Tuesday, August 03, 2010

FDA Reply Brief in NJOY Electronic Cigarette Case is Not Compelling Because It Ignores FDA Tobacco Law

The Food and Drug Administration (FDA) has filed its reply brief, which responds to NJOY's brief submitted to the D.C. Court of Appeals. The case involves the issue of whether the FDA has the authority to regulate electronic cigarettes as drugs/devices under the Food, Drug, and Cosmetic Act (FDCA) or whether it instead must regulate electronic cigarettes as tobacco products under the Family Smoking Prevention and Tobacco Control Act (heretofore referred to as the Tobacco Act).

As I explained previously, NJOY's argument is that its electronic cigarettes are not drugs and devices under FDCA because they are not marketed for use with a medicinal or therapeutic purpose. They are, instead, marketed as an alternative form of smoking. NJOY argues that there is a substantial history of judicial interpretation of the FDCA as well as Agency interpretation and implementation of the FDCA which establishes that affecting the structure or function of the body is not enough for a device to be regulated under FDCA. It also must be intended for a medicinal or therapeutic purpose, as indicated by marketing claims. Because NJOY makes no claim that its electronic cigarettes are intended for smoking cessation (a point apparently conceded by FDA), it argues that its products do not meet the criteria for regulation under the FDCA.

In its reply, FDA offers two main counter-arguments.

First, FDA argues that under FDCA, a product need not be marketed with a medicinal or therapeutic claim in order to be considered a drug or device. It must simply affect the structure or function of the body: that is, it must have a physiologic effect, even if there is no marketing claim that the product is intended to treat, prevent, or cure a particular condition.

Second, FDA argues that smoking pleasure cannot be divorced from the pharmacologic effects of nicotine, so the fact that electronic cigarettes are marketed as a smoking alternative does not take away the fact that these products are intended to deliver the pharmacologic effects of nicotine.

The Rest of the Story

Let me explain why I believe the FDA's argument is flawed.

The problem inherent in the FDA's argument is that the FDA is reading the FDCA divorced from the Tobacco Act. In other words, FDA is attempting to interpret the FDCA as if the Tobacco Act were never enacted. However, the Tobacco Act is now in force. Thus, any current reading of the FDCA must interpret it in light of the existence of the Tobacco Act. They must be read and interpreted together, as co-existing laws that define the regulatory structure of tobacco products, drugs, devices, and drug-device combinations. In fact, the Food, Drug, and Cosmetic Act has actually been amended to contain the Tobacco Act. So they are not even two separate laws. The Tobacco Act is a part of the Food, Drug, and Cosmetic Act. In fact, the Tobacco Act is officially Subchapter IX of the Federal Food, Drug, and Cosmetic Act.

Given that these two Acts must be read together, one must first consider the definition of a tobacco product under the Tobacco Act (i.e., under Subchapter IX of the FDCA). A tobacco product is: "any product made or derived from tobacco that is intended for human consumption, including any component, part, or accessory of a tobacco product (except for raw materials other than tobacco used in manufacturing a component, part, or accessory of a tobacco product)." However, "the term ‘tobacco product’ does not mean an article that is a drug under subsection (g)(1), a device under subsection (h), or a combination product described in section 503(g)."

Because electronic cigarettes have as one component nicotine that is derived from tobacco, they constitute a tobacco product under section (rr)(1) of the Tobacco Act. To determine whether electronic cigarettes are a drug delivery device, and therefore not a tobacco product under section (rr)(2), one must examine the intent of Congress in enacting the Tobacco Act.

The FDA argues that electronic cigarettes are a drug delivery device because they deliver nicotine, which has pharmacologic effects, and that smoking satisfaction or pleasure cannot be divorced from these pharmacologic effects. In putting forward this argument, the FDA incorrectly interprets the law because it ignores the fact that the Tobacco Act is now the law of the land. The former law, under FDCA alone, is not the law which the D.C. Court of Appeals must consider. The law which the Court must consider is the current law, which includes the Tobacco Act.

The clear intent of Congress under the Tobacco Act is to consider products whose primary purpose is to produce satisfaction or pleasure from the recreational use of nicotine as tobacco products and not as nicotine delivery devices subject to regulation under subchapter V. It is indisputable that Congress intended for cigarettes and smokeless tobacco products to remain defined as tobacco products and not as drug delivery devices, even though they deliver nicotine, which is has pharmacologic effects and even though “smoking ‘satisfaction’ or ‘pleasure’ cannot be divorced from the pharmacological effects of nicotine.” Had Congress intended for any device which delivers nicotine for pleasure to be considered a drug delivery device, it would have indicated such. Instead, Congress made it eminently clear that the delivery of nicotine alone is not sufficient for a device to be considered a drug delivery device. Cigarettes and smokeless tobacco both deliver nicotine – which has pharmacologic effects – but neither is considered a drug delivery device. Clearly, to be considered a drug delivery device under the Tobacco Act, a product that otherwise meets the definition of a tobacco product must do more than simply deliver nicotine.

The FDA’s reply brief misses this critical point. Pages 13-15 – in which the brief argues that electronic cigarettes are drug delivery devices because they deliver a pharmacologically active substance with significant physiologic effects (nicotine) — are irrelevant to the case because the delivery of nicotine is not by itself enough to categorize a nicotine-delivering product as a drug delivery device.

What is the additional characteristic that a nicotine-delivering product must have in order to be considered a drug or device? The product must also be marketed with a medicinal or therapeutic claim. This is why Congress intended nicotine replacement products – such as nicotine gum, nicotine patches, and nicotine inhalers – to be regulated under the drug/device provisions of the FDCA, rather than under the tobacco product provisions. These products are marketed to treat a particular medical condition: nicotine dependence. They are marketed to produce a particular therapeutic effect: smoking cessation. They are also marketed to prevent certain physical symptoms: those of nicotine withdrawal. It is these additional medicinal and therapeutic claims which make NRT products drugs or devices under the amended FDCA, rather than tobacco products.

Remember that under the Tobacco Act, NRT products meet the definition of tobacco products under section (rr)(1). The reason that section (rr)(2) kicks in is that these products are marketed for more than simply the recreational delivery of nicotine. They are not marketed as smoking alternatives. They are marketed specifically for smoking cessation and the treatment of nicotine dependence and nicotine withdrawal.

Using the reasoning put forward in the FDA’s reply brief, any product which meets the definition of a tobacco product under section (rr)(1) would also meet the definition of a drug or device under section (rr)(2) because it delivers nicotine, which is intended to affect the structure and function of the body and which has significant physiologic effects. The FDA’s argument that to be considered a drug or device, the product need not be intended for a therapeutic use is fallacious. Such an interpretation of the Tobacco Act would render the entire Act meaningless.

Thus, the FDA’s first argument – that electronic cigarettes are drug delivery devices because any nicotine-delivering product is a drug delivery device, regardless of whether it is intended for therapeutic or merely recreational use – is fallacious because it is inconsistent with the clear intention of Congress in enacting the Tobacco Act. The argument essentially ignores the Tobacco Act altogether, attempting to interpret the meaning of a drug or device under the original FDCA, as if it had not been amended by the Tobacco Act.

The FDA’s first argument is also fallacious because it would lead to the absurd result that every product which affects the structure or function of the body is a drug or device. A barbell, for example, would be a device because it affects the structure or function of the body by building muscle mass.

In providing examples to show that the FDA regulates products which are not therapeutic, the reply brief points to weight reduction products and birth control pills. These are incorrect examples, because weight reduction products do serve an important medicinal purpose: they reduce weight which lowers the risk for disease. Birth control pills also serve an important medicinal purpose: they prevent pregnancy and treat a number of gynecologic conditions. Other examples provided by the FDA are similarly poor. Breast implants, Botox, and hair growth products serve medicinal purposes.

Perhaps part of the problem is that the reply brief is unnecessarily narrow in its interpretation of the term “therapeutic.” NJOY is not claiming that a product has to be marketed with a disease-curing claim to be regulated as a drug or device; it also allows that a product could be marketed with a medicinal or remedial claim. It could be a remedy for unwanted hair, for example.

The FDA’s reliance only on the term “therapeutic” without also considering the term “medicinal” is the reason for its fallacious set of examples purporting to show that the FDA routinely regulates products without any therapeutic purpose. Without a therapeutic purpose? Perhaps. But without a therapeutic or medicinal purpose? No.

This also explains why the FDA’s other example – that of its regulation of street drug alternatives – is also a flawed one. These products are sold with a clear medicinal purpose: to induce a “high.” It may not be a “therapeutic” purpose in that it is not curing a disease, but it certainly is a “medicinal” purpose in that it is creating a state of drug intoxication, hallucinations, and/or euphoria. The very fact that these products are designed to “mimic” psychoactive drugs is an indication that they are sold with a “medicinal” type of intent.

There is, therefore, no inconsistency in NJOY’s argument that drugs and devices regulated by the FDA are almost uniformly intended to serve some therapeutic or medicinal purpose. You will note that in putting forth this argument in the reply brief, the FDA conveniently left out the word “medicinal” and only included the term “therapeutic.” But the NJOY brief clearly included both terms: “FDA has previously acknowledged the absurdity of that position and has almost uniformly restricted its regulatory actions to articles that have a therapeutic or medicinal use.”

The FDA also asks the Court of Appeals to interpret the law historically, rather than the intent of Congress clearly expressed by the Tobacco Act enacted in 2009, in arguing that the Brown & Williamson decision dictates Congress' regulatory scheme for various types of nicotine-delivering products (see page 20 of the reply brief). While Congress may not previously have developed an alternative regulatory scheme for products that deliver nicotine but are not "cigarettes and smokeless tobacco products," it certainly has now. In enacting the Tobacco Act, Congress provided for comprehensive regulation of all nicotine delivering products under one of two schemes: either the FDCA or the Tobacco Act.

Had Congress only intended to address the regulation of cigarettes and smokeless tobacco products, it would have defined tobacco products to include only "cigarettes and smokeless tobacco products." Instead, however, Congress defined tobacco products as "any product made or derived from tobacco." Clearly, this includes all nicotine-delivering products. The key question is whether a nicotine delivering product is merely a tobacco product under section (rr)(1), or whether it is also a drug or device under the superseding section: (rr)(2).

As I have argued above, the only rational interpretation of the intent of Congress is that it meant to have nicotine delivering products that make a therapeutic or medicinal claim regulated as drugs/devices, and nicotine delivering products that make only recreational claims regulated as tobacco products.

Two other serious problems with the FDA's reply brief warrant mention.

First, the FDA wildly misstates the purpose of NJOY electronic cigarettes. On page 19, the brief states: "But there is not -- and has never been -- a congressional policy of protecting the importation of battery-operated cartridges filled with liquid nicotine for the purpose of addicting new users." This statement relies upon the assertion that NJOY's purpose in marketing its products is to get consumers addicted to nicotine.

If that were the case, then NJOY would most certainly not market a zero-nicotine cartridge. That NJOY markets a zero-nicotine cartridge is evidence that the company's intent is to provide an alternative smoking device that gives consumers maximum ability to decide what type of smoking experience they want to have, even to the point of deciding whether or not they want nicotine in the cigarettes. This hardly seems like a ploy to addict consumers to nicotine.

Similarly, on page 26, the reply brief asserts: "Nothing in the new law remotely supports an injunction intended to allow the importation of battery-powered nicotine-delivery devices aimed at 'encouraging nicotine use.'" NJOY's products are not intended to "encourage nicotine use" but to provide an alternative source of nicotine delivery for consumers who are already addicted to nicotine. And in some cases, to provide a non-nicotine smoking alternative for consumers.

Second, the FDA's final argument is that continued use of NJOY's products would cause immediate and irreparable harm to the public's health (see pages 24-26). However, nowhere in this section does the reply brief provide credible evidence to show exactly how the public's health will be harmed. The brief, for example, warns that youth will find electronic cigarettes attractive and become addicted to nicotine. However, it does not provide any evidence that even a single youth has ever used an electronic cigarettes. Similarly, the brief warns that the cartridges may kill people because nicotine is toxic. Yet the brief fails to provide a single example of toxicity caused by ingestion of an electronic cigarette cartridge. The burden of proof is on the Agency to show that continued use of electronic cigarettes will produce immediate and irreparable harm, but it fails to produce any credible evidence to support such a claim.

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