NJOY - an importer and distributor of electronic cigarettes - has filed a cogent brief with the DC Court of Appeals in which it compellingly argues that the FDA lacks authority to regulate electronic cigarettes as drugs or drug/delivery devices because NJOY does not market these products as treating smoking dependence.
I will attempt to explain the legal reasoning provided in the brief by outlining, in logical order, four critical points.
1. Electronic cigarettes are clearly defined as "tobacco products" under the law.
The Family Smoking Prevention and Tobacco Control Act (heretofore referred to as the Act) 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 (except for raw materials other than tobacco used in manufacturing a component, part, or accessory of a tobacco product)."
Because electronic cigarettes have as one component nicotine that is derived from tobacco, they constitute a tobacco product under the Act.
2. In order for a product defined as a "tobacco product" to be regulated as a drug or drug/device combination, it must meet the definition for a drug or drug/device and must fit into the regulatory scheme established under the Food, Drug, and Cosmetic Act (FDCA), as interpreted by the Agency and the courts.
The Act makes it clear that even if a product meets the definition of a "tobacco product," it still may be regulated under the FDCA if it also meets the definition of a drug, device, or drug/device combination. The Act states: "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)."
What readers need to understand, however, is that there is a history of Agency actions and court rulings relevant to the interpretation of the definition of what constitutes a drug, device, or drug/device combination under FDCA, and these actions and rulings must be considered in deciding whether electronic cigarettes fit the definition.
3. The FDCA has been interpreted, both by the Agency and by the courts, as defining drugs, devices, and drug/device combinations as articles that not only are intended to affect the structure and function of the body or to prevent, treat, or cure a disease, but also are marketed with a therapeutic or medicinal purpose or claim.
The FDCA defines drugs as "articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and articles (other than food) intended to affect the structure or any function of the body of man or other animals." Devices are similarly defined as "an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is ...intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or intended to affect the structure or any function of the body of man or other animals... ."
The FDA asserts that because electronic cigarettes are intended to affect the structure or function of the body (through the delivery of nicotine), they constitute both a drug and a device (i.e., a drug/device combination) under the FDCA.
It sounds straightforward: electronic cigarettes are intended to affect the structure or function of the body. The definition of a drug requires that either the drug affect the structure or function of the body or that it be intended to prevent, treat, or cure a disease or condition. Thus, electronic cigarettes are drugs under the FDCA.
But don't be hasty. It's not so straightforward.
Consider this: you are the manufacturer of a piece of gym equipment. Let's say you produce an all-in-one piece of training equipment that allows the user to do 24 different exercises that work out multiple muscle groups in different parts of the body. You advertise the product as helping people to keep in shape by giving them exercise and enhancing their muscle tone by increasing the strength of their muscles. You do not make any claim that the equipment will have a therapeutic effect. In other words, you don't market the product as treating or curing any particular disease or condition.
Now, according to the FDA's argument in the electronic cigarette case, gym equipment would meet the definition of a device under the FDCA because this equipment is clearly intended to affect the structure and function of the body. It is explicitly marketed to increase muscle tone and muscle strength. Thus, it is a device under the FDCA and it is subject to the FDCA regulations.
However, the FDA has historically (and currently) not treated exercise equipment as a medical device and has not regulated exercise equipment as a device under the FDCA unless the gym equipment is marketed with a therapeutic purpose (i.e., if it is marketed as treating a particular medical condition). Much of the gym equipment that you use at your health club - such as barbells, free weights, and Nautilis and other exercise machines - is not subject to FDA regulation under the Food, Drug, and Cosmetic Act. The exception is powered exercise equipment "intended for medical purposes, such as to redevelop muscles or restore motion to joints or for use as an adjunct treatment for obesity."
The FDA has stated that: "FDA does not regulate exercise equipment intended only for general physical conditioning and/or for the development of athletic abilities in individuals who lack physical impairment. Therefore, it is not necessary to notify FDA of an intent to market a device if it will not be labeled or promoted for medical uses. However, FDA will regulate the equipment and may require premarket notification if any promotional material appears which makes medical claims after marketing begins."
In other words, the FDA has explicitly acknowledged that the definition of a medical device includes not only the intent to affect the structure or function of the body but also the intent for the product to be used for medical or therapeutic purposes.
Elsewhere, FDA confirms this: "FDA only regulates exercise equipment as a medical device if it is marketed with claims to prevent, treat, or rehabilitate injury or disability. Otherwise, it is a consumer product."
The NJOY brief provides another example of this important distinction. In 2002, the company Applied Digital Solutions sought to market two types of implantable chips. These were devices that could be inserted just under the skin. One of the chips was intended to store personal information, such as financial information, for security purposes. The other chip was intended to store health information intended to help medical personnel treat the person in case of illness or injury.
Clearly, both of these products were devices that were intended to affect the structure and function of the body. In fact, they were intended to become a part of the body by being at least semi-permanently installed or implanted under the skin.
However, the FDA decided that only one of the chips was a medical device under the FDCA.
You guessed it ... the FDA decided that the health information chip was a medical device but that the security chip was not. The FDA wrote that it "believes that the health information VeriChip is a medical device subject to FDA’s jurisdiction. FDA agrees, however, that the personal ID/security VeriChip is not covered by the FD&C Act."
In fact, the FDA provided a very clear and detailed argument for why it is that the ID/security VeriChip was not a device under the FDCA even though it was clearly an implant that affected the structure of the body:
"it does not appear that the personal ID/security VeriChip is a medical device, even though it is an “implant.” It is of course true that virtually any product that comes into contact with the body-and many that do not- could be said to have an effect on the structure or a function of the body. However, as you note in your Section 513(g) submission, FDA’s medical device jurisdiction under Section 201(h)(3) extends only to such products that are marketed by their manufacturers or distributors with claims of effects on the structure or a function of the body." ...
"It is well settled that intended use is determined with reference to marketing claims. ... Indeed, just four years ago, the United Sates Court of Appeals for the Fourth Circuit found that “no court has ever found that a product is ‘intended for use’ or ‘intended to affect’ within the meaning of the FD&C Act absent manufacturer claims as to that product’s use.” [Brown & Williamson Tobacco Corp. v. FDA 153 F.3d 155, 163]." ...
"The pertinent legislative history supports this interpretation. Specifically, the Senate Report accompanying the legislation that became the Federal Food, Drug, and Cosmetic Act of 1933 ... states: 'The use to which the product is to be put will determine the category into which it will fall ... The manufacturer of the article, through his representations in connection with its sale, can determine the use to which the article is to be put.'" ...
"As the D.C. Circuit found, that intended use is determined by manufacturer marketing claims “has now been accepted as a matter of statutory interpretation” by the federal courts. ... Accordingly, assuming that no medical claims arc made for the personal ID/security VeriChip, and the product marketed for that purpose contains no health information, FDA can conclude that it is not a medical device."
The FDA's letter goes on to explain that if the Agency regulated as drugs or devices all products that are intended to affect the structure and function of the body, even if they were not intended or marketed for medical/therapeutic purposes, it would lead to absurd consequences: "if [the FDCA] were interpreted to give FDA jurisdiction over any product foreseeably having an effect on the structure or a function of the body, then regulatory authority would shift from the CPSC [Consumer Product Safety Council] to FDA for a host of non-health-related products. Hiking boots, shirts, pants and coats; exercise equipment; insulated gloves; airbags; and chemical sprays can be said to affect bodily structure or function. Clothing and gloves, for example, keep the body warm. It is for this reason that FDA's regulations discuss objective as well as subjective intent. ... there must be “objective intent” in the form of marketing claims."
The Rest of the Story
Based on the above arguments, we come to following conclusion:
4. Unless electronic cigarettes are marketed with therapeutic claims (i.e., as a treatment for smoking dependence or as a device to enable a person to achieve smoking cessation), they are not subject to FDA regulation under the Food, Drug, and Cosmetic Act. Instead, they are subject to FDA regulation as tobacco products under the Family Smoking Prevention and Tobacco Control Act.
This is a very strong and compelling argument that NJOY lays out in its brief. 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 does not meet the criteria for regulation under the FDCA.
Of course, under this reasoning, electronic cigarette distributors which do make therapeutic claims may be subject to FDA regulation under the Food, Drug, and Cosmetic Act. But as long as companies refrain from making such claims, and market their products - like NJOY does - as an attractive alternative to smoking regular cigarettes - their products should be regulated as tobacco products, not as drug/device combinations.
It is also important to point out that if the Court accepts this reasoning, then electronic cigarettes will also have to refrain from claiming that these devices are safer than smoking regular cigarettes. Why? Because making such claims would classify their electronic cigarettes as a modified risk tobacco product and they could not be marketed as such without prior FDA approval (which I argue elsewhere would be nearly impossible to obtain).
But at least if the Court accepts this reasoning, the FDA will be unable to ban electronic cigarettes as many anti-smoking groups have urged it to do. They will remain on the market as a viable alternative for cigarette smokers who want to get off of regular cigarettes.