FDA Puts Flavored Vapor Products on 30-Day Notice

SILVER SPRING, Md. — After months of speculation, the Trump Administration kicked off 2020 by taking action against flavored vapor products.

On Jan. 2, the Food and Drug Administration (FDA) announced a ban on flavored electronic cigarette and vapor products. Under the new policy, companies that do not cease the manufacture, distribution and sale of unauthorized flavored cartridge-based e-cigarettes — other than tobacco or menthol — within 30 days risk FDA enforcement actions.

"The United States has never seen an epidemic of substance use arise as quickly as our current epidemic of youth use of e-cigarettes. [Department of Health and Human Services] HHS is taking a comprehensive, aggressive approach to enforcing the law passed by Congress, under which no e-cigarettes are currently on the market legally," said HHS Secretary Alex Azar.

"By prioritizing enforcement against the products that are most widely used by children, our action today seeks to strike the right public health balance by maintaining e-cigarettes as a potential off-ramp for adults using combustible tobacco while ensuring these products don’t provide an on-ramp to nicotine addiction for our youth. We will not stand idly by as this crisis among America’s youth grows and evolves, and we will continue monitoring the situation and take further actions as necessary," he added.

According to FDA Commissioner Stephen M. Hahn, the flavor ban, coupled with the recent federal Tobacco 21 law, "balances the urgency with which we must address the public health threat of youth use of e-cigarette products with the potential role that e-cigarettes may play in helping adult smokers transition completely away from combustible tobacco to a potentially less risky form of nicotine delivery."

He added the agency expects "responsible members of the industry" to comply with premarket requirements; however, the FDA is ready to take action against any unauthorized e-cigarette products

"We'll also closely monitor the use rates of all e-cigarette products and take additional steps to address youth use as necessary," Hahn added.

The FDA final deeming rule establishing its authority to regulate e-cigarettes and other electronic nicotine delivery systems (ENDS) went into effect on Aug. 8, 2016. Under the rule, all products needed to obtain premarket authorization from the agency to remain on the market. To date, the FDA has not approved any Premarket Tobacco Applications (PMTA) for any ENDS.

As a result, according to the FDA, all ENDS products currently on the market are considered illegally marketed and are subject to enforcement, at any time, in the agency's discretion.

Beginning 30 days from the publication of guidance in the Federal Register, the FDA intends to prioritize enforcement against these illegally marketed ENDS products by focusing on the following groups of products that do not have premarket authorization:

• Any flavored, cartridge-based ENDS product (other than a tobacco- or menthol-flavored ENDS product);
• All other ENDS products for which the manufacturer has failed to take (or is failing to take) adequate measures to prevent minors’ access; and
• Any ENDS product that is targeted to minors or likely to promote use of ENDS by minors.