FDA media blitz to discredit e-cigs

On July 22, 2009, a press release from the US FDA declared the electronic cigarette to be hazardous based on tests that concluded the cartridges of some e-cigs contained “detectable” levels of tobacco specific nitrosamines (TSNAs). But, in fact, the FDA offensive against the e-cig actually began many months prior to the July 22 press release.

In March, FDA actions led to shipments of the e-cig being denied entry into the US by customs officials. Health Canada followed a similar course of action.

The FDA unilaterally declared the e-cig to be a drug-device, the drug being the nicotine also found in cigarettes and NRT (Nicotine Replacement Therapy) products such as Nicorettes and Nicoderm. But, they had done so without public notice or public comment and, apparently, with little or no discussion with distributors of the device. So, long before their press release, efforts were underway to scuttle the fledgling e-cig industry.

One odd thing about the FDA move to restrict import of the device was that the action was taken before the results of the tests which found detectable (but not hazardous) levels of carninogens were known. That report was dated May 4, 2009, several months after the import restrictions imposed by the FDA.

The import restrictions meant distributors could not fill orders from consumers interested in purchase and use of the e-cig. Faced with the prospect of losing their business, one distributor, Smoke Everywhere (SE), filed a lawsuit against the FDA on April 28, 2009. They claimed that the FDA had no authority to regulate the e-cig because it was a smoking product, not a drug therapy. In May, a second distributor (Njoy) joined the lawsuit.

This lawsuit was referred to in an e-mail sent to anti-smoking activists by the FDA on April 29, 2009: “Other background, hidden factors: Action involves three largest distributors. One of the distributors has just sued FDA seeking a restraining order to prevent us from holding their product at the border.”

The FDA e-mail advised anti-smoking activists of the plan for “enforcement action” to be taken against distributors. The correspondence, from Heather Zawalick, set the planned release date of the campaign as May 5, 2009. The plan was described in the e-mail. “Extensive rollout planned including press conference at HHS, press release, fact sheet, video for upload to YouTube, podcast, consumer article, consumer Q &A, key message points, internal media Q & A, Op-Ed, photos of products for posting on Internet.”

The FDA was, in effect, contemplating a full scale media blitz to discredit the e-cig and discourage it's use. The still unanswered question is why?

Many well known public health advocates had recognized the potential health benefits from the e-cig, and were endorsing it's use as an effective means to reduce the alleged harm of conventional cigarettes. So, why was (is) the FDA so intent on discouraging the distribution and sale of electronic cigarettes with their import restrictions and scare-mongering tactics ?

After receiving the e-mail outlining the agency's pending assault, some notable anti-smoking activists are known to have protested the proposed action.

Among them was Dr. Joel Nitzkin, the chair of the AAPHP (American Association of Public Health Physicians) Tobacco Control Task Force. His written response to the FDA began: “I must vigorously oppose the proposed FDA ban on electronic cigarettes”.

In his May 1, 2009 e-mail to Heather Zawalick , Dr. Nizkin pointed out the dismal success rate of NRT in smoking cessation (a 95% failure rate at 12 months). He also noted that: "As best we can tell, on the basis of currently available research data, these products promise a risk of illness and death well under 1% of the risk posed by cigarettes."

To put that number into perspective,Health Canada estimates 37,000 smoking related deaths annually in Canada. Reducing that number by 99% leaves a total of 370. The numbers are far greater in the US. The obvious question to be asked: Is ignoring the enormous potential to save tens of thousands of lives really in the best interests of the consumer?

Nitzkin also pointed out there there were other ways to deal with the FDA contention that the e-cig might encourage teens to become addicted to nicotine: “there are ways to address this . . . that would inhibit teen use of such products while allowing current adult smokers who are unwilling or unable to quit to enjoy the health benefits this product can offer.”

Dr. Nitzkin and other like-minded professionals were ignored.

The FDA press release, originally scheduled for May 5, 2009 was postponed to July 22, 2009, possibly to allow for passage of legislation giving the FDA regulatory control over tobacco products as well as drugs. Or, perhaps it was postponed to allow the FDA to complete preliminary tests to support their strategy of condemning the e-cig as unsafe.

By coincidence, the tests conducted by the FDA were conducted on samples of cartridges taken from the two distributors who had launched a lawsuit against the FDA (although only SE was party to the lawsuit at the time) . “The Center for Drug Evaluation and Research through the Office of Compliance (OC) has requested that the Division of Pharmaceutical Analysis (DPA) evaluate two brands of electronic cigarettes (e-cigarettes) for nicotine content and other impurities.”

Nor was the FDA free of outside influence when making their decision to denounce the electronic cigarette. In April, Action on Smoking and Health (ASH), a rabid anti-smoker organization, filed a legal petition demanding the FDA begin regulatory proceedings over the e-cig.

And, US Senator Frank Lautenberg wrote to the FDA in March: “I am writing to request that the Food and Drug Administration (FDA) take immediate enforcement action against manufacturers of “electronic cigarettes” and take these products off the market until they are proven safe.”

This overly-long ramble does not prove a conspiracy to undermine the electronic cigarette, nor is it meant to.

But, it does suggest that the FDA response to the introduction (and growing popularity) of the e-cig is not based on credible science. It does suggest that the FDA actions are driven by pressure from political and special interest groups, rather than concern for the public health. In fact, all the major anti-smoker groups, the ALA, CTFK, ACS, etc., support the FDA in their opposition to electronic cigarettes. And, the question, in light of all the evidence, remains: why?

At most, the preliminary tests conducted by the FDA demonstrate that there may be some (easily resolved) quality control issues with some e-cig manufacturers. But FDA efforts to cripple the industry are not in the best interests of the consumer.

The biggest fear of the FDA and the anti-smoker crowd appears to be that the electronic cigarette walks and talks like a duck. It looks like a cigarette, and to many, those who use it look like smokers. And, that's unacceptable to the anti-smoker crowd.

Additional reading:
Michael Siegel - FDA and Anti-Smoking Groups are Committing Medical Malpractise on a Massive Scale
StandFAST - Why anti-smokers oppose the e-cig