FDA Warns E-Cig Companies for Illegal Sales

Unauthorized e-liquid products must be removed from market, FDA says

(RxWiki News) The US Food and Drug Administration (FDA) has issued warning letters to 10 companies for illegally selling electronic cigarette products.

These companies are the first manufacturers the FDA has warned for not getting premarket authorization for their products from the FDA. The deadline to file a premarket tobacco product application to receive this authorization was Sept. 9, 2020.

“The premarket application process ensures that new tobacco products, including many already on the market, will undergo a robust scientific evaluation by the FDA,” said FDA Commissioner Dr. Stephen M. Hahn in a press release. “Scientific review of new products is a critical part of how we carry out our mission to protect the public — especially kids — from the harms associated with tobacco use. In addition to the important premarket scientific review, prioritizing enforcement against those who violate the law by selling unauthorized products is how we help protect public health.”

Now, e-cigarette manufacturers must receive premarket authorization from the FDA in order to legally sell their products. The FDA warned these 10 companies:

  • Little House Vapes LLC
  • Castle Rock Vapor LLC
  • Dropsmoke Inc.
  • Perfection Vapes Inc.
  • CLS Trading LLC d/b/a Vape Dudes HQ
  • Session Supply Co.
  • Coastal E-Liquid Laboratory/GC Vapors LLC
  • Dr. Crimmy LLC d/b/a Dr. Crimmy’s V-Liquid
  • CMM Capital LLC d/b/a ETX Vape
  • E-Cig Barn LLC

Combined, these companies are selling more than 100,000 products that must comply with federal regulations, the FDA noted. Many of these products are tobacco- and nicotine-related products like e-cigs and e-cig liquids (the flavored nicotine solutions that e-cigs vaporize and users inhale).

These companies have 15 working days to respond to the FDA's warning letters. If they fail to respond and comply with FDA rules, they could face financial penalties and product seizures, among other penalties.

E-cig use has skyrocketed in recent years, especially among young users. These battery-powered devices use a heated coil to heat a nicotine solution into a vapor that the user inhales.

While some research has suggested that e-cigs may deliver fewer toxins than traditional cigarettes, these devices are still unsafe to use, according to the Centers for Disease Control and Prevention (CDC). E-cig use has been tied to a risk of becoming addicted to conventional tobacco cigarettes later on.

If you need help breaking your nicotine habit, talk to your health care provider or community pharmacist.

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Review Date: 
January 18, 2021