New FDA oversight of vaporizers could have a big impact on the vaping industry:
. . .the entire landscape is about to change…and it will most likely favor Big Tobacco, in one way or another.
But why the shift?
In May 2016, the FDA finalized a rule (a very dense 134 page rule, to be exact) extending their regulatory power established by the Tobacco Control Act in 2007 to cover all tobacco products, which now includes e-cigarettes. That rule officially went into effect on August 8, 2016,starting the clock for the entire industry to disprove that their products are “not appropriate for the protection of public health.”
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The FDA defines a new group of cigarette technology as Electronic Nicotine Delivery Systems (“ENDS”), which includes “vaporizers, vape pens, hookah pens, electronic cigarettes (E-Cigarettes), and e-pipes,” among others. Despite the term “nicotine” being included in the terminology, the FDA extends their regulation to any tobacco-related product, regardless of whether it contains nicotine. Further, the regulation extends to ENDS and any component of ENDS products, such as e-liquids, atomizers, batteries, cartridges, flavorings, and even software.
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Coupled with that broad definition of regulated products is a broad definition of the term “manufacturer,” which includes all companies that “make, modify, mix, manufacture, fabricate, assemble, process, label, repack, relabel, or import ENDS.” This language is so broad that it essentially includes any company directly or tangentially involved in the ENDS industry.
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What does it take to be approved by the FDA for ENDS products? Every manufacturer must submit an application to market each of their new tobacco products, which may not actually be new or a tobacco product. The term “each” is accurate, as an application must be submitted for each separate SKU (stock keeping unit), and each application must include studies that support their assertion that their product is appropriate for the protection of the public health. Estimates for each application submission range from two million to thirty million dollars, and most manufacturers must submit the applications within twenty-four months of the effective date of August 8, 2016.
Read the rest at Points. The author predicts “the near extinction of the e-cigarette market.”
It’ll be interesting to see how this plays out. Some words from Bill White have been on my mind as I’ve watched the emergence and evolution of vaping. He said something like, “I can’t tell you what the major drugs of misuse of the future will be. But, I can tell you that they are already here and someone will find a new way to use them. Look at the way the invention of the syringe and ‘rocking’ cocaine transformed the relationship between the user and the drug.”
We’ve only seen the tip of the iceberg with vaporizers and we know that regulation is a very imperfect instrument. Will FDA regulation help or create black markets that are worse than our current trajectory?