Tobacco companies must submit any products introduced or changes since early 2007 for review through the Fda (FDA) under new guidelines introduced by the united states regulatory agency on Wednesday.
Under the new regulations, manufacturers have until March 22 to prove the cigarettes and other cigarettes and tobacco products they marked are “substantially equivalent” towards the goods they offered on the market prior to February 15, 2007, the Associated Press (AP) is reporting.
“Which means the components and design are similar and do not raise different public health concerns,” the AP reporters said. “The FDA said hello may deny an application when the product poses an increased health risks to users or causes nonusers to begin using tobacco.”
Under the new policy, companies who introduce new products after March 22 must obtain a market order in the FDA before selling their cigarettes, roll-your-own tobacco, and smokeless products, according to various media reports.
“Manufacturers frequently alter ingredients without anyone understanding what they’re consuming,” Lawrence Deyton, Director of the FDA’s Center for Tobacco Products, told Bloomberg’s Molly Peterson and other reporters in a conference call Wednesday. “No longer will changes to products consumed by millions of Americans be made without anyone knowing.”
“For a new product to be a substantial equivalent, it must be the same when it comes to ingredients, design, composition, heating source along with other characteristics for an existing single predicate product,” added David Ashley, director from the Office of Science at the FDA’s Center for Tobacco Products. “Whether it has different characteristics, they have to not raise different questions of public health.”
In an argument answering the FDA announcement, Matthew L. Myers, President of the Campaign for Tobacco-Free Kids, said: “We applaud the FDA for quickly and effectively implementing its new authority over cigarettes and tobacco products. The FDA has seized the opportunity presented through the new law to safeguard our kids and lower the death and disease caused by tobacco use, the nation’s number one cause of preventable death.”
According to Centers for Disease Control and Prevention (CDC) statistics, 46.Six million people, or approximately one out of every five Americans, currently smoke cigarettes. Furthermore, the CDC states that as much as 3% of the US adult population uses smokeless tobacco, and tobacco in general is responsible for more than 440,000 deaths annually.