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Democrats Should Join the Call for FDA to Accelerate Approval of Smokefree Products 

By Martin Cullip

In a welcome and overdue development, it has been reported that a group of nearly 70 House Representatives has written to the Biden Administration urging for the approval process for smokefree products to be accelerated by the U.S. Food and Drug Administration (FDA).

This is positive news for the public health of Americans. It is also disappointing that none of the signatories are Democrats.

The House Republicans, led by Rep. Richard Hudson (R-NC), correctly identify that “[t]his is a matter of public health. According to an ever-increasing amount of scientific research, smoke-free products hold enormous potential for current smokers to quit by switching to these less harmful products.”

The FDA has been in a logjam when it comes to authorizing products other than combustible tobacco. Vaping devices, nicotine pouches (such as the much-discussed brand Zyn), and tobacco that is heated not burned to significantly reduce risk face inordinately long delays before the administration will allow their sale. This is in contrast with traditional combustible tobacco products, which are waved through without delay because of the FDA’s “Substantial Equivalence” rule.

It may come as a surprise to the American public that it is far easier for new types of combustible cigarettes, which are known to be responsible for around 480,000 deaths in the U.S. every year, to be brought to market than reduced-risk nicotine products which are far less harmful and present the potential to make smoking obsolete and save millions of lives.

This expedited process for combustible cigarettes happens because the FDA treats authorization of nicotine products on whether they were on the market by February 15, 2007. Deadly cigarettes were on the market before 2007, while all but the most primitive vaping devices were not. Therefore, the FDA judges all new cigarettes to be known technology (if you can call dried leaves in a paper tube, technology) and they get a pass, while innovative and potentially life-saving products have to apply for Premarket Tobacco Product authorization.

As a result, the FDA has authorized 212 combustible tobacco products to be sold in the U.S. since August 2020.  This happened while only allowing just 23 e-cigarettes – from over 6 million applications – and a handful of smokefree tobacco products. Thousands of other applications are bottled up in the system, along with nicotine pouches like Zyn, with no date given as to when they can begin tempting people away from smoking.

Signatories to the House Republicans’ letter are correct that this is an unacceptable state of affairs and that something must be done about it. By contrast, Democrat Representatives repeatedly demand that these safer products be kept off of shelves, thereby protecting the sales of combustible cigarettes and prolonging smoking-related disease and death.

It is extraordinary that Democrats do not see the threat of this approach to the nation’s public health, especially for those in lower-income neighborhoods and amongst deprived communities where smoking is most predominant. Even more so when one considers that they are the party of Biden’s Cancer Moonshot aspiration.

In state hearings, legislation is presented by Democrats almost daily, attempting to apply bans, restrictions, taxes, and other imaginative burdens to products that have been proven to dramatically reduce smoking rates in jurisdictions where they are liberally regulated. 

They are mostly borne out of misinformation peddled by ideological nicotine prohibitionists, which can only lead to harm in those populations. 

The House Republicans’ letter recognizes this and rightly observes that “[w]e cannot allow scare tactics and misinformation to keep 30 million adult smokers in the U.S. from making informed decisions and providing them with information about and access to alternative products that present less risk than continued smoking.”

It is time that Democrats woke up and smelled the coffee on this subject. Instead of cheering on delays and obfuscation by the FDA, Democrats should be actively engaging with Biden and encouraging him to act in the interests of public health. Making smoke-free products more available to people who currently smoke can only turbocharge their party’s efforts to reduce cancer incidence rates.

This should not be a partizan political matter. House Republicans have made a correct call with their letter, there is no shame in Democrats echoing that message of embracing tobacco harm reduction.

Martin Cullip is an International Fellow at the Taxpayers Protection Alliance‘s Consumer Center.

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