Sept. 9 Deadline Arrives for Makers of E-Cigarettes and Other Tobacco Products to Apply to Keep Products on Market – FDA Must Protect Kids and Public Health

Today, September 9, is the court-ordered deadline for manufacturers of e-cigarettes and certain other tobacco products to apply to the U.S. Food and Drug Administration to keep their products on the market. The following is a statement from the American Academy of Pediatrics, American Cancer Society Cancer Action Network, American Heart Association, American Lung Association, Campaign for Tobacco-Free Kids and Truth Initiative:

With the September 9 deadline, the FDA has yet another opportunity to reverse the current epidemic of youth e-cigarette use and stop tobacco companies from addicting a new generation of kids with e-cigarettes, cigars and other tobacco products. The FDA must protect kids and public health, not the interests of the tobacco industry. Our organizations call on the FDA to take the following critical actions:

• The FDA must strongly enforce the September 9 deadline and promptly remove products that do not file the required applications by the deadline. To allow the public to assess industry compliance with, and FDA enforcement of, the deadline, the FDA should quickly follow through on its commitment to publish a list of tobacco products for which applications are submitted by the September 9 deadline.
• The FDA should not authorize the sale of any flavored tobacco products given the clear evidence that flavored products appeal to youth and have driven the youth e-cigarette epidemic.
• The FDA must require manufacturers to provide rigorous scientific evidence demonstrating that a product will actually benefit public health before authorizing its sale, as the law requires.

Four long years after e-cigarettes, cigars and certain other tobacco products became subject to FDA oversight, manufacturers must finally obtain FDA authorization to continue selling these products. During those four years, youth e-cigarette use has skyrocketed to epidemic levels and millions of kids have been put at risk of nicotine addiction. The cause of this crisis is clear: tobacco companies have lured kids with appealing flavors and hooked them with massive doses of nicotine. The FDA must act decisively to stop them.

To gain FDA authorization to market a new tobacco product, federal law (the 2009 Family Smoking Prevention and Tobacco Control Act) requires manufacturers to demonstrate that the product is “appropriate for the protection of the public health.” In enforcing this standard, our organizations have urged the FDA to apply the following key principles:

• The FDA should not authorize any product that will lead youth or other non-tobacco users to initiate use of the product.  Given the strong evidence that flavors attract youth and the lack of evidence that flavored products help smokers quit, no flavored tobacco product – including menthol-flavored products – can meet this test.
• Manufacturers must provide evidence that the product does not deliver nicotine at levels that increase the risk of abuse and addiction among youth.
• The FDA must require that manufacturers prove a product will predominantly be used by smokers who would otherwise continue smoking, that they will switch completely to the new product, and that the product does not deter or lead to a significant decrease in the number of users who would otherwise have quit using tobacco products altogether.
• Manufacturers must also demonstrate that using a product is significantly less harmful than using other tobacco products as actually used by consumers.
• Given the disproportionate burden of tobacco on vulnerable populations, the FDA must require the submission of data sufficient to allow an assessment of the product on those populations.

The FDA’s application of these rigorous public health protections is especially critical in light of the clear evidence that tobacco companies have not changed and want to continue selling products that harm kids and public health. Manufacturers have applied to keep selling e-cigarettes that deliver the same massive doses of nicotine that caused the current youth addiction crisis and to sell these products with menthol and other flavors that appeals to kids. And the tobacco industry has waged a desperate effort to delay the September 9 deadline, exploiting the COVID-19 pandemic in its efforts to do so. This is an industry bent on addicting more kids, not protecting public health. The FDA must stand up to this predatory industry and protect the health of America’s kids.