Iowa AG Worried About FDA Marketing Denials

Iowa Attorney General Tom Miller has expressed unease about the U.S. Food and Drug Administration’s Sept. 9 decision to deny large numbers of e-cigarettes access to the marketplace.  

“We are concerned about the impact of the FDA’s actions, particularly the unintended consequences of pulling from the market less harmful alternatives to cigarettes,” Miller wrote in a statement. “We believe the best information available indicates that most youths are not getting e-cigarettes from vape shops and that a significant number of adults are using products from vape shops to move away from combustible cigarettes.

“Let’s not forget the overwhelming risk to public health: The CDC estimates the burden of tobacco use in the United States is 480,000 lives a year, all of which is due to the use of cigarettes.

“We believe in the strong, science-based regulation of alternative tobacco products, and the FDA is the best agency to undertake that task. Policymakers must strike the right balance between making accessible potentially lifesaving lower risk nicotine products while discouraging use by those who wouldn’t smoke, especially youth.”

On Sept. 9, the FDA issued marketing denial orders to more than 130 companies, requiring them to pull an estimated 946,000 products from the market. The next day, the agency denied another set of applications, bringing the total to 946,000 products and 168 companies.

The regulatory agency released a revised list of MDOs that includes 125 company names but not any specific products that were denied.

“We continue to work expeditiously on the remaining applications that were submitted by the court’s Sept. 9, 2020, deadline, many of which are in the final stages of review,” the agency wrote in its announcement. “For premarket tobacco product applications, our responsibility is to assess whether applicants meet the applicable statutory standard for marketing their new products. As we have said before, the burden is on the applicant to provide evidence to demonstrate that permitting the marketing of their product meets the applicable statutory standard.”