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FDA is poised to block the import of most vape products. Here is what you can do to protect your business and the industry.
Our firm is closely monitoring a new U.S. Food and Drug Administration (FDA) Proposed Rule that could significantly impact the vape industry by restricting imports of unauthorized vape products. A “Proposed Rule” is an advance publication of a proposed new government regulation (i.e. law) which provides the public and industry an opportunity to read a draft version of a regulation and provide feedback. This potential regulation has the power to disrupt a large portion of the industry, and if you are not prepared, your business could be next in line.
On August 16, 2024, FDA published a Proposed Rule that would essentially create a system to block the import of nearly all vape products that do not have marketing authorization. To date, only seventeen (17) vape products worldwide have cleared FDA’s premarket approval process, and those come from just three (3) manufacturers. For everyone else, this rule threatens to cut off access to critical products that keep your business running.
Under the new rule, vape products that are imported into the U.S. would be required to include a Submission Tracking Number (STN), a unique identifier that shows that the product has gone through FDA’s Premarket Tobacco Product Application (PMTA) process. This STN would need to be submitted electronically during import filings. If you do not have the right number, or no number at all, your product will likely not make it past customs. As most products in the market today do not have FDA’s approval, they could soon be barred from entering the U.S. altogether. This is where the real danger lies for vape companies, from retailers to manufacturers.
This is a dangerous slippery slope. First, vape imports are blocked. Next, it is nicotine e-liquids. Eventually, even empty hardware itself could be targeted. Once FDA establishes a streamlined system for banning unapproved vape products, they could easily expand it to cover more and more categories. By the time your supply chain is cut off, it is too late.
But there is still time to make your voice heard. FDA is accepting comments on this Proposed Rule until October 15, 2024. That means the industry has a small window of time to push back, share concerns, and potentially shape the final version of the rule. This is your chance to influence the future of your business and the industry.
As part of our commitment to your business, we are hosting a virtual town hall on Wednesday, September 25th from 12:30 PM to 1:30 PM ET to discuss how this Proposed Rule could impact your business and what you can do to stop it. The town hall will feature Deanna Clark, Esq., Managing Attorney of the Clark-Esposito Law Firm, P.C., and Mark Anton, Former Executive Director of the Smoke Free Alternatives Trade Association (SFATA).
During this town hall, you will learn what FDA’s Proposed Rule means for your vape imports, the potential consequences for your business if it becomes law, and how to submit an effective comment to oppose the new rule before the October 15th deadline.
Register for the town hall via Eventbrite by clicking the button below.
As a bonus, for those who attend our Town Hall discussion, we will provide comment submission instructions, including the technical requirements for submission, as well as some important “Do’s and Don’ts” so that you can submit your own comments, feedback, and objections to FDA’s Proposed Rule and make your voice heard.
The comment process is an important government accountability and public feedback mechanism which allows individuals, advocates, industry representatives, and businesses the opportunity to explain to government how a Proposed Rule may result in unforeseen harms, point out defects in Proposed Rules, describe likely impacts on businesses and wider industry, and to voice general support or objections to a new regulation.
In our work, we read dozens of Proposed Rules and Final Rules every year, and virtually all of them take into account the informed feedback of businesses and experts in the affected sector, including even abandoning some Proposed Rules where sufficient feedback from the public demonstrates that the Proposed Rule was ill advised to begin with, or where its ultimate implementation would cause more problems than it would fix.
Those attending will receive the bonus comment submission instructions, including the technical requirements for submission, as well as some important “Do’s and Don’ts” to help ensure your comment is counted and considered!
For attendees who may want additional assistance in preparing lengthier comments, formulating arguments in opposition to the Proposed Rule, general assistance with submission, or those interested in filing PMTA in order to obtain an STN, our office is always available to discuss all of these options with you.
The clock is ticking, and failing to engage in this process could have long-term consequences for your business and the industry. Do not wait for your products to be blocked at the border.
We are here to help ensure that your business survives, and thrives, in this rapidly changing regulatory landscape. Give our office a call today at (917) 546-6997, we would be happy to speak with you.
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