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The interesting question will be how many of these restrictions will be challenged by manufacturers, and how happy will Reynolds be to walk through this maze. “
“The FDA will be RJR’s partner every step of the way,†Scheineson said. “I’m not sure RJR is okay with all of this, or whether they are choosing to push their way to widen the trail.”
Intense debate
The move lends a level of credibility to FDA oversight over the industry, analysts said.
The FDA has been drawn into a decade of intense debate, evidenced by dozens of scientific studies touting or refuting the public health role of non-combustible nicotine and tobacco products.
The FDA said it “takes into account the risks and benefits to the population as a whole, including users and non-users of tobacco products, and most importantly, young people. This included reviewing the available data on the likelihood of use of the product by young people.
“As part of the tobacco pre-market application (PMTA) process, manufacturers must demonstrate to the agency that, among other things, the marketing of the new tobacco product would be appropriate for the protection of public health.”
“These products (Vuse) were found to comply with this standard because, among several key considerations, the agency determined that study participants who only used authorized products were exposed to fewer harmful and potentially harmful constituents. aerosols compared to users of burnt cigarettes. “
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