P.A.C.T Act Update

FDA

Theoreon Services Inc. is focused on compliance, and all of our sales are in strict accordance with age verification rules, restrictions on sales, and excise taxes. We look forward to serving you, our customer, long term and in compliance with the new laws.

There will be some changes, but we will communicate them to you on our website and via email in the coming weeks.

Mail Ban - We will no longer be able to ship electronic cigarettes through the US Postal Service at the end of April. UPS and FedEx have also announced their decision to no longer ship electronic cigarettes. We are working around the clock to ensure that our customers continue to receive product with minimal interruption.

We will keep you posted on this front.

Restrictions on Online Sales - New federal compliance requirements restrict the online

Sale of electronic cigarettes – At Theoreon, we have always implemented strict compliance requirements over the past few years to ensure that we meet our obligations under the FDA and federal law; we endeavor always to fully comply with these new requirements.

What does this mean for our customers?

Effective March 28, 2021, all orders will be required to be sent with Adult Signature Required in all 50 states.

From March 25 2021, customers may notice additional taxes added to the price of their orders, which we will now be required to collect, depending upon the state. We will be as transparent as possible with respect to these charges.

FDA Update

Update Regarding Theoreon PMTA Application

FDA

As you may know, the FDA required all manufacturers of Electronic Nicotine Delivery Systems to submit a Pre-Market Tobacco Application by September 9, 2020 in order to remain on the market.

We are happy to report that Theoreon has submitted its PMTA in advance of the September 9th deadline and our submission is currently pending FDA review. We take our regulatory obligations seriously and the safety of our consumers is of utmost importance. As part of this process, we have undertaken rigorous scientific testing of all of our products at accredited laboratories. We wanted to thank our team of scientists and regulatory advisers, who have worked tirelessly over the past year to make this submission possible.  

The FDA submission is simply a first critical step in an on-going regulatory process. We look forward to working with the FDA to obtain a formal marketing order for our products. We will keep you apprised of developments throughout this process.

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