E-LIQUIDS WITH SEASONING
Nicotine salts are another area of considerable interest at the moment . There are many salts , benzoate , salicylate , levulinate and even some companies with bespoke formulations of their own . It ’ s not just a case of adding the base acid to your formulation . You need to be sure it ’ s ionised . The products are made by combining the nicotine with a base acid – benzoic acid in the case of nicotine benzoate – but you need to be sure it ’ s ionised , the nicotine is still there , it ’ s just loosely bound to the base acid this gives for faster absorption of the nicotine and a smoother vape experience . Customers report getting a fast , harder nicotine hit , which is great for those smokers who were not getting the satisfaction from 18 or 20mg / ml e-liquids made with traditional nicotine .
Again , there are complications that need to be considered :
· It ’ s a significant formulation change , so you need to update your notification
· It needs new emissions and toxicology data
· You need to get your dose right
· Your labelling needs changing
You are changing your formulation , so you must let the competent authorities know by updating your notification through the EU portal . If you are swapping out nicotine for salt nic , you can replace your current product , or if you ’ re adding to the range , it ’ s a new EC-ID and new notification charges . As it ’ s a new formulation , you will need to re-emissions test your product and also update your toxicology . You ’ re not adding the base acid , you ’ re replacing the nicotine , and these base acids can be quite tricky , so you need some specialist toxicology reporting from a recognised expert or you ’ re going to have difficulty in making it safe to use declaration . It ’ s almost a full new TPD process . Again you can re-use your toxicology on the base flavour , but some people are tweaking these as well so you may find it ’ s a brave new product for a brave new world . You need to set your dose too . The TPD limits you to 20mg / ml , but if you add 20mg / ml of your nicotine salt you will be under dosing the nicotine , most salts are around 55-65 percent nicotine , this varies . For nicotine benzoate 36mg / ml of the salt will contain 20mg / ml of free base nicotine , so go with the nicotine dose not the salt dose , the market is looking for high nicotine levels , so this is not a mistake you want to make .
Your label will be quite different as well . Here are some things to consider :
· On the front of the packaging , give the free base nicotine dose , but as an equivalent , for example say 20mg / ml or 2.0 % equivalent nicotine . This also applies for the dose per puff . Give it as free base nicotine . This will avoid confusing the customers as they can relate it to what they are used to .
· On the ingredients listing you need to be clear that you have added nicotine salts not nicotine and base acid . At ADACT we have spoken to trading standard experts and they are clear : if you are adding the nicotine salt disclose that , so this is where you can put your salt amount , ie 36mg / ml nicotine benzoate
· CLP , you need to update your CLP in accordance with the standard requirements . Your CLP is likely to change from that of the base flavour .
As with pod systems as you embrace these new trends , it ’ s critical that you remain compliant so speak to your compliance agency at an early stage .
UPDATE ON BANNED SUBSTANCES
Another disruption that has happened the past few weeks is companies receiving letters from the MHRA explaining that there are banned substances in their products and they need to be removed from the market . This has taken many by surprise as the original letters sent by the MHRA in April have not made it through SPAM filters , so no action has been taken . Firstly , a bit of background on this , at the beginning of the TPD process there was a draft guidance on ingredients and that contained information on banned substances , but this was in draft format . In February this year , the MHRA sent out some notifications to companies about banned substances . They had intended to finalise the guidance previously but this did not happen , so it was finalised without notice or further consultation , which caught everybody on the hop . Now that certain ingredients have been banned , a number of companies will need to reformulate their products and stop manufacturing on the old formulation . We have been in touch with most manufacturers and they have re-formulated their products without the banned substances . These safe versions can be swapped out , but there is a subtle change in flavour and you need to test your liquids to make sure they ’ re satisfactory . Once you have re-formulated you will need to re-emissions test your formulation and update your notification . If you received such a letter , you need to do the following :
· Acknowledge receipt of the letter with the MHRA and confirm that you are no longer manufacturing product to the problem recipe
· Contact your compliance team to identify the problem component
· Reformulate to remove the problem component
· Re-emissions test the new formulation
· Update the XML and update your notification
· Write to the MHRA to confirm you have made changes and are going back to market with the new formulation
For more information on any of the topics addressed in this feature , contact ADACT Medical on + 44 1302 98 60 88 or email enquiries @ adactmedical . com or see www . adactmedical . com
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