The Family Smoking Prevention & Tobacco Control Act requires that all tobacco products must receive a PMTA before they can be sold across the United States. Initially set for May 12th, as the deadline was approaching, a number of entities including Altria Group Inc. and tobacco association NATO, had asked the FDA to push the deadline back due to the complications caused by the Coronavirus pandemic.
To this effect, on March 30th the agency filed a request for a 120-day extension on the deadline, and on April 3rd, Judge Paul Grimm of the United States District Court for the District of Maryland had to the request, moving the deadline to September 9th, 2020.
The FDA itself had expressed concern about possible repercussions
According to the Tobacco Act, all tobacco products need to be authorized for every aspect including adjustments in packaging, manufacturing processes, and product design. The “FDA is also granted the right to exercise enforcement discretion, which permitted the deferment of enforcement on premarket authorization requirements for products available on the market, as of Aug. 8, 2016,” said McGrady.
Sadly, the PMTA regulatory process was clearly mainly designed for product manufacturers who can afford the time and financial costs that come with it, leaving the smaller business in ruins. “The costs associated with PMTA will force JVapes’ five locations in Arizona, Colorado, and Oklahoma to close doors,” said Amanda Wheeler owner of JVapes in Prescott, Arizona.
A non-affordable regulatory process
Wheeler is also the vice president of the Rocky Mountain Smoke-Free Alliance. She explained that for each product that they produce in-house comes a stock-keeping unit (SKU) attached to UPCs to track sales and inventory. Wheeler added that PMTA authorization ranges from $8.6 million to $11.1 million per SKU, or per product and product variations.
“Let’s say I have 100 products and each of the flavors has five nicotine levels, which means five SKUs per flavor, legal and other fees will cost my stores over $5.5 billion. There’s not a small business owner in the United States who can afford $5.5 billion for SKU applications.”
To this effect, the PMTA process is putting at least 14,000 small and medium-sized vape businesses across the United States in a precarious situation. “PMTA will also force me to lay-off 31 of my employees,” Wheeler continued. “With the record unemployment rates due to COVID-19, now is not the time to remove even more jobs from the market.”
Additionally, despite all the available scientific evidence indicating the reduced risk of the products, the law mandates that the FDA define the scientific characteristics for each product application submitted. To this effect, all applicants must prove to the federal government that their products have a scientific benefit appropriate for protecting the public from smoking-related diseases.