About | HeinOnline Law Journal Library | HeinOnline Law Journal Library | HeinOnline
LOG IN
LOG IN

73 Food & Drug L.J. 624 (2018)
How Might Manufacturers of E-Cigarettes Get New Product and MRTP Orders from FDA More Quickly and Easily

handle is hein.journals/foodlj73 and id is 649 raw text is: How Might Manufacturers of E-Cigarettes Get New Product and MRTP Orders from FDA More Quickly and Easily? ERIC N. LINDBLOM* ABSTRACT 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.' INTRODUCTION E-cigarettes are uniquely positioned to serve as less-harmful alternatives to smoking because they enable users to inhale nicotine into their lungs, as smokers do, but without using any combustion or tobacco. By delivering nicotine from a liquid solution in aerosol form without combustion, e-cigarettes can sharply reduce user and nonuser * Eric N. Lindblom is the Director for Tobacco Control and Food & Drug Law at Georgetown Law's O'Neill Institute for National & Global Health Law, and the former Director of the Office of Policy at FDA's Center for Tobacco Products (2011-2014). Before FDA, Mr. Lindblom was General Counsel and Director for Policy Research at the Campaign for Tobacco-Free Kids. I This paper grew out of a discussion at the FDLI Annual Conference's Risk-Based Regulation of Tobacco Products breakout session, May 4, 2018. Although the proposed strategy focuses on e-cigarettes (loosely defined as any product that delivers nicotine into the lungs of consumers without either tobacco or combustion), it might also be used by companies selling certain smokeless tobacco products or other non- smoked tobacco-nicotine products that research has established or indicates are less harmful to consume than smoked tobacco products. 624

What Is HeinOnline?

HeinOnline is a subscription-based resource containing thousands of academic and legal journals from inception; complete coverage of government documents such as U.S. Statutes at Large, U.S. Code, Federal Register, Code of Federal Regulations, U.S. Reports, and much more. Documents are image-based, fully searchable PDFs with the authority of print combined with the accessibility of a user-friendly and powerful database. For more information, request a quote or trial for your organization below.



Short-term subscription options include 24 hours, 48 hours, or 1 week to HeinOnline.

Purchase Access

Contact us for annual subscription options:

Contact Us

Already a HeinOnline Subscriber?

Log In

profiles profiles most