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.