FDA Is Reviewing Applications for Over 6.5 Million New Tobacco Products, What's the Result

On August 26, 2021, the U.S. FDA(Food and Drug Administration) issued the first marketing denial orders (MDOs) for electronic nicotine delivery system (ENDS) products after determining the applications for about 55,000 flavored ENDS products from three applicants lacked sufficient evidence that they have a benefit to adult smokers sufficient to overcome the public health threat posed by the well-documented, alarming levels of youth use of such products. The products from JD Nova Group LLC, Great American Vapes, and Vapor Salon subject to this action are non-tobacco-flavored ENDS and they include flavors such as Apple Crumble, Dr. Cola and Cinnamon Toast Cereal.

However, dated back to Sept. 09, 2021, the FDA faced the unprecedented task of reviewing applications for over 6.5 million “deemed” new tobacco products-many of which were already on the market. A majority of the applications submitted by a court-ordered deadline of Sept. 9, 2020, were for electronic nicotine delivery systems (ENDS) products, such as e-cigarettes and e-liquids, which had never been through the FDA review process. 

It’s reported that: “We’ve made significant progress in the months since, working diligently to better understand these products and, as of today, taking action on about 93% of the total timely-submitted applications. This includes issuing Marketing Denial Orders (MDO) for more than 946,000 flavored ENDS products because their applications lacked sufficient evidence that they have a benefit to adult smokers sufficient to overcome the public health threat posed by the well-documented, alarming levels of youth use of such products. Flavored ENDS products are extremely popular among youth, with over 80% of e-cigarette users ages 12 through 17 using them. ” As we can learn from the above, the key points of enforcing the statutory examinations are 1. Improve public health from regulating tobacco products; 2. Protect youngsters from smoking and vaping.

It’s just more evident from this paragraph, “As required by statute, a key consideration in our review of premarket tobacco product applications submitted for products like e-cigarettes is to determine whether permitting the marketing of the product would be “appropriate for the protection of the public health,” taking into account the risks and benefits to the population as a whole. This determination includes consideration of how the products may impact youth use of tobacco products and the potential for the products to completely move adult smokers away from use of combustible cigarettes. Importantly, 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 determination as to whether the statutory standard for marketing is met. ” 

As of today, the agency has taken action on applications for over 6 million ENDS products, including refusing to file (RTF) one company’s applications for approximately 4.5 million products because required contents were missing as well as issuing 132 MDOs for more than 946,000 flavored ENDS products.

All new tobacco products on the market without the statutorily required premarket authorization are marketed unlawfully and subject to enforcement action at the FDA’s discretion

The FDA is committed to completing the review of the remaining products as quickly as possible to provide regulatory certainty and will continue to keep the public informed of our progress. Meanwhile, products for which no application is pending, including, for example, those with a Marketing Denial Order and those for which no application was submitted, are among our highest enforcement priorities. If such products are not removed from the market, the agency intends to follow its usual enforcement practices in these circumstances and will issue a warning letter before initiating enforcement action (such as civil money penalties, seizure, or injunction) and afford the recipient an opportunity to respond.

With the massive applications of ENDS products, the FDA said: “We are committed to working as quickly as possible to transition the current marketplace for deemed new tobacco products to one in which all products available for sale have undergone a careful, science-based review by the FDA and met the statutory standard. Continuing to take appropriate regulatory actions to protect the public, especially youth, from the harms of tobacco products remains one of the agency’s highest priorities.”

The large number of the rejected flavored ENDS products just heavily struck the e-liquid manufacturers and direct or indirect told them that detrimental vape juice cannot be introduced to the public despite how delicious and moreish the e-liquid is. Meanwhile, before launch a ENDS product, you should submit the papers and tests of the product’s safety and validity, or you’ll receive a warn letter even enforcement actions just to warn you remove the unqualified product from market. All these efforts done by the FDA apparently not only aim to regulate the ENDS products market place but also protect the youth and improve public health. By the way, it also accelerates the innovation and development of e-cigarette industry in a right way.