Nicotine products significantly reduce harm and the risk of tobacco-related disease

FDA

US Food & Drug Administration, Modified Risk Tobacco Product Applications Draft Guidance

  • In 2019, the US Food and Drug Administration (FDA) granted its first-ever risk modified order to a range of nicotine products.
  • To qualify, the products had to demonstrate that they:
    • “Significantly reduce harm and the risk of tobacco-related disease to individual tobacco users.” 
    • “Benefit the health of the population as a whole taking into account both users of tobacco products and persons who do not currently use tobacco products.”
  • Since 2019, it has granted modified risk status to a range of nicotine pouches and electronic devices.
  • These products can be advertised and labelled as being less harmful than cigarettes.
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