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FDA Proposal for Deeming Regulation

Bill Godshall Commentary and Presentation

FDA proposes a deeming regulation that would give the e-cigarette industry to Big Tobacco, would ban >99% of vapor products two years after issuance of Final Rule, allows only 75 days for public comments (for complex 241 page regulatory proposal):

Smokefree Pennsylvania's Bill Godshall urges opposition to FDA deeming regulation at Food and Drug Law Institute's (FDLI) annual conference in DC (just before the regulation was proposed):

Impact of FDA Deeming Regulation on Public Health
FDLI Annual Conference
April 23, 2014
Washington, DC

Presentation by Bill Godshall
Executive Director
Smokefree Pennsylvania
1926 Monongahela Avenue
Pittsburgh, PA 15218
This email address is being protected from spambots. You need JavaScript enabled to view it.

Editor's Note
Please note that this presentation was given by Bill on the 23rd, the day before the FDA released its proposals for a deeming notice. Therefore, it is an analysis of the situation and not a specific response to the proposals. No doubt he will soon issue a commentary on that topic.

"For disclosure, neither I nor Smokefree Pennsylvania have ever received any funding from any tobacco, drug or electronic cigarette company or trade association.

According to the CDC, cigarette smoking causes 480,000 deaths annually in the US. In sharp contrast, the scientific and empirical evidence indicate that cigar smoking cause no more than several hundred deaths annually, smokeless tobacco causes no more than several dozen deaths annually, pipe smoking cause no more than several deaths annually, there's no evidence that e-cigarettes or dissolvables have ever killed anyone, and no evidence e-cigs or dissolvables cause any disease.

More than 99% of all tobacco attributable morbidity, mortality and health care costs in the US are caused by cigarette smoking, while <1% are caused by the combined use of smokeless tobacco, cigars, pipe tobacco and e-cigarettes.

But five years ago, FDA spokesperson Rita Chappelle revealed the agency's unscientific, unethical and inhumane policy to deceive Americans about e-cigs to defend the FDA's unlawful e-cig ban: "We don't want the public to perceive them as a safer alternative to cigarettes."

Unfortunately for smokers and public health, this is still an underlying policy of Obama's DHHS, which also deceptively claims that 'tobacco use' instead of 'œcigarette smoking' is the nation's leading cause of disease and death (including Mitch Zeller's slide during the last panel discussion).

For nearly thirty years, DHHS has claimed that smokeless tobacco is NOT a safe alternative to cigarettes despite epidemiologic evidence indicating smokeless tobacco is 99% less hazardous than cigarettes.

So nobody should be surprised, but everyone should be alarmed, that federal health officials have been deceiving smokers and the public to believe that all tobacco/nicotine products are as hazardous as cigarettes, except for the nicotine products marketed by drug companies, which DHHS deceptively promotes as the most effective ways to quit smoking even though gums, lozenges and patches have a 95% failure rate as smoking cessation aids. The growing mountain of scientific and empirical evidence consistently indicates that e-cigarettes are 99% (+/-1%) less hazardous than cigarettes, and are consumed almost exclusively (i.e. 99%) by smokers and exsmokers who switched. E-cigs have helped several million smokers quit smoking or sharply reduce their cigarette consumption, and have replaced nearly one billion packs of cigarettes in the US during the past eight years.

The evidence also indicates that e-cigs are more effective than FDA approved NRT products for smoking cessation and reducing cigarette consumption, and e-cigs pose fewer safety risks than FDA approved Chantix.

E-cigs emit similar trace levels of constituents as FDA approved nicotine inhalers and pose no air pollution risks to nonusers. And in sharp contrast to claims by CDC Director Tom Frieden, e-cigs haven't been found to create nicotine dependence in any nonsmoker, e-cigs haven't been found to precede smoking in any daily smoker, and there's no evidence that ingesting nicotine or e-liquid has ever killed anyone.

Since e-cigs have already helped a million smokers quit smoking and since e-cigs are 99% less hazardous than cigarettes, the only way public health could be negatively impacted by e-cigs is if 100 million nonsmokers begin vaping and no more smokers do so, which isn't going to happen. Same thing for smokeless tobacco products.

In sum, there is no evidence that public health would benefit if FDA imposes the deeming regulation, which the agency has stated its intent to impose since 2011. And yet, the FDA continues to falsely claim that all of its regulations are based upon scientific evidence.

To its credit, the FDA did remove a false statement from its website stating: "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." But DHHS has never corrected its many other false and misleading claims about e-cigs, smokeless tobacco or cigars, although Mitch Zeller has acknowledged there is a continuum of risk.

So what would be the impact of the deeming regulation?
Sections 905(j) and 910 would ban ALL e-cigarettes, cigars, pipe tobacco and dissolvable products because the manufacturers didn't file Substantial Equivalence reports with FDA before the May 2011 deadline, and because no e-cig products on the market today are Substantially Equivalent to a product on the market before February 15, 2007.

So while Judge Leon's 2010 ruling overturning the FDA's unlawful e-cig ban and the largely free market have enabled vapor products to significantly benefit the health of many smokers during the past several years, the FDA deeming regulation would not only halt, but would reverse all that progress because many vapers would return to cigarettes.

To avoid losing another lawsuit, FDA might exempt e-cigarettes, cigars and other currently unregulated products from these 2007 and 2011 deadlines. But even if FDA changes these deadlines for newly regulated products, all e-cigarette products would be banned once Premarket Tobacco Applications are required for e-cigarettes.

The FDA has not yet approved any Premarket Tobacco Applications or any MRTP applications, and it could cost manufacturers millions of dollars to file each application. Recently the FDA announced that it has refused to accept four Premarket Tobacco Applications, as well as six of the seven submitted MRTP applications (with the seventh withdrawn by the manufacturer).

The FDA has also announced that it issued 17 SE orders and 17 NSE orders, that 334 SE reports were withdrawn by the manufacturer, and that the agency refused to accept 36 letters requesting an exemption from filing a SE report. Meanwhile, the FDA still hasn't taken action on more than 3,000 SE reports filed for products back in 2011, and still hasn't proposed new color graphic warnings for cigarettes packs (after a federal court struck down the agency's previously approved warnings as unconstitutional), which were required by Congress in the TCA.

The TCA requires the FDA to consider the potential impact of black markets before approving new tobacco product regulations. Since FDA's 2009 e-cigarette import ban created a thriving and rapidly growing black market for e-cigarettes, the FDA 'deeming' regulation could create a significantly larger black market since far more e-cig products are consumed now.

Unless the FDA exempts e-cigarettes from Section 911, manufacturers and importers would be prohibited from truthfully informing smokers that their products are less hazardous than cigarettes. And unless the FDA extends the smokeless tobacco exemption in 911(b)(2)(C) to e-cigarettes, manufacturers couldn't even truthfully claim that e-cigarettes are "smoke free" or emit "no smoke".

Since the TCA defines a 'Tobacco Product' as "any product made or derived from tobacco that is intended for human consumption, including any component, part, or accessory of a tobacco product", the FDA 'deeming' regulation would also apply to e-cigarette hardware, cartridges, batteries and rechargers.

The deeming regulation would reduce the number of legal e-cig manufacturers from more than a thousand to less than a half dozen, and would reduce the number of legal e-cig products from tens of thousands to less than a half dozen. In sum, the deeming regulation would decimate the e-cig industry and give it to Altria, Reynolds, Lorillard, and maybe one or two large e-cig companies, and could have similarly devastating impacts on cigar and pipe tobacco companies and products.

If FDA bans the sale of e-liquid or flavorings to consumers, it would ban the most effective smoking cessation products, as most vapers who quit smoking use mods and e-liquid instead of cigalike e-cigs. If FDA applies the same or similar advertising and marketing restrictions to e-cigs that are now imposed on cigarettes and smokeless tobacco products, fewer smokers would switch to e-cigs. All FDA regulations on e-cigs would also increase the price of e-cigs that are allowed on the market. But none of these changes would benefit public health.

During the past 20 years, J & J, GSK, Pfizer and other drug companies have given several hundred million dollars to CTFK, ACS, AHA, ALA, AMA, Pinney Associates (which employed Mitch Zeller for most of the past decade) and others to promote FDA approved drugs as the only effective way to quit smoking, and to demonize and lobby for bans and/or unwarranted regulations on smokeless tobacco products, dissolvables, and e-cigarettes.

32 states have now banned the sale of e-cigs to minors, and many more would have done so by now had it not been for opposition lobbying by CTFK, ACS, AHA, ALA, which have been opposing bills to ban e-cig sales to minors in about a dozen states.

Since it is likely to take two years before the FDA deeming regulation takes effect, everyone who truly desires to ban e-cig sales to minors should be supportive of these state laws. But we haven't heard the FDA, CDC, Senator Durbin, Rep Waxman or other proponents of the FDA deeming regulation urge states to ban e-cig sales to minors because most of them want FDA to once again ban e-cig sales to adults (under the false guise of protecting the children).

Please note that the US DOT still hasn't issued a final rule on the airline vaping ban it proposed back in 2011.

Smokers have a human right to truthful health information and legal access to less hazardous alternatives. Similarly, public health officials have an ethical duty to inform smokers that all smokefree tobacco and nicotine products are far less hazardous alternatives to cigarettes, and to keep all less hazardous alternatives legal and affordable for smokers.

The actions and misleading claims by DHHS on smokeless tobacco and e-cigs are probably the most egregious public health malpractice ever committed by the US government, as the 45 million smokers whose lives DHHS has jeopardized far exceed the number of victims of the US Public Health Service's infamous Tuskegee syphilis study.

Instead of proposing, and instead of issuing a final rule for the deeming regulation, the FDA should complete the tasks mandated by Congress in the TCA, and should begin to truthfully informing smokers and the public that all smokefree tobacco and nicotine products are far less hazardous alternatives to cigarettes.

The free market for e-cigs has saved the lives of many smokers and will continue doing so. In sharp contrast, the FDA deeming regulation and other e-cig regs would protect cigarette markets and large cigarette companies, while threatening the lives of vapers, smokers and secondhand smokers.

Thank you."

- Bill Godshall