FDA’s proposed cap on nicotine in tobacco products to avert thousands of deaths

A proposed rule to reduce the amount of nicotine in cigarettes and other combusted tobacco products to non-addictive levels is being finalised by the Food and Drug Administration (FDA) after seven years of waiting.

If implemented and adopted by Kenya, the move will not only see about 12,000 annual tobacco-related deaths averted but also make it harder for future generations to become addicted in the first place. It will also allow addicted smokers to quit or switch to potentially less harmful products.

The rule will also reduce the risk of lung cancer and other tobacco-related diseases as well as the burden of disability and severe illness.

If implemented, the rule will cap the nicotine level at 0.7 milligrammes per gramme of tobacco in cigarettes and certain other combusted tobacco products, which is significantly lower than the average concentration of these products on the market today.  According to the Pharmacy Times, the current average concentration of nicotine per cigarette is around 10mg to 12mg, but a smoker usually absorbs only one mg to two mg of that nicotine when inhaled, meaning not all the nicotine in a cigarette is actually taken into the body by the smoker.

“Nicotine is the primary addictive chemical in tobacco products, which is the main reason people continue to use them despite the known health risks. In the case of combusted products such as cigarettes, nicotine addiction leads to users being repeatedly exposed to a toxic mix of chemicals in the smoke that causes disease and death,” states the FDA.

It adds: “Based on the scientific evidence outlined in the proposed rule, the proposed nicotine level for cigarettes and certain other combustible tobacco products would be low enough to no longer create or sustain addiction. Importantly, a large body of research also shows reduced nicotine content cigarettes do not lead smokers to compensate for lower nicotine by smoking more.”

The proposal will apply to cigarettes, cigarette tobacco, roll-your-own tobacco, most cigars (including little cigars, cigarillos, and largest cigars), and pipe tobacco. It will, however, not apply to e-cigarettes, nicotine pouches, non-combusted cigarettes (such as heated tobacco products that meet the definition of a cigarette), water pipe tobacco (hookah), smokeless tobacco products, or premium cigars.

FDA’s population health model projects that more than 12.9 million people who smoke cigarettes would stop doing so one year after the rule becomes effective, including those who would completely switch to noncombusted tobacco products. 

 “Today’s proposal envisions a future where it would be less likely for young people to use cigarettes and more individuals who currently smoke could quit or switch to less harmful products. This action, if finalised, could save many lives and dramatically reduce the burden of severe illness and disability, while also saving huge amounts of money,” said FDA Commissioner Robert M Califf.

FDA notes that no tobacco product is safe. However, the health risks for different tobacco products exist on a spectrum, which is sometimes referred to as a “continuum of risk.” “Combusted, or smoked tobacco products—such as cigarettes—are the most harmful type of tobacco products. Non-combusted products—such as e-cigarettes and other smokeless tobacco products—generally have lower health risks than cigarettes and other combustible tobacco products,” states the FDA.

It adds: “While e-cigarettes can generally be a lower-risk alternative for adults who smoke cigarettes, the use of these prodcuts is not risk-free. The products deliver harmful chemicals and contain nicotine, which is highly addictive. Moreover, given the harmful chemicals found in e-cigarettes, further high-quality research on both short- and long-term health outcomes is needed. Given that there is no safe tobacco product, youth and adults who do not use tobacco products should not start using e-cigarettes.”

The FDA first announced its intent to propose such a rule in 2018 in a bid to tackle tobacco use and cigarette smoking in order to advance public health. Then, the agency sought to determine the potential maximum nicotine level that would be appropriate for the protection of public health, whether a product standard be implemented all at once or gradually, and whether unintended consequences, such as the potential for illicit trade or for addicted smokers to compensate for lower nicotine by smoking more, would occur.

As of now, the agency is seeking public comment and input from its Tobacco Products Scientific Advisory Committee, which reviews and evaluates safety, dependence, and health issues relating to tobacco products.

mchelangat@ke.nationmedia.com