Trump administration officials announced in September that they were inventing such a policy – which became known as a “flavor ban”. This is partly due to the fact that the policy, as originally announced, would apparently strip all flavors except tobacco from the U.S. market. At the time, officials said the policy would be finalized in several weeks.
Over the following months, many legislators and health groups criticized the administration for not finalizing the policy, while reports surfaced that it was supporting its original promise.
“The final policy is full of loopholes that allow thousands of flavored e-cigarette products to remain available,” said Matthew L. Myers, president of the Campaign for Kids Without Tobacco.
Politics, he added, “will not stop the youth e-cigarette epidemic that is engulfing a generation of our children.”
What is the policy?
It is not a law, nor is it binding. And it doesn’t change the fact that electronic cigarettes are on the market illegally – nobody has received “marketing authorization” from the FDA.
And it’s actually not a ban, according to Bonnie Halpern-Felsher, founder and executive director of the Stanford Tobacco Prevention Toolkit.
“It’s an application of what they already had on the books,” he said.
According to the FDA, the new policy “represents the current thinking of the Food and Drug Administration” and “describes how we intend to prioritize our control resources”.
The agency can and has sought e-cigarette manufacturers and retailers for a variety of reasons, including advertising and selling to minors. These actions included warning letters, fines, seizures and injunctions.
But the FDA doesn’t have unlimited resources to look for companies that break the law.
“The FDA will make enforcement decisions on a case-by-case basis,” says the policy, “recognizing that it is not in practice able to take enforcement actions against any illegally marketed tobacco product and that it must make better use of the Agency’s resources. “
What’s inside? What happens?
According to the policy, the FDA intends to prioritize cartridge vaping products based on flavors other than tobacco and menthol.
A cartridge, or pod, is described as “any small closed unit (sealed or unsealed) designed to fit or function as part of” a vape.
Disposable vapors, those with an open tank system and the respective e-liquids, which are available in various flavors, are not included in the policy.
The FDA says it is a way to follow products that are commonly used among children, while still leaving a door open for adult smokers who may instead vape.
The agency notes that many cartridge vaporizers “are easy to hide, can be used discreetly, have a high nicotine content and are produced on a large scale.” Their immediate usability, adds the FDA, can “lower the barriers to initiation” among young people.
Mitch Zeller, director of the FDA’s Center for Tobacco Products, said in an email statement that the policy also focuses on the application of any vaping product with marketing intended for minors or whose producers have failed to take “appropriate measures” to prevent minors from obtaining their products.
In September, the FDA revealed that 27.5% of high school students were currently e-cigarette users in 2019, up from 20.8% in 2018 and 11.7% in 2017. Researchers estimate that over 5 million US middle and high school students currently use e-cigarettes and 970,000 use them daily.
“Let’s be clear,” said Zeller, “based on this policy, if we see a product intended for children, we will act.”
What happens next?
If everything goes according to plan, flavored cartridges should no longer be available on the shelves or online in the United States, with the exception of tobacco and menthol.
Realistically, however, this will require awareness and cooperation between retailers regarding the effectiveness of the policy and the products concerned.
“While we anticipate that industry members will cease the production, distribution and sale of unauthorized electronic cigarette products, the public could continue to see some of the types of products described in the [FDA’s] market priority as the agency works to keep manufacturers and retailers responsible – both in physical stores and online – responsible, “according to an email from an FDA spokesman.
The email added that the agency will begin “inspections and surveillance of manufacturers and resellers” to make sure companies follow suit.
The only way these flavored products would be placed on the market is if they receive the marketing authorization from the FDA after assessing their impact on public health.
In the end, all vaping products will have to undergo the same market review. This deadline is currently set for May. Products not included in the recently adopted FDA policy can remain on the shelves for up to one year while the agency considers their questions.
Some companies – including Logic and Reynolds, the manufacturer of Vuse products – have already submitted questions, company executives said Wednesday during a hearing of the Energy and Trade Committee. The FDA does not disclose the total number of applications received.
How will vaping habits change?
The way in which the new policy will influence vaping habits between adults and children, however, is still uncertain. Stanford’s Halpern-Felsher said there is simply not enough data to know.
For example, will young people be more likely to use menthol cartridges? Or will they look for flavors between vaporizers or disposable items? Halpern-Felsher believes that children are much less likely to stop vaping altogether.
In addition, children are already using these products, he added.
“Young people used open systems and disposable items before the FDA claimed they would regulate [them]”he said.” I have seen Puff Bar in use for months now. “
The Puff Bars are disposable vaporizers that have flavors like “Pink Lemonade”, “Blue Razz” and “O.M.G (Orange, Mango, Guava)”. Halpern-Felsher shared a photo with CNN showing a collection of vaping products confiscated from a Northern California school prior to the FDA announcement, including a number of Puff Bars – which contain more e-liquids than a pod Juul, he added.
CNN contacted the Puff Bar manufacturer for comment, but received no response. On its website, the company claims to oppose the sale of its products to minors and urges retailers to follow regulations, including checking identity documents and not delivering free samples.
“We will protect our families, protect our children and protect the industry,” President Donald Trump told Mar-a-Lago reporters in December.
Experts are also keeping an eye on adults who use tobacco products: will they remain satisfied with their choices? Will some go back to cigarettes or become two users accordingly?
For its part, the FDA says it can always correct the course, especially if it sees a new trend among young people.
The agency “will continue to closely monitor data on youth use of all e-cigarette products and adjust our application priorities to address youth use if necessary,” said Zeller.