The Flexibility to Regulate Synthetic Nicotine Products as Drugs
This conclusion also has been followed after the enactment of the Tobacco Control Act. In Sottera v. FDA, an e-cigarette company sued the FDA after the agency sought to regulate the company’s products as drug-device combinations.90 Relying on Brown & Williamson, the D.C. Circuit concluded that, because the e-cigarettes at issue had tobacco-derived nicotine and therefore met the TCA’s definition of a “tobacco product,” the FDA must regulate them as tobacco products, so long as they are “customarily marketed.”That is, according to Sottera, the FDA lacked the discretion to regulate the e-cigarettes pursuant to its drug and device authorities, provided that the seller was not making “therapeutic claims.”
Consistent with Sottera, in a 2017 final rule on the meaning of “intended use,” the FDA clarified that it will regulate products made or derived from tobacco as drugs or devices only when they are intended for disease treatment or prevention (e.g., if they are marketed with smoking cessation claims) or if they are marketed with claims that the product affects the structure or function of the body that were not commonly and legally made at the time Brown & Williamson was decided.
But, crucially, these limits on the agency’s flexibility to regulate tobacco products as drugs, devices, or drug-device combination products do not apply to Synthetic Nicotine products. Synthetic products are not made or derived from tobacco, meaning they generally are not tobacco products.94 Additionally, many of the concerns about the application of the FDA’s drug authorities to tobacco products that drove the majority’s decision in Brown & Williamson are not present for Synthetic Nicotine products. If synthetic nicotine e-cigarettes live up to advocates’ claims that they are a safe(r) way to use nicotine, these products should not provoke the same concern that they cannot satisfy the “safe and effective” standard needed for drug approval as cigarettes did. Similarly, the Synthetic Nicotine industry is a nascent one, without the economic, social, and political significance of the tobacco industry that helped motivate the majority’s conclusion in Brown & Williamson that Congress did not intend for the FDA to regulate tobacco products. Finally, Congress explicitly chose to apply the TCA’s requirements only to “tobacco products,” declining to direct the FDA to regulate drugs containing nicotine, such as the smoking cessation products long regulated as drugs, under the new TCA scheme. Therefore, unlike in the FDA’s attempt to regulate traditional tobacco products as drug-device combination products in the 1990’s, the FDA regulating Synthetic Nicotine products as drugs would not raise concerns that the FDA was contravening the will of Congress.
This means that, as with any other novel product, the FDA has considerable flexibility to determine whether a Synthetic Nicotine product falls within the drug definition. That is, the inquiry for determining whether a particular Synthetic Nicotine product is a drug is the same as it is for any non-tobacco product. There is no need to consider whether the Synthetic Nicotine product is “customarily marketed,” nor are there any tobacco-specific limits on the agency’s authority to regulate Synthetic Nicotine products as drugs.
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