After her husband passed away from lung cancer,
Kimberly Manor started an innovative business
to help longtime smokers quit. At Moose Jooce,
a vape store in Lake, Michigan, Kimberly sells
vaporizers—small electronic devices that deliver
nicotine to users in a mist of inhaled water vapor
without the additional chemicals and tar found in
cigarette smoke. Kimberly’s business prospered,
and she has helped hundreds of people in her small
town to quit smoking.
Unfortunately, the Food and Drug Administration (FDA) threw a wrench in Kimberly’s business model. In 2016, the FDA created a rule deeming vaping products—vaporizers and the liquid used in them—to be subject to the same restrictions placed on cigarettes under the
Tobacco Control Act of 2009, even though
vaping products contain no tobacco.
Vaping allows people to obtain nicotine and mimic the experience of smoking without the major causes of cancer—combustion gases, smoke, and tar. Nicotine is extracted from a plant in the tobacco family or from synthetic tobacco. Because vaping can be customized for the user, former smokers can gradually reduce their nicotine intake by using liquids with declining nicotine levels and eventually no nicotine at all. For example, vaping helped Steve Green, the owner of Mountain Vapors in Sonora, California, quit smoking after 30 years and recover from early signs of emphysema.7
The Deeming Rule, as the FDA’s regulation of vaping devices is called, imposes years of regulatory hurdles and hundreds of thousands of dollars in costs per product, which is stifling innovation and harming small shop owners across the country. The rule’s mandates take effect in stages. In 2021, it will require “premarket” approval to keep existing vapor products on the market, which means each liquid with a different flavor or different level of nicotine, including liquids with no nicotine, will have to be approved individually through a lengthy process at a cost of up to $466,000 (by the FDA’s own estimation).8 And any product introduced after the Deeming Rule went into effect in 2016 must go through this process immediately, which has effectively halted innovation.
For Kimberly and Steve, this rule also means they are no longer able to repair products for their customers. This premarket approval process will be prohibitively expensive for small business owners across the country, while big companies can better afford the approval process for their few vaping products.9
In addition to stifling Kimberly’s and Steve’s ability to sell vaping products, the Deeming Rule also limits their free speech. No matter how accurate their product descriptions and ingredient lists are, they must secure FDA approval for them. In
addition, they are severely restricted in their ability to advertise or educate consumers about how they can quit smoking using vaping products without FDA approval for their speech.
Steve notes that the “restrictions stop me from sharing my personal story.” As he explains, “For years, I smoked 2-1/2 packs of cigarettes a day, and it nearly gave me emphysema. Vaping freed me from my addiction, and the doctor says I’ve recovered.”10
Beyond making it expensive and onerous for entrepreneurs, vapers, and cigarette smokers who want to quit, the Deeming Rule has a more fundamental problem: The rule was issued by a career employee. While the employee has been with the FDA for 30 years and was promoted to a senior career position, she was never nominated by any President or confirmed by the Senate for any democratically accountable office. For that basic reason, the rule was illegal the moment it hit the books. Tenure does not confer constitutional authority.
Steve notes that the “restrictions stop me from sharing my personal story.”
The Constitution requires regulations to be issued by appointed officials subject to the democratic process, not by unelected public servants. The career employee who issued the Deeming Rule,
Leslie Kux, probably didn’t know that the rulemaking power she was asked to exercise was unconstitutional. But good intentions can’t transform an illegal rule into a legal one.
Kimberly and Steve have teamed up with Pacific Legal Foundation to sue the FDA over this unconstitutional practice of using career bureaucrats to issue rules binding on Americans. In early 2018, PLF attorneys challenged the Deeming Rule with three lawsuits, representing eight small vaping businesses and the nonprofit Tobacco Harm Reduction 4 Life.11 In these and other lawsuits, PLF’s clients seek to enforce the constitutional separation of powers and the democratic accountability that the Founding generation established in the Constitution.
Vaping store retailers are only one example of those harmed by illegal regulations uncovered by our research—regulations that restrict individuals and small businesses across the country.
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