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US Food & Drug Administration, Modified Risk Tobacco Product Applications Draft Guidance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