Draft for Comments || Guidelines for the Authorization of Vaporized Nicotine and NonNicotine Products and Novel Tobacco Products with Medicinal or Therapeutic Claims or Reduced Risk Statements Pursuant to Sections 12 (k), 12 (l), and 13 (c) of Republic Act No. 11900

SECOND SUBMISSION OF POSITION PAPERS ON THE DRAFT GUIDELINES FOR THE ISSUANCE OF FDA AUTHORIZATION FOR VAPORIZED NICOTINE AND NON-NICOTINE PRODUCTS AND NOVEL TOBACCO PRODUCTS WITH MEDICINAL OR THERAPEUTIC CLAIMS OR REDUCED-RISK STATEMENTS

The Food and Drug Administration (FDA) is calling for the  second (2^nd) submission of position papers on the draft guidelines for the issuance of FDA authorizations for vaporized nicotine and non-nicotine products (VNNPs) and novel tobacco products (NTPs) with medicinal or therapeutic claims on it marketing materials or packaging or explicit reduced-risk statement.

All concerned stakeholders are enjoined to submit their position papers/comments on or before 27 May 2024 to the FDA thru email at [email protected].

Attached herewith are the documents for commenting:

1. Draft FDA Circular – Guidelines for the Authorization of Vaporized Nicotine and Non-Nicotine Products and Novel Tobacco Products with Medicinal or Therapeutic Claims or Reduced Risk Statements Pursuant to Sections 12 (k), 12 (l), and 13 (c) of Republic Act No. 11900

Thank you very much.