As of May 23, 2019 the FDA is starting a new program “to give CTP staff an opportunity to visit facilities that develop, manufacture, or test ENDS devices or e-liquids… to gain a better understanding of the processes involved in the development, manufacturing, and testing of ENDS devices and e-liquids.” The department in charge of this new program is the CTP’S Office of Science and they have started this project to give their own staff an opportunity to visit the facilities to help them grasp a visual education on how the industry functions as it pertains to its manufacturers. Facility visits will not be an inspection of your facility, but a tool for their team to familiarize themselves with vapor manufacturing processes.
This program is not limited to just open system manufacturers but also for those responsible for manufacturing pod systems or cartridges. This project will take place over the duration of the 2020 year, but while it seems like many may jump at the chance to educate the FDA it seems that they only plan on visiting five or fewer ENDS devices or e-liquid manufacturers. The FDA stated that all travel expenses associated with these site tours will be their responsibility. If you would like to submit your site for participation in this project additional information that would aid in them making a decision would be:
- A company description, including site of the company
- A list of devices or e-liquids your company develops or manufactures, include whether or not your company performs e-liquid and aerosol testing
- The name and contact information of your point of contact for the request
- The physical address of site for which you are submitting a request
- A proposed 1-day agenda that will aid with planning travel, indicated start and end times and addresses for all sites during tour.
If you would like to put your site up for participation they will be accepting requests for participation starting May 24,2019 until July 23,2019 at www.regulations.gov or by writing in to Dockets Management Staff, Food and Drug Administration, 5630 Fishers Lane, Rm 1061, Rockville, MD 20852. To identify requests for participation the FDA has asked that you include the following docket number in your request {Docket No. FDA-2019-N-2037}
As always if you have any questions feel free to contact us for a free consultation at (909)635-6588