The FDA’s flawed PMTA process on vaping products does not help consumers

On March 24, the Food and Drug Administration ha annunciato its authorization for several tobacco-flavored e-cigarettes and heat-not-burn devices made by Logic to be sold in the US market. In their announcement, the agency stated that e-cigarettes are “appropriate for the protection of the public health,” and their benefits outweigh the risks of youth smoking.

Logic is one of the few companies that produced alternative tobacco products that have received FDA premarket approval. Another e-cigarette authorization was granted in October 2021 to Vuse Solo vaping device and its tobacco-flavoured e-liquid pods.

While the agency’s decision to allow vaping is good news for vapers, the FDA has thus far dropped the ball on the thousands of vape products and liquids provided by small companies. This is creating a limited market that will restrict choices for consumers, consequently creating more barriers for smokers to switch to less harmful alternatives.

While the FDA acknowledges the need for enhanced harm reduction efforts and the benefits of vaping products, it is intentionally creating more harm than good by showing bias towards certain e-cigarettes products and limiting access to the market for other companies. Last year, the FDA denied 55,000 flavoured e-cigarette products’ marketing applications for failing to provide evidence that they appropriately protect public health.

Most people who switch from cigarettes to e-cigarettes switch to non-tobacco flavoured products. Flavours such as strawberry, menthol, melon, honey, etc., are popular among ex-smokers. Many prefer other flavours to tobacco because tobacco reminds them of the cigarette taste, which could potentially push many people back to smoking, rejecting all harm-reduction efforts. A recent study done by World Vapers’ Alliance and the consumer advocacy group, Consumer Choice Center, found that if the US were to put in place vape flavour bans, over 7.7 million vapers would go back to smoking.

For decades, the United States has been a leader in global innovation, revolutionizing solutions in technology, health care, and harm reduction. Yet, with the current trends in PMTA approvals, the FDA is creating barriers for many consumers to quit smoking and change their lives for the better.

To protect public health, the FDA needs to grant access to many more companies, allowing them to enter the vaping market with their products and flavours, in order to create more choices and opportunities for smokers to quit and embrace a healthier lifestyle.


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Lo svapo può salvare 200 milioni di vite e gli aromi svolgono un ruolo chiave nell'aiutare i fumatori a smettere. Tuttavia, i responsabili politici vogliono limitare o vietare i gusti, mettendo a rischio il nostro sforzo per porre fine alle morti legate al fumo.

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