The Food and Drug Administration recently rejected two menthol e-cigarette products. Meaning well, the agency has set a goal “to make tobacco-related disease and death part of America’s past, not America’s future.” The hope is that by doing so, they will “ensure a healthier life for every family.”
To that end, it also proposes eliminating menthol in cigarettes and flavor in cigars and e-cigarettes.
Even if the FDA is successful, it will unlikely reduce real-world risk. There are too many other, more dangerous, places for people to turn to for their fixes.
This all started in 1996 when FDA Commissioner David Kessler proposed that his agency regulate tobacco products. In 2009, the FDA was given that authority, creating the Center for Tobacco Products. Among other requirements, it is required to regulate different classes of products, including cigarettes, cigars, hookahs and e-cigarettes, “based on a public health standard that considers the risks and benefits of the tobacco product on the population as a whole.”
Regulating entire classes of products differs from the FDA process with food additives, whose safety must be ascertained based on the individual product. The task is to answer this relative risk question: Will eliminating (or not approving) a tobacco product create more risk to the population relative to an alternative product? That requires estimating the actual dangers of both new and existing products.
This, in turn, requires knowing how potent (risk per usage) the product is and how often it is consumed. It is essential to compare exposure risks — someone who smokes a pack of cigarettes daily to, for example, a youth who “had smoked a cigar on at least one day during the past 30 days.”
E-cigarettes don’t make the easiest comparisons. They were invented to reduce risk by creating a more effective smoking-cessation tool — something safer for smokers than cigarettes — but now they have come under attack as they may also be addictive and attract new, young smokers. Even if they are less risky than cigarettes, risk analysts must determine how many existing cigarette smokers will turn to e-cigarettes compared to attracting new smokers who would not have started with cigarettes. There is a lot of uncertainty in any such calculations, but navigating this type of uncertainty is part of what risk assessors are good at doing.
The attraction for any tobacco product is nicotine, a mild stimulant. Although nowhere near the high produced by other drugs, nicotine stimulates the release of dopamine that provides pleasure — hence the addictive quality. Accompanying nicotine in cigarettes and other tobacco products are contaminants such as tar, arsenic and carbon monoxide that present most risk.
The problem is, in blocking somewhat safer products from the market to achieve zero risk, the FDA may cause consumers — young people in particular — to turn to other, potentially higher-risk products. Even if tobacco products were to be eliminated, the desire to achieve euphoric states would not disappear.
This desire, whether it involves tobacco, cannabis, wine, mushrooms or any number of other things, goes back many thousands of years. They have been used for religious ceremonies, medicine and just for getting high. Routine use of peyote dates back 5,700 years. The regular use of alcohol goes back much further, to 7,000 BC. Today, young people routinely experiment with products to get high, like drinking cough syrups with a hallucinogen called DXM (e.g., Robitussin) or “huffing” air fresheners that can cause cardiac arrest. The use of marijuana among young adults, which many see as safe but may cause mental health issues, has significantly increased (26 percent in five years).
The FDA should seek to reduce, as much as possible, the use of the most dangerous tobacco products, particularly cigarettes. Beyond that, it should acknowledge that young and old consumers will continue to seek euphoric states, as they have for millenniums. Beginning with this proposition, they must carefully weigh the risks of keeping new products off the market or banning classes of products that satisfy consumer urges with lower health risks than other products. Otherwise, it may not only fail to ensure healthier lives but also inadvertently make people less safe.
Congress gave the FDA, a public health authority with expertise in risk analysis, the authority to regulate tobacco products. FDA should exercise that expertise wisely.
