US Food & Drug Administration, Modified Risk Tobacco Product Applications Draft Guidance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