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E-Cig Makers On the Top of FDA’s Most Wanted List

E-Cig Makers On the Top of FDA’s Most Wanted List

Just in time for the new school year, US public health officials from FDA and CDC have issued a joint warning: avoid e-cigarettes and other vaping devices.

With a growing number of cases of a severe lung disease being allegedly linked e-cigarette use, regulators are trying to get their hands around the cause of this disease, as well as other side effects and risks – such as seizures – we are learning about as vaping products grow in popularity.

The agency’s #1 target may be industry darling Juul Labs Inc., which faces a tough regulatory and legal road ahead. Juul faces a lawsuit that alleges the company makes e-cigarettes “that contain excessively high levels of nicotine without warning that they’re addictive,” according to an Associated Press article about the lawsuit. The article notes that the suit accuses Juul of making e-cigarettes that contain “three times more nicotine” than what would satisfy the cravings of an adult smoker. U.S. Surgeon General Jerome Adams has even been on the record noting that each Juul cartridge contains as much nicotine as an entire pack of cigarettes, using a nicotine mixture that is designed to deliver a “smoother, more potent nicotine buzz.”

Juul is also fighting lawsuits alleging the company markets its products to teenagers. Public health officials seem to endorse those allegations. Former FDA Commissioner Scott Gottlieb said earlier this year that “the dramatic spike of youth [vaping] … was driven in part at the very least if not largely by Juul.”

But Juul is not alone in its struggles. When the U.S. House Energy and Commerce committee recently asked for information about the public-health aspects of e-cigarettes, Reynolds American Inc.’s Vuse, Fontem Ventures’ blu eCigs and Japan Tobacco International USA Inc.’s Logic also received the oversight letter. All three of these companies have also faced legal action related to product safety and public health issues. Meanwhile, Altria announced the end of last year that it was discontinuing its Green Smoke and MarkTen product offerings.

It seems FDA is seeking a poster child for the vaping industry, but what its regulatory action will look like remains uncertain. There’s no indication yet that recalls will be required, but smart companies need to be prepared for that development.

In the meantime, other companies and organizations with any exposure to this industry should be watching this space carefully. That goes for Juul’s competitors, marijuana and CBD marketers, as well as retailers who sell these products. It shouldn’t be shocking to anyone if this product category follows a similar path that cigarettes did years ago. If it does (and we think it will), here’s a few lessons we should remember from tobacco issues of the past:

  1. Marketing claims will be evaluated and adjusted. Juul’s marketing campaign has come under scrutiny from regulators and the courts. Regulatory and legal action will continue based on past actions by manufacturers. But in the future, we can expect labeling and marketing changes that, at the very least, feature appropriate warnings.
  • Product availability will change, and it’s not just the manufacturers that will feel the pressure. There’s a reason CVS never sold e-cigarette products once they stopped selling traditional tobacco products. Retailers like 7-Eleven and Wawa, as well as traditional tobacco product stores, should be ready to handle any changes in product offerings, marketing, and recall activity that may be required in the months to come.
  • Lawsuits and public pressure will continue, but those actions won’t be limited to manufacturers. Consumer advocates, victims’ families and plaintiffs lawyers that often the best way to put pressure on manufacturers is to increase the heat on their retail customers.

What it all comes down to is that big changes in the regulation of e-cigarettes and vaping devices are likely in the near future. Now’s the time to plan for them – whether it’s a product recall, change in marketing and communications strategy, or even an exit strategy.

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