Food and Drug Law Journal   |  June 9, 2018

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According to manufacturers and some members of the public health and tobacco control communities, exclusively using e-cigarettes is much less harmful and risky to users and exposed nonusers than tobacco smoking. But federal law prohibits manufacturers and importers from labeling or marketing their e-cigarettes as delivering fewer toxins or being less harmful than cigarettes or other smoked tobacco products unless they first obtain permissive orders from FDA. Being allowed to make such reduced-exposure or reduced-risk claims would help a manufacturer attract smokers to use its e-cigarettes instead, giving them a powerful new competitive advantage. But no e-cigarette company has yet applied to FDA to obtain the new product and modified risk tobacco product (MRTP) orders they need to be allowed to market their e-cigarettes as less toxic or less harmful to use. Apparently, the process for obtaining the necessary permissive orders from FDA is too complicated, costly, and uncertain even to be worth trying. This paper suggests a way that e-cigarette companies might secure new product and MRTP orders more quickly and easily—or at least establish a test case that could prompt the courts to ensure that the order process provides a reasonable way for e-cigarettes to enter or stay on the U.S. market and be advertised with reduced-risk claims, consistently with FDA’s statutory duty to protect the public health.

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