In a landmark decision, the U.S. Food and Drug Administration issued marketing denial orders to notorious e-cigarette maker Juul Labs Inc. that prohibit the company from distributing and selling its products in the United States.
In addition to halting sales and distribution, Juul must also remove products already at retailers.
The June 23 announcement comes after Juul’s Premarket Tobacco Product Applications, or PMTAs, failed to provide the FDA with enough evidence to show that the benefits of its e-cigarette products outweighed the benefits. risks.
“Today’s action is further progress in the FDA’s commitment to ensure that all e-cigarette and e-nicotine delivery system products currently marketed to consumers meet our public health standards,” FDA Commissioner Dr. Robert M. Califf said in a statement.
Consumer advocates and medical organizations, including the American Medical Association, welcomed the FDA’s decision. Many have cited Juul’s role in creating a teen vaping epidemic.
“WADA applauds the FDA’s decision today to remove all Juul Labs Inc. e-cigarette products from the US market. For too long, companies like Juul have been allowed to sell e-cigarettes that appeal to our country’s youth, ultimately creating another generation of young people addicted to tobacco products,” said the president of the American Medical Association, Dr. Jack Resneck Jr., in a statement.
The FDA said it will ensure Juul, retailers and distributors comply with the order, and is prepared to take enforcement action against parties that do not comply. The enforcement actions do not apply to consumers because the FDA does not have the authority to prosecute individuals for possession of Juul products.
So far, the agency has authorized the sale of 23 e-cigarettes and related products in the United States and will continue to review PMTAs through the end of 2023.
Dangers of Juul and other vaping products
Part of the concern about Juul’s products is that the company has been unable to show that its vaping device and pods are “appropriate for the protection of public health,” according to the FDA. And the argument for vaping has always been that e-cigarettes help consumers quit smoking traditional cigarettes.
The studies provided by Juul were filled with insufficient and conflicting data, according to the agency. There was not enough information about “the genotoxicity and potentially harmful chemicals leaking from the company’s proprietary e-liquid pods”.
In 2019, the same year the FDA issued its PMTA guidelines, Juul received a warning from the FDA for several unsubstantiated claims its representatives made while talking to school children, including that the FDA was about to to say that Juul was “99% safer” than cigarettes. and “completely safe”, among other claims.
Even before the FDA made its decision to pull Juul from the market, the company had been beleaguered by claims that its products encouraged addiction and could cause other health problems.
As of June 15, Juul faces more than 3,800 federal lawsuits alleging the company manufactures faulty and dangerous products and fails to tell consumers that its products are more potent and addictive than cigarettes. Plaintiffs claimed Juul’s side effects ranged from seizures to death.
You may be eligible for compensation.
FDA clearance does not mean vapes are safe
A few studies suggest that vaping may offer a safer alternative to traditional cigarettes and help people quit smoking. But a growing number of studies show that e-cigarettes do not help people quit smoking and may in fact encourage dual use, i.e. vaping and smoking traditional cigarettes.
Even when the FDA cleared an e-cigarette for sale, it never claimed the product was safe. For example, in May the agency cleared the first e-cigarette through the PMTA route, the Vuse by RJ Reynolds. RJ Reynolds was able to show that his product was less dangerous than traditional cigarettes, but the FDA never rated it safe.
“This clearance allows these products to be legally marketed in the United States. Although this action allows the sale of these specific products in the United States, it does not mean that these products are safe and not more ‘FDA-cleared,'” the agency said in May. “All tobacco products are harmful and potentially addictive. Those who do not use tobacco products should not start.
The American Lung Association echoes the sentiments of the FDA on e-cigarettes and offers help for people looking to quit all tobacco products.
“It is very important to keep in mind that electronic cigarettes, including Juul, are tobacco products. Continuing to use e-cigarettes is not quitting smoking,” Erika Sward, assistant vice president of national advocacy for the American Lung Association, told ConsumerNotice.org in an email. “The Lung Association recognizes how difficult it is to end an addiction to tobacco products, especially Juul – which intentionally put high levels of nicotine in its products to get people even more hooked on its products.”
Sward said the American Lung Association is available to help Juul users and other addicts quit smoking. Consumers can visit lung.org/quitsmoking, speak with their healthcare providers, or call 1-800-Quit-Now.