WASHINGTON, D.C. — This morning, outgoing FDA Commissioner Scott Gottlieb issued a press announcement on a “potential safety issue” relating to vaping products and seizures. According to the FDA, over the last nine years, 35 seizures have reported to the FDA’s Adverse Event Reporting System (AERS) by the doctors of individuals who reported that they vaped at some point prior to suffering a seizure or convulsion.
Commissioner Gottlieb repeatedly noted in his announcement that no link has actually been established. Indeed, the FDA acknowledged that “a few” of these individuals reported a prior history of seizure diagnosis, “a few” reported the use of marijuana or amphetamines, and some suffered seizures after just “a few puffs” or “up to one day after use.”
According to the Centers for Disease Control & Prevention, three million adults and 470,000 children suffer from epilepsy or seizures in the United States. Therefore, it would be expected that some number of e-cigarette users would suffer from seizures regardless of whether they vaped or used no nicotine products.
In a news story published by Vox, Dr. Michael Eriksen, the Dean of the Georgia State University’s School of Public Health, attempted to inject some caution into the debate. “It is 35 cases over 10 years. [That’s] three to five a year with millions of users. So [it’s a] one-in-a-million chance, while one of out two smokers die from smoking,” explained Dr. Eriksen.
Not surprisingly, the FDA has thus far failed to acknowledge any “potential safety issues” relating to pharmaceutical nicotine products and seizures. According to the FDA’s AERS, 34 patients reported seizures between 2008 and 2017 while taking Pfizer’s Nicotrol nicotine nasal spray or GSK’s Nicoderm CQ nicotine patch. That is from just two of the many FDA-approved nicotine replacement therapy products available across the country.
Gregory Conley, President of the American Vaping Association — a nonprofit that advocates for sensible regulatory policies towards vaping products with the aim of maximizing the number of adult smokers who switch to vaping — offered the following comments:
“While any and all potential risks should be investigated, this release by the FDA is incredibly irresponsible. There is absolutely nothing to suggest that these seizures were caused by vaping. With more than one percent of US adults suffering from epilepsy or seizures, it would actually be highly unusual if zero consumers of a product used by millions of adults over the last decade reported suffering a seizure.
“Two pharmaceutical nicotine products — Pfizer’s Nicotrol inhaler and GSK’s Nicoderm CQ patch — are linked to essentially the same number of seizures over a similar period of time. Yet, there is no glossy FDA press release designed to scare the public into believing that using a pharmaceutical quit smoking product could cause them to suffer seizures. It is only vaping products, which are rapidly eating into the profits of GSK and Pfizer, that receive this absurd and unscientific treatment.
“The fearmongering from the FDA is only going to get worse from here. We are now less than two-and-a-half years away from the FDA requiring every vaping product on the market to retroactively undergo what the agency calls ‘premarket’ review. Due to the sky-high costs and lack of guidance from the FDA, we estimate that over 99 percent of products on the market today will be banned after these applications come due in August 2021.
“In a post-Gottlieb world, FDA will have to defend themselves against members of Congress asking how they can justify eliminating tens of thousands of American jobs. The only way they can do that is with a misinformation campaign.”
About the American Vaping Association
The American Vaping Association is a nonprofit organization that advocates for fair and sensible regulation of vapor products, otherwise known as electronic cigarettes, with the goal of maximizing the number of adult smokers who use these products to quit smoking. The AVA was founded by Gregory Conley, a consumer and industry advocate with a long track record of advocating for vapor products dating back to 2010.
We are dedicated to educating the public and government officials about public health benefits offered by vapor products, which are battery-powered devices that heat a liquid nicotine or nicotine-free solution and create an inhalable vapor. The AVA is not a trade group and does not speak for any particular businesses, including our industry sponsors.