Earlier this year, President Donald Trump had issued an executive order mandating federal agencies to identify burdensome regulations that could negatively impact the economic growth post-COVID-19. As the May 12th PMTA deadline was fast approaching, spokesman for the FDA, Michael Felberbaum, had said that the agency had received numerous inquiries from the industry expressing concern about the impact of Covid-19 on the May 12th deadline.
“The FDA is currently engaged in internal discussions to determine how to best address this issue,” said Felberbaum. “We encourage manufacturers who have concerns about meeting the May 12 deadline for any reason to contact the FDA directly.”
Subsequently, on March 30th the agency filed a request for a 120-day extension on the deadline. On April 3rd, Judge Paul Grimm of the United States District Court for the District of Maryland agreed to the request, moving the deadline to September 9th, 2020.
“FDA remains aware of the recent surge in youth use of e-cigarettes and the public health imperative that these and other deemed new tobacco products undergo premarket review,” the FDA said in a statement released March 31. “The agency is committed to implementing and enforcing the premarket requirements in the law.”
The PMTA process threatens 3000 jobs in Colorado alone
“On average, the cost of one PMTA ranges from $8,600,000 to $11,100,000 per SKU. For example, one vape manufacturer and retail store has over 100 products, each of the flavors has five nicotine levels, which means 5 SKUs per flavor resulting in legal and other fees in excess of $5,550,000,000 for one business, making it unaffordable.”
Earlier this Summer, the Rocky Mountain Smoke-Free Alliance (RMSFA), which represents over 125 small vape business owners and manufacturers of safer alternatives to cigarettes across the State of Colorado, pointed out that the PMTA threatens to obliterate almost 3000 jobs in Colorado and should be on the list to alter per POTUS’ executive order.
As the industry continues to be disrupted by COVID-19, it currently cannot withstand over-regulation. To this effect, the alliance has been asking the FDA to work on creating an easier process, that is also feasible for small vape businesses.
“On average, the cost of one PMTA ranges from $8,600,000 to $11,100,000 per SKU. For example, one vape manufacturer and retail store has over 100 products, each of the flavors has five nicotine levels, which means 5 SKUs per flavor resulting in legal and other fees in excess of $5,550,000,000 for one business, making it unaffordable,” explained the RMSFA in a Press Release.
The smaller vape business cannot withstand the costly process
“Due to the obscene costs associated with PMTA, the federal government essentially is regulating small businesses out of business and lumping small businesses in with Big Tobacco,” said RMSFA president, Amanda Wheeler. “With Colorado’s near-record unemployment rates due to COVID-19, we are calling on our federal elected officials and the Trump administration to adopt a plan that keeps responsible adults safe and preserves the American Dream for our small business owners and their employees.”
“RMSFA is asking the FDA to acknowledge that one size does not fit all when it comes to PMTA and to work us and the state alliances to create a process that makes sense for small vape businesses in advance of the Sept. 9 deadline,” said Wheeler. “America was built on the foundation of entrepreneurial spirit and we must continue to support small businesses in our state and country.”