With some confusion reigning over the new TPD rules and regulations, it seemed prudent to provide a short list of questions you should ask your E-Liquid supplier. So here goes. Here are 5 questions to ask your supplier to make sure your E-Liquid will be TPD compliant, and the answers you should receive:
The answer to this should be an unequivocal yes. Over the past few years suppliers have had time to adapt to the new TPD rules and to create complete transparency regarding the quality of their products.
TRAs (Toxicology Risk Assessments) are necessary for every compound found in their product. They must hold the complete formulas for your flavourings and their CAS (Chemical Abstracts Service) numbers.
The above test will make it possible to show the amount of nicotine the body will receive over a certain period of time.
The MHRA (Medicines and Healthcare Products Regulatory Agency) has required that manufacturers assume a 100% uptake from all affected products, therefore eliminating certain variables and the necessity of clinical trials.
Furthermore, nicotine uptake can be bracketed to display the higher and lower-end nicotine concentration, as long as the results are similar this will also show medium-range contents.
Since emissions testing on each SKU (Stock Keeping Unit -- per flavour, per strength) -- is a must, an array of different equipment is used to analyse the emissions released by your product, including ICP (Inductively Coupled Plasma) and GC-MS to TD-GC-MS-FID (Thermal Desorption-Gas Chromatography-Mass Spectrometer-Flame Ionization Detector).
Under the guidance of the TPD, the European Commission will be establishing technical standards to guarantee a leak free filling for electronic cigarette tanks. A working document published by the company Nerudia provides a pretty accurate idea of what the future requirements will be.
The EU TPD in all its wisdom, has decreed that there must be a leak fee filling system for e-cigarette tanks. "Given the toxicity of the nicotine-containing liquids used in electronic cigarettes and refill containers", the composers of the Directive determined that it is "appropriate" to ensure "that electronic cigarettes can be refilled in a manner that minimizes the risk of dermal contact or accidental ingestion of such liquids."
It has been deemed that it is now the Commission's responsibility to reach this goal with the preparation of technical standards.
At present, indications are that clearomizers and refill bottles are supposed to meet one of two requirements in order to be legally sold in the European Union.
Last of all, refilling instructions, including graphic illustrations, must be given to consumers. The width of the nozzle and of the clearomizer's opening must be shown to permit consumers to identify the compatibility between the bottles and the tanks.
The first solution seems to be in agreement with the work done in France by the AFNOR on vaping products. It was proposed the maximum flow rate of 20 drops per minute and to show the external diameter of the refill nozzle.
Starting in 2018, the product packages and advertisements of all newly-regulated covered tobacco products must have the warning:
If the tobacco product manufacturer submits a self-certified statement to the FDA that the newly-regulated tobacco product does not contain nicotine (and that the manufacturer has data to support this assertion), then an alternate statement must be used on product packages and advertisements:
Characterization of the E-Liquid and vapour will include testing for nicotine content, nitrosamines and other volatile organics, and heavy metals. This can be simply accomplished by analytical chemistry methods using GC/MS, HPLC-UV and ICP-MS.
What this translates to is that nitrosamines and other volatile organics can be released in the vapor as degradation products of the E-Liquid. Forced degradation studies i.e. exposing the E-Liquid to extreme heat, oxidation, light, and acidic conditions for extended periods of time to create the worst-case scenario, would "force" degradants to come out. These degradants can then be identified and analysed by GC/MS. Short-term (1 month) and long-term stability studies (6 months-1 year) can also be used to determine whether the E-Liquid is degrading over time.
Heavy metals can also leach out of the metal components of the e-cigarette into the vapour inhaled by the consumer. A commonly used heavy metal in e-cigarettes is tin, which makes up solder joints in the cartridge. Tin can be cytotoxic and when inhaled as part of the e-cig vapour, will directly reach the respiratory system of the user. In this case, ICP-MS can be used to detect the presence of even trace amounts of heavy metals and quantify them.
Ultimately, the FDA is concerned about the potential hazards of e-cigarettes which prompted it to propose new regulations. While some claim these new rules are designed to make it more difficult to sell e-cigarettes, with the main goal being to drive e-cigarette retailers out of business, other e-cigarette sellers have been complying with these rules long before they had to.
To prove the safety of their products in marketing applications, manufacturers of e-cigarettes would benefit from performing rigorous tests such as degradation studies, stability studies, and analyses of degradants and heavy metals.
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