On June 8, more than 50 members of Congress signed a letter addressed to Food and Drug Administration (FDA) Commissioner Dr. Robert Califf, expressing concerns over FDA’s delays in reviewing pending Premarket Tobacco Product Applications (PMTAs) and its failure to remove unauthorized products from the market. The letter strongly urges “FDA to (1) expeditiously complete review of remaining e-cigarette PMTAs; (2) follow the science on the risks flavored [e-cigarettes] pose to youth and deny PMTAs for all non-tobacco flavored e-cigarettes, including menthol flavored products; and (3) increase enforcement actions against companies that make, distribute, and sell flavored products without a marketing order, especially products with a significant market share, or products that are most popular with youth.” The letter also requests that FDA respond to several questions by June 23, as summarized below (as of the date of this blog post, we are not aware of any FDA response).
- Why is FDA not taking aggressive action to remove all e-cigarettes that have failed to obtain marketing orders from the market?
- Why is FDA exercising its enforcement discretion for any flavored e-cigarette?
- Which categories of e-cigarettes are receiving enforcement discretion from FDA, and why?
- What is the public health rationale for not taking enforcement action against companies with a pending PMTA? What about companies that never submitted a PMTA?
- What steps has FDA taken to identify e-cigarettes that are on the market illegally, and what enforcement action has FDA taken against them?
- Will FDA commit to taking immediate enforcement action to remove these unauthorized e-cigarettes from the market?
- Why is FDA allowing synthetic nicotine products to remain on the market?
Below, we organize the letter’s requests into topic groups and provide our thoughts.
PMTA Review Timing
We agree that FDA should clear its backlog of PMTAs as efficiently as possible; however, it should do so in a manner that authorizes all products that are appropriate for the protection of public health based on sound science, and not on a policy that “weighs the scales” against all flavored e-cigarettes.
“Follow the Science”
The letter requests that FDA “follow the science on the risks flavored [e-cigarettes] pose to youth and deny PMTAs for all non-tobacco flavored e-cigarettes, including menthol flavored products.” As highlighted in ongoing litigation involving FDA, there is no rule banning non-tobacco flavored e-cigarettes, and for FDA to deny PMTAs for these products without considering the merits of each PMTA would result in a de facto, unlawful flavor ban. FDA should not “move the goal posts” by changing its standards for evaluating PMTAs that have already been submitted based on prior FDA guidance.
Enforcement Action and Discretion
In all fairness, as we previously reported in our Tobacco Law Blog here and here, FDA has increased enforcement activity against e-cigarette companies over the last several months. Enforcement action against companies that choose to ignore FDA requirements is generally a good thing for industry, especially for members that spend extraordinary resources complying with such requirements.
Current FDA guidance prioritizes “enforcement of any ENDS [Electronic Nicotine Delivery System] product that is offered for sale in the United States after September 9, 2020, and for which the manufacturer has not submitted a premarket application (or after a negative action by FDA on a timely submitted application).” (Emphasis added). FDA’s rationale is “that it is unable, as a practical matter, to take enforcement action against every illegally marketed tobacco product, and that it needs to make the best use of Agency resources.” Industry relies on this guidance to make business decisions in an uncertain regulatory environment and any FDA response to the letter should remain consistent with its guidance.