FDA readjusted the submission time of PMTA for e-tobacco enterprises to August 15, 2021 in mid-March 2019.
PMTA, as Premarket Tobacco Application means that after February 15, 2007, the legitimate promotion of any new tobacco product will need to be approved by FDA. FDA needs to consider whether this product is conducive to public health (regarding smokers and non-smokers as a whole). After passing, FDA will issue a “Premarket Tobacco Product Marketing Orders” certificate for the relevant products.
The news of iQOS entering the U.S. market recently became a sensation because FDA passed the PMTA application for iQOS products and iQOS got the “certificate” which authorized iQOS heat not burn products and vape cartridges of different tastes. FDA determined that authorizing these products for the U.S. market is appropriate for the protection of the public health because, among several key considerations, the products produce fewer or lower levels of some toxins than combustible cigarettes.
PMI submitted PMTA to FDA on March 31, 2017. It took more than two years for the new tobacco iQOS to win preliminary victory. Therefore, the power and position of FDA is decisive on the road of the global vape revolution.
In July 2017, the FDA announced that all vape brands and manufacturers need to submit PMTA by August 2022, and said that this method will better standardize the industry.
However, the exponential growth of JUUL in the U.S. market has pushed the problem of “teenagers vaping” to the limelight that the electronic cigarette industry has never faced, and has attracted wide attention from all walks of life. In mid-March 2019, the FDA readjusted the submission time of PMTA for e-cigarette enterprises to August 15, 2021.
On Wednesday, the local court ruled that the FDA’s review of U.S. e-cigarette products had been delayed for several years, evading its due legal responsibility. Last year, the American Academy of Pediatrics, the Smokeless Children’s Movement and other groups filed federal lawsuits in Maryland. They said that the FDA’s regulatory oversight has led to the unhealthy trend of vaping among teenagers today. “Now the FDA has an obligation to take immediate action to protect our children, and if e-cigarette manufacturers want to continue to sell their products in the market, they must meet FDA standards,” they said.
In 2016, the FDA acquired the power to regulate e-cigarette products, to limit e-cigarette advertisements on social media, and to limit the taste of vape juice and so on, but it never formulated formal rules and product standards.
Therefore, e-cigarette practitioners and enthusiasts complain that their rights and interests have been infringed, and anti-smoking advocates believe that FDA control is insufficient, while the use of e-cigarettes by teenagers has not been effectively alleviated.
The FDA says employees and manufacturers need more time to develop regulatory measures for tobacco products. FDA spokesman Michael Felberbaum said in an e-mail statement that they were reviewing court decisions and “will continue to address the headache of heavy use of electronic cigarettes by children.”
Gregory Conley of the American Electronic Cigarette Association said the government must appeal the ruling to protect adults’ right to use less harmful electronic cigarettes.
Last September, a federal judge said the FDA must continue to add graphic warning labels to cigarette packages, and Wednesday’s decision was similar. The Federal Court asked the FDA to take this step in accordance with the 2009 law, but the process was suspended by legal proceedings against tobacco companies.
“The court is clearly urging the FDA to step up regulatory pressure on the industry at the request of medical and consumer groups,” said Marc Scheineson, a former FDA official.
Despite the constant controversy over electronic cigarettes, the commercial value of electronic cigarettes in the United States can not be underestimated. Electronic cigarettes in the United States have developed into a huge industry worth billions of dollars. The FDA and most health experts agree that e-cigarettes may be less harmful than traditional cigarettes because they do not produce carcinogenic by-products. However, little research has been done on the long-term health effects of e-cigarettes, especially on young people.
Water can carry a boat and overturn it. How will the FDA balance new types of tobacco, such as e-cigarettes? Can FDA review of e-cigarettes eradicate the problem of vaping among adolescents? The answer is still uncertain.