Nicotine Suppliers to e-Juice Manufacturers

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Flavoring industry veteran Eduardo Berea of Alternative Ingredients, and Polish company Chemnovatic fill in Tobacco Asia on the workings of nicotine manufacturers supplying the e-juice industry.

By Thomas Schmid

Flavoring specialist Eduardo Berea is the international sales manager of long-standing US company Alternative Ingredients, Inc. (AI) and a board member of CORESTA. AI supplies the vaping industry with e-flavor concentrates and nicotine solutions (10% concentration in propylene glycol or glycerine, as well as 10:45:45 ratio mixes of nicotine, propylene glycol, and glycerine, respectively), using pure USP-certified nicotine in the manufacturing process. The most common nicotine concentrations in e-juices sold to end consumers are 0.6, 0.9 and 1.2% (corresponding to approximately 6, 9, and 12 mg/ml, respectively) for open systems, according to Berea.

He says that in terms of price “tobacco-derived [i.e. natural] nicotine is more competitive by a 10-fold or so” to synthetic nicotine. But he also extols natural nicotine’s better flavor properties, asserting that he ”has yet to taste a synthetic nicotine with a clean, neutral flavor profile.” Berea adds that in terms of existing regulations in the US, it has been argued that because the tobacco act specifically regulates product derived from tobacco only, synthetic nicotine would not fall under the CPT code. But then again… nicotine is a controlled substance anyway, so if synthetic nicotine is not classified as a “tobacco product”, it might just as well end up being considered as a “pharmaceutical product”. “And I think that path [would be] much more challenging [with regards to FDA approval],” Berea analyzes.

AI typically obtains most its nicotine supplies from either Europe or India. As the company requires REACH registration from its vendors, this has limited it to currently only three suppliers. Domestic vendors are used as backups. Ensuring that any nicotine it utilizes in its manufacturing processes complies with either USP or EUP gives AI the safety that “undesirable ingredients” (read: impurities) are present at “extremely low levels,” sometimes even only in traces, i.e. below the level of detection. But Berea says it is still important to mention that only because a nicotine has a USP or EUP-compliant purity grade does not necessarily mean it also will taste good. “I have tested some compliant products that turned out to have an intense fishy or plastic-like taste, which made them unsuitable for us,” he recalls.

The European Commission’s Tobacco Products Directive (TPD) states that only ingredients of high purity are to be deployed in the manufacture of the nicotine-containing liquid. Which is the reason why AI decided to exclusively use nicotine that has been USP-certified, therefore “guaranteeing the highest purity commercially available,” according to Berea. Besides, adhering to USP quality standards also “helps diminish as much as possible the risks to public health by keeping the undesirable ingredients like TSNA’s extremely low.”

Careful supplier screening is crucial

There are numerous nicotine suppliers located in regions like China, India, or Eastern Europe that offer nicotine of any type and description, often at very low prices. Practically all of these vendors claim on their websites that their nicotine products comply with USP or EUP. While this may or may not be factual, Berea “would recommend being very cautious.” He says “the problem is that having a USP test performed is quite expensive,” an expense that perhaps might be shunned by one or another of the more unscrupulous vendors. Additionally, there apparently even are “some suppliers” that claim to be REACH-registered when in reality they only “have a letter of intention to become registered.” Measures that any interested commercial buyer should implement would, therefore, include a careful screening of the supplier in question, thoroughly checking their documentation, tasting their product and, if possible, have a third party lab perform an analytical test of a product sample.      

False representations of any kind are of course a no-no at AI. Every vaping liquid lot produced by the company is fully traceability as per every single ingredient in the mix, “from each and every aroma chemical to the solvents used and of course the nicotine.” “We offer a certificate of analysis with every individual product batch, which documents, in the case of nicotine-containing e-liquids, the specific gravity, refractive index, pH, nicotine content, and the flavor-sensory conformity.”

Polish outfit Chemnovatic Sp. z o.o. Sp. k. is among a slew of nicotine-supplying firms based out of Eastern Europe. Established in 2013 in the city of Lublin, the company ships its products worldwide, although the bulk (65%) of its customers are located in Europe (see table 1). Apart from 99.99% pure nicotine, Chemnovatic also trades in nicotine solutions based on carrier agents, as well as ready-to-use e-liquids with and without nicotine, including “nic shots” and CBD liquids.

“Depending on the client’s needs, we can either provide raw materials for their own production or ready-made products for end-consumer use,” says the company’s sales manager, Emil Soltan.

Purification with academic involvement

In terms of nicotine, Chemnovatic produces the substance at its highly-specialized factory, where it undergoes a meticulous purification process that was developed in cooperation with Polish universities. “The final product is fully made and certified in Poland,” asserts company co-owner and c.e.o., Marcin Lawecki. The raw tobacco used for nicotine extraction presently is mostly being purchased from outside Poland. “as local tobacco leaf does not have a high enough nicotine content to allow for a cost-efficient extraction.”

This is why the company, in 2017, started developing its own strain of tobacco seeds that will grow into plants with high nicotine concentrations. Again, Polish scientists from various institutions are involved in that project. “In 2018, we harvested the first plants [from those seeds], and the results have been very good,” Lawecki discloses. “We eventually want to switch our entire nicotine production to be derived from our own leaves as the raw material, but it is going to be a slow process that might take another two to three years.”            

About 98% of Chemnovatic’s nicotine output is extracted from tobacco leaves utilizing a technical process known as “supercritical extraction”, the remaining 2% being chemically synthesized. “Some countries prohibit the use of natural nicotine and thus companies there have to resort to synthetic nicotine, which we are able to supply,” explains Lawecki. The advantage of natural nicotine is its considerably lower production cost, while synthetic nicotine is many times more expensive. However, the synthetic form of nicotine is not without merits, as it is much easier to purify to a high level. Correspondingly, one of the cons of natural nicotine is that it contains more impurities, which however can be purged in the purification process.

REACHing out

The company is permitted by the European Commission’s REACH regulation (which came into force only in May 2018) to produce up to 10 metric tons of nicotine per annum, plus one ton of nicotine salicylate and benzoate salts. But REACH also provides manufacturers with the option to apply and register for a production output exceeding 10 tons, which Chemnovatic plans to do “before the end of the year”.      

Concerning Chemnovatic’s product standards, regulatory affairs specialist, Marcin Gorecki, asserts that all of the company’s nicotine “is frequently analyzed according to USP and EUP requirements and we can provide quality certificates at any time upon request. Chemnovatic has been focused on quality from the very beginning, which helped us to grow very quickly in just a few years.” He adds that such certification is of crucial importance to customers because it assures them of consistently high quality and safety standards. “We know very well that the ingredients we sell to manufacturers have a great influence on their final product quality. The better the quality of their products, the more they can sell. And the more they can sell, the more ingredients they need from us. It is a very simple principle.”            

When new customers approach Chemnovatic with inquiries for nicotine orders, the company involves them in a thorough pro-active discussion. “The more details we have, the easier it will be for us to advise the customer on the proper nicotine type suited to their manufacturing,” explains Lawecki. Another important aspect is the legal regulations enforced in any given country where the product is to be marketed. “Often the clients themselves do not know if they can import nicotine into their country at all,” Lawecki says. “In such a situation we try to help them by contacting the appropriate authorities to determine what requirements must be met to send the shipment without running into problems.” For example, there are countries where a particular variety of nicotine is banned entirely or some of its potential uses are not permitted. (Read more on these legal aspects in our side box.) 

Natural Nicotine or Nicotine Salts?

Natural nicotine extracted from the tobacco plant is the most commonly used form of nicotine in the production of e-juice, as it is colorless and odorless and also extensively documented and scientifically examined. It also is easier to obtain and considerably cheaper than synthetic nicotine. However, nicotine salts, which are chemical compounds of nicotine with other substances, are growing in popularity.

Nicotine salts mostly come in powder or crystal form and are less prone to oxidation (chemical deterioration) than natural nicotine. Which keeps them stable for longer periods of time even when dissolved in a carrier agent (e.g. propylene glycol) as is the case in vaping liquids. Furthermore, nicotine salts are quickly absorbed into the bloodstream and provide vapers with a strong and long-lasting effect. Due to their lower pH level when compared to natural nicotine, they are also incredibly smooth, which means that one of the main sensory perceptions during vaping, the “throat hit,” becomes less harsh.

A Veritable Minefield of Regulations

The export (and subsequent import into the destination country) of nicotine and nicotine products classified as hazardous are subject to a plethora of obligations, regulations, guidelines, conditions and, yes, even bans. For international land transport, hazardous substances have to be carried out under the regulations stipulated by the ADR Convention (“L’Accord Européen Relatif au Transport International des Merchandises Dangereuses par Route”). Air cargo is subjected to the rules imposed by IATA, the “International Air Transport Association”. Similarly, sea transport is regulated based on the IMDG, “International Maritime Dangerous Goods Code”.

The ADR, IATA, and IMDG regulations encompass rules on the necessary training of involved personnel and the forwarding company’s liability for the transported dangerous or hazardous goods, but also classifications of dangerous goods in accordance with UN recommendations, packaging rules, labeling specifications, documentation rules, and a whole slew more. Then there are, at least as far as Chemnovatic is concerned, the regulations imposed by the European Chemicals Agency (ECHA).

“Once a year, we must report on the amount of nicotine exported to countries outside of the EU, including the destination countries, customer names, and other data,” details Chemnovatic’s co-owner and c.o.o., Bartlomiej Gęca. “And before we can legally export nicotine and nicotine products classified as hazardous materials in compliance with CLP), we must apply to ECHA for a RIN number, which must be done 35 days before the planned shipment date.”

But, there are countries that do not have signed contracts with ECHA, in which case legal exportation is impossible. “Furthermore, before sending the nicotine abroad, we need to know exactly what type is legal in a given country and what uses of it are permissible if we want to avoid unnecessary problems,” Geca says. “In such cases, it’s imperative to constantly maintain contact with the customer to quickly react and respond to any difficulties when the customs office questions the shipment.”

Another issue is specialized taxes that some countries have started to apply on nicotine products. “We also need to consider that fact to not be caught off guard during customs clearance.”