Major Flavored ENDS Manufacturers Receive FDA MDOs

Vapor | FDA Marketing Denial Orders Flavored ENDS

The list of companies that have received Marketing Denial Orders (MDOs) for their flavored electronic nicotine delivery system (ENDS) products continues to grow. In the past week, several major players in the ENDS category have received MDOs from the U.S. Food and Drug Administration (FDA), effectively now forced to remove their products from the market. Those companies include AVAIL Vapor, Beard Vape Co., Humble Juice Co., and Turning Point Brands.

At the time of publishing, 295 MDOs have been issued by the FDA towards ENDS products. These orders have impacted over 1,089,000 flavored ENDS products, with few if any in this category having come out with a favorable outcome from submitting their Premarket Tobacco Applications (PMTA) to the FDA for consideration.

In response to receiving the MDO, Turning Point Brands issued the following statement:

“The company stands behind the high quality of its PMTA, which we believe established that the products’ continued marketing would be “appropriate for the protection of public health,” the standard established by the Family Smoking Prevention and Tobacco Control Act of 2009. These products are crucial to improving public health by helping adult smokers migrate to less harmful products. TPB will continue to engage with the FDA and other stakeholders as we consider options moving forward, including a formal appeal of the decision and potential legal relief.

“The PMTA denied by this MDO included an in-depth toxicological review, a clinical study, and studies on patterns and likelihood of use. We believe the data demonstrated that TPB products do not appeal to never users, youth, or former users and that a significant majority of users of TPB products had completely ceased use of combustible cigarettes. The scientific literature on lower-risk nicotine delivery systems shows that these products can significantly improve public health by providing alternatives that are much less harmful than combustible cigarettes.

“While we believe the FDA’s current conclusion is misguided, we will continue our dialogue with the agency in search of a path forward,” said Larry Wexler, President and CEO, Turning Point Brands. “As we explore options for appealing this decision, we are hopeful that the agency reaffirms its commitment to science-based decision making and to its announced Comprehensive Plan, which includes fully transitioning adult consumers down the continuum of risk in order to reduce the morbidity and mortality associated with combustible cigarette use by preserving the diverse vapor market.”

“The company continues to monitor regulatory developments and intends to take appropriate measures to manage and mitigate any risk exposure that may result from these and any future MDOs.”

Some of the companies that have received MDOs in recent weeks are reportedly considering using synthetic nicotine in their products in order to maneuver around the FDA [read more here]. Currently, the FDA does not regulate synthetic nicotine and most regulations are based on the premise that these deemed tobacco products are contain nicotine derived from tobacco leaves. The FDA’s stance or regulatory plans for synthetic nicotine remains unclear.