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News | 7 electronic cigarettes authorized by the US FDA to be applied for through the PMTA pathway for market launch
Author.
LCS
Source:
Post time:
2024-07-24
On July 18, 2024, the U.S. Food and Drug Administration (FDA) approved seven applications for the pre-market tobacco product application (PMTA) pathway for electronic cigarettes to be marketed in the United States.
So far, the FDA has authorized 34 types of electronic cigarette products and devices. The FDA has also compiled a downloadable and printable single page brochure that includes all authorized electronic cigarette products（ https://digitalmedia.hhs.gov/tobacco/hosted/E-Cigarettes-Authorized-FDA-JULY2024.pdf ）； These are currently the only electronic cigarette products that can be legally marketed and sold in the United States, and any act of manufacturing, importing, selling, or distributing electronic cigarettes without obtaining the required pre-market authorization may be investigated by law enforcement agencies.
Although the FDA authorizes the sale of these tobacco products in the United States, it does not mean that these tobacco products are safe, nor does it mean that these products have been "FDA approved," meaning that the FDA does not endorse the safety of the products. The FDA evaluates PMTA applications based on public health standards, and approval 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 demonstrate that the product's results are appropriate for protecting public health when considering the risks and benefits to the entire population. Specifically, it refers to the applicant providing evidence that these tobacco flavored products may provide benefits to adult smokers that are sufficient to offset the risks of the products, including those to adolescents. However, this does not authorize or indicate that it is appropriate to sell these products as modified risk tobacco products. In fact, the FDA considers all tobacco products to be harmful and potentially addictive.
Six of the seven products authorized this time are tobacco flavored cartridges. This also conveys to society the official taste intention of the United States towards e-cigarettes, that is, e-cigarette flavors should lean towards tobacco flavors. Although the FDA is still concerned about teenagers being involved in vaping, the likelihood of teenagers using tobacco flavored e-cigarette products is relatively low compared to other flavors (the annual National Youth Tobacco Survey in the United States shows that only 6.4% of students currently using 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 coming into contact with or being exposed to smoke environments. The FDA will closely monitor the marketing methods of these products, and if the company fails to comply with any applicable legal or regulatory requirements, the FDA will take appropriate action. If the FDA determines that continuing to sell related products is no longer suitable for protecting public health, including if there is a significant increase in the use of these products by adolescents or former cigarette users, or if current cigarette users no longer use this product but instead completely switch to new products, the FDA may suspend or revoke the current authorization.
As a well-known institution in China that has been deeply involved in testing for 20 years, Lixun Testing (www.lcs-Cert. com) has obtained CMA or CNAS qualification recognition in many fields. At the same time, a series of testing methods have been developed for electronic cigarette products, which can provide authoritative electronic cigarette product testing reports.
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