What products does electronic cigarette belong to in FDA?
Date:2023-04-03 09:50:45 Classification
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What products does electronic cigarette belong to in FDA? Electronic cigarettes belong to tobacco products in the FDA, and electronic cigarette certification is a PMTA proposed by the FDA in the United States for electronic cigarette products. The full name of PMTA is "Pre market Tobacco Product Application", which means "Pre market Tobacco Product Application". All businesses selling e-cigarette products in the United States must submit a Pre market Tobacco Product Application (PMTA) to the United States Food and Drug Administration (FDA). Only approved e-cigarette products can be legally sold in the United States market.
During the PMTA review, the FDA conducts extensive assessments of the data from time to time to reassess its risk benefits and ensure that it is "suitable for protecting public health" (APPH).
After the PMTA deadline in September 2020, e-cigarette companies are expected to obtain a series of product marketing licenses by the end of 2021, 12 months after submitting their applications. Most enterprises that have received a Marketing Denial Order (MDO) issued by the FDA do not have sufficient evidence in the materials submitted by the PMTA to indicate that flavored e-cigarettes have more advantages than tobacco substitutes.
On March 15, 2022, a new law signed by President Joe Biden of the United States officially took effect, expanding the scope of FDA regulation on tobacco products, including products using synthetic nicotine into regulations on electronic cigarettes, heating products, and oral nicotine bags. This will bring these products into line with regulatory requirements for tobacco derived nicotine Next Generation Nicotine Delivery Products (ENDS). From the effective date of the bill, manufacturers of synthetic nicotine e-cigarettes and oral nicotine bags will have 60 days to submit PMTA information to enable their products to continue to be sold in the United States market.