E-cigarettes were essentially aimed to be an alternate form for smokers to get their nicotine; however, since their release it has become increasingly aware of the stroke risks the e-cigarettes are having on people.
CNBC reported that the agency has received about 92 new reports of people, especially kids and young adults, experiencing seizures after using e-cigarettes since it first announced its investigation into the issue in April. The FDA said it’s unclear whether e-cigarettes caused the seizures and cautioned these cases occurred over a 10-year period.
“Today, we’re notifying the public of another potential emerging safety issue of which the FDA has recently become aware. We have reports indicating that some people who use e-cigarettes, especially youth and young adults, are experiencing seizures following their use. Seizures or convulsions are known potential side effects of nicotine poisoning and have been reported in scientific literature in relation to intentional or accidental swallowing of nicotine-containing e-liquids.”
However, an FDA review of voluntary adverse event reports for these products submitted to the agency and to poison control centers has identified a total of 35 reported cases of seizures following use of e-cigarettes between 2010 and early 2019. While 35 cases may not seem like much compared to the total number of people using e-cigarettes, we are nonetheless concerned by these reported cases. We also recognize that not all of the cases may be reported. We believe these 35 cases warrant scientific investigation into whether there is in fact a connection.
The company further stated, “We want to be clear that we don’t yet know if there’s a direct relationship between the use of e-cigarettes and a risk of seizure. We can’t yet say for certain that e-cigarettes are causing these seizures. We’re sharing this early information with the public because as a public health agency, it’s our job to communicate about potential safety concerns associated with the products we regulate that are under scientific investigation by the agency. This also helps encourage the public to voluntarily report additional adverse events that can better inform our work,” said the FDA in a press release from April 2019.
Since that release, the FDA has said they have had more data come through to them, which prompeted the numbers to rise in their investigation. With CNBC being told that having 92 additional reports over the short period of time from the inital announcement was concerning.
“We appreciate the public response to our initial call for reports, and we strongly encourage the public to submit new or follow-up reports with as much detail as possible,” acting FDA Commissioner Ned Sharpless said in a statement.
“Additional reports or more detailed information about these incidents are vital to help inform our analysis and may help us identify common risk factors and determine whether any specific e-cigarette product attributes, such as nicotine content or formulation, may be more likely to contribute to seizures,” he added.
The FDA said the evidence it has analyzed so far doesn’t establish a clear pattern or cause for the cases. They also added the additional reports “do not necessarily indicate an increase in frequency or prevalence” of seizures among people who vape.
On Thursday, Aug. 8, the FDA released this statement on their website saying, “Today, the U.S. Food and Drug Administration issued warning letters notifying four companies that 44 flavored e-liquid and hookah tobacco products do not have the required marketing authorization, and thus cannot be legally sold in the United States. These new actions are part of the FDA’s ongoing, aggressive effort to investigate and take action against illegally marketed tobacco products amid the epidemic of youth e-cigarette use in America.”
“Today’s actions they took make clear that we will continue to keep a close watch on whether companies are breaking the law and will take swift steps when violations are found. Our work in this area has already resulted in a number of companies removing products from the market,” said Acting FDA Commissioner Ned Sharpless, M.D.
“The marketing of illegal tobacco products is particularly concerning given the epidemic of youth vaping that we’re facing, which we know has resulted in part from irresponsible practices of manufacturers, importers and retailers who have targeted kids in their marketing of these products. We are committed to tackling the troubling trend of youth e-cigarette use by continuing to use all available regulatory tools to ensure these products aren’t being marketed to, sold to, or used by kids. It is critical that we remain vigilant in our efforts to stem the increase in use and nicotine addiction in children driven by e-cigarettes, which threatens to erase the years of progress we’ve made combatting tobacco use among kids.”
They advised that the companies that were sent letters from the agency for illegally selling their products without required marketing authorization are:
- Mighty Vapors LLC doing business as Ovo Manufacturing & Distribution for products including: Hulk Tears NicSalts, Frozen Hulk Tears NicSalts, Majestic Mango NicSalts, Frozen Majestic Mango NicSalts, Mystery Pop NicSalts and Frozen Mystery Pop NicSalts
- Liquid Labs USA LLC doing business as Likido Labs USA for products including: Vape SZNS Salty SZN Pom Berry Salts, Vape SZNS Salty SZN Kapital Grape Salts and Vape SZNS Salty SZN Neon Sours Salts
- V8P Juice International LLC for products including: V8P Saltz Blonde Bombshell, V8P Saltz Mami Merengue, V8P Saltz Port Master, V8P Saltz Last Samurai, V8P Saltz Cowboy Killer and V8P Saltz Caribbean Don
- Hookah Imports Inc. for ROR Tobacco products including flavors such as Yummy Gummy, Sexy Senorita and Raspberry Lemonade
To read the full details in their latest release, click here