Recently, there have been various different studies and news articles surrounding vaping and of the ingredients used to make them, as well as mentions of certain additives which could possibly be deemed harmful if vaped.
In this article, we’ll explain what ingredients we use in our e-liquids, describe what additives you should be aware of when vaping and talk about the current Vitamin E Acetate situation.
Making Harmony CBD e-liquid
All Harmony E-Liquids share the same ingredients: Propylene Glycol (PG), Vegetable Glycerin (VG), Cannabidiol Isolate (CBD) and flavourings (either PG-based or terpene-based).
The vast majority (85%-98%) of a Harmony E-Liquid is usually made up of a mixture of PG and VG in a ratio of 80 to 20 weight%. The CBD content ranges from around 0.3% to 10%. PG-based flavourings are added at 5%-10% and terpene-based flavourings at 1%-3%, depending on the exact composition and safety calculations (further information see below).
Both PG and VG have a long history of use in pharmaceutical applications and have a well-studied safety profile. Further to this, we only purchase these two carrier ingredients at a pharmaceutical quality, respecting the recommendations of storage conditions and shelf life. This means both compounds are at the very least 99% pure and contain no detectable residues that might cause harm to human health as per european pharmacopeia.
CBD isolate is generally regarded as safe and non-addictive by the World Health Organisation. Harmony has a strict quality control system in place to ensure the quality and integrity of every batch of CBD isolate that is used for production. Further information as to why isolate and not broader spectrum extracts are used in Harmony products can be found below.
The main reason for concerns about safety in E-liquids usually arises from the use of flavourings. Conventional E-liquid flavourings are commonly PG-based and Harmony is only ever purchasing such flavourings from reputable suppliers within the EU. The European Tobacco Products Directive prohibits the use of certain flavouring compounds known to cause harm upon inhalation and we guarantee that our providers respect these regulations. Additionally, Harmony always carefully reviews the safety documentation provided for the flavouring materials to ensure to only use them in quantities that won’t pose a risk to the users health as of current knowledge.
Our terpene-based flavours are carefully crafted in-house from certified, isolated, food grade aroma raw materials listed in the EU list of flavouring substances as defined by Regulation EU 872/2012. The raw materials used by Harmony are purchased only from reputable aroma material suppliers within the EU. Every finished flavour formulation is sent to an independent consultancy that creates a Material Safety Data Sheet (MSDS) for the mixture, outlining any hazards and precautions to take and containing detailed information on all hazardous ingredients present in the mixture. On the basis of this MSDS, a final concentration in the E-liquid can be calculated where any potentially hazardous components are diluted to the point where they don’t cause harm to human health as of present knowledge.
Finally, for every finished e-liquid formulation a safety data sheet is created by an independent third-party entity the same way as for the terpene-based flavourings. All mandatory and recommended labelling elements (like for example allergen warnings) are included in Harmony’s packaging design, which is regularly reviewed and updated to ensure consumers can make a fully informed purchasing decision.
Testing Harmony products
Harmony and its producers carry out testing with trusted third party laboratories to ensure ingredients are up to the highest quality standards.
Every batch of CBD isolate is tested by Harmony and its suppliers independently for its potency by means of HPLC or UPLC (High Performance Liquid Chromatography or Ultra Performance Liquid Chromatography), a technique that allows the separation, detection and quantification of Cannabinoids and other compounds in a mixture. CBD isolate is only released for the production of E-Liquids if the CBD content of the material is 99% or higher and there are no detectable traces of THC present.
In addition, the raw material can be tested for residual solvents, pesticides and heavy metals. This is carried out for every single batch by the producer and occasionally re-tested by Harmony according to a fixed Quality Control plan. Solvent and pesticide testing is usually carried out through special HPLC techniques that can detect and quantify these compounds at a ppm (parts per million) level. The presence of pesticides of hazardous levels of residual solvents immediately disqualifies the raw material from use in production.
Heavy metal content is usually measured by means of ICP (inductively coupled plasma) spectroscopy. Again, the presence of contaminants above safety levels defined by European Regulations dismisses the raw material from use in production.
Lastly, a finished E-liquid formulation can be assessed by means of emission testing. The process of vaporisation is recreated by a special apparatus and the resulting vapour analysed for the presence and quantity of hazardous compounds like formaldehyde, acrolein and others. The test results are then evaluated by a trained professional to judge whether contaminants are present at levels hazardous for human health.
The difference between CBD Isolate and “Cannabis Extracts” in Vaping
All Harmony vaping products are produced with CBD isolate and never with what is commonly referred to as “Cannabis extracts” or “broad/full spectrum extracts”. The reason for this is simply the difference in purity and the presence/absence of certain components like for example fats, fatty acids, hydrolysis products and terpenes.
A full spectrum extract is generated by first extracting dried and milled hemp with either a solvent or CO2 and subsequent removal of the solvent, which yields a dark green/brown paste high in cannabinoids. In some cases, this paste is already marketed as “full spectrum extract”. However, most times, this concentrate is then heated to convert CBDA to CBD, followed by a short path distillation to remove Chlorophyll and other larger impurities, yielding a brown to yellow semi-solid, the full spectrum extract. In order to remove traces of THC and create a so-called “broad spectrum extract”, another distillation under reduced pressure is carried out. Both the full and broad spectrum extract typically contain between 75 and 85% CBD, but also relatively high amounts of residual terpenes, as well as plant oils, fatty acids and hydrolysis products thereof (generated in the previous heating steps).
The levels and exact composition of these impurities usually vary batch-to-batch. While these components are sought after when manufacturing for example food supplements to support claims of an “entourage effect”, they can actually be dangerous in vaping applications for various reasons. Plant oils and waxes for example are suspected to cause lipid pneumonia and decreased lung functionality when inhaled, while fatty acids and hydrolysis products can cause irritation and worsen the signs of respiratory illnesses.
Terpenes in uncontrolled amounts can cause or trigger allergies, especially when the consumer isn’t warned of their presence on the label, where they are “hidden” under the term “broad/full spectrum extract”. It is down to the manufacturer of vaping products containing such extracts to carry out the right quality checks and inform their consumers the best they can. While Harmony supports the opinion that vaping such products is still safer than smoking, it also decided against launching them for the time being, and only manufacture with CBD isolate instead.
CBD isolate can be produced from broad spectrum extract by means of further purification. A “winterization” step is often included, where the extract gets dissolved in alcohol and stored very cold, which causes the waxes to precipitate so they can be filtered off. After removal of the alcohol, the residue is dissolved in a non polar solvent. Pure, isolate CBD then crystallizes over time and can be collected and dried in a vacuum oven. This isolate has a purity of >99% and is virtually free of waxes and oils. The only common “impurity” is a small trace amount of CBDV (Cannabidivarin, a phytocannabinoid), which happens to co-crystallize with CBD.
A different method for the production of pure CBD isolate would be its total synthesis from suitable starting materials followed by purification in a laboratory setting. Again, the final product would be free of waxes, oils, terpenes and in this case even CBDV.
The Current Vitamin E Situation
Vitamin E acetate (or Tocopheryl acetate) is a compound derived from Vitamin E itself and widely available and used as a food supplement and skincare-ingredient. Both Vitamin E and its acetate have antioxidant properties, however the acetate has a somewhat lower acidity and longer shelf life. It is a viscous, colourless, oily substance with a high boiling point (363 ºC).
At this point, it is up to speculation why it ended up in vape cartridges, as it is not a known contaminant of Cannabis extracts or any commonly used solvents and flavourings. However, it seems some companies sold it as a thickening/diluting agent for extracts, although there is no data on inhalation toxicity and the high boiling point and molecular weight of the compound should discourage from the use in vaping devices. The wrongful perception that it might be a “healthy and natural” option, combined with the low cost point and convenient viscosity profile might have played a role, but the exact reasons are yet to be determined.
Under European regulations laid out in the Tobacco Products Directive (TPD) the addition of additives to E-liquids is strictly forbidden, so it is highly unlikely such products would enter the legal market.
There have been a number of unregulated vaping products which are currently being investigated in the United States. The FDA announced it had analysed 18 cannabis vaping products, 10 of which contained Vitamin E Acetate, which have been directly linked to the lung disease outbreak in the US.
At Harmony, we do not use Vitamin E Acetate in any of our CBD liquids. We use a mixture of CBD, PG, VG as well as flavourings, none of which contain this vitamin. We also publicly publish our certificates of analysis online to ensure that the concentration of CBD is correct.
To clear up any other doubts about the safety of vaping, Public Health England in the UK released a study showing that vaping is 95% safer than smoking. However, we do not recommend that anyone who hasn’t smoked or vaped before starts using Harmony products.
We hope that this article has been of help to you, but if you want to find out more about the contents of our e-liquids, or have any other questions please don’t hesitate to get in touch.