Rome News-Tribune

The FDA’s drift toward harm production

- Marc Hyden is the director of state government affairs for the R Street Institute and a weekly columnist for the Newnan Times-Herald.

The Food and Drug Administra­tion made headlines recently as the hulking federal agency banned the company JUUL from selling its ecigarette­s in the United States even though they have long been on the market.

The FDA justified its decision, according to the Wall Street Journal, because the agency “wasn’t aware of a hazard associated with using JUUL devices but that the company hadn’t submitted sufficient evidence that its devices were safe.”

The e-cigarette maker vehemently disagrees, and even obtained a temporary stay from the US Court of Appeals for the District of Columbia — permitting their products to remain on store shelves for the time being.

Neverthele­ss, while some have heralded the FDA’s ruling as a step in the right direction, it is cause for concern for those who are dedicated to reducing the harm caused by combustibl­e cigarettes, which greatly impact the Peach State.

As it stands, some 16% of Georgians smoke cigarettes, nearly 12,000 die a year due to smoking and the related healthcare services cost billions of dollars annually. Put simply, smoking takes a heavy toll on Georgia and the hazards are well-known. Despite this, for many years, people continued smoking combustibl­e cigarettes, in part, because abstinence-only approaches have failed and many of the traditiona­l quit tools have proven largely inadequate.

Meanwhile, e-cigarettes have shown great promise in reducing the dangers posed by combustibl­es.

They provide smokers a nicotine alternativ­e that mimics smoking but with a reduced harm profile. After all, e-cigarettes don’t rely on the same combustion process of cigarettes, which releases around 7,000 chemicals — more than 70 of which are carcinogen­ic.

As a result of this and that e-cigarettes don’t contain tobacco — but rather vape juice — Public Health England announced that they are 95% less dangerous than combustibl­es. What’s more, they have become a leading tool smokers use to kick the habit, and a 2021 study found that e-cigarettes appear to be a more effective cessation tool than therapies, like the nicotine patch, gum, or lozenges.

Considerin­g the benefits of e-cigarettes compared to combustibl­es, you’d think the federal government would want these harm reduction tools to be readily accessible to adult smokers, but that may not be the case.

The FDA’s attempted ban on JUUL would have affected around one third of the market — severely limiting adults’ options — but this is far from the feds’ first foray into the e-cigarette world.

In early 2020, the FDA banned the “manufactur­e, distributi­on and sale” of many e-cigarette flavors. The agency handed down this decision in an attempt to dissuade children from trying c-cigarettes, which is a noble goal. Minors should absolutely not use any nicotine products whatsoever, and the feds have taken strides to prevent them from doing so, including raising the age to purchase tobacco products to 21 years old.

While it isn’t clear how much — if any — of the federal government’s ban on many flavors impacted illegal youth usage, the prohibitio­n promises to adversely impact the health of current smokers.

Research has shown that adult smokers greatly prefer non-tobacco flavors and enjoy a broad array of tastes. In fact, these flavors have likely contribute­d to smokers making the switch to less harmful e-cigarettes, but with many of them now banned, it stands to reason that fewer adults will give e-cigarettes a try — further damaging public health.

Meanwhile, the FDA is telegraphi­ng other confusing signals.

As it wages an offensive on e-cigarettes, it authorized the marketing of low-nicotine combustibl­e cigarettes as a modified risk tobacco product. While these have far less nicotine and are therefore less addictive, they still rely on the same combustion process responsibl­e for releasing dangerous carcinogen­s. The fact that the FDA would seemingly endorse low-nicotine combustibl­es for current smokers but curtail access to less harmful e-cigarettes sends a confusing message to say the least.

While it is too early to tell if the FDA’s actions on ecigarette­s are harbingers of things to come, history suggests that the agency may work to further limit access to e-cigarettes as a cessation product, which is an action that some states have already considered. The proposals have ranged from taxing the products into oblivion or simply banning them outright. If the FDA pursued a similar path, it would be a curious step for an organizati­on dedicated to “protecting the public health” of Americans.

Yet rather than ensuring the availabili­ty of harm reduction products, like e-cigarettes, the agency is attempting to restrict the market. This only ensures that more smokers will remain addicted to deadly products that the FDA hasn’t attempted to ban.

While it may be years before JUUL’s lawsuit against the FDA is resolved, the FDA should adopt a better strategy for combatting cigarette usage, instead of drifting toward a strategy of harm production.

 ?? ?? Marc Hyden
Marc Hyden

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