Because Brown & Williamson and Sottera do not apply to products like Synthetic Nicotine that are not “tobacco products,” the determining factor for whether synthetic nicotine products are drugs is, simply, their intended use. Although the precise rule for determining intended use is currently the subject of debate,98 myriad kinds of evidence may be relevant to the analysis. Most clearly, a seller’s representations about its product might be evidence of the seller’s intended use.100 But the plain language of the statute, which describes uses as “intended” rather than “labeled,” “promoted,” or “claimed,” makes apparent that evidence other than a sellers’ representations also can be relevant.

The available evidence for Synthetic Nicotine suggests that there is strong case for FDA to conclude that these products fall within the FDCA’s broad definition of a drug. Companies’ representations about their products, the design of the products, and the circumstances surrounding their distribution all support this conclusion, as described in detail below.

Moreover, when sellers have challenged the FDA’s authority to regulate a product—or challenged the FDA’s determination about which category a product falls within—courts have generally sided with the FDA.  Thus, even if one (or two) of the sources of evidence, discussed below, about the intended uses of Synthetic Nicotine products were unpersuasive to courts, courts may be likely to agree with, or defer to, the agency’s interpretation that a Synthetic Nicotine product is a drug.

To be clear, determining a product’s intended use is a product specific-inquiry. The features of the particular product at issue, including the seller’s representations about the product, must be assessed individually. But in this Article, we do not take on the task of fully examining individual products or identifying specific products that meet the definition of a drug. Rather, we demonstrate that, based on the illustrative examples identified below, it appears that Synthetic Nicotine products generally fall within the drug definition.

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Because Brown & Williamson and Sottera do not apply to products like Synthetic Nicotine that are not “tobacco products,” the determining factor for whether synthetic nicotine products are drugs is, simply, their intended use. Although the precise rule for determining intended use is currently the subject of debate,98 myriad kinds...