2FIRSTS | Special Report | Breeze and Glas Seek White House Review as FDA Advances Flavored ENDS Guidance
Breeze and Glas are seeking White House review as the FDA advances guidance on flavored electronic nicotine delivery systems (ENDS).Summary
The U.S. Food and Drug Administration (FDA) is advancing draft guidance on flavored electronic nicotine delivery systems (ENDS), prompting two companies, Breeze Smoke and Glas, to request White House review. Both companies filed requests under the same regulatory identifier (RIN 0910-ZC78), indicating significant industry concern. Breeze Smoke experienced a 90% revenue decline following FDA enforcement, while Glas, represented by a leading FDA regulatory law firm, is potentially nearing a critical stage in the PMTA review process. The draft guidance aims to clarify evidentiary standards for flavored ENDS under the Family Smoking Prevention and Tobacco Control Act, focusing on whether products are “appropriate for the protection of public health.” The Office of Information and Regulatory Affairs (OIRA) is currently reviewing the guidance, evaluating regulatory and economic impacts, but will not override FDA’s scientific determinations. The final guidance could significantly impact the authorization pathway for flavored ENDS products in the U.S. market.
(Source：2Firsts)
