To Make America Healthy Again Trump should get rid of PMTAs

The incoming Trump administration made many promises on the Campaign trail. Among these are assurances that he would revitalize U.S. business, to “save vaping.”

He can kill two birds with one stone by eliminating the Premarket Tobacco Product Application (PMTA) process for e-cigarettes. In so doing, he would affirm free enterprise and individual liberty as the foundation of prosperity.

Currently, the FDA mandates vape producers to submit PMTAs before having approval to sell their products in the U.S., a process that ranges in cost from $28,566–$2,595,224

Makers must also submit studies assessing the risks and benefits of their devices, resulting in an astronomical product rejection rate. The FDA has only approved 34 e-cigarettes for sale. These requirements pose significant barriers to entry for vaping products and only make it harder for smokers to quit.

If the Trump administration is serious about American health and business, it should be looking to cut the red tape. Encouraging more alternatives to smoking will help more Americans quit the habit. In addition, it will encourage domestic innovation.

Today, smoking is “the leading cause of preventable death” in the United States, causing approximately 480,000 per year and accounting for“one in five deaths annually.” Cigarette smoking is associated with illnesses ranging from cancer, heart disease, COPD, diabetes, and evenmacular degeneration.

Vaping is not risk-free; however, it presents significantly lower risks than smoking. Per Public Health England, e-cigarettes are 95% less harmful than combustible cigarettes. E-cigarettes expose vapers to smaller amounts of toxic chemicals, at levels up to “450 times lower” than tobacco smoke. Smokers who switch to vaping reduce cardiovascular risks by lessening the narrowing of their arteries.

E-cigarettes can save lives. Earlier this year, the New England Journal of Medicine published a Swiss study that randomly assigned 1246 participants to an intervention group that provided free e-cigarettes and tobacco cessation counseling and a control group that was supplied with counseling and vouchers for nicotine replacement products.

The study found that 28.9% of the participants given e-cigarettes continuously abstained from smoking for six months versus 16.3% in the control group.

Another study published by Cochrane Review found nearly double the number of smokers were able to quit with vapes than traditional nicotine replacement therapy.

The FDA’s stringent approval process jeopardizes the health of Americans by limiting market access to less harmful products, making it harder for smokers to quit.

The PMTA process has been especially hostile towards flavored devices, approving just four menthol-flavored e-cigarettes for sale this summer.

Flavored e-cigarettes are the most effective tool in helping smokers quit. Fruit-flavored vapes are the most popular flavors among former smokers. Why? Because non-tobacco flavored e-cigarettes break the association between tobacco and nicotine. One survey revealed that only15% of former smokers found tobacco-flavored e-cigarettes effective in quitting smoking. The tobacco flavor serves as a trigger enticing a former smoker to indulge in the real thing.

So menthol vapes are actually a slap in the face to most menthol smokers looking to quit. Their only legal alternatives are a hair away from tasting like their preferred cigarette.

It’s no wonder vapers are turning to illegal Chinese e-cigarettes for their peach-mango fix.

Currently, a plethora of costly regulations has led the once boutique vaping industry to consolidate, leaving only big tobacco at the table. Eliminating the PMTA process would lead to an explosion in U.S. innovation in the vaping market.

PMTAs are an obstacle between smokers and the most effective cessation method. The Trump administration can improve public health and foster domestic business by eliminating the FDA’s overbearing oversight of vapes. Sweden is beating the U.S. in the race to snuff out smoking. That’s because the Swedish government has been much more friendly to their number one smoking cessation method, snus.

If we want a healthier America, the first step forward is to embrace vaping as a harm reduction measure and get rid of the PMTAs.

Peter Clark is a Young Voices Contributor and World Vapers’ Alliance Fellow. Follow him on X at blog_logic.