Bill Godshall: Last Day to Tell FDA to Stop Blocking Smoke-Free Tobacco Alternatives

June 4th, 2012 is the deadline to submit comments on FDA’s Modified Risk Tobacco Product (MRTP) Application Draft Guidance in which the FDA refused (after being repeatedly urged) to acknowledge that smokeless (or noncombustible) tobacco products are far less hazardous alternatives to cigarettes.

Under the FDA’s Draft Guidance for MRTP Applications, it would cost any smokeless tobacco manufacturer (and any e-cigarette manufacturer if the agency “deems” them regulated by Chapter IX, as the agency has repeatedly stated its intent to do) at least $10 million conducting  unnecessary research before applying to the FDA to truthfully claim that any of its smokefree tobacco products is less hazardous than cigarettes.  Unless the FDA significantly changes its Draft Guidance on MRTP Applications, only several large tobacco companies could even afford to conduct this unnecessary research, and even that would be a very risky investment since the FDA continues to falsely claim “To date, no tobacco products have been scientifically proven to reduce risk of tobacco-related disease, improve safety or cause less harm than other tobacco products,”at the agency’s ironically titled “Health Fraud” website on Section 911 and MRTP.

Under FDA’s MRTP Application Draft Guidance, tens of millions of American smokers will continue smoking cigarettes and dying simply because Obama’s FDA doesn’t want them or the public to know that smokefree tobacco products are far less hazardous alternatives to cigarettes.

Action Requested

Please submit comments to the FDA on its Draft Guidance for MRTP Applications urging the agency to:

• truthfully acknowledge that smokefree tobacco products are less hazardous than cigarettes, and to

• eliminate proposed research requirements for a smokefree tobacco product to claim it is less hazardous than cigarettes since its already a well established fact.

Bill Godshall
Executive Director

Smokefree Pennsylvania
1926 Monongahela Avenue
Pittsburgh, PA 15218
412-351-5880
FAX 412-351-5881
smokefree@compuserve.com