-export, online sale, distribution and online-offline advertising.

Addressing a press conference then, Nirmala Sitharaman said, "E-cigarettes were promoted as a way to get people out of their smoking habits but reports have shown that many people are not using it as a weaning mechanism but are rather addicted to it." Making it as a punishable offence, the government said that the decision was aimed to protect the youth from the health hazards caused by e-cigarettes.

Along with India, other countries that have banned e-cigarettes are Japan, Qatar, Singapore, Thailand. In most of the countries there are some kind of restrictions imposed related to e-cigarettes, either on its sale or on advertising or have formed certain age limit to access it.

FDA on e-cigarettes

The FDA rule has banned its access to minors and as of 8th August, 2016, FDA has expanded its regulatory powers to include e-cigarettes. Based on this ruling, the FDA will evaluate certain aspects, including ingredients, product characteristics and health risks.

This year 'The Real Cost' Youth E-Cigarette Prevention Campaign was initiated by FDA with an aim to educate youth about the risks of using e-cigarettes. The FDA is also committed to provide resources for educators, parents, and community leaders to prevent usage of e-cigarettes and to help children quit smoking  who are already addicted to e-cigarettes.