Local vape shop owner sues FDA

February 9, 2018

With her partner Patrick Bitterman, Kimberly Manor owns two vape businesses, one in Lake and the second in Houghton Lake.

With her partner Patrick Bitterman, Kimberly Manor owns two vape businesses, one in Lake and the second in Houghton Lake.

By Pat Maurer
Correspondent

Kimberly Manor’s business caters to people who have found a better way to “kick the tobacco habit.”

Kimberly is owner of Moose Jooce in Lake, a “vape shop” that sells electronic nicotine devices and makes custom mixes of e-liquid for them.

She and her partner Patrick Bitterman opened a second location in Houghton Lake in September.

The devices provide nicotine without all of the dangerous ingredients in tobacco and in fact, are not even a tobacco product.

Kimberly said she has helped over 500 people quit smoking by switching to a vaping device.

She said, “Vaping is a technology that’s proven to be more effective than gums, patches and cessation pills combined.”

She continued, “There has been literally thousands of studies on vaping – with no proof of any real, lasting damage. I’m living proof; my mother is living proof; my brother is living proof. And dozens of other friends and family members are living proof that vaping works and works tremendously fast.

After she lost her husband to lung cancer, Kimberly made a big career change and opened her business to try and help others.

Until recently, she has been able to do that, but the Food and Drug Administration‘s new “Deeming Rule” has put a stop to her efforts … and may put her out of business.

She can no longer tell her clients about the benefits of vaping and how much safer it is than smoking tobacco products because the FDA is requiring prior approval before she and other businesses are allowed to tell clients the truth. In fact they have to prove to the FDA that the truth will improve public health.
The Washington Examiner on February 3rd said, “In order to inform consumers that vapor products are safer than cigarettes, businesses need to submit a Modified Risk Tobacco Product application. The FDA has never granted one of these applications.”

To get approval for sale, products made for vapor devices (the liquid) will have to go through a very expensive pre-market approval process by 2022 when applications are due.

Manors said the cost of the applications will drive her out of business. “No small business owner will be able to afford it.” She said, “Even though there is no tobacco in the e-liquid I manufacture, I was forced by the FDA to register as a “Tobacco Manufacturer.”

Vape business are no longer able to explain why the products are safer than tobacco, and the sale of the products will soon be impossible for small businesses.
Manor said, “By 2022,” she said, “I will have to pay $500,000 for a PTMA (premarket tobacco product application). When you create a new tobacco product or modify a tobacco product in any way, you must obtain an order from the FDA authorizing the marketing of the before the product may be introduced or delivered introduction into interstate commerce.”

She continued, “I have 40 flavors, each available in seven levels of nicotine. Each of those flavors are available in three different amounts, 30 ml. 60 ml. and 120 ml. Each one is a SKU or “Stock Keeping Unit” and, she continued, “each of the 840 SKUs will cost me at least $500,000 for each application.”

Kimberly and several others who own similar businesses are fighting back. She and her co-defendant and partner Patrick Bitterman filed a lawsuit in Washington D.C. last Tuesday. Their attorneys, the Pacific Legal Foundation have taken on the lawsuit pro-bono, she said.

They aren’t alone, the PLF also filed lawsuits Tuesday in Texas and Minnesota on behalf of other businesses, saying the deeming rule is unconstitutional and threatens individual liberty.

In fact these rules are proving disastrous to other businesses that specialize in vaping products.

A career bureaucrat at the FDA, Leslie Kux decided in 2016 that vaping products would be subject to the same regulations that Tobacco Control puts on cigarettes. In other words she issued a “Deeming Rule” to regulate these products under the Tobacco Control Act, although they contain no tobacco.

The U.S. Constitutions says she does not have the authority to make the rule because it has to be issued, or signed by a Senate-confirmed official, either the Secretary of Health and Human Services or the FDA Commissioner. Only principal officers of the U.S., confirmed by the Senate can issue regulations tht are binding on the public.

This isn’t the first time this violation has happened. Kux has issued nearly 200 of these rules, all invalid, according to the Constitution.

The Washington Examiner said, “Thanks to this regulatory mess by 2022 we could face the bizarre situation where cigarettes, which kill half of their lifelong users, remain abundant and new cigarettes can come to market with ease, but products that are safer and help people quit smoking will be regulated out of existence.”

The situation is already causing problems for the vapor industry. Some liquids are no longer available due to the difficulty in navigating the regulatory process.
The Examiner called the deeming rule, “one of the worst regulations on the books today.”

Manor said, “I cannot understand why the FDA is trying to stop a miracle innovation that can save millions of lives. There are thousands of studies proving vaping is up to 95 percent less harmful than smoking. Yet I can’t tell you that if you come into my stores.”

The introduction to Manor and Bitterman’s lawsuit against the FDA says, “The Food and Drug Administration’s Deeming Rule enables the FDA to treat a variety of non-tobacco vaping products as if they were tobacco products…thus triggers burdensome regulatory requirement, including a ban on truthful speech unless the speaker obtains government preapproval for each statement…the Deeming Rule is unconstitutional because the FDA employee who issued it had no constitutional authority to do so and because the rule violates the First Amendment’s free speech protections.”

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