The FDA is pressurizing to drag new products of e-cigarette from their shelves if companies fail to show that they are selling the products legally. The letters have been sent to twenty-one cigarette producers by FDA on Friday requesting data to check whether they have illegally added more than new 40 devices as well as nicotine liquids into markets without taking any approval from agency. The units of companies like British-American Tobacco, Japan Tobacco and Imperial Brands are the manufacturers who received letter from FDA. The market leader, Juul, did not get any letter as they were already aware of this due to a surprise inspection held at their headquarters located in San Fransisco.
The e-cigarettes launched after 8th August, 2016 are more likely to undergo FDA evaluation for getting marketed. The already available products have to apply by this year end, but the deadline has been extended till the year 2022 by FDA. The newly launched product formulations, features or flavors are considered to be breaking the policy set by FDA. It is the recent move cracked by FDA on youth who smoke e-cigs, which have already reached the epidemic levels, says the officials. The actions include extension of applications and pulling down the flavored e-cigs from the US market.
The companies are warned that FDA will strictly monitor the growth of e-cigs and other similar products if they are marketed illegally without considering the compliance policy of agency, and swift actions will be taken against the companies breaking the law, says Scott Gottlieb in the statement. But, some products have been launched after the deadline of August; however, those products are not available widely in the market. The manufacturers may have rebranded the e-cigs or purchased them from different company and renamed them for marketing them like a new product in market.