FDA is still tormenting itself with vaping regulations
The U.S. Food and Drug Administration issued marketing denial orders on more than 946,000 flavored vape products, but on Thursday they postponed all highly anticipated actions on e-cigarettes from Juul Labs, the industry leader often criticized by health officials.
The product denials were based on a lack of evidence that their benefits to adult smokers might outweigh the public health threats of their growing popularity among teenagers in America.
Many of the products ordered from the market by the FDA are already being sold, others were still in the application process. This includes vaping liquids and e-cigarette products.
Thursday’s announcement was only part of a comprehensive, ongoing review of the vaping industry that could ultimately reshape the vaping market.
A year ago, manufacturers had to submit all vaping products for review and approval by the FDA or have them withdrawn from the market.
FDA is making slow progress
An estimated 500 companies submitted more than 6.5 million product applications. Although the FDA had a court-ordered deadline to review all applications by September 9, 2021, it was unable to complete the process.
In August, the FDA ordered JD Nova Group LLC to cease sales of 4.5 million nicotine liquid products because of failure to meet application requirements. Another 55,000 other products from various companies were also banned after the FDA review last month.
In 2020, the FDA temporarily restricted sales of certain sweet and fruity e-cigarette cartridges, believed to be stimulating younger smokers.
“We have made significant progress. However, there is more work to be done to complete our remaining reviews and ensure that we continue to take reasonable steps to protect our country’s youth from the dangers of all tobacco products, including e-cigarettes, which are still the most common among teenagers The tobacco product consumed are the United States, “the FDA statement said.
The announcement was made to Dr. Attributed to Janet Woodcock, acting FDA commissioner, and Mitch Zeller, director of the FDA’s Center for Tobacco Products.
Products have to show public health
As part of the application process, the manufacturers had to prove that the products were in the interest of public health. For example, the product could convince cigarette smokers to switch to a less harmful option.
The FDA would also weigh this against the product’s appeal to teenagers and adults who have never smoked.
Vaping young adults had already declined significantly a year ago, in part due to new federal restrictions raising the legal age to buy to 21 years and restricting sweet and fruity products.
The agency announced on Thursday that it had processed 93% of the applications submitted by the submission deadline.
Waiting for Juul e-cigarettes
To the disappointment of many, the FDA has not responded to any motion from Juul, which has often been the main criticism of parents, anti-tobacco advocates, and politicians for its nicotine-rich products.
Juul has faced lawsuits from 13 states and the District of Columbia, mainly on allegations that it played a major role in the vaping epidemic and marketed its products to minors.
However, the company has only submitted tobacco and menthol flavored e-cigarette refills for review by the FDA, according to numerous sources.
Juul has been the vaping market leader since 2018 and holds a 50% share of the US $ 9 billion market.
Earlier this year, they resolved one of many lawsuits by agreeing to pay $ 40 million to the state of North Carolina.
“The FDA is still reviewing applications for JUUL’s products and has devoted tremendous resources to these and other applications for the millions of products it has received,” FDA spokeswoman Alison Hunt told DrugWatch.com.
FDA officials have already told some manufacturers that approved products will likely come with rigorous marketing and sales efforts designed to restrict access to teenagers. The company’s marketing campaigns must also pass FDA approval.
Some health organizations and lawmakers have asked the FDA to ban all sweet and fruity e-cigarettes and to consider the use of nicotine concentration caps on all products. However, the FDA has insisted on reviewing each product individually rather than making universal rules.
The FDA has regulated the sale and marketing of traditional tobacco products like cigarettes for decades, but it has only recently begun to question the vapor industry.
“We are continuing to work quickly on the remaining applications, many of which are in the final stages of review,” the announcement said. “As already mentioned, it is up to the applicant to prove that the authorization for placing his product on the market complies with the applicable legal standard.”