Final Rule Issued: Intended Use ….. Far From the Final Word.

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.  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]
RIN 0910–AH19

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.  bit.ly/2lxvPiO

Advertisements

Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out /  Change )

Google+ photo

You are commenting using your Google+ account. Log Out /  Change )

Twitter picture

You are commenting using your Twitter account. Log Out /  Change )

Facebook photo

You are commenting using your Facebook account. Log Out /  Change )

Connecting to %s