On July 21, the U.S. Food and Drug Administration (FDA) today issued a warning letter informing 10 companies, including cool clouds distribution Inc. (which operates puff bar), to remove their flavored disposable e-cigarettes and liquid e-cigarettes that appeal to young people from the market because they do not have the required pre-sale authorization.
The new measures are part of the FDA's ongoing efforts to combat illegal tobacco products in the public health crisis of e-cigarette use among American teenagers. The agency is particularly concerned about the appeal of seasoned disposable e-cigarettes to young people and continues to monitor all available data.
FDA director Stephen M. Hahn said the FDA continues to give priority to enforcement of e-cigarette products, especially those that are most attractive and accessible to young people. We are concerned about the popularity of these products among young people and want to show all tobacco manufacturers and retailers that the FDA will keep a close eye on the market and hold companies accountable even during the ongoing pandemic.
Despite the suspension of on-site inspection activities such as retail compliance checks and e-cigarette store inspections due to the covid-19 pandemic, our enforcement of unauthorized e-cigarette products remains in force, and these warning letters are the result of ongoing Internet surveillance of violations of tobacco laws and regulations, said jitch Mitch Zeller, director of the FDA center.
Puff bar, HQD tech USA LLC and myle vape Inc. are receiving warning letters about illegal sale of disposable e-cigarettes.
FDA's review of the company's website shows that each company is selling or distributing unauthorized tobacco products introduced or modified for the first time after August 8, 2016, which extends the FDA's authority to the effective date of all tobacco product identification rules.
Any new tobacco products that do not meet the pre market requirements of the federal food, drug, and Cosmetic Act (FD & C act) are adulterated and mislabeled and are not allowed to be sold without FDA authorization.
Puff bar and HQD tech USA LLC have also been mentioned for marketing their products as improved risk tobacco products in violation of their FDA directive for effective marketing without FDA approval.
In addition, the FDA issued seven other warning letters to eleaf USA, vape deal LLC, majestic vapor LLC, e cigarette Empire LLC, Ohm city vapes Inc., breazy Inc. and hina Singh enterprises (doing business with just eliquids distro Inc.).
These companies sell or distribute unauthorized electronic nicotine delivery system (ends) products targeted at or likely to promote the use of young people. These companies are believed to engage in unauthorized sales of electronic liquids that mimic the often sold food packaging and appeal to young people, such as cinnamon toast, crispy cereal, Twinkies, cherry cola and popcorn, or with cartoon characters.
The FDA has asked each company to respond within 15 working days, detailing how each company intends to address the agency's problems, including the date each company stopped selling and / or distributing these tobacco products, and plans to maintain compliance.
If the violation is not corrected, it may lead to further litigation, such as civil fine, prosecution or injunction.
In addition, products imported into the United States with incorrect or adulterated trademarks are subject to detention and refused entry.
Actions taken by the FDA during the covid-19 pandemic also included the recent issuance of a warning letter to stemstix Inc., a manufacturer of electronic cigarette liquids, about violations of the FD & C act, including unauthorized sale of new tobacco products, marketing of tobacco products with false and misleading advertising, and unauthorized modified marketing.
In addition, last month, the agency sent letters to seven tobacco manufacturers asking for information to help the FDA check whether certain tobacco products were first sold after the effective date of the recognition rules.
In the past four months, the agency has also rejected at least 74 disposable end products from the U.S. market in violation of the FD & C act.