FDA and Failure to Reduce Harm

If there are two things the bureaucracy does well, they are overreaching and just plain not getting the job done. Such is the case with the Federal Food and Drug Administration. 

Tomorrow, 11 April 2024, at 1 PM in 2154 Rayburn, the FDA will appear before the House Oversight and Accountability Committee. Hopefully, appropriate pressure will be applied to bring about a few changes in the bureaucracy.

It is well documented that smoking combustible tobacco products is pretty bad for your health and will increase your likelihood of early death. Smoking is the number one cause of preventable disease and death worldwide. One step to lessen that impact is a move toward harm reduction.  

Harm Reduction is an approach that can be used for everything from tobacco use and opioid abuse to preventing the spread of sexually transmitted and blood-borne diseases like HIV or hepatitis. Are you using intravenous drugs? Try switching to another consumption method to reduce the likelihood of contracting hepatitis or HIV. Are you working on quitting cigarettes? Try a nicotine lozenge or a vape pen. In both scenarios, risky behavior is still being engaged in, but some of the externalities, or harms, are being reduced. 

Here’s where the FDA comes in. The Family Smoking Prevention and Tobacco Control Act of 2009 created the FDA Center for Tobacco Products and charged them with tobacco harm reduction. Fantastic. In order for those products to get to market, the FDA must approve them. Except the FDA isn’t reviewing and authorizing new products. Since 2009, more than 26 million premarket tobacco product applications (PMTAs) have been submitted for FDA review. How many have been approved? Fewer than 50. There is a separate path for tobacco products designated as a modified risk tobacco product (MRTP). You know, harm reduction. The number of approvals here is just as poor; there are only four, with a few accessories approved for each. 

So, by law, what should take 180 days or less is taking more than three years on average to allow smokers to make less harmful choices. The FDA needs to review these applications within 180 days, as required by law, and enable consumers to have less harmful options to engage in less risky behavior and reduce the number of preventable deaths. Otherwise, consumers may continue to smoke cigarettes, as it is notoriously difficult to quit, or engage in using other risky products that the FDA has not approved.  

At this point it is easier for someone with opioid use disorder to engage in harm reduction than a tobacco smoker. Why can’t it be easy for both so we can all get a little bit healthier and reduce some unnecessary harm?