According to the FDA, these unauthorized products are packaged as toys, food or cartoon characters, which are likely to lure young people to use them. And none of the companies in this batch have applied to market for these products. The FDA is committed to keeping tobacco products away from American teenagers that are designed to be blatantly aimed at children, and the agency will continue to hold companies accountable that illegally sell e-cigarettes, especially those targeting teens, the head of the FDA said. company.
In the warning letter, the FDA stated that unauthorized e-cigarettes are adulterated and counterfeit, and that the sale or distribution of unauthorized e-cigarettes to U.S. consumers is prohibited under the U.S. Federal Food, Drug, and Cosmetic (FD&C) Act. Failure to correct violations in a timely manner may result in additional FDA action such as injunctions, seizures, and/or civil monetary penalties.
In addition, imported products supplied to the United States risk being detained or denied entry if they appear to be counterfeit or adulterated. Retailers and distributors should communicate with suppliers to discuss possible options for unauthorized products in inventory.
In addition to the warning letters issued this time, as of October 28, the FDA has issued more than 440 warning letters to companies that illegally sell e-cigarettes containing tobacco nicotine, and more than 60 warning letters to companies that illegally sell e-cigarettes containing non-tobacco nicotine letter.
On October 18, the U.S. Department of Justice (DOJ), on behalf of the FDA, sued six e-cigarette manufacturers in the Federal District Court for a permanent injunction, because these manufacturers ignored FDA previous illegal warnings and failed to submit e-cigarette products to the market. Continue to illegally produce, sell and distribute products without application.