Previous FDA Actions by CASAA


CASAA press release: Public demand for FDA recognition of e-cigarettes as "safer alternative" increases dramatically


Call to Awareness: Sign Petition and Contact your Legislators!
Despite the incredible promise that e-cigarettes hold for the millions of smokers in the U.S., the FDA has been decidedly hostile towards e-cigarettes and other reduced harm alternatives to smoking. The FDA attempted to characterize e-cigarettes as pharmaceutical products ,which would have resulted in a de facto ban. When that didn’t work, the FDA continued its war against tobacco harm reduction, misinforming the public about the relative risks associated with e-cigarette use.

The FDA has announced that in April 2012 it will issue guidance on e-cigarettes and will regulate them as tobacco products. Depending on its approach, the FDA could effectively decimate the e-cigarette industry through excessive regulations. In light of the actions of the FDA to date, vapers should hold little hope that the FDA's proposed regulations will be reasonable.

We need to take every opportunity to voice our concerns to those who are in a position to put pressure on the FDA, namely, the White House and Congress...


CASAA submits comments to the FDA
Currently e-cigarettes are not regulated under either the CTP or CDER, but the CTP has announced that it intends to issue a deeming regulation that would bring e-cigarettes and other tobacco products under the Agency’s regulatory authority.

The FDA held a public hearing on Section 918 on Monday, December 17, 2012. Many THR advocates testified. See:

The FDA will use the testimony that was given at the December 17 hearing, plus the written comments submitted by January 16, 2013 as input for the report to Congress required by the Tobacco Act. CASAA encouraged members to submit written comments. This resulted in over 5,300 comments made by CASAA members and other concerned citizens....


Call to Action! Submit Written Comments – Sec. 918 of Tobacco Act
The FDA held a public hearing on Section 918 on Monday, December 17, 2012. Many THR advocates testified. See:

For the hearing, we issued a Call to Awareness. This is now a related (as noted below) but separate Call to Action. The FDA will use the testimony that was given at the December 17 hearing, plus the written comments submitted by January 16, 2013 as input for the report to Congress required by the Tobacco Act....


CASAA testifies at FDA hearing
Yesterday, the FDA held a public hearing to obtain input on certain questions related to the implementation of the Federal Food, Drug, and Cosmetic Act, as amended by the Family Smoking Prevention and Tobacco Control Act (FSPTCA). CASAA President Elaine Keller spoke on behalf of the organization.  Also presenting before the FDA panel* as private citizens or as representatives of other organizations were CASAA's Legal Policy Director Gregory Conley, CASAA's Scientific Director Carl V Phillips, and CASAA advisor Bill Godshall.

The hearing was held for the FDA's consideration of new regulations regarding already approved smoking cessation products such as gums, patches and lozenges (NRTs) and the possible "fast tracking" of innovative new products that are intended to promote 1) total abstinence from tobacco use, 2) reductions in consumption of tobacco, and 3) reductions in the harm associated with continued tobacco use.

While electronic cigarettes and low-risk, smoke-free tobacco products were not being considered at this hearing, CASAA supports the consideration of NRT for long-term use as a form of tobacco harm reduction (THR) for smokers who cannot or will not quit, rather than requiring the products to be used solely as tools for complete nicotine abstinence. It is CASAA's opinion that this could open the door for products such as electronic cigarettes and low-risk, smoke-free tobacco products to also be considered as THR products. Therefore, CASAA's presence at the hearing was to speak on behalf of tobacco harm reduction policies.

The topic of electronic cigarettes did arise several times and some known opponents of electronic cigarettes admitted that testimony given by electronic cigarette consumers was compelling and warranted future study. Surprisingly, most of the anti-tobacco speakers at the hearing seemed to agree with THR advocates that smoking cessation is a far more urgent goal than total nicotine abstinence.

"Risk needs to be assessed not in comparison to abstinence but in comparison to a percentage scale of harm impact," CASAA's Dr. Phillips told members of the FDA panel. "Smoke-free alternatives are far healthier. A lifetime of [smoke-free nicotine/tobacco] use is less harmful than a couple months of relapse smoking."


CASAA Article: FDA Regulation Could Make E-Cigarettes Less Effective


CASAA's comment on FDA Draft Guidance for Modified Risk Tobacco Product Applications
Click the link above to read the comment letter CASAA has submitted to the FDA. 

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" they should be regulated by Chapter IX, as the FDA has stated it intends to do) tens of millions of dollars conducting unnecessary research before applying to the FDA to truthfully claim that any of its smokefree tobacco products is less hazardous than cigarettes....


CASAA Article: FDA's partial truths and exaggerations endanger health


CASAA testifies at TPSAC
On January 19th, CASAA President Elaine Keller, CASAA Director Gregory Conley and CASAA advisors Bill Godshall and Dr. Carl Philips spoke before the FDA Tobacco Products Scientific Advisory Committee, advocating once again for tobacco harm reduction policies.

The Tobacco Products Scientific Advisory Committee (TPSAC) is intended to advise the Commissioner or designee in discharging responsibilities as they relate to the regulation of tobacco products. As part of the TPSAC’s required report to the Secretary of Health and Human Services, the committee heard public comments on issues related to "the nature and impact of the use of dissolvable tobacco products on the public health, including such use among children." It is CASAA's opinion that the committee is largely one-sided, as many committee members are known anti-tobacco and anti-nicotine prohibitionists and against tobacco harm reduction.

Listen to their speeches here: Video link to 1/19 TPSAC. Testimony from CASAA/harm reduction advocates starts about 5hr 22min mark.

View Elaine's presentation slides here:


CASAA Testimony - FDA MRTP Workshop
FDA Workshop - Scientific Evaluation on Modified Risk Tobacco Products CASAA Public Testimony by CASAA Vice President Elaine Keller, CASAA Advisor Bill Godshall of Smokefree Pennsylvania, along with other tobacco harm reduction advocates.


CASAA's presentation at TPSAC
On Friday, July 22 CASAA's vice president, Elaine Keller, spoke before the Tobacco Products Scientific Advisory Committee (TPSAC.) According to the FDA, the Committee's purpose is to review and evaluate safety, dependence, and health issues relating to tobacco products and provide appropriate advice, information and recommendations to the Commissioner of Food and Drugs.

Watch Mrs. Keller's excellent presentation here (starts at 49:55):

CASAA highly recommends that anyone interested in tobacco harm reduction (and the attitudes we are up against fighting for e-cigarettes and smokeless alternatives) watch the video above and also the video from Thursday, July 21 found here: July 21-22, 2011: TPSAC Meeting Webcast Information