FDA Publishes Final Rule To Reduce Ambiguity For Products Made Or Derived From Tobacco

The FDA on Jan. 9th published a final rule entitled Clarification of When Products Made or Derived From Tobacco Are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding “Intended Uses” to clarify that products made or derived from tobacco will be regulated as drugs, devices or combination products rather than tobacco products if they “are intended to 1) diagnose, cure, mitigate, treat or prevent disease, including use in smoking cessation, or 2) affect the structure or any function of the body in any way that is different from effects related to nicotine that were commonly and legally claimed in the marketing of cigarettes and smokeless tobacco prior to March 21, 2000.”

Source:

Food and Drug Administration

Source Date:

January 10, 2017

https://www.tma.org/article/2017/clarification-when-products-made-or-derived-tobacco-are-regulated-drugs-devices-or-0?utm_source=TMA+Publications&utm_campaign=11d472ef4d-EMAIL_CAMPAIGN_2017_01_12&utm_medium=email&utm_term=0_f85a4ca640-11d472ef4d-72141293

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