The Food and Drug Administration just made it clear that it cannot tell the difference between eggplants and tobacco leaves. It has assumed control over nicotine that does not come from tobacco but rather is derived from vegetables or created in labs. This development is part of the continued fallout over the FDA’s 499-page “deeming regs,” which brought e-cigarettes, e-liquid, and devices used for vaping under its tobacco-control authority.
Boston University professor Michael Siegel submitted a question to the FDA that simply asked: “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?”
In a drawn-out response posted July 25, the FDA wrote that it does indeed have regulatory power over e-liquid that is not derived from tobacco. This attempts to clarify the FDA’s regulations, but all it does is reiterate that the FDA is waging a war on both orally inhaled nicotine and nicotine-free e-liquid — not tobacco.
Nicotine is present in many foods that humans eat (including eggplants, potatoes, and tomatoes), and it can be created in a lab. Some e-liquid companies are already selling synthetic, tobacco-free nicotine. While nicotine is addictive, it is uncontroversial that the carcinogens and toxins released from burning cigarettes are what kills smokers. The FDA even admitted this much by stating in its “deeming regs” 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 it contain the vast majority of dangerous toxins found in cigarettes. This is why the British Royal College of Physicians found that vaping e-liquid is 95 percent safer than smoking cigarettes.
This treatment of vaping — even when e-liquid has no connection to tobacco — shows that the FDA’s reasoning is circular at best and a deadly power grab at worst. Before looking at direct quotes from the FDA, here is how the FDA’s example of torturous logic proceeds:
‐The FDA has the authority to regulate tobacco products under the 2009 Family Smoking Prevention and Tobacco Control Act.
‐Since e-liquid can contain nicotine that is derived from tobacco, it falls under the FDA’s regulatory authority.
‐Components and parts (tanks, cartridges, pods, wicks, atomizers) of devices reasonably expected to be used while vaping also fall under the FDA’s authority.
‐These regulated components and parts can be used to vape e-liquid that contains tobacco-free nicotine and e-liquid that does not contain any nicotine at all.
‐Therefore, tobacco-free nicotine and nicotine-free e-liquid fall under the FDA’s tobacco authority.
From page 257 of the FDA’s regulations:
The definition of “tobacco product” includes any product made or derived from tobacco, including any component, part, or accessory of a tobacco product. An e-liquid made or derived from tobacco meets this definition and, therefore, is subject to FDA’s chapter IX authorities. E-liquids that do not contain nicotine or other substances derived from tobacco may still be components or parts and, therefore, subject to FDA’s tobacco control authorities, if they are an assembly of materials intended or reasonably expected to be used with or for the human consumption of a tobacco product and do not meet the definition of accessory.
And from page 222:
Nicotine-free e-liquid that is intended or reasonably expected to be used with or for the human consumption of tobacco products in most cases would be a component or part of a tobacco product and, therefore, within the scope of this rule.
There are major problems with the FDA’s power grab. If Congress wanted the FDA to have control of all products that contain nicotine, it would have spelled that out in law. Instead, Congress limited the purview of the Family Smoking Prevention and Tobacco Control Act to tobacco and smoking. Simply put, Congress did not grant the FDA the power to regulate any substance that contains nicotine as a tobacco product.
All FDA control of vaping will do is stifle innovation in a dynamic industry, making it harder for smokers to kick their deadly habit.
As if the FDA’s unauthorized extension of its regulatory authority to non-tobacco-derived nicotine was not enough, it also claims it can regulate e-liquid that does not contain any nicotine — which is the most common type of e-liquid used by teenagers. According to the National Institute on Drug Abuse, only 29 percent of 12th-graders who vaped reported using e-liquid that contained nicotine (or were unsure).
To show just how clueless the government is when it comes to reducing the harms of cigarette smoking, the FDA wrote on page 218 of its deeming regs that “regardless of the nicotine content of the tobacco products, FDA believes that deeming tobacco products will result in significant public health benefits and that the additional restrictions imposed by this rule are appropriate for the protection of the public health.”
In reality, all FDA control of vaping will do is stifle innovation in a dynamic industry, making it harder for smokers to kick their deadly habit or for young people to avoid getting hooked in the first place. Vaping has been shown to be much more effective at helping smokers quit than going cold turkey or using other nicotine-replacement therapies such as patches or gum. Vaping’s increase in popularity has also occurred during a major decline in high-school smoking rates (from 15.7 percent in 2013 to 10.8 percent in 2015).
If the FDA’s main concern is public health, it desperately needs to learn the difference between smoking and vaping — and the difference between tobacco and eggplants.