UNITED STATES
FDA authorises first-ever modified risk claim

The US Food and Drug Administration (FDA) has announced that it has authorised the marketing of eight Swedish Match USA snus smokeless tobacco products through the modified risk tobacco product (MRTP) pathway, according to a press release.

The agency said that switching from cigarettes to these authorised products lowers certain health risks. The eight snus smokeless tobacco products will be sold under the “General” brand name, according to the announcement. This decision authorises Swedish Match to market these products with the claim that “Using General Snus instead of cigarettes puts you at a lower risk of mouth cancer, heart disease, lung cancer, stroke, emphysema, and chronic bronchitis.”
This decision was made after the FDA reviewed scientific evidence which was submitted by the company that supports this claim, the agency said. However the agency warned that this authorisation “does not mean these products are safe or ‘FDA approved.’” In the statement, the FDA added, “All tobacco products are potentially harmful and addictive, and those who do not use tobacco products should continue to refrain from their use. The modified risk orders are product-specific and limited to five years.”
“Today’s action demonstrates the viability of the pathway for companies to market specific tobacco products as less harmful to consumers, but only following a thorough scientific evaluation by the FDA. Our team of scientific experts examined these applications to ensure that the tobacco products meet the public health standards in the law. While we are authorising these specific modified risk tobacco products, it’s important for the public to understand that all tobacco products — including these — pose risk. Anyone who does not currently use tobacco products, especially youth, should refrain from doing so,” said Acting FDA Commissioner Ned Sharpless.

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