FDA Clarifies Tobacco Jurisdiction, Definitions
Editor’s Note: The FDA’s Final Rule, “Clarification of When Products Made or Derived From Tobacco Are Regulated as Drugs, Devices, or Combination Products” is available here.
From: CSP Daily News
By Angel Abcede, Senior Editor/Tobacco, CSP
SILVER SPRING, Md. — In an attempt to better define whether tobacco-derived products are intended for medical use or for more traditional, nicotine satisfaction, the FDA published anextended document this week, hoping to shed more light on its regulatory authority and what rules apply to different products.
The document titled, Clarification of When Products Made or Derived From Tobacco Are Regulated as Drugs, Devices or Combination Products; Amendments to Regulations Regarding Intended Uses, recapped key points about regulation and discussed the comment phase of the FDA’s review process, agreeing with or refuting concerns raised.
