On January 2nd, the FDA released their finalized enforcement policy. We’ve all been on the edge of our seats waiting for this since September 11th, 2019. Compared to what was proposed in September, this policy is preferable to the vaping industry and vapers around the U.S. In this article, I’ll explain what the “FDA finalizes enforcement policy on unauthorized flavored cartridge-based e-cigarettes that appeal to children, including fruit and mint” means for us, as well as the threats that still are looming around vaping.
What this enforcement policy means
Within 30 days from publication of this policy in the National Register all flavored e-cigarette cartridges (excluding menthol & tobacco flavors) will have to be removed from the market on the 4th of February. This does not include responsibly marketed e-juice flavors in bottles.
This policy is in response to the rise in teen vaping. The huge majority of underage users vape with cartridge based flavors cited in this enforcement policy.
This is not an outright ban either. Companies that manufacture flavored cartridges can submit their PMTA (Pre-Market Tobacco Application). They must prove their products are not a risk to public health in their application. Once approved, the product can return to the market. We’ll talk more about the PMTA process later.
Besides the removal of flavored cartridges, there was a lot of reiteration of previous enforcement in FDA’s Flavored Vape Cartridges Finalized Enforcement Policy. This includes ensuring no one under the age of 21 purchases vaping products, no advertising to children, no child-appealing packaging, etc.
This policy also mentions an order limit to prevent people buying in bulk and selling to underage users. This limit was not set by the FDA. They are trusting the industry to use common sense practices and limits to avoid this.
The Dodged Bullet
On September 11th, 2019, President Trump proposed a ban on all flavored e-liquids/cartridges that didn’t have pre-market approval (excluding tobacco flavors). Since no flavor or cartridges have yet to receive pre-market approval from the FDA, we would have seen a mass exit of our industry. Vaping as we know it would have gone the way of the DoDo. Only specific flavors (tobacco and possibly menthol) would have been available until a flavor received pre-market approval, which could have taken a year or more.
Although we’ll see a temporary exit of a few products, this policy will help reduce the “Teen Vaping Epidemic”, while also allowing us adults to vape the flavors we love. It will also keep thousands of businesses from closing, which would have happened if the proposed September 11th policy came to fruition.
The Still Looming Threat
This FDA enforcement policy also touched on something very important to the vaping industry. That is the PMTA due date. If you don’t know what a PMTA is, please read this blog on “What is a PMTA?”. In a few short words, the PMTA is a pre-market tobacco application that will cost companies about $117,000-$466,000 per product they manufacture. When I say “per product” I mean per SKU. So, each nicotine strength of a flavor and each VG/PG ratio is considered a different product. This will likely cause most vape product manufacturers to leave the market.
The policy touched on the push of the vaping industry to change the date back to August 8th, 2021. It stated it would not change the date, so it will remain May 12th of 2020, just 4 short months from now.
Our industry will be changed forever. This will affect every vape company, retailer, manufacturer, and especially you, the vaper.
With this policy, vaping lives to see another day. Although we’re thankful for that, we need to keep our eyes on the horizon. Specifically, the PMTA due date. Please support a vaping advocacy group like the VTA or CASAA or one of the many others.
To stay up to date on vaping regulation, here are our favorite Twitter accounts to follow:
Posted by Lacey Krusmark on Jan 7th 2020