In a letter sent to the Electronic Cigarette Association (ECA) on September 8, the Food and Drug Administration (FDA) appears to be exerting jurisdiction over all electronic cigarettes under the Food, Drug and Cosmetic Act (FDCA), regardless of the claims made by manufacturers or distributors of these products.
In the letter, the FDA refers not only to the specific electronic cigarettes addressed in its warning letters, but to all "similar products." The FDA states: "Although the agency has been granted separate authority to regulate tobacco products that are not drugs, devices, or combination products under the recently enacted Family Smoking Prevention and Tobacco Control Act, the e-cigarettes that FDA addressed in the warning letters, and similar products, meet the definitions in the Act for drugs and devices, with a drug primary mode of action."
Note that the letter does not state: "and products marketed in a similar way." Moreover, the letter mentions only that electronic cigarettes must meet the requirements for new drugs under the FDCA. It makes no mention of the possibility that if electronic cigarette companies make no drug claims, their products will be regulated as tobacco products rather than as drug-device combinations.
Clearly, the FDA is asserting jurisdiction over electronic cigarettes because these products deliver pharmacologically active nicotine and not merely because of drug claims made by specific companies.
In the letter, the FDA places an onerous burden on electronic cigarette companies in terms of what they must show prior to approval of their products: "FDA notes that an NDA [new drug application] would need to provide information including: a description of the chemistry of the drug substance and drug product, their manufacturing processes (which must comply with FDA requirements for Good Manufacturing Practices) and their controls (including in process and end product specifications); a description and characterization of the device; a characterization of the pharmacokinetic delivery of nicotine, including site of absorption and pharmacokinetic parameters associated with use at the recommended dosing level; non-clinical toxicology studies to support the safety of the proposed route of administration (note that the pulmonary route is considered a novel route of administration); any novel excipients and drug substance/drug product impurities; and data from adequate and well-controlled clinical trials to support the safety and efficacy of the product for the intended use."
The Rest of the Story
There are two aspects to the rest of the story.
First, the FDA lacks appropriate legal grounds to assert jurisdiction over electronic cigarettes as indicated in this letter. While the FDA could potentially argue that if electronic cigarette companies make direct drug claims about their products, these devices could be regulated under FDCA, I do not believe there is a legal basis for the FDA regulating electronic cigarettes under FDCA in the absence of marketing claims which establish that the primary intended use of the product is to aid smokers in achieving smoking cessation (and therefore, that the primary purpose of the product is to treat a medical condition: smoking dependence).
While I have discussed this in previous commentaries, it is worth repeating here. A major ground upon which the FDA is asserting jurisdiction over electronic cigarettes is that these products are "capable of delivering nicotine" and that "nicotine is a pharmacologic agent." This ground may have been a legitimate one to regulate electronic cigarettes prior to passage of the Tobacco Act, but it no longer holds water given the regulatory framework that was established, quite clearly, by the Tobacco Act and its amendments to FDCA.
The problem is this: the same ground being used by the FDA to assert jurisdiction over electronic cigarettes under FDCA could also be used by the Agency to assert jurisdiction over cigarettes and smokeless tobacco products under FDCA. Is it not the case that cigarettes and smokeless tobacco are "capable of delivering nicotine" and that "nicotine is a pharmacologic agent"? Clearly, then, cigarettes and smokeless tobacco are products intended to "affect the structure or function of the body" and under the FDA's reasoning, must also be regulated as drugs under FDCA. As such, the FDA should take them off the market until their safety can be established in clinical trials, no?
Well, the reason why the FDA cannot assert jurisdiction over cigarettes and smokeless tobacco products under FDCA is simple: because they are defined as tobacco products under the Tobacco Act and therefore must be regulated as tobacco products under the Tobacco Act, rather than as drugs under FDCA.
However, here's the clincher: So are electronic cigarettes.
Under the Tobacco Act, electronic cigarettes are also defined as being tobacco products because they are derived from tobacco.
The definition of a tobacco product under the Tobacco Act (i.e., under Subchapter IX of the FDCA) clearly includes electronic cigarettes. 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)."
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.
Clearly, the assertion that electronic cigarettes deliver nicotine which is a pharmacologic agent is not sufficient to establish jurisdiction over these products as drugs under FDCA because if it were, then the FDA would also have to assert jurisdiction over cigarettes and smokeless tobacco products under FDCA for the exact same reason.
The fact that electronic cigarettes deliver nicotine - which has pharmacologic effects that affect the structure and function of the body - is not sufficient grounds for the FDA to assert jurisdiction over these products under FDCA. If it were, then the FDA could also regulate cigarettes under FDCA, which was obviously not the intent of the Congress in enacting the Family Smoking Prevention and Tobacco Control Act. Any reasonable construction of the meaning of the regulatory framework established under the Tobacco Act must acknowledge that the delivery of nicotine alone is not sufficient to regulate a tobacco product - such as electronic cigarettes - under FDCA.
The second aspect of the rest of the story is that although the FDA states in its letter that it "intends to regulate electronic cigarettes and related products in a manner consistent with its mission of protecting the public health," it is actually doing the exact opposite.
The onerous burden that the FDA outlines for electronic cigarette approval ensures that these products will never be approved and will never have a chance to compete in the market place. The costs required to produce the kind of data that the FDA is demanding are prohibitive. These are a collection of very small companies and it is unlikely that these companies could produce the kind of funding required to carry out the clinical trials and other studies necessary to gain approval under FDCA.
More importantly, it would take a minimum of five years, and probably closer to eight years, to plan and conduct the necessary studies and to obtain the necessary data. Most of the electronic cigarette companies are reliant upon their current sales and could not afford to suspend their sales for 8 years while waiting for these studies to be completed. I believe that it would result in the de facto end of the electronic cigarette market in the United States.
In other words, while the language being used is couched in legalese, what the FDA is actually indicating here is that it has no intention to approve electronic cigarettes and that it favors an approach by which these products are taken off the market and tobacco cigarettes are allowed unfettered reign over the market for smokers' business.
To express it another way, the FDA is essentially banning or putting insurmountable obstacles in front of the relatively safer electronic cigarettes, but approving - without any regulatory burden - the deadly real ones.
This is the exact opposite of regulating electronic cigarettes "in a manner consistent with its mission of protecting the public health." In fact, it represents regulating tobacco products and electronic cigarettes in a manner inconsistent with its mission of protecting the public health.
What this does is help to ensure that smokers do not quit smoking and that they do not switch away from their Marlboros, Camels, Kools, Salems, and Newports over to much safer tobacco-free products that have no known risks beyond the nicotine delivery. It helps ensure that smokers who want to quit have no choice other than to use the dismally effective nicotine replacement products which offer them no better than about an 8% long-term success rate. It helps ensure that cigarette profits will remain strong at the expense of the health of smokers. It protects the profits of Big Tobacco and Big Pharma at the expense of the protection of the public's health.