Delay?? I posted that like 20min ago.
Here's the text of the email:
Dear NicSelect Customers and Potential Customers,
The next several months will be a challenge for many of you as you prepare to adhere to the FDA regulations and the PMTA (pre-market tobacco approval) requirements. Naturally, we all hope that our industry can successfully challenge the grandfather date and bring about other modifications we believe are needed.
Regardless of what may come, we and Alchem International, makers of NicSelect® 100% Pure Nicotine USP, will do whatever we can to assist with your compliance efforts. We will soon be submitting a TPMF (tobacco products master file) on NicSelect® to the FDA that you can reference in your PMTA applications. And if you are selling products in Europe, we assure you we are REACH compliant and can help you with your TPD (Tobacco Products Directive) dossiers. We can also refer you to associations/consultants in Europe that can assist you with that process.
Alchem International has been making plant-based extracts for the pharmaceutical, nutritional, cosmetic and e-cigarette industries for over 75 years. Unlike newcomers to the market, we are thoroughly versed and experienced in dealing with regulatory agencies both here and abroad. We are regularly inspected by FDA and we currently have 4 active DMF’s (Drug Master Files) in place at FDA for pharmaceutical API’s (Active Pharmaceutical Ingredients).
We are committed to the long-term success of this industry. In fact, because of current and projected future demands in the US and Europe, we are preparing to double our current capacity of NicSelect® to continue to be able to supply your needs. Please feel free to call me to discuss how we can help you succeed in this ever-changing regulatory landscape.
Thomas H. Schrier
Vice President of NicSelect
Business Development & Sales
Alchem USA, Inc.
5819 Highway 6 South
Suite 140 Missouri City,