What does FDA say? Recently FDA published a final rule about the following- “Intended Use”-Products Made from Tobacco. Is my product a Drug, Device and/or Both? Here is the rule summary and link. Check back soon for an update. http://bit.ly/2lxvPiO
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 201, 801, and 1100 [Docket No. FDA–2015–N–2002]
Clarification of When Products Made or Derived From Tobacco Are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding ‘‘Intended Uses’’
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
SUMMARY: The Food and Drug Administration (FDA) is issuing this final rule to describe the circumstances in which a product made or derived from tobacco that is intended for human consumption will be subject to regulation as a drug, device, or a combination product under the Federal Food, Drug, and Cosmetic Act (the FD&C Act). This action is intended to provide direction to regulated industry and to help avoid consumer confusion.
Check back soon for an update. http://bit.ly/2lxvPiO