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# Guide on Smoking Cessation Products
- URL: https://www.fdaweb.com/guide-on-smoking-cessation-products/
- Published: 2023-04-28T12:00:00.000Z
- Updated: 2026-09-14T18:28:30.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5154321

FDA has released a final guidance on [Smoking Cessation and Related Indications: Developing Nicotine Replacement Therapy (NRT) Drug Products](https://lnks.gd/l/eyJhbGciOiJIUzI1NiJ9.eyJidWxsZXRpbl9saW5rX2lkIjoxMDAsInVyaSI6ImJwMjpjbGljayIsInVybCI6Imh0dHBzOi8vd3d3LmZkYS5nb3YvcmVndWxhdG9yeS1pbmZvcm1hdGlvbi9zZWFyY2gtZmRhLWd1aWRhbmNlLWRvY3VtZW50cy9zbW9raW5nLWNlc3NhdGlvbi1hbmQtcmVsYXRlZC1pbmRpY2F0aW9ucy1kZXZlbG9waW5nLW5pY290aW5lLXJlcGxhY2VtZW50LXRoZXJhcHktZHJ1Zy1wcm9kdWN0cz91dG1fbWVkaXVtPWVtYWlsJnV0bV9zb3VyY2U9Z292ZGVsaXZlcnkiLCJidWxsZXRpbl9pZCI6IjIwMjMwNDI4Ljc1OTM3MDgxIn0.KCCFbfUUzhEkXufOnb9HBCjl1tdRhfEm9JGt4sdruTQ/s/1255720147/br/167250418403-l?ref=fdaweb.com). The agency says the guidance includes “several innovations in the regulatory pathway for NRT drug products. For example, the guidance discusses ‘reduction in risk of relapse’ as a potential indication to assist smokers in remaining smoke-free.”

The document outlines development options for two new potential treatment regimens: (**1**) pretreatment before quit day, and (**2**) quitting by gradual reduction (“reduce to quit”). It also discusses combination use of more than one NRT product. Additionally, it addresses additional efficacy endpoints that may be used in NRT drug products that have already demonstrated effectiveness in smoking cessation or reduction of risk of relapse, such as reduction in urge to smoke, and relieving withdrawal symptoms.