According to foreign reports, as of March 31, the U.S. Food and Drug Administration (FDA) issued 166 warning letters from January 1. Compared with 97 in the same period of 2020, there was an increase of 69.
In 2020, the center for tobacco products issued 139 warning letters, accounting for 22% of all FDA warning letters.
In the first quarter of this year, 77 of 166 letters (currently 79) were related to tobacco products, accounting for 46% of warning letters. The vast majority of the products in dispute are e-cigarettes or e-liquids, which violate the FDA's pre market approval requirements for sale in the United States.
Katie insogna, an analyst, said that in almost every warning letter on tobacco products issued during the review period, the FDA referred to manufacturers because their electronic liquid products were considered new tobacco products, did not submit a pre marketing tobacco product application (PMTA) and were not exempt from the rule,
As a result, these products are considered counterfeit under section 902 (6) (a) of the food, drug and Cosmetic Act (FDCA). The agency also marked many of these products as false brands under FDCA section 903 (a) (6) because it did not provide notices or other information about these products as required by FDCA section 905 (J).
It is the responsibility of manufacturers to ensure that their tobacco products and all associated labels and / or advertisements - including on websites, social media and search engines - comply with the applicable provisions of the FDCA and FDA implementation regulations. In many recent warning letters, the FDA acknowledged that the recipient was a registered manufacturer with thousands of products already on the FDA market.
According to the practice of most FDA warning letters, the agency usually gives companies 15 working days to respond. Failure to resolve any violations may result in regulatory actions, including but not limited to civil fines, seizures and / or injunctions.
Because many of these companies already have licenses for other tobacco products, they face the risk of additional regulatory scrutiny and negative action when they are marked as selling unauthorized products, insonia wrote.
Many of the FDA's warning letters focus on false claims about covid-19 related products. Like covid-19 products, tobacco products, especially e-cigarettes, are subject to special regulatory scrutiny. Companies selling these two types of products should pay special attention to applicable federal regulations to avoid negative actions.