FDA: ‘Tobacco Product Regulation Is Here’
(WASHINGTON) — For the first time, the Food and Drug Administration has exercised its authority to regulate new tobacco products, approving the marketing of two new cigarettes made by the Lorillard Tobacco Company.
“Newport Non-Menthol Gold Box 100s and Newport Non-Menthol Gold Box — these two products have been determined to be substantially equivalent to specific predicate products,” said the FDA’s Mitchell Zeller of the Center for Tobacco Products.
The move to authorize any tobacco product may seem odd to some. According to the FDA, tobacco kills more than 400,000 Americans a year, more deaths than alcohol, illegal drugs, homicide, suicide, car accidents and AIDS combined. Tobacco costs the U.S. more than $193 billion a year in health care costs and lost productivity.
But Zeller said the two approved cigarettes aren’t substantially different from what’s already for sale in the U.S. In fact, the FDA rejected four other requests.
“The FDA concluded that while the new products have different characteristics than the predicate products, the new products do not raise different questions of public health,” Zeller explained.
According to Zellar, Tuesday’s FDA decision was especially significant because it marked the first day that a regulatory agency anywhere in the world has made a science-based determination on a free-market basis that a product either can or cannot be marketed.
“The day of evidence-based tobacco product regulation is here,” he said.
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