FDA e-cig regulations deemed ‘incomprehensible” by Forbes Magazine
In a blistering article published on July 25, Forbes Magazine takes issue with new FDA e-cig regulations that somehow manage to classify electronic cigarettes as tobacco products even though the majority are essentially tobacco-free. Reporter Jacob Sullum wonders if the legal mumbo-jumbo used to write the deeming regulations was intentionally meant to confuse the entire vaping industry or does the FDA fail to understand the fundamental differences between nicotine and tobacco.
After all, lots of other things contain nicotine, including eggplant, tomatoes, and potatoes. Yet retailers of these nicotine-infused products are not required to undergo the million-dollar approval process set forth under the new FDA e-cig regulations. To gain further insight into the legal rationale used to write the legislation, Forbes consulted with the notorious Michael Siegel from Boston University.
Boston University’s Michael Siegel: ‘I have no clue what the heck the FDA is talking about.’
Professor Michael Siegel is the guy who often states to mainstream media that e-cigarettes are far less harmful than tobacco cigarettes. He also consistently refutes unsubstantiated allegations by the FDA, the CDC, and anti-vaping groups that e-cigs are a gateway to teen smoking. And according to Forbes Magazine, even Siegel believes that the “FDA is incapable of giving succinct – or even comprehensible” answers to very basic questions.
For example, Siegel’s blog mentions a recent question submitted to the FDA by a local vape shop owner. The letter asks whether zero-nicotine e-liquids would fall require a Pre-Market Tobacco Application (PMTA) under of the FDA e-cig regulations. After waiting several weeks for a response, the business owner received an incoherent response that is “more than 1,300 words long and consists mostly of irrelevant boilerplate.” Here is a small portion of the letter that leaves both Forbes Magazine and Michael Siegel scratching their heads.
“As it relates to e-liquids that contain zero nicotine, generally, if your zero-nicotine product is not made or derived from tobacco, it may still be a tobacco product subject to FDA regulation if it is intended or reasonably expected to be used with or for the human consumption of a tobacco product; or intended or reasonably expected to alter the performance, composition, constituents, or characteristics of a tobacco product (with certain exceptions relating to controlling moisture or temperature for storage and initiating external heat source), your product is subject to FDA regulation. These products will be evaluated on a case-by-case basis. This applies to closed and open system devices that contain zero-nicotine.”
Huh? The question should be very easy to answer with a simple “yes” or “no” response. Do retailers of zero-nicotine e-juice need to file a PMTA with the FDA? According to Forbes Magazine and Michaela Siegel, they still have no idea.
Misleading information and apparent contradictions within the FDA e-cig regulations
The FDA response mentions the use of a nicotine-free e-juice “with or for the human consumption of tobacco.” What does this mean? Does the FDA really expect consumers to mix their e-liquid with pipe tobacco? Well, this tortuous statement might be trying to claim that vape mods and other technology with the potential to be used for either zero-nicotine or nicotine-enhanced “tobacco products” will require PMTA approval. If this is true, then a non-disposable e-cig containing nicotine-free e-liquid would not need a PMTA, right?
Maybe not. Another confusing point is contained in the last line of the same paragraph. “This applies to closed and open system devices that contain zero-nicotine.” So, in short, the FDA seemingly contradicts itself in just this one short blurb. Imagine how many times this happens in the entire 1300-word response.
Does all this sound familiar? Perhaps this is because Sen. Ron Johnson, Chairman of the Senate Committee on Homeland Security and Governmental Affairs, has been receiving the same sort of convoluted gibberish throughout his communications with the FDA, as well. Johnson has already sent three different letters to the agency since the FDA e-cig regulations were first announced on May 5, demanding clarifications to a long list of concerns. And when he finally heard back from the FDA, the agency’s response was deemed “insufficient” by the Wisconsin Senator.
If U.S. Senators, University Professors, and Forbes Magazine can’t get a straight answer out of the FDA, then what hope does a local vape shop owner have of complying with the new e-cig regulations and staying in business? For most retailers, FDA compliance will be extremely time-consuming and costly, perhaps $1 million and 18-months of waiting for each and every product. But thanks to the incomprehensible wording used in the FDA e-cig regulations themselves, retailers are struggling to even identify which products need a PMTA and which ones do not.
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