The Deeming Rule: The FDA's Destruction of the Vaping Industry
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The Deeming Rule
THE FDA'S DESTRUCTION OF THE VAPING
INDUSTRY
I currently work alone to build [devices that power atomizers in
e-cigarettes] for my local community. It took me years to find a hobby
that I excelled at and thoroughly enjoy. Business has been steadily
increasing and [I] have plans to expand and hire employees. But at
the proposed fees, I would have no choice but to stop.'
INTRODUCTION
The Food and Drug Administration (FDA) is the oldest
consumer protection agency in the United States, officially
created in 1930.2 The agency is tasked with the responsibility of
protecting the public health by ensuring the safety, efficacy and
security of human and veterinary drugs, biological products,
medical devices ... our nation's food supply, cosmetics, and
products that emit radiation.3 It has regulated the tobacco
industry since researchers discovered that cigarettes were
detrimental to human health.4 According to the FDA, tobacco
use kills more than 480,000 people in the United States each
year, and each day about 600 youth become daily smokers5
About 42.1 million Americans smoke cigarettes.6
The FDA's new Deeming Rule, an amendment to
President Barack Obama's 2009 Family Smoking Prevention and
1 Brief of Amicus Curiae Smoke-Free Alternatives Trade Association in
Support of Plaintiffs' Motions for Summary Judgment at 7, Nicopure Labs, LLC v. Food
and Drug Administration, 266 F. Supp. 3d 360 (D.D.C. 2017) (No. 16-0878), 2016 WL
6355070 (survey response from an artisan in the business of crafting hand-engraved box
mod units for vaping use).
2 U.S. Food & Drug Administration: History, U.S. FOOD & DRUG ADMIN., http://
www.fda.gov/AboutFDA/WhatWeDolHistory/default.htm [https://perma.ce/34LZ-AVCE].
3 U.S. Food & Drug Administration: What We Do, U.S. FOOD & DRUG ADMIN.,
http://www.fda.gov/AboutFDA/WhatWeDo/ [https://perma.cc/CH9C-4LL3].
4 Kristi Keck, Big Tobacco: A History of its Decline, CNN (June 19, 2009) http:l
edition.cnn.com/2009/POLITICS/06/19/tobacco.decline/ [https://perma.ccIYP2T-U6GT].
5 Overview of the Family Smoking Prevention and Tobacco Control Act, U.S.
FOOD & DRUG ADMIN., https://www.fda.gov/TobaccoProducts/GuidanceCompliance
RegulatoryInformation/ucm246129.htm [https://perma.cc/9Z46-A7VD].
6 Id.
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The Deeming Rule: The FDA's Destruction of the Vaping Industry
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