What's the deal with 28.5mg/ml nicotine?

First, let’s get some facts out of the way.

Fact 1

There are two types of nicotine widely used in vaping products

  • Freebase nicotine.

  • Nicotine salts.

In the early 2010s, freebase nicotine was commonly used in all vaping products. This type of nicotine is inherently "basic" (the opposite of acidic), which can make it harsh to inhale.

 

Towards the end of the 2010s, nicotine salts were introduced. Although they are still based on nicotine, their chemical composition differs from that of freebase nicotine.

 

To simplify, nicotine salts are formed by combining freebase nicotine and acid. This combination lowers the overall pH of the compound, resulting in a smoother inhalation experience.

 

For the purpose of this explanation, let's consider that nicotine salts are produced by mixing freebase nicotine with an acid in equal proportions - for instance, to produce 100mL of nicotine salts, one would combine 50mL of freebase nicotine with 50mL of acid. The specific 50/50 ratio, however, can vary based on the manufacturer of the nicotine salts and the type of acid used.

 

Freebase nicotine:

 

  • Is the “original” type of nicotine

  • is chemically simple

  • has a high pH, i.e., is “basic”

  • can be harsh to inhale

 

Nicotine salts:

 

  • Is the “new” type of nicotine

  • are chemically complex

  • have a lower pH, i.e., are less "basic"

  • are smoother to inhale

 

Nicotine salts are particularly popular among new vapers and those who need higher nicotine levels but want a less harsh experience. The addition of acids, like benzoic acid or lactic acid to freebase nicotine, helps to stabilise the nicotine and allows it to be absorbed more efficiently by the body. This efficient absorption can mimic the nicotine delivery of traditional cigarettes, making the transition to vaping easier for smokers.

 

Additionally, the smoothness of nicotine salts makes it possible to vape higher concentrations of nicotine without the harsh throat hit that freebase nicotine produces. This can be especially beneficial for those who are trying to quit smoking, as it allows them to satisfy their nicotine cravings more effectively without the discomfort associated with high levels of freebase nicotine.

Fact 2

We measure nicotine concentration in e-liquids, whether they be freebase or salt, in mg/mL.

Concentration (mg/mL): This figure tells us how much nicotine is in each millilitre of the e-liquid. For example, if an e-liquid has a nicotine concentration of 6mg/mL, that means each millilitre of the e-liquid contains 6 milligrams of nicotine.

 

Total Volume (mL): This is the total amount of the e-liquid you have, say in a bottle. For instance, if you have a 100mL bottle of e-liquid.

 

To find out how much total nicotine is in the whole bottle (ie, the “total nicotine content”), you multiply the concentration by the total volume:

 

Total Nicotine (mg) = Concentration (mg/mL) × Volume (mL)

 

Using the numbers from our example:

 

Total Nicotine = 6mg/mL × 100mL = 600mg

 

So, in a 100mL bottle of e-liquid with a nicotine concentration of 6mg/mL, there would be a total of 600 milligrams of nicotine in the bottle.

 

It's essential to understand that the method of measuring nicotine content remains consistent, regardless of the type of nicotine being utilised.

 

For instance, to prepare 100mL of a 10mg/mL freebase nicotine e-liquid, you would incorporate 1000mg of freebase nicotine into the mixture. Similarly, to create 100mL of a 10mg/mL nicotine salt e-liquid, you would also add 1000mg of nicotine salt.

 

Thus, the calculation process for determining the amount of nicotine in both scenarios is identical.

A bit of history.

In 2021, the New Zealand government implemented the Smokefree Environments and Regulated Products Regulations 2021 (SERPA), which set the standards for legally permissible vaping products in the country.

 

According to Schedule 5 (Product Safety Requirements for Vaping Products), Part 1 (Vaping Substances) of the original SERPA, there are specified limits on the concentrations of different types of nicotine in vaping substances. This regulatory action addresses the chemical composition of nicotine salts, which typically consist of a 50/50 blend of freebase nicotine and acid. Consequently, nicotine salts contain half the freebase nicotine compared to equivalent concentrations in standard freebase nicotine products.

Nicotine

14

The strength of free-base nicotine in a vaping substance must not exceed 20mg/mL.

15

The strength of nicotine salt in a vaping substance must not
exceed 50mg/mL.

16

The total nicotine content in a container of vaping substance sold at retail must not exceed 1,800mg, whether it is present as free-base nicotine or nicotine salts.

Our understanding of these straightforward regulations is as follows:

 

For a nicotine salt product, the maximum concentration allowed is 50mg of nicotine salt per millilitre of liquid, equating to 50mg/mL.

 

For a freebase nicotine product, the limit is set at 20mg of freebase nicotine per millilitre of liquid, or 20mg/mL.

 

Regardless of the type of nicotine used, the total nicotine content in any retail container (calculated as the volume in millilitres multiplied by the concentration in mg/mL) must not surpass 1800mg.

 

Easy, right? You can vape 20mg/mL freebase, or you can vape 50mg/mL salts (because there is less nicotine in salts, hence the higher allowable strength - a 50mg/mL nicotine salt product contains only around 25-28mg/mL freebase nicotine).


However, it appears there was some confusion, and in 2023, the Ministry of Health updated these standards, specifying:

Nicotine

14

For a vaping substance that contains nicotine only in salt form and is intended for use in a reusable vaping device, the concentration of nicotine must not exceed 28.5mg/mL.

15

For all other vaping substances, the concentration of nicotine must not exceed 20mg/mL.

16

The total nicotine content in a container of vaping substance sold at retail must not exceed 1,800mg, whether it is present as free-base nicotine or nicotine salts.

You might wonder why these adjustments were necessary.

 

In short, the rationale behind the Ministry's update is attributed to some manufacturers' ambiguous interpretation of the nicotine strength limits.

 

What some manufacturers were doing was a bit tricky. They were taking advantage of the fact that nicotine salt is half nicotine and half acid. Instead of saying there's 50mg of the whole mixture (nicotine plus acid) in each millilitre, they only counted the nicotine part. So, they were actually putting up to 100mg of the mixture (which would be 50mg of nicotine and 50mg of acid) in each millilitre but only reporting it as 50mg because they only counted the nicotine.

 

They were essentially doubling the amount of nicotine salt but only reporting half of it. This deceptive practice led to stronger-than-intended products being sold, prompting the Ministry to clarify and tighten the regulations to prevent such misinterpretations.

 

As such, the Ministry updated the regulations to ensure that regardless of the type of nicotine salt used, the nicotine portion of the salt can only equal 28.5mg/mL of the final product. This means that if the nicotine salt composition used is 57% nicotine and 43% salt, the maximum strength of the nicotine salt in an e-liquid would still remain at 50mg/mL. This adjustment ensures that the actual nicotine content aligns with safety standards and public health objectives.

 

To clarify, the regulations themselves did not fundamentally change. Vendors who have been selling 50mg/mL nicotine salt products containing 25-28.5mg of "equivalent freebase nicotine" were always in compliance with both the original and the updated laws. These products have remained, and continue to be, compliant with the regulatory standards set forth. This consistency ensures that the products meet safety guidelines while providing clarity and stability for retailers and consumers alike.


It’s crucial to understand that the nicotine salt used in the manufacture of e-liquids doesn't contain any freebase nicotine or acid in their original forms.

 

During production, these components chemically combine to form a completely new substance: nicotine salt. This detail is key because it clarifies that there are no separate freebase nicotine or acid elements present in the finished product.

 

The confusion and regulatory challenges have largely stemmed from certain parties exploiting what they perceived as a loophole. However, this was not so much a loophole as a misuse of the regulatory language—a legally dubious approach that relied more on manipulating the interpretation and wording of the law rather than adhering to its intended spirit and purpose. This strategy was essentially about selling non-compliant products under the guise of a technicality, not genuine compliance with the intent of the regulations.


Vape Traders’ Stance.

We understand there's been some confusion regarding the absence of the freebase nicotine equivalency on these labels. I would be happy to explain our position and the regulatory environment surrounding our products.

 

Firstly, it's important to note that all our new labels, introduced from early to mid-2023, include both the nicotine salt concentration and the equivalent freebase nicotine concentration in mg/mL.

 

This change was implemented to enhance transparency and align with international standards. Specifically, for the Australian market, the TGO110 regulations explicitly require that labels on nicotine salt products display the equivalent concentration of nicotine base form in mg/mL. As a beneficial side effect, by stating both the nicotine salt and equivalent freebase nicotine strengths on our labels, we positioned ourselves ahead of the curve - our products now contain more information than is currently required by regulations, potentially setting a standard for future requirements.

 

However, regarding your concern about our older labels, the regulatory landscape in New Zealand under the Smokefree Environments and Regulated Products Regulations 2021 distinguishes between "free-base nicotine" and "nicotine in salt form", with different nicotine strength limits for both forms of nicotine.

 

New Zealand's regulations broadly define "nicotine" to include both freebase nicotine and nicotine salts, without specifically requiring labels to indicate the equivalent freebase nicotine concentration.

 

All of our e-liquids, whether they contain nicotine salts or other forms, have always adhered to these regulations. It's important to note that the law does not mandate the inclusion of "freebase equivalent" mg/mL on labels for products intended for the New Zealand market. However, we have voluntarily included this information on all products released in the last 18 months.

 

Recent updates to the regulations have further clarified the acceptable nicotine strength limits to prevent misleading practices regarding nicotine content. These updates are consistent with our original interpretation and compliance efforts.

 

To summarise, the labelling of our products has always been in full compliance with New Zealand's regulatory requirements. The absence of freebase nicotine equivalency on our older labels is in no way a non-compliance issue but rather a reflection of the regulatory guidelines at the time of their production.

 

I hope this explanation clears up any misunderstandings and reassures you of our commitment to not only follow regulatory standards but to exceed them wherever possible.