Thursday, September 23, 2010

D.C. Court of Appeals Has Made It Clear that Drug Definition Under FDCA Relies Upon Primary Intended Use of a Product

I have argued that except in extreme cases where electronic cigarettes are marketed with the primary intent of relieving or treating symptoms of nicotine withdrawal, they do not fall under the FDA's jurisdiction under the Food, Drug, and Cosmetic Act (FDCA) because they are tobacco products, rather than drugs or devices, under the law. Here, I demonstrate that the courts in general - and the D.C. Court of Appeals in particular - have made it clear that the definition of a drug or device under FDCA relies upon the primary intended use of the product, consistent with my interpretation of the law. For this reason, I believe that the D.C. Court of Appeals ought to rule that electronic cigarettes marketed by NJOY are not subject to jurisdiction by the FDA under FDCA.

In 1977, Action on Smoking and Health (under the direction of John Banzhaf) filed a petition with the FDA demanding that it regulate cigarettes as drugs under FDCA because they contain nicotine which clearly affects the structure and function of the body (one of the definitions of a drug under FDCA). The FDA declined, arguing that it is the manufacturer's intent in its marketing, not the actual use of the product by consumers, which determines the intended use of a product.

Then FDA Commissioner Donald Kennedy wrote: "The petitioners have presented no evidence that manufacturers or vendors of cigarettes represent that the cigarettes are 'intended to affect the structure or any function of the body of man...' Statements by the petitioners and citations in the petition that cigarettes are used by smokers to affect the structure or any functions of their bodies are not evidence of such intent by the manufacturers or vendors of cigarettes...".

In response to the denial of its petition, ASH filed a lawsuit in the D.C. District Court challenging the FDA's decision. The judge issued a summary judgment on the part of the defendant and dismissed the case. ASH appealed, sending the case to the D.C. Court of Appeals (see: Action on Smoking and Health v. Harris. 655 F.2d 236 [1980]).

The appellate court ruled that ASH failed to establish that manufacturers or vendors intended cigarettes to affect the structure or function of the body, even though consumers were using the product in such a way. Therefore, the court ruled, cigarettes do not meet the definition of a drug under FDCA and need not be regulated by the FDA as such. The court thus affirmed the decision of the district court.

In making its ruling, the D.C. Court of Appeals reviewed the legislative history of the Food, Drug, and Cosmetic Act, noting that Congress made it very clear that only when a product is marketed by the manufacturer as affecting the structure or function of the body or having a therapeutic effect is the product considered to be a drug subject to regulation under FDCA. The court cited an exchange between the FDA commissioner and a Congressman in which the commissioner explains that "a chiropractor's table would not be a drug under the Act unless the manufacturer 'were to ship that table into interstate commerce, and say that that table would cure various ills.'"

The D.C. Court of Appeals stated quite clearly that: "the crux of FDA jurisdiction over drugs lay in manufacturers' representations as revelatory of their intent. ... Such an understanding has now been accepted as a matter of statutory interpretation. As the Second Circuit has noted, 'the vendors' intent in selling the product to the public is the key element in this statutory definition.'"

Perhaps the most important opinion expressed by the D.C. Court of Appeals in ASH v. Harris is that consumers must use the product nearly exclusively with the intent alleged by the Agency in order for that intent to be inferred under FDCA. Specifically, the D.C. Circuit wrote: "In cases such as the one at hand, consumers must use the product predominantly--and in fact nearly exclusively--with the appropriate intent before the requisite statutory intent can be inferred."

Furthermore, the appellate court held that this requirement for near exclusivity of product use held for both prongs of the definition of drugs and devices in FDCA: "In similar cases involving the determinative intent under section 201(g)(1)(B) of the Act, for example, 'articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease...', courts have accorded limited discretion to the Administration in its attempt to establish the requisite intent based primarily upon consumer use."

The appellate court concludes its argument by emphasizing that: "ASH did not establish, and arguably cannot establish, the near-exclusivity of consumer use of cigarettes with the intent 'to affect the structure or any function of the body of man...".

The second Circuit, in FTC v. Liggett & Myers Tobacco Co. (203 F.2d 955 [1953]), emphasized the absurdity of an interpretation that any product which affects the structure or function of the body could be regulated as a drug: "Anything which stimulates any of the senses may be said, in some perhaps insignificant degree, to affect the functions of the body of man. Consequently any article which, used in the manner anticipated by the manufacturer thereof, comes into contact with any of the sense may be said to be an article 'intended to affect the functions of the body of man' ... . Surely, the legislators did not mean to be as all-inclusive as a literal interpretation of this clause would compel us to be."

The Rest of the Story

The D.C. Circuit's standard of "near exclusivity" of consumer use is one which is not met by the FDA in its assertion of jurisdiction over electronic cigarettes. In the case of NJOY electronic cigarettes, the FDA has failed to cite any evidence that the intended use of the product is to affect the structure or function of the body or to treat any disease. In the case of other brands, the FDA has failed to show that the product is used nearly exclusively by consumers with the intent that the Agency alleges.

To be sure, the primary use of electronic cigarettes by consumers is as an alternative to cigarettes. Most vapers are using e-cigarettes specifically because they are unable to quit smoking but want a safer alternative. Thus, they have switched over - either in whole or in part - to electronic cigarettes.

While it is true that some consumers have made statements about the use of e-cigarettes in quitting smoking or the alleviation of nicotine withdrawal symptoms, it does not appear to be the case that consumers are using electronic cigarettes nearly exclusively with a therapeutic intent. Nor does it appear that most manufacturers are marketing the product with a primary - or nearly exclusive - intent of treating nicotine dependence or nicotine withdrawal.

For these reasons, I believe that the FDA has failed to meet the requisite statutory burden in demonstrating that electronic cigarettes are intended to affect the structure and function of the body and/or to treat a disease under the FDCA as amended recently by the Tobacco Act. Without such a showing, electronic cigarettes fall under the definition of tobacco products under the law, and must be regulated as such.

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