FDA Registration Info
September 13th, 2017
Dear Mister-E-Liquid Customers,
As many of you know, the FDA is requiring that all manufacturers have their manufacturing facilities registered by September 30th, 2017. Additionally, all products intended for consumer use must also be registered on this date.
On February 17th, 2017, we received confirmation that our product submission and facility registration had been received by the FDA CTP. Since February, we have received two pieces of correspondence from the CTP in regards to our submission. The first gave us a tracking number which allows us to internally check the status of our submission. The second response we received from the FDA was brought to us on behalf of our attorney, Azim Chowdhury of Keller & Heckman. This correspondence essentially stated that due to the large volume of items that we sent them, there would be a substantial delay in receiving items such as TP1 numbers and our FEI numbers. To this date, we still await our submission to be processed by the FDA.
Mister-E-Liquid has been assured by our legal counsel that our registration complied with all the standards that the FDA set forth and will pass the requirements for the submission. The Deeming Regulations stipulated that these registrations were due to the FDA by the specified date, originally. This date has changed several times, however, the matter is still the same, we have been in compliance since February and await the CTP’s ability to process our information.
In the meantime, we guarantee you that we are compliant. The products on your shelves that you purchased from us are compliant, and will remain compliant. While we cannot provide you TP1 numbers and FEI numbers at this time, we assure you, our products are allowed on the market.
As an aside, Mister-E-Liquid estimates that the ingredient submission, which is due November 8th, 2017, will also be complete before the required deadline. We have spent countless hours with our attorneys and staff to ensure that not only will these submissions be done before the required date, but also that they will be done correctly. Unfortunately, it is possible that due to the extreme volume of information, we may experience more delays from the FDA. In the event that this happens, we will be certain to communicate to you the status of these submissions.
Let this letter serve as not only a letter of intent, but a guarantee that Mister-E-Liquid will continue to comply with all state and federal regulations. The high quality products you know and love will be here and they will continue to meet both the standards set by the federal government and our own, much more stringent standards.
Ronald L. Pease II
September 13, 2017
Re: Mister E-Liquid, LLC Registration and Product Listing
To Whom It May Concern:
The purpose of this letter is to confirm that Mister E-Liquid, LLC (MEL) has properly submitted its Establishment Registration and Product Listing (the “Submission”) to the U.S. Food and Drug Administration (“FDA”), pursuant to Section 905 of the Food, Drug and Cosmetic Act, as amended by the Family Smoking Prevention and Tobacco Control Act. We have confirmed that the Submission has been received by FDA and is currently being processed. Based on this, it is our opinion that MEL and its products are in full compliance with all applicable FDA laws and regulations. As soon as FDA has completed processing MEL’s registration, we will provide you with its FDA Establishment Identification (FEI) number and Tobacco Product (TP) numbers. Please feel free to contact me with any questions or concerns.
If you have any questions at any time, please feel free to contact me.