How tobacco companies use chemistry to avoid menthol ban

In 2020, lawmakers in California and Massachusetts banned menthol, a chemical that causes a cooling sensation, as an additive in cigarettes. The idea was, in part, to reduce youth smoking; menthol makes cigarettes tastier, creating a “cooling” sensation. Regulators have deemed the chemical unsafe for its role in promoting nicotine addiction.

Soon after, I learned in detail how the tobacco industry circumvented these laws by replacing menthol with other cooling chemicals in their new “nonmenthol” cigarettes and other tobacco products. This is the oldest trick in the book when dealing with chemicals considered dangerous or problematic: stop using the original molecule and find or make a substitute with the same function but for which there is little or no safety data. This allows the company to continue producing chemicals of concern while agencies such as the Food and Drug Administration or the Environmental Protection Agency scramble to reach these new alternatives.

So while these new products may be legal, the initial concerns remain. In this case, RJ Reynolds simply replaced the menthol with a synthetic, odorless cooling agent known as WS-3, which has the same cooling effect that the menthol bans were meant to address. In fact, WS-3 has a very similar basic molecular structure to menthol, with some modifications. However, the cooling sensations caused by both menthol and WS-3 reduce the harshness of cigarette smoke, thus maintaining the appeal of cigarettes.

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That the tobacco industry can do this so easily speaks to a fatal flaw in the way we regulate chemicals in this country — not by what the concern or desired effect of a compound is, or what we know about related compounds, but the end chemical product with chemical product. according to the final product. However, no one wants to eliminate just an individual chemical; we want to eliminate the underlying concerns that triggered regulations in the first place. That is, in the case of these cigarettes, stopping the “cooling” effect that makes smoking more enjoyable regardless of the actual molecule that provides the sensation. The status quo means that regulators are constantly chasing small tweaks and clever substitutions instead of regulating the classes or, better, the properties that make molecules of concern.

This mole game occurs in all types of products, not just cigarettes: we ban an individual chemical that is replaced by another that is not on a restricted substance list. We’ve seen the same story play out for bisphenol A, a precursor to plastics and an endocrine disruptor that interferes with the body’s normal hormone production and function. As bisphenol A (BPA) became more and more regulated by countries around the world, it was replaced by bisphenol S (BPS), which contains only a slight change in the molecular structure of BPA. Although BPS has helped achieve the goal of removing BPA from commercial products, products containing BPS also cause the same endocrine problems. By banning BPA, we have eliminated the chemical, but not the concern.

So why was this obvious flaw allowed to continue? First, it is not recognized as a defect. Perhaps this is best explained by: “Chemicals have rights too” in the US. There is a prevailing view that when we move to regulate a chemical we are putting that compound “on trial” where the evidence must generally meet a certain standard of peer review and the process must include review and comment public. Unfortunately, the US chemistry regulatory system moves more slowly than even our judicial system. For example, it has taken many years for regulatory action to be taken on known problem substances – such as dichloromethane, chloroform and trichlorethylene – where the science supporting the danger is well established. But the pace of statutory science review and regulatory costs is unfortunately not the biggest impediment.

The biggest problem is that we focus on the chemical and not the concerns (eg toxicity, addictive nature, etc.). What this means? It means that a chemical’s ability to cause harm is based on the combination of its inherent physical and chemical properties. Its ability to make someone sick or change our atmosphere isn’t based on what we humans call—and yet so regulate—one discrete chemical at a time.

Slow. Laborious. Expensive. Inefficient.

It doesn’t have to be this way.

Changing this regulatory framework can benefit the chemical industry by stimulating sustainable innovation while being more effective in protecting public health and the environment. Using our understanding of how physical and chemical properties relate to different concerns gives us a new way to protect human health—by regulating the concern, not the chemical. We can define groups of chemicals, based on similar physical and chemical properties, which are safe and which are of concern. This approach relies on intrinsic molecular properties that cause both hazard and function, rather than individual chemical structure. Regulatory authorities can use this insight when a new chemical is proposed for commercial use. Innovative companies can benefit from inventing new substances based on this knowledge to design molecules that are more likely to be safe. This approach also creates greater regulatory certainty, reducing a company’s risk of bringing a chemical to market or introducing a chemical into their product that could eventually be banned.

For cigarette coolants, this would mean banning any chemical, regardless of structure, that activates the menthol receptor, called TRPM8. This receptor is located on the sensory neurons that allow us to sense cold temperature and is also activated by cooling agents such as WS-3 found in the new “nonmenthol” cigarettes. Menthol cigarettes have already been banned in Canada, the European Union and other countries, with some countries such as Germany and Belgium banning various TRPM8 activators. Interestingly, the Belgian approach specifically restricts any additives to tobacco products that “facilitate the inhalation or intake of nicotine”, including “all components and mixtures with cooling and/or analgesic effects”. This is essentially a property-based approach.

A property-based approach can be used to help define a safer chemical space – and to give regulatory confidence – as well as to delineate the hazardous chemical space, where chemicals with certain properties known to be associated with hazards would be subject to more careful control. Fortunately, leading companies in many industrial sectors – from cosmetics to electronics – are starting to think and design this way.

If we want to have a chemical world that is truly safe and sustainable by design, we should match our regulatory framework to our intentions. That is, rather than banning individual molecules causing us to pursue each new molecule of concern for decades with a new regulation, we should aim to ban the intrinsic concern defined by a set of defined physicochemical properties. This would lead to chemicals that are safe for humans and the planet based on their intrinsic and safe properties.

Fast. Agile. Efficient. Effective.

In this way, the goal of protecting vulnerable people from the additives that make cigarettes more appealing and enjoyable would have been achieved, rather than seeing these hopes in smoke.

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