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Thursday, food and Scott Gottlieb, Commissioner for the Administration of Medicines, proposed new rules to reverse the e-cigarette consumption epidemic among young people, including by limiting in-person sales of flavored electronic cigarettes to areas subject to an age limit and reinforcing the age verification for online sales.
Gottlieb described the "child-friendly" flavors, such as candy and fruit, as "the heart of the epidemic". However, e-cigarettes flavored with mint, menthol and tobacco are exempt from the proposed amendments to help adult smokers who are trying to quit smoking. he said.
The FDA proposal is similar to the changes announced by Juul, the leading manufacturer of electronic cigarettes, earlier this week. On Tuesday, the company announced that it would suspend store sales of flavors like mango, fruit, cream and cucumber, but could put them back on the shelves if retailers imposed restrictions. ;age. "I think Juul has a big sigh of relief," says Marc Scheineson, a former FDA associate commissioner and partner at the Alston & Bird law firm.
Gottlieb said the agency had yet to finalize its policies, which did not specify how convenience stores or other outlets could develop a section that would make products "not visible or accessible to people under 18" . Vape stores restricting access to buyers 18 and older will not be affected, he added.
The FDA's approach is a creative way to tackle e-cigarettes while avoiding some legal pitfalls, according to Azim Chowdhury, a partner of Keller and Heckman, who leads the company's tobacco and electronic steam business. A total ban on flavorings would open the agency to prosecution because of the restrictions imposed by the Tobacco Control Act, as well as potential problems with the First Amendment regarding the freedom of expression of business. Instead, Gottlieb relied on the FDA's discretionary power with respect to the approval process to limit the distribution of e-cigs to children.
Electronic cigarette products sold before August 2016, like Juul, can remain on the market until August 2022, by which time they must submit a cumbersome and expensive application requiring clinical studies and long-term data. On Thursday, Gottlieb threatened to change the application process for e-cigs based on or they are sold, as well as the types of products sold. Manufacturers of electronic cigarettes who want to sell fruity flavors in stores without age-limited areas may have to apply earlier, which would be a heavy financial burden, Chowdhury said.
Public health advocates praised the FDA for taking action, especially a different piece from Thursday's announcement to ban menthol cigarettes, a product disproportionately marketed to African Americans. But they warned that the industry could not be trusted.
"We can not fail to look further than Juul who has repeatedly said that he was going to stop their online advertising," said Erika Sward, deputy national vice president of human rights advocacy. American Lung Association. Juul Tuesday is committed to closing his US social media accounts. But Juul has become viral thanks to social media posts, such as videos on YouTube, and the company has given little guidance on whether it has paid for influencers or affiliate marketing campaigns .
For decades, the tobacco industry has used product placement, outsiders and substitutes to advertise its products, according to Sward. "This is not a new tactic," she adds.
Lawyers were also alarmed by the exemption for electronic mint cigarettes. The FDA's willingness to give smokers access to menthol electronic cigarettes is understandable, says Tricia Kenney, communications manager for Truth Initiative, a non-profit organization dedicated to preventing youth smoking. "But mint is not menthol." Truth Initiative research shows that mint is one of the most popular flavors among 18 to 21 year olds, while 15 to 17 year olds use it three times as much fast as menthol. "A roll of Life Savers comes in mint – it's a candy flavor," says Kenney.
In addition to the restrictions on flavors, the FDA also released the results of its annual national survey, according to which more than 3 million high school students are now using electronic cigarettes, an increase of 78% over the previous year. 39, last year; among college students, use increased by 48% to 570,000 students. The authors of the study said that this rise was probably due to the popularity of electronic cigarettes like Juul.
After receiving the raw data from the investigation in September, Gottlieb called on manufacturers like Juul to take voluntary action and heightened the pressure in October with a search of the Juul headquarters in San Francisco for more documents. The company's sales and marketing practices are also being prosecuted by users who claim that Juul has been accustomed to nicotine.
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