Two amicus briefs filed late last week support the position that NJOY's electronic cigarettes may not be regulated by the FDA as drug delivery devices because the products are not marketed with any therapeutic claims.
In the first amicus brief, filed by myself along with Bill Godshall, Dr. Joel Nitzkin, the American Council on Science and Health, the National Vapers Club, Midwest Vapers Group, and Consumer Advocates for Smokefree Alternatives Association, we make two major arguments. First, we argue that the FDA may not regulate NJOY's electronic cigarettes as drug delivery devices under the Food, Drug and Cosmetic Act (FDCA) because to be considered a drug delivery device, the device must be marketed with a therapeutic or medicinal claim.
We argue that "e-cigarettes are not “drugs,” “devices,” or “combination products” under the FDCA. A decade ago, in FDA v. Brown & Williamson Tobacco Corp., the Supreme Court held that the FDA does not have jurisdiction to regulate tobacco products. In support of this conclusion, the Court cited the FDA’s long-held position that it “lacked authority under the FDCA to regulate tobacco absent claims of therapeutic benefit by the manufacturer.” In this case, the district court enjoined the FDA from regulating NJOY’s e-cigarettes “absent a proffer of evidence that the products are ‘intended to have a therapeutic effect.’” The FDA has failed to proffer any such evidence."
Second, we argue that the FDA is incorrect in asserting that an injunction on its enforcement of a ban on electronic cigarettes will endanger the public's health. On the contrary, we argue that it is the removal of electronic cigarettes from the market which will endanger the public's health by forcing hundreds of thousands of ex-smokers (vapers) to return to cigarette smoking. There is no identified chemical exposure produced by the use of NJOY electronic cigarettes (other than nicotine) that the FDA or any anti-smoking group has asserted - backed up by scientific evidence - poses a significant risk to users. In contrast, the cigarettes that would otherwise be smoked by vapers if e-cigs were taken off the market contain thousands of chemicals, many of which have been documented to cause significant harm to human health.
We therefore argue: "Against this backdrop, the FDA’s relentless attempt to ban the import of ecigarettes as unlawful drug-device combination products is nothing less than a derogation of its mission to protect the public health. The FDA knows that it cannot ban traditional cigarettes—indisputably one of the chief preventable causes of illness and death worldwide—so instead it seeks to regulate (and ban) what must surely be a safer alternative. In the context of a regulatory regime that contemplates the continued legality of traditional cigarettes, the amici believe that safer substitutes should be embraced, not abolished."
We conclude by asking the appeals court to uphold the district court's decision to issue an injunction preventing the FDA from enforcing its declared ban on NJOY's electronic cigarettes: "For the foregoing reasons, the amici respectfully request that the Court affirm the district court’s decision to enter a preliminary injunction barring the FDA from detaining NJOY’s products."
The second amicus brief, filed by the Washington Legal Foundation, provides a detailed argument why the FDA may not exert jurisdiction over NJOY's electronic cigarettes under the FDCA. The argument is summarized as follows: "Most relevant here, WLF participated as amicus curiae in FDA v. Brown & Williamson Tobacco Corp., 529 U.S. 120 (2000), the landmark Supreme Court decision holding that FDA lacked authority to regulate tobacco products under the Federal Food, Drug, and Cosmetic Act (“FDCA”). There, as here, WLF was concerned about FDA’s theory of regulation, which asserted that “intended use” of a product within the meaning of Section 201(g) and (h) of the FDCA could be determined with reference to the products’ actual or foreseeable use, or other nonstatutory factors such as a product’s inherent attributes, rather than therapeutic claims made by the manufacturer. Such a capacious interpretation would give FDA unfettered discretion to regulate virtually any consumer product as a drug or medical device, well exceeding the proper ambit of the agency’s authority under the FDCA."
In other words, the FDA is attempting to assert that NJOY's electronic cigarettes are drug delivery devices simply because they affect the structure and function of the body and may be used by some consumers for smoking cessation, even though the company makes no therapeutic claim (such as advertising the product as being an effective smoking cessation treatment). The Washington Legal Foundation points out that if the FDA's interpretation is accepted, it would have the preposterous result of placing all sorts of items under FDA regulation, include carrots. Since carrots are thought by many consumers to prevent eye disease, the FDA's reasoning would lead to carrots being regulated as a drug, according to the brief.
The Washington Legal Foundation presents a detailed history of court decisions which make it clear that the intended use of a product is to be determined by the marketing claims made for that product, not by other factors such as the actual use of the product or merely by whether the product affects the structure and function of the body.
Indeed, as the brief points out, a former FDA chief counsel himself noted: "For decades, it generally has been understood that intended uses are established by manufacturer statements. It is not that intended uses are established by events in the minds of manufacturers (whatever those may be) and that the statements are merely evidence of what has occurred in those minds; rather, the statements create the intended uses, and the minds (and evidence of what has occurred in those minds) are irrelevant."
The brief concludes that: "In sum, there is no basis to defend FDA regulation of a drug or medical device absent a manufacturer making claims that the product will provide a therapeutic or medical benefit."
The Rest of the Story
These amicus briefs will be considered by the court. Oral arguments in the case are scheduled for September 23.