To:        AWMA Distributor Members

From:   Scott Ramminger & Anne Holloway

Re:        Bullet Pts. For Distributors to Use in Submitting FDA Comments

Date:    September 22, 2009
   
        As you may know, the U.S. Food and Drug Administration (FDA) is asking for comments and information on the implementation of the Family Smoking Prevention and Tobacco Control Act that was recently enacted by Congress.  The agency’s request for submission of comments is addressed to “all interested parties” who may wish to “share views on the implementation of the new law.”  While AWMA will submit comments on behalf of the industry, you may want to add your own voice as a businessman or woman to that effort.  For this reason, AWMA is attaching some bullet points to this email regarding items you may want to address in any comments you decide to submit to the agency.  These bullet points are intended only as a guideline and you may want to put them into your own words before submitting comments with the FDA.

        The deadline for submitting formal comments with the FDA is September 29th, 2009.  You may submit your comments to either of the following two addresses – the first address is the electronic submission method and the second is the U.S. Postal Service address for the agency.

http://www.regulations.gov

or

Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane
Room 1061
Rockville, MD  20852
 

Bullet Points for FDA Comments
 

• My name is ______and I am the ______(company position) of __________(company name).  My company employs ______ people in ________(company location).
• I am concerned as a (small/large) business owner that FDA may not fully understand the distributor role in the tobacco supply chain and as your agency implements this comprehensive tobacco law I urge you to continue to seek out our input to ensure the promulgation of reasonable regulations.  
• While I am committed fully to upholding this new law, I also urge the agency to improve the clarity of communications with respect to the various provisions of the new law to be implemented.  An example of this lack of clarity would be the most recent call for a ban on flavor cigarettes and the confusion a letter from your agency dated Sept. 14th recently caused among our industry.  
• A large part of the confusion is due to a paragraph in the FDA letter that states the ban on flavored product applies to all tobacco products “that meet the definition of a ‘cigarette’ in section 900(3) of the Act even if they are not labeled as ‘cigarettes’ or are labeled as cigars or as some other product.”  Our Association – the American Wholesale Marketers Association – and others, have asked the agency for clarification along with a list, by brand, of products that are banned.
• In addition, we call upon the FDA to be sensitive to the need for so-called “sell through” provisions as that agency works to implement this new law and the various bans on specific labels and items.  Our business needs time to sell out existing inventory before any ban goes into effect.  Tobacco products inventory represents a significant investment for my company and the effects could be devastating if I do not have time to sell through existing products.
• I am also concerned over a provision of the new law that would hold distributors liable for errors in packaging or labeling on cigarettes.  This is a responsibility rightly put in the hands of manufacturers.  My company – and distributors as a whole – do not add or remove any labeling and receive these products pre-packaged and pre-labeled from the manufacturer.  I believe that I should be taken out of the liability loop and treated like retailers who are exempt from this liability.
• Finally, I urge the FDA to examine closely the existing system of records now in use by our industry before calling for any new record-keeping or reporting requirements under the new law.  Existing records systems for distribution of tobacco products should address the agency’s needs at minimal cost to the agency or to my company and the distribution industry at large.
• Thank you for your kind consideration of my concerns as you work to implement the new tobacco law.