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The FDA’s Deeming Rule On Vapor Products Must Be Challenged

Legal challenges to the U.S. Food and Drug Administration’s (FDA) final deeming rule on vapor products are mounting, with lawsuits focusing on various aspects of the regulations, including claims ranging from violations of the Regulatory Flexibility Act and Administrative Procedure Act, to infringement of freedom of speech under the First Amendment and encroachment of the Fifth Amendment’s due process clause.

It is likely that more lawsuits will follow. In fact, the Smoke-Free Alternatives Trade Association (SFATA) supports the Right to Be Smoke-Free Coalition (RSF) who have filed a suit of their own challenging the FDA’s industry-crushing rule.

One of our fundamental objections to the deeming rule is that the FDA lacks the authority to regulate vapor products in the absence of therapeutic claims. Many legal experts agree that the Tobacco Control Act was never intended to apply to vapor products.

FDA is trying to extend its jurisdiction over e-cigarettes

The courts have been vigilant in policing the FDA’s over assertion of jurisdiction. The Supreme Court rejected the agency’s attempt to regulate nicotine as a “drug” and cigarettes and smokeless tobacco as “devices” in FDA v. Brown & Williamson Tobacco Corporation. Likewise, in Sottera Inc. v. FDA, the U.S. Court of Appeals for the D.C. Circuit rejected the FDA’s attempt to regulate e-cigs as unregulated medical devices, holding that unless a vapor product is marketed for therapeutic purposes, the agency may not regulate them as drugs, devices or combination products.

At the time the D.C. Circuit issued its ruling in Sottera, the FDA had not yet deemed e-cigs to be subject to its authority. Thus, the question presented in Sottera was not whether e-cigs are tobacco products, but whether they were, as FDA then asserted, “drugs” or “devices.” The D.C. Circuit rejected the FDA’s position, noting that the agency had frequently expressed the view that “cigarettes are beyond the scope of the Food, Drug and Cosmetic Act (FDCA) absent health claims establishing a therapeutic intent on behalf of the manufacturer or vendor.”

The FDA’s final regulations purport to address the jurisdictional lines established by Sottera by deeming vapor products as tobacco products subject to the FDCA. However, vapor products do not meet the definition of a “tobacco product.” As defined in Section 201 of the FDCA, as amended by the Tobacco Control Act, 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.”

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