FDA clarifying rule issued

The US Food and Drug Administration has sought to clarify what in its view tobacco products and products derived from tobacco are, and which part of the agency deals with those products.

The clarification comes in the form of a recently issued 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’.

‘This rule describes circumstances in which a product made or derived from tobacco is subject to regulation by the FDA’s Center for Drug Evaluation and Research, Center for Devices and Radiological Health, or Center for Tobacco Products,’ the FDA said in a recent posting.

‘This rule is intended to help manufacturers and researchers better understand which regulatory standards apply to their products or studies, respectively.

‘The agency also anticipates that the rule will help consumers clearly distinguish products made or derived from tobacco that are intended for tobacco cessation from those intended for other uses.’