AWMA’s Anne Holloway attended the TMA conference this week and spoke directly with the Food and Drug Administration (FDA) Ombudsman, Les Weinstein, along with other FDA regulators on distributor concerns over FDA implementation of the Family Smoking Prevention & Tobacco Control Act.  Specifically, Holloway raised concerns over the lack of clarity and guidance from the agency with respect to the upcoming manufacturer deadline for the ban on descriptor labeling such as “light” and “ultra light” and pressing the point that distributors need, and expect, that under the new law they will have “unlimited” sell-through of old product.

Holloway reiterated the concerns raised at AWMA’s recent meeting with FDA Chief of Compliance, Ann Simoneau, during the annual Day on the Hill program where AWMA President, Scott Ramminger, spoke directly about the need for an unlimited sell-through of old product under this provision.  FDA Ombudsman, Les Weinstein, said he would take these concerns directly to those responsible for implementing these provisions of the law and told Holloway that he was also in receipt of the AWMA letter to Simoneau outlining in detail the distributors’ concerns on this issue.  

Dr. Lawrence Deyton, the new head of the FDA Center for Tobacco Products also spoke at the conference and acknowledged the problems within the agency with respect to issuing prompt and clear guidance.  However, Dr. Deyton stated that many of these problems are attributable to the fact that this is a brand new office within FDA and he wished that Congress had allowed for a year to get the new office up and running before it began issuing deadlines under the new tobacco law.  

AWMA continues to press vigorously for quick and clear guidance on this – and other issues – from the agency and will continue to report to members on any new developments.