The incoming Trump administration made many promises during the campaign. That includes a commitment to revitalize U.S. business to “save e-cigarettes.”
By eliminating the Premarket Tobacco Product Application (PMTA) process for e-cigarettes, we can kill two birds with one stone. In doing so, he will confirm that free enterprise and individual liberty are the foundations of prosperity.
Currently, the FDA requires e-cigarette manufacturers to submit a PMTA before receiving approval to sell their products in the United States, and the cost of this process ranges from $28,566 to $2,595,224.
Manufacturers are also required to submit studies evaluating the risks and benefits of their devices, resulting in astronomical product failure rates. The FDA has approved only 34 types of e-cigarettes for sale. These requirements create significant barriers to entry for e-cigarette products and only make it more difficult for smokers to quit.
If the Trump administration is serious about America’s health and business, it should try to cut through red tape. Providing more alternatives to smoking will help more Americans kick the habit. Furthermore, domestic innovation will also be encouraged.
Smoking is now the “leading cause of preventable death” in the United States, with approximately 480,000 people smoking annually and accounting for “1 in 5 deaths annually.” Smoking is associated with a variety of diseases, including cancer, heart disease, COPD, diabetes, and even macular degeneration.
Vaping is not without risks. However, the risks are significantly lower than smoking. According to Public Health England, e-cigarettes are 95% less harmful than combustible cigarettes. E-cigarettes expose vapors to small amounts of toxic chemicals at levels up to “450 times lower” than cigarette smoke. Smokers who switch to e-cigarettes reduce cardiovascular risk by reducing artery narrowing.
E-cigs can save lives. Earlier this year, the New England Journal of Medicine put 1,246 participants into an intervention group that offered free e-cigarettes and smoking cessation counseling, and a control group that offered counseling and a voucher for a nicotine replacement product. published a Swiss study with random assignment.
The study found that 28.9% of participants given e-cigarettes consistently quit smoking for six months, compared to 16.3% of the control group.
Another study published by the Cochrane Review found that nearly twice as many smokers were able to quit using e-cigarettes compared to traditional nicotine replacement therapy.
The FDA’s rigorous approval process puts Americans’ health at risk by restricting market access to less harmful products and makes it harder for smokers to quit.
The PMTA’s process has been particularly hostile to flavored devices, with only four menthol-flavored e-cigarettes approved for sale this summer.
Flavored e-cigarettes are the most effective tool to help smokers quit smoking. Fruit flavored vapes are the most popular flavor among ex-smokers. why? This is because non-tobacco flavored e-cigs break the link between tobacco and nicotine. In one study, only 15% of ex-smokers found tobacco-flavored e-cigs to be effective in quitting smoking. Tobacco flavors can entice ex-smokers to indulge in real cigarettes.
So menthol vaping is actually a slap in the face for most menthol smokers considering quitting. Their only legal alternative is to immediately enjoy the taste of their favorite tobacco.
No wonder vapers turn to illegal Chinese e-cigarettes to get rid of their peach-mango mood.
Now, costly regulations have consolidated the once-luxury e-cigarette industry, leaving only Big Tobacco on the table. Eliminating the PMTA process will lead to an explosion of innovation in the US e-cigarette market.
PMTA is a barrier among smokers and the most effective smoking cessation method. The Trump administration can improve public health and foster domestic business by eliminating the FDA’s overbearing oversight of e-cigarettes. Sweden is beating the US in the race to eradicate smoking. That’s because the Swedish government has been much more positive about snus, the number one smoking cessation method.
If we want a healthier America, the first step is to embrace e-cigarettes as a harm reduction measure and repeal the PMTA.
Peter Clark is a Young Voices contributor and a World Vapers’ Alliance Fellow. Follow him on X at blog_logic.
