Next Generation Nicotine Delivery Products (NGPs) is the term used to refer to those products that are designed to deliver nicotine in a less harmful manner than traditional cigarettes.
Traditional tobacco products, such as cigarettes and cigars, are well known to be harmful to the user. The harm is due to the user inhaling smoke, the products of combustion, and harmful compounds present in tobacco, such as Tobacco Specific Nitrosamines (TSNAs).
Electronic Nicotine Delivery Systems (ENDS), Heated Tobacco Products (HTPs) and Modern Oral Nicotine Pouches (MONPs), are the next generation of nicotine products that aim to deliver nicotine satisfaction to the user without combustion, and in the cases of ENDS and MONPs, in the absence of tobacco. The absence of combustion typically results in a significantly reduced number of toxicants and reduced toxicant exposure to the user.
Due to the wide range of products enabling nicotine delivery, many use the idea of a continuum of risk to perceptualize the risks posed by the different products:
Broughton Nicotine Services only deliver projects associated with NGPs – we do not undertake projects relating to combustibles.
Electronic Nicotine Delivery Systems (ENDS)
Modern Oral Nicotine Pouches (MONPs)
Heated Tobacco Products (HTPs)
Nicotine Replacement Therapy (NRT)
ENDS come in many forms representing the diversity in needs of the consumer. Products may be simple in operation with no refilling required and, breath activated. At the other end of the spectrum they can be products where the user can customize their device and its use with multiple heating coils, variable power settings and the opportunity to add their own choice of e-liquid.
ENDS contribute to tobacco harm reduction and a smoke-free future by allowing smokers to switch to a product that generates an inhalable aerosol without combustion. This is typically achieved by heating the e-liquid to form an aerosol which is then inhaled.
The aerosol from these products can be understood in terms of its chemical composition. Although there may be compounds present due to thermal degradation of the e-liquids ingredients, due to the absence of combustion, the chemical composition of the aerosol contains far fewer constituents than cigarette smoke. The US FDA list just 33 compounds of particular interest, although they also state that respiratory irritants plus other compounds of interest should be considered in their PMTA for ENDS guidance, June 2019. In practice, not all of the 33 compounds listed in the PMTA guidance, are found when the products are analyzed.
The e-liquids used with ENDS are typically made with propylene glycol (PG), glycerol (VG), nicotine and flavorings.
Modern Oral Nicotine Pouches aim to deliver nicotine satisfaction to the user by combining nicotine with a filler material (typically plant-based cellulose) in a pouch.
MONPs may be used by smokers seeking to reduce exposure to smoke.
The nicotine filler material and flavorings are contained in a pouch that the user places under the lip. Such products have been formulated to enable nicotine to absorb through the gum.
This type of product eliminates lung exposure to toxicants related to using a nicotine product.
HTPs utilize a tobacco stick or rod, that may look similar to a cigarette. The tobacco stick is inserted into a battery-powered device that heats the tobacco, and this heating process generates aerosol containing nicotine that the user can inhale. Due to the inclusion of tobacco in a stick format, HTPs offer an experience more like smoking a cigarette than ENDS. There is a defined end point for the session when the heater switches off and the tobacco stick is discarded.
As with ENDS, HTPs come in a variety of flavorings to suit the user.
HTPs contribute to tobacco harm reduction and a smoke-free future as, although they contain tobacco, the is no combustion and therefore no smoke. What some may perceive as smoke is actually aerosol generated by heating the specially formulated tobacco.
As can be seen on the continuum of risk, NRT products represent some of the least harmful methods of consuming nicotine. NRTs use tobacco-derived nicotine certified to USP and EP standards. From a regulatory perspective, such products follow medicinal pathways with their own specific requirements.
Although nicotine is toxic in high doses, nicotine itself is not considered to be the harmful chemical in cigarettes, instead it is the inhalation of chemicals and by-products generated through combustion that are most harmful.
Although many chemicals relating to tobacco smoke have been found to be carcinogenic, the UK MHRA and the Royal College of Physicians have concluded that there is no evidence that medicinal nicotine causes cancer. In addition, although nicotine causes temporary changes to the cardiovascular system, such as increased heart rate and blood pressure, nicotine use via nicotine replacement therapy has not been associated with increased cardiovascular events.
Typically, the nicotine used in NGPs is tobacco-derived. This means tobacco is grown and the nicotine is extracted and purified.
An emerging NGP product variant relates to the use of synthetic nicotine.
In the U.S., the regulatory pathways to enable the sale of an NGP as a consumer product are the Premarket Tobacco Product Application (PMTA) and the Modified Risk Tobacco Product (MRTP) application. This relies on the products being “tobacco products”.
It is possible to manufacture ENDS and Modern Oral Nicotine Pouches with synthetic nicotine instead of using tobacco derived nicotine meaning the resultant product would not contain any ingredient or component that comes from tobacco. If this product can then be used with a product deemed a tobacco product, for example a synthetic nicotine e-liquid that can be refilled into any ENDS product, it is captured by the PMTA process. In the case of a synthetic nicotine oral pouch, the product does not fall strictly into the remit of products that FDA Center for Tobacco Products (CTP) currently regulates. However, this does not mean that synthetic nicotine products will never come within FDAs remit in the future.
It is industry expectation that this will be the case, but it is unclear when or how this will happen. It should also be noted that, due to differences in the manufacturing process for synthetic nicotine compared to tobacco- derived nicotine, there will likely be different considerations for testing impurities.
Broughton Nicotine Services have deep CRO capabilities and an experienced team of scientific and regulatory professionals to deliver full-service global regulatory projects. Our knowledge of global regulatory pathways offers significant insights that can be incorporated into your project plans. Our mission is to accelerate safer nicotine-delivery products to market; advancing a smoke-free future.
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Overview of our full-service PMTA compliance solution, from planning through to compilation and submission.
Understand what’s involved in a PMTA and how the recommendations relate to your ENDS business.