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The FDA has developed new guidelines for the regulation of electronic cigarettes, particularly with respect to flavored nicotine products.
The first major change is that the FDA has extended by one year the expiry date of the FDA flavored product approval application. Manufacturers of all flavored nicotine electronic delivery system (ENDS) products will now have to submit their pre-market applications by August 8, 2021.
The second change introduces a new compliance policy for ENDS flavored products.
At the time of implementation of the current compliance policy, in 2017, the use of e-cigarettes among youth was stabilizing. But the dramatic growth in the popularity of e-cigarettes among minors over the past two years has resulted in a number of policy changes, including limiting sales of flavored ENDS products via certain retail channels beginning in November 2018.
"The most recent data show that more than 3.6 million middle and high school students across the country were current users (in the last 30 days) in 2018," wrote Gottlieb in his announcement. "This represents a dramatic increase of 1.5 million children since the previous year. The data also showed that youth who used electronic cigarettes also used them more frequently and that they used flavored electronic cigarette products more often than in 2017. "
Identifying the flavored pods as culprits was the first step, but the FDA is now introducing a policy that examines the degree of accessibility of any flavored ENDS product to minors in order to determine whether or not it can stay on the market. market.
For online sales, retailers must have an age verification process that connects to third-party data sources in order to sell flavored nicotine products. For physical retailers, the policy states that flavored nicotine products must be behind some kind of age, either at the entrance of the store or in another section of the store itself. In other words, there must be a barrier to entry before POS between minors and flavored products ENDS.
From the announcement:
Our proposed policy provides examples of circumstances that we will consider – for example, if flavored ENDS products are sold in places where minors can enter at any time (for example, the entire establishment or an area thereof). this); or, for online sales, whether the products are sold without appropriate limitation of the amount that a customer can purchase within a given period of time, and without independent third-party verification services of age and age. identity to compare customer information with third-party data sources, such as public records. We also want to know precisely if there are new technologies that may prevent youth access to outlets and if we intend to consider using it. of these tools when finalizing the instructions.
The key point is that the FDA is considering giving priority to the application of these products based on the fact that they are sold in a way that poses a higher risk for minors to access them and become addicted.
While this proposal includes further regulation of the nascent e-cigarette industry, it could be a significant step forward for space in the long term. The e-cigarette industry will not realize its potential as an alternative to cigarettes until the problem of using minors is solved forever.
The FDA considers flavored ENDS products as a gateway for young people. By closing access to these products as soon as possible, the industry, from manufacturers to retailers to regulators, has the opportunity to plan how these products can be sold and distributed around the world. future, or if flavored products should exist at all.
The new plan does not propose the application of all ENDS products – ENDS products for tobacco, menthol and mint can remain on the market and retain their initial 2022 deadline for approval applications to the FDA before marketing.
Juul Labs had this to say in response to the draft directive:
We are committed to reducing youth use while maintaining our ability to eliminate fuel-laden cigarettes, the leading cause of preventable death worldwide. As part of our November 2018 action plan to keep JUUL products out of the reach of youth, we stopped the sale of flavored JUULpod at retail stores, strengthened our retail and shopping compliance program. secret, enhanced our online age verification system, Facebook and Instagram and are continually working to remove inappropriate content from third-party social media. We support class-wide measures, including the restricted and responsible sale of flavored products, and will review today's draft directive as we work with the FDA, state attorneys general, local municipalities and community organizations as a transparent and accountable partner in the fight against the use of minors.
Commissioner Gottlieb announced his resignation a week ago. Dr. Ned Sharpless, director of the National Cancer Institute, will take office as Acting Commissioner of the FDA in April.
Gottlieb has taken measured measures to keep ENDS products out of reach of minors while allowing adult smokers to have an alternative on the market. It remains to be seen whether Sharpless will thread the needle just as well, but Altria 's shares fell on the announcement of his appointment.
Today's proposal is open to the public for 30 days.
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