The U.S. Food and Drug Administration said it will need more time to complete its review of e-cigarette products sold in the United States. According to the FDA, flavored tobacco products are very appealing to young people, with over 80 percent of e-cigarette users aged 12 through 17 using them. Hence, it is imperative to assess the potential impact of its use.
The agency has made decisions on over 90% of the new tobacco products that were submitted. It has had a year to judge if those products were in the interest of public health, analyzing if they were effective in helping smokers quit and if that outweighed introducing new users, including teenagers, to e-cigarettes.
"We've made significant progress in the months since, working diligently to better understand these products and, as of today, taking action on about 93 per cent of the total timely-submitted applications," Janet Woodcock, MD, Acting Commissioner of Food and Drugs -- FDA, said in a statement on Thursday.
"This includes issuing Marketing Denial Orders (MDO) for more than 946,000 flavored ENDS products because their applications lacked sufficient evidence that they have a benefit to adult smokers sufficient to overcome the public health threat posed by the well-documented, alarming levels of youth use of such products," she added.
The FDA said it has reviewed 93 percent of the applications submitted, which included 6.5 million products. It will continue to review the remaining 7 percent of products
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