Does the FDA have the authority to regulate vapes made with tomato-based nicotine?
When the FDA deeming regulations were first announced in 2016, the vaping industry and its consumers were understandably confused. If the e-liquids used in vapor products are 100% tobacco-free, then how does the federal government have the legal authority to reclassify them as tobacco products and, consequently, regulate them the same way as conventional combustible tobacco cigarettes?
Vaping advocates and public health experts like Dr. Michael Siegel of Boston University immediately began searching through the nearly 500-page document detailing the new guidelines. On initial review, the regulatory agency in charge - the U.S. Food and Drug Administration – seemed to have unintentionally included a legal loophole of sorts. According to the deeming regulations, any product that is “intended or reasonably expected’ to be used for human consumption of a “tobacco product” falls under its jurisdiction.
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But what if the electronic vaping device includes an e-liquid whose nicotine was derived from a source other than tobacco? After all, there are many plants that contain this naturally occurring substance, including potatoes, eggplants, and tomatoes. There are even synthetic nicotine solutions which are entirely manufactured in laboratories that have no connection whatsoever to nicotine-containing plants found in nature.
Scientists have known for decades that its’s the burning of tobacco leaves that results in multiple carcinogens entering into the bloodstream by way of its tar-filled smoke. The FDA itself even admitted this fact in the fine print of the FDA deeming regulations, stating that nicotine exposure is “not responsible for the high prevalence of tobacco-related death and disease in this country.”
E-liquid does not burn, nor does its vapor contain the monstrous amount of dangerous toxins and carcinogens found in the smoke of combustible tobacco cigarettes. This simple fact is the basis for why the UK Royal College of Physicians determined in April 2016 that vaping is 95 percent less harmful than smoking.
Siegel asks the FDA about non-tobacco nicotine vaping products
Just days after the release of the FDA deeming regulations in 2016, Dr. Siegel sent a letter to the regulatory agency asking the simple question: “Are e-cigs that do not contain nicotine (or any other tobacco extracts) also covered by the FDA deeming regulations? If so, will they also require pre-market approval like products that do contain nicotine?”
On his website The Rest of the Story: Tobacco and Alcohol News Analysis and Commentary, Siegel discusses the rather drawn-out and rather obscure response. In short, the FDA seems to be claiming that it does indeed have the legal authority to regulate non-tobacco nicotine products, but it consistently paints a picture of waging a war on orally ingested nicotine – all forms – rather than a war on tobacco. A portion of the FDA’s response to Siegel’s letter includes the following.
“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.”
There are a few problems with the FDA’s power grab, however. If the Congress wanted the FDA to regulate all products that contain nicotine – eggplants, tomatoes, and potatoes included – then it would have spelled that out clearly by passing a new law. Instead, Congress only passed the Family Smoking Prevention and Tobacco Control Act which confines the FDA regulatory authority to only tobacco and smoking products.
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