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FDA asks if tobacco standard will impact illicit trade

The US FDA is working on a tobacco product standard in a bid to curb smoking-related diseases, but is asking for feedback on how such a standard could affect the illicit trade in tobacco products.

According to FDA Commissioner Scott Gottlieb tackling tobacco use – and cigarette smoking in particular – is a priority for the agency as it tries to advance public health, but it wants to be certain that any measures it takes do not inadvertently have an impact to swell the illicit market, which would likely be a primary source of nonconforming tobacco products.

The overarching objective is to develop a product standard that would lower nicotine in cigarettes to “minimally or non-addictive levels” and encourage smokers to quit, Gottlieb said last week. All told, the FDA would like to see the smoking rate reduce from around 15 per cent of the US population at the moment to 1.4 per cent, which it says would lead to more than eight million fewer tobacco-caused deaths through the end of the century.

In tandem with the new policy the agency has published a draft concept paper which discusses potential illicit trade implications of product standards more generally, and tries to assess “the possible health effects of a tobacco product standard in the form of demand for contraband or nonconforming tobacco products.”

In a nutshell, the regulator is concerned that by enforcing standards that could change the design and manufacturing of tobacco products, consumers may decide that the resulting legitimate products lack appeal – and so turn to illicit sources that don’t conform to the standard and could be much more harmful to health.

The document provides a comprehensive rundown of the regulator’s assessment of the illicit trade in tobacco – including sources, distribution, marketing and purchasing behaviour – and notes that most buyer pay little attention to the illegality of the transaction. Far more important, it suggests, is the price, taste of the product, erratic supply and uncertainty about what illicit products may contain.

The document also envisages scenarios where illicit trade could be both boosted or reduced as a result of its proposals. For instance, it notes manufacturing costs for illicit tobacco could rise, making large-scale production harder and easier to detect by enforcement agencies.


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