The U.S. FDA authorizes 7 e-cigarettes to be marketed through the PMTA route

On July 18, 2024, the U.S. Food and Drug Administration (FDA) newly approved 7 e-cigarettes to be marketed in the U.S. through the PMTA (premarket tobacco product application) route.

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So far, the FDA has authorized 34 e-cigarette products and devices. The FDA has also compiled a downloadable and printable single-page flyer of all authorized e-cigarette products (https://digitalmedia.hhs.gov/tobacco/hosted/E-Cigarettes-Authorized-FDA-JULY2024.pdf); these are the only e-cigarette products that can be legally marketed and sold in the United States at present, and any manufacture, importation, sale or distribution of e-cigarettes without the required pre-market authorization may be investigated and dealt with by law enforcement.

Although the FDA authorizes the sale of these tobacco products in the United States, this does not mean that these tobacco products are safe, nor does it mean that these products are "FDA approved", that is, the FDA does not endorse the safety of the products. The FDA evaluates PMTA applications based on public health standards, and approval or rejection is based on the statutory standards required by the 2009 Family Smoking Prevention and Tobacco Control Act to verify whether the information submitted in the PMTA is sufficient to prove that the product is appropriate to protect public health when considering the risks and benefits of the entire population. Specifically, it means that the applicant provides evidence that these tobacco-flavored products may bring benefits to smoking adults that are sufficient to offset the risks of the products, including risks to teenagers. However, this does not represent authorization or indicate that it is appropriate to sell these products as modified risk tobacco products. In fact, the FDA believes that all tobacco products are harmful and potentially addictive.

Six of the seven products authorized this time are tobacco-flavored cartridges. This also conveys to the society the official intention of the United States on the flavor of e-cigarettes, that is, the flavor of e-cigarettes should tend to be tobacco flavored. Although the FDA is still concerned about the involvement of teenagers in e-cigarettes, teenagers are less likely to use tobacco-flavored e-cigarette products than other flavors (the results of the annual National Youth Tobacco Survey in the United States show that only 6.4% of students who currently use e-cigarettes report using tobacco-flavored products). In order to further reduce the use of these products by teenagers, the FDA has imposed strict marketing restrictions on new products to prevent teenagers from contacting or being exposed to smoke environments. The FDA will closely monitor the marketing methods of these products and take appropriate action if the company fails to comply with any applicable statutory or regulatory requirements. If the FDA determines that continued sales of the relevant products are no longer appropriate to protect public health, including if the use of these products by teenagers or former cigarette users increases significantly, or if current cigarette users no longer use this product but completely switch to new products, the FDA may suspend or revoke the current authorization.

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