Following up on AWMA’s Day on the Hill breakfast meeting with FDA chief of compliance, Ann Simoneau, the association sent a strongly worded letter to Ms. Simoneau outlining our concerns over the agency’s lack of guidance and clarity with respect to the implementation of the new FDA tobacco law.  During the May 13th breakfast meeting with Ms. Simoneau as the guest speaker, questions were raised regarding the sell through of old product after the June 22nd deadline for new descriptor labeling.  Despite the fact that we are just weeks from this deadline, Ms. Simoneau could not answer specific questions regarding how such old product will be treated under the new law.  

In response, AWMA sent a strongly worded letter to Ms. Simoneau clearly outlining our concerns in this matter and urging the agency to provide “concrete answers to basic questions about how distributors may conduct their businesses in this new environment.”  The letter from AWMA also points out that despite FDA supposed assistance through the website for retailers and wholesalers to ask questions of the agency “those things are rendered meaningless without concrete, timely answers to basic questions.”  A copy of the letter can be found at the link below.

AWMA will continue to press the FDA for clear and immediate guidance on this issue and will report back to members as soon as a response is received from the agency.

CLICK HERE for a copy of the letter to Simoneau.

To listen to the audio of Ann Simoneau, click the attached link: http://dl.dropbox.com/u/7174034/Ann%20Simoneau%20AWMA%205-13-10%20Speech...