FDA’s Request for Extension of Premarket Review Deadline for Certain Tobacco Products Granted
On July 12, 2019, the Food and Drug Administration (FDA) set forth the process to require manufacturers of e-cigarettes, cigars and other new tobacco products that were on the market as of Aug. 8, 2016 to submit applications for premarket review by May 12, 2020. The court where the original order was given recently granted the FDA a 120-day extension to this deadline, effectively pushing the deadline for premarket review to September 9, 2020. Businesses that submit their applications by the deadline will generally be allowed to continue to market their products with little to no FDA enforcement actions, given that the FDA does not impose a regulation based on their application.
Many businesses in the tobacco industry have contacted the FDA with concerns that they would be unable to meet the original May 12th deadline due to complications posed by the COVID-19 pandemic. Similarly, the FDA has expressed a strong doubt for effectively processing applications being that a large number of FDA employees have relocated to the U.S. Public Health Service division to aid in combating the pandemic. These are the major reasons given for the deadline extension, but the FDA will still continue to review applications and monitor online markets for the tobacco products in question.
In January 2020 the FDA provided a guidance memo which resulted in the inspection of more than 2,000 brick-and-mortar and online retailers of tobacco products. Their data collected from these inspections has led to their goal of prioritizing the monitoring and regulation of certain e-cigarette products that are widely used by youth.
The original statement from the FDA can be found here.
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