Traces of nitrosamines and high levels of nicotine in the pouches

An independent German study of 46 references of "pouches" (nicotine pouches) found high levels of nicotine, pH values that promote its passage into the blood and traces of nitrosamines specific to tobacco. These results diverge from those of the manufacturers and call for better regulation of these products.

Despite their strong resemblance, in their shape and mode of use, with snus (tobacco pouches to be inserted between the gum and the lip), the pouches do not contain tobacco, but only nicotine, in the form of free-base (nicotine extracted from tobacco and purified), which impregnates plant fibers. The nicotine contained in these pouches is absorbed by the oral mucosa.

While snus is banned in the European Union outside Sweden, pouches benefit from a legal grey area due to the absence of tobacco.[1], allowing them to be sold as food products. The nicotine content of these pouches is only imperfectly indicated on many marketed references. Therefore, the German Federal Ministry of Food and Agriculture has commissioned an analysis of their potential health risks.

High nicotine levels

The German Federal Institute for Risk Assessment analyzed 46 pouches marketed by twenty different producers and purchased online from European and non-European sites.[2]. Nicotine contents were estimated in mg/pouch and mg/g of pouch. Detection of tobacco-specific nitrosamines and measurement of pH were carried out since nitrosamines are carcinogenic and a high pH promotes the absorption of nicotine through the oral mucosa.

The two references claiming to be nicotine-free did not actually contain any. Of the 44 other references, 38 used a simple description or even an arbitrary rating scale (from 1 to 4, without mention of rate) to indicate the nicotine content of the products. In 28 cases, or more than half of the sample, only a descriptive mention indicated this content, under terms ranging from "easy" and "medium", to "strong", "extra strong", "power", "ultra" or "brutal".

Nicotine levels ranged from 1.79 mg to 47.5 mg/pouch, with a median level of 9.48 mg/pouch. The maximum level announced by one manufacturer was 11.9 mg/pouch. These levels are significantly higher than those observed in the United States in a previous study, with a maximum of 6.73 mg/pouch. The measured values are worrying, as nicotine ingestion can be toxic and its absorption has negative effects on the cardiovascular system. While all products were marked not to sell to minors under 18, only ten included a warning regarding pregnant women, for whom these types of products are strongly discouraged.

High pH and presence of nitrosamines

The measured pH values ranged from 5.5 to 10.5, with a median value of 8.8. Since the pKa of nicotine is 8.01, its absorption through the oral mucosa is greatly facilitated by these pH values, especially since the median proportion of free-base nicotine of 86% (values ranging from 60 % to 100 %) further facilitates this absorption. Overall, these pouches are designed to exert a strong addictive potential.

The presence of tobacco-specific nitrosamines, some of which are carcinogenic (NNN, NNK), was observed in trace amounts in 26 of the products tested and quantifiable in 17 of them, suggesting an incomplete purification process of free-base nicotine. For their part, studies funded by manufacturers have never yet mentioned the presence of nitrosamines, their analysis methods being less detailed.

A necessary regulatory response

European regulations are currently struggling to regulate pouches. The European Food Safety Authority sets the maximum threshold for daily ingestible nicotine at 0.0008 mg/kg of body weight, or 0.048 mg for a 60 kg person. The lowest nicotine levels for the pouches analyzed are 1.79 mg, or 22 times higher than the maximum threshold for a 60 kg person, which means that the pouches cannot be marketed as food products.

The authors of the study advocate: (1) limiting nicotine content, (2) requiring the quantity of nicotine in each pouch to be clearly indicated, (3) using nicotine purification to avoid the presence, even very low, of nitrosamines, (4) requiring a health warning for pregnant women, and (5) ensuring effective control of the legal age of purchase. At the same time, the addition of a wide variety of flavors, the use of attractive packaging, and the promotion of these products on social networks should be regulated in order to reduce their attractiveness to young people. Finally, clinical studies should determine the addictive potential of these products and validate whether they can be considered valid alternatives to smoking.

Keywords: nicotine pouches, nicotine free-base, nitrosamines, pH

©Generation Without Tobacco

MF