Federal Officials Endorse Impossibly High Standard for E-Cigarettes

NPR host Diane Rehm on August 5 discussed “Smoking in America Today” with Dr. Tim McAfee, Director of Office of Smoking and Health at the Centers for Disease Control and Prevention; Mitch Zeller, Director of Center for Tobacco Products at the FDA; Dr. Thomas Glynn, Director of Cancer Science and Trends at the American Cancer Society; Michael Felberbaum, journalist covering tobacco for the Associated Press; and Craig Weiss, President and CEO of e-cigarette maker NJOY (program available here).

The federal officials and Dr. Glynn held essentially identical views on e-cigarettes, providing a strong signal that FDA regulation is likely to be burdensome or even punitive.

Early in the program, Rehm asked about relative risk: “Is there any evidence whatsoever from the public health community regarding electronic cigarettes and whether they are in fact safer than tobacco products?”

The CDC’s McAfee gave an extended answer, starting with: “Well, there’s several different ways that we’re thinking about this, we think it’s an incredibly important question.”  Important, but unanswered, as Dr. McAfee shifted to the familiar cigarette mantra: “… we need to focus on the harm that’s caused by cigarette smoking, and ways to get smokers to quit and to prevent nonsmokers from starting.”  As for e-cigarettes, “.. the challenge is that we don’t yet know how e-cigarettes are going to completely fit into that.  The availability of a cigarette alternative that does deliver nicotine without also delivering harmful by-products of combustion… could this play a beneficial role in reducing tobacco-related death and disease?  This would be especially true if a large number of smokers successfully switched completely to e-cigarettes, either permanently or as a transition phase to nicotine abstinence.”

Dr. McAfee expressed concern that alternative tobacco products might foster dual use, prevent smoking cessation and serve as a gateway to smoking for new users and former smokers. “… The other alternative is that the availability of e-cigarettes could result in harm by increasing the initiation of cigarette use among youth and young adults or by delaying quitting among smokers who, rather than switching, engage in dual use, which currently looks like that’s the majority situation.  People are using them in situations where it’s hard to smoke cigarettes.  And we see ex-smokers think ‘Hey, maybe I can go back to e-cigarettes,’ and that re-kindles their nicotine addiction.  And they actually start smoking cigarettes themselves.”    

Regulator Zeller returned to these themes later in the program.  He alluded to, but never quite acknowledged, the vast difference in risk between traditional and electronic cigarettes: “The thing that’s most interesting about e-cigarette is that we look at individual-level risk, what is the risk, say, to a current smoker who would be otherwise unable or unwilling to quit, if that person completely substituted all of their conventional cigarettes for an e-cigarette, that’s individual-level risk.”

However, he made clear that FDA regulation isn’t about individual smokers: “… Policy is going to be made here at the population level, and there’s population-level harm.  Who is actually using these products?  And how are they being used?  Tim [McAfee] talked about this earlier.  Are current smokers going to be less inclined to quit, and more likely to engage in what we call dual use of both the combustible version and the electronic version?  Are kids going to start using e-cigarettes?  These are the kinds of questions that we have that ultimately comes down to behavior, and right now we have far more questions than answers.”

I discussed in 2010 scientific evidence documenting that a population-level evidentiary standard was “unattainable” (here).  I also said that the standard was unprecedented.  The FDA has regulatory authority over other consumer items – food, cosmetics, drugs, medical devices and vaccines.  FDA regulations assure that drugs, medical devices and vaccines provide the intended medical benefit.  Far more importantly, they assure that all of these products are safe to consume.  The FDA does not traditionally compromise individual safety with a population standard.

Today, the FDA also regulates tobacco products.  One of these (the cigarette) is highly toxic, killing over 400,000 Americans every year.  When the FDA asserts regulatory authority over e-cigarettes, it would be criminal to use an arbitrary population standard to deny American smokers access to these products. 

The E-Cigarette Revolution

Richard Craver, a writer for the Winston-Salem Journal, recently described the growing popularity of e-cigarettes (here).  Bonnie Herzog, a Wells Fargo security analyst who has followed the tobacco industry for many years, described e-cigarettes as “here to stay,” suggesting that sales would reach $1 billion within a few years.  In an August research note to investors (here), Herzog predicted that e-cigarette sales could surpass combustible cigarettes within ten years.

These predictions are based on impressive increases in e-cigarette sales since 2008.  The chart illustrates UBS data presented by NJOY CEO Craig Weiss during a conference call with Goldman Sachs on December 14.  U.S. e-cigarette sales totaled $20 million in 2008; they have doubled each subsequent year, to $500 million in 2012.  As Weiss noted, the explosive growth occurred even as the category was inundated with low-quality products that provided a suboptimal experience to smokers.  That problem is being resolved by substantial investment in quality improvement.  NJOY, which has a 40% share of convenience store e-cigarette sales, introduced King (here), describing it as “the first electronic cigarette with the look, feel and flavor of the real thing.”

 

Product improvements can be expected because cigarette manufacturers are also investing in the category.  In April, Lorillard purchased Blu (here), and Craver reports that the company has invested $40 million in a marketing campaign.  In July, Craver reported that RJ Reynolds launched e-cigarette Vuse in limited test markets in Virginia and North Carolina (here). 

British American Tobacco announced on December 19 that it had purchased CN Creative (here).  This company makes the Intellicig e-cigarette brand (here) and Ecopure nicotine solution (here), which it says is produced with pharmaceutical- and food-grade products and undergoes stringent testing.  BAT also owns Nicoventures (here), a company devoted to providing “…a new choice to smokers looking for a safer alternative to cigarettes.  Nicoventures will focus exclusively on the development and commercialization of innovative regulatory approved nicotine products that provide a consumer-acceptable alternative to cigarettes without the serious risk to health of smoking.  We want to explore the development of innovative nicotine products that, subject to regulatory approval, will provide smokers with an alternative to cigarettes and a product they actually want to use.”

Wells Fargo’s Herzog also notes that the steep decline in cigarette consumption will affect state payments from the 1998 Master Settlement Agreement.  While cigarette manufacturers promised to pay the 46 MSA states about $206 billion over more than 20 years, their payments will be reduced if cigarette sales decline.  This could lead state governments to impose excise taxes on e-cigarettes to cover those losses. 

So far, e-cigarettes have avoided excise taxes because they are not classified as tobacco products.  However, in 2011, federal courts ruled that e-cigarettes are tobacco products (here), so the “excise tax honeymoon” that e-cigarettes and their users have enjoyed won’t last forever.    

The tobacco harm reduction revolution is unstoppable, and e-cigarettes are poised to play a major role.  State legislators can facilitate smokers’ switch to healthier e-cigarettes by keeping excise taxes low, or nonexistent.

Federal Appeals Court to FDA: E-Cigarettes Are Tobacco Products, Not Medicines

One month ago a federal appeals court affirmed Judge Richard Leon’s decision requiring the FDA to regulate e-cigarettes as tobacco products, rather than as drug-delivery devices, as the agency had attempted to do. This week the appellate court rejected the FDA’s request to review the decision, so the only remaining option for the agency is to appeal to the Supreme Court (here).

The FDA had decided that e-cigarettes were being sold without sufficient evidence of safety and efficacy – the expensive and time-consuming regulatory challenge that all drug manufacturers must address. The agency had begun seizing shipments, triggering the suit.

As I noted one year ago (here), Judge Leon found that the 2009 “Tobacco Act applies to ‘tobacco products,’ which Congress defined expansively as ‘any product made or derived from tobacco that is intended for human consumption’…Congress enacted the Tobacco Act to confer FDA jurisdiction over any tobacco product – whether traditional or not – that is sold for customary recreational use, as opposed to therapeutic use. As such, the Tobacco Act, in effect, serves as an implicit acknowledgment by Congress that FDA's jurisdiction over drugs and devices does not, and never did, extend to tobacco products, like electronic cigarettes, that are marketed in customary fashion for purely recreational purposes.”

The reaction from nicotine prohibitionists has been predictable. Matthew Myers, president of the Campaign for Tobacco-Free Kids, called the decision “wrong on the law, wrong on the facts…” and he urged “the government to appeal this ruling.”

Why is Mr. Myers so upset? According to the New York Times, he was a primary author of the Tobacco Act (link here). The legislation placed “any product made or derived from tobacco that is intended for human consumption” under FDA control.

It is wonderful irony that the courts have interpreted Myers’ legislation to free a potentially broad array of recreational nicotine products from drug regulation. It is also a dramatic, positive development for tobacco harm reduction, public health and millions of inveterate smokers, effectively accomplishing what I first advocated in 1995 – deregulation of nicotine. (link here)

This week I was interviewed about the e-cigarette issue by www.AllTreatment.com, which focuses on ways of making treatment and recovery more accessible to anyone struggling with addiction. That interview is available here.

Federal Judge to FDA: E-Cigarettes Are Tobacco Products, Not Drugs or Devices

On January 14, federal judge Richard J. Leon ruled that the FDA does not have the authority to regulate e-cigarettes as drug-delivery devices. (The 32-page opinion, available here is required reading for anyone interested in American tobacco policy). In addition to being a victory for e-cigarette manufacturers, this decision has enormous positive implications for tobacco harm reduction and for American smokers.

In 2008 and 2009, the FDA detained e-cigarette shipments being imported by two American distributors, Smoking Everywhere and NJoy, on the grounds that the items were unapproved drug-delivery devices. Judge Leon ordered that “the FDA shall not detain or refuse admission into the United States of [Smoking Everywhere's and NJoy’s] electronic cigarette products on the ground that those products are unapproved drugs, devices, or drug-device combinations.”

The judge found that the 2009 “Tobacco Act applies to ‘tobacco products,’ which Congress defined expansively as ‘any product made or derived from tobacco that is intended for human consumption’…Congress enacted the Tobacco Act to confer FDA
jurisdiction over any tobacco product – whether traditional or not – that is sold for
customary recreational use, as opposed to therapeutic use. As such, the Tobacco Act, in effect, serves as an implicit acknowledgment by Congress that FDA's jurisdiction over drugs and devices does not, and never did, extend to tobacco products, like electronic cigarettes, that are marketed in customary fashion for purely recreational purposes.”

Finding that e-cigarettes, like all tobacco products, are subject to FDA oversight but fall outside of both drug and device categorization, Judge Leon characterized the FDA’s attempt to apply pharmaceutical standards to e-cigarettes as “bootstrapping run amuck.”

Judge Leon’s decision was not popular with tobacco prohibitionists. Matt Myers, president of the Campaign for Tobacco-Free Kids, seethed: “"Nicotine in products currently regulated as drugs and devices is derived from tobacco products, but that doesn't make them tobacco products.” The federal court, thankfully, found otherwise.

According to the New York Times, Myers was a primary author of the Tobacco Act. His goal was to cast the regulatory net widely and subject all tobacco-related products to FDA control. It is therefore ironic that the court has interpreted his legislation to free a potentially broad array of recreational nicotine products from the most stringent categories of regulation.

Judge Leon’s opinion may open up other commercial opportunities for recreational nicotine. Currently, pharmaceutical companies market nicotine gum, patch and lozenges as temporary “medications” for smokers who are attempting to achieve nicotine abstinence, the holy grail of tobacco prohibition. This has been an utter disaster, since the products are successful for only about 7% of smokers who try them, as I explained in a previous post. In addition, the FDA has refused to respond to a petition by New York State Commissioner of Health Richard Daines to revise package labeling and sale of nicotine that would greatly expand consumer awareness and availability.

But Judge Leon’s decision removes nicotine from FDA jurisdiction as a medicine as long as no therapeutic claims are made. If this ruling stands, it will allow pharmaceutical companies to reposition nicotine gum, patches and lozenges as recreational devices with higher doses that satisfy smokers, and sell them at prices competitive with cigarettes. This would liberate nicotine from the onerous and unnecessary restrictions and warnings currently mandated by the FDA.

This would be a revolutionary development for tobacco harm reduction. It would in effect accomplish what I first advocated in 1995 – deregulation of nicotine.

The FDA Crusade Against E-Cigarettes

On July 22, 2009, the FDA released the results of laboratory tests of e-cigarettes, which were conducted by the Division of Pharmaceutical Analysis at the FDA’s Center for Drug Evaluation and Research. In a press release, the FDA said: “These tests indicate that these products contained detectable levels of known carcinogens…” The FDA report can be downloaded here.

For many years, I have investigated the cancer risks of cigarette smoking and smokeless tobacco use. As I wrote in a recent post, the FDA has never regulated nicotine effectively, and the agency had previously signaled its intention to ban e-cigarettes. So while the agency’s new analysis of e-cigarettes comes as no surprise, it does undermine the assumption that the FDA bases it oversight activities purely on scientific principles.

The FDA analyzed 18 cartridges from two e-cigarette manufacturers, Smoking Everywhere and Njoy (there are many other manufacturers). With respect to “carcinogens,” the agency looked at four tobacco-specific nitrosamines (TSNAs) with very long chemical names; I’ll abbreviate the agents here as NNN, NNK, NAT and NAB.

I have some experience with TSNAs, since I participated in a project with a scientist at the Swedish National Food Administration to measure the levels of these agents in smokeless tobacco products. Our research showed that TSNAs are present in most American tobacco products at extremely low levels, about 0.1 to 12 parts per million by weight. At this level of TSNAs, someone who puts 1 gram (about 1/28th of an ounce) of smokeless tobacco in his mouth is exposed to, at most, about 10 one-millionths of a gram of TSNAs. There is abundant scientific evidence that exposure at this minuscule level is not associated with ANY cancer in smokeless tobacco users.

The FDA analyzed 14 products from Smoking Everywhere, but the agency only reported the TSNA levels for 7 of those products. Why did the FDA test only half of the company’s products for carcinogens? And how did they choose those products? There are some clues in the report. First, the products that weren’t tested simply had blank boxes in the results chart. A footnote says, “Open boxes indicate the sample was not available for testing.” Another note in the methods section admitted that “…not all sample lots were available for analysis…as they were consumed in other testing.” In other words, the FDA didn’t purchase enough of the products to conduct the testing in a systematic and scientific manner. Maybe it’s a budget problem. On the Smoking Everywhere website cartridges are $9.99 each.

The FDA tested 3 out of 4 Njoy products for TSNAs.

What the FDA didn’t test is even more important than what the agency tested. The report noted that the “Nicotrol Inhaler, 10mg cartridge was used as a control for some test methods.” That inhaler is a pharmaceutical nicotine product that is regulated by the FDA, but the agency didn’t test the product for TSNAs. This is a critical omission, because in 2006 a published research study revealed that pharmaceutical nicotine products contain TSNAs. In fact, it’s been known for almost 20 years that nicotine medications contain TSNAs.

Why did the FDA analyze e-cigarettes for carcinogens, when there is no evidence the agency ever conducted carcinogen studies of products that they have regulated for over 20 years? Is it possible that the FDA approved medicines that contained TSNAs, but the agency is now disapproving e-cigarettes because they contain the same contaminants? To answer this important question, we have to know how high – or how low – the TSNA levels are in these products.

Unfortunately, the agency did not report TSNA levels. Instead, it reported that TSNAs were either “Detected” or “Not Detected,” which is entirely inadequate. For hundreds of years, one of the basic tenets of medicine has been “the dose makes the poison.” Mere detection of a contaminant is meaningless; the critical question is: At what concentration is it present?

So what does “Detected” mean in the FDA analysis? In other words, what was the lowest TSNA concentration that the test detected?

As I noted earlier, many tobacco products have TSNA levels in the single-digit parts per million range, a level at which there is no scientific evidence that TSNAs are harmful. According to the report, the FDA used an analytic method published in 2008. The report notes that “the published method is quite sensitive for the TSNAs…” and it goes on to explain that the level of detection is 40 parts per TRILLION.

The implications of this are astounding. Apparently, the FDA tested e-cigarette samples using a method that detects TSNAs at about 1 million times lower concentrations than are even possibly related to human health.

In summary, the FDA tested e-cigarettes for TSNAs using a questionable sampling regimen, and methods that were so sensitive that the results may have no possible significance to users. The agency failed to report specific levels of these contaminants, and it has failed to conduct similar testing of nicotine medicines that have been sold in the U.S. for over 20 years.

These are not the actions of an agency that is science-based and consumer-focused. These pseudo-scientific actions are clearly intended to form the justification for banning a category of products that are probably 99.9% safer than cigarettes. According to Dr. Murray Laugesen, a respected New Zealand researcher, “Simply banning e-cigarettes will simply consign thousands of e-smokers back to smoking tobacco and an early death.”

The FDA and anti-tobacco extremists who support it should be held accountable for their prohibitionist actions.

The FDA has a legitimate interest in two matters involving e-cigarettes: assuring that cartridges contain the advertised quantity of nicotine, and that they do not contain contaminants.

I welcome the FDA to correct any errors in this critique. I attempted but was unable to reach the scientist who conducted the analyses.