AWMA Sends Message to FDA ‘More Clarity Less Onerous Regulation’ On Listening Session Call

Publish Date: 
September 24, 2009

AWMA’s President, Scott Ramminger, and Vice President of Government Affairs, Anne Holloway, joined on a conference call with FDA Principal Deputy Commissioner, Dr. Josh Sharfstein, and newly appointed Director of the Center for Tobacco Products, Dr. Lawrence Deyton, to discuss our industry’s concerns over the implementation of the new tobacco law.  

Both Ramminger and Holloway called on the agency to provide greater clarity with respect to the ban on flavored cigarettes.  Specifically, AWMA called on the agency to provide our distributors with a listing of the actual brands to be banned.  Ramminger noted the recent confusion over language an FDA letter dated Sept. 14th had caused leaving some doubt as to what exactly FDA’s intention is with respect to the flavor ban.

Holloway also noted the need to remove distributors’ from the liability provisions contained in the new law with respect to errors in labeling and packaging of cigarettes.  And, Holloway also urged the FDA to consider using tracking and reporting requirements already in place as the result of passage of other laws instead of creating new, onerous record-keeping requirements.

Finally, Ramminger called on regulators to take efforts to better understand our industry and urged representatives from FDA to actually sit down in face-to-face meetings with our distributor members in addition to these “listening sessions.” 

Also on the call, distributor members Jode Bunce and Charlie Casper who joined in calling on the FDA to issue more clarity on the flavor ban and expressed concern over tracking and tracing requirements that may be forthcoming, urging the agency to consider the costs associated with these technology issues.

While the regulators on the call offered no clarity as to the intention of the FDA with respect to the flavor ban, Dr. Deyton concluded the “listening session” with a promise to review all the comments received on the call as well as the written comments to be submitted to the agency by Sept. 29th.  

AWMA recently sent a memo to all our distributor members offering a sample letter they can use to write directly to the FDA asking for clarity with respect to the recently implemented flavored cigarette ban.  In addition, AWMA also sent out a memo providing our distributor members with bullet points they can use in submitting their own written comments to the agency on their individual general concerns with respect to the implementation of the new tobacco law.  AWMA will be submitting comments with the FDA before the deadline of September 29th on behalf of the industry.

To view the memo with bullet points, CLICK HERE