Last week, as the expensive and cumbersome deadline for tobacco pre marketing authorization (PMTA) passed, many smaller e-cigarette companies inevitably faced bankruptcy.
The family smoking prevention and tobacco control act requires all tobacco products to obtain PMTA certification before they can be sold in the United States. With the deadline approaching and complications caused by the coronavirus pandemic, several entities, including Altria Group Inc. and Tobacco Association NATO, have asked the US Food and drug administration to postpone the deadline.
To this end, the agency filed a request on March 30 to extend the deadline by 120 days, and on April 3, judge Paul Grimm of the United States District Court for the Maryland district had to make a request to change the deadline to September 9, 2020.
In an article recently published in inside sources, another writer at vaping post, Michael McGrady, noted that when the PMTA requirement was first discussed, FDA and the US national economic adviser expressed some concerns. Their main concern is that the implementation of new tobacco regulations will bring disaster to the booming tobacco industry.
Under the tobacco act, all tobacco products need to be authorized in all aspects, including packaging, manufacturing process and product design adjustments. “The food and drug administration has also been given the right to exercise enforcement discretion, allowing for deferral of pre marketing authorization requirements for existing products on the market,” McGrady said.
Sadly, the PMTA regulatory process is clearly designed primarily for product manufacturers who are able to bear the time and financial costs that come with it, which puts smaller companies on the market. “Costs associated with PMTA will force jvapes to close five plants in Arizona, Colorado and Oklahoma.” Said Amanda Wheeler, owner of jvapes in Prescott, Arizona.
Wheeler is also vice president of the Rocky Mountain smokeless alliance. She explained that each product they produced in-house had an inventory unit (SKU) attached to the UPC to track sales and inventory. Wheeler added that the scope of PMTA licensing ranged from $8.6 million to $11.1 million per SKU, or per product and product variant.
“Suppose I have 100 products with five nicotine levels for each flavor, which means there are five inventory units for each flavor, and legal and other costs will cost my store more than $5.5 billion. In the United States, no small business owner can pay $5.5 billion for a SKU application. “
Therefore, the PMTA process makes at least 14000 small and medium-sized e-cigarette enterprises in the United States into an unstable situation. “The PMTA will also force me to fire 31 employees,” Wheeler continued. With covid-19 leading to record unemployment, this is not the time to take more jobs out of the market. “
In addition, although all available scientific evidence indicates that the risk of the product has been reduced, the FDA is required by law to determine the scientific characteristics of each product application submitted. To this end, all applicants must demonstrate to the federal government that their products have an appropriate scientific benefit for protecting the public from smoking related diseases.