Tobacco companies must submit any products introduced or changes since early 2007 for review by the Food and Drug Administration (FDA) under new guidelines introduced by the US regulatory agency on Wednesday.
Under the new regulations, manufacturers have until March 22 to prove that the cigarettes and other tobacco products that they marked are “substantially equivalent” to the goods they offered for sale prior to February 15, 2007, the Associated Press (AP) is reporting.
“That means the ingredients and design are similar and do not raise different public health concerns,” the AP reporters said. “The FDA said it may deny an application if the product poses an increased health risk to users or causes nonusers to start using tobacco.”
Under the new policy, companies who introduce new products after March 22 must obtain a market order from the FDA before selling their cigarettes, roll-your-own tobacco, and smokeless products, according to various media reports.
“Manufacturers frequently alter ingredients without anyone knowing 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 in terms of ingredients, design, composition, heating source and other characteristics to an existing single predicate product,” added David Ashley, director of the Office of Science at the FDA’s Center for Tobacco Products. “If it has different characteristics, they must not raise different questions of public health.”
In a statement responding to 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 tobacco products. The FDA has seized the opportunity presented by the new law to protect our children and reduce 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, 46.6 million people, or approximately one out of every five Americans, currently smoke cigarettes. Furthermore, the CDC states that up to 3% of the US adult population uses smokeless tobacco, and tobacco as a whole is responsible for more than 440,000 deaths annually.
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