FDA Labeling and Ad Restrictions for Nicotine-Containing Products


by Jeffrey Buckley

Updated: August 7, 2020

fda labeling August 10th

Underage vaping. FDA crackdowns. Trade tariffs on Chinese e-cig products. American vapers have had a rough 2018. Things are about to get worse for them, as the deadline approaches for all tobacco products, even no-nicotine e-juice, to carry warning labels.

A New Era of Regulation

August 10th is coming fast. That is the date when health warning labels must be on “covered tobacco products.” The warnings are to inform consumers about the dangers of nicotine.
Closed system devices (vapes with e-juice already inside) are “covered tobacco products.” Liquid e-juice is also a “covered tobacco product” (CTP).

The FDA is giving a one-month grace period for companies to comply. After September 10th, all CTPs must carry the following warning label:

WARNING: This product contains nicotine. Nicotine is an addictive chemical.

Not only that, but the rules have their own rules. The warnings must adhere to strict guidelines issued by the FDA.

  • The label must occupy at least 30% of the package’s display panels
  • The text must not have a font size lower than 12-points and use only sans serif fonts, like Arial and Helvetica
  • The text must be black on a white background, or black on a white background, to increase the contrast
Even products without nicotine are subject to the new rules. No-nicotine e-juice, for example, must carry a different label, which reads: “This product is made from tobacco.” 

The alternative label for non-nicotine products has its own requirements. Manufacturers have to submit reports supporting the claim of “no-nicotine.”

Why All the New Rules?

The labels are a part of the campaign by the FDA to rein in the vape industry. Up until 2016, no one regulated e-cigarettes. The growth of e-cigs has sparked a sudden desire to regulate them, almost out of existence. Fears that e-cigs like the Juul are pushing a new generation to nicotine has forced the FDA to take action. On August 8th, 2016 the FDA gave itself the authority to oversee all tobacco products.

The ruling changed what the FDA considers a tobacco product. E-cigarettes and e-juice with nicotine became tobacco products, and so, subject to FDA regulations. The new labeling rules are a part of that broader regulatory push.

E-cig companies did catch a break when the agency pushed back another deadline.

The 2016 rule gave producers and retailers only 90 days to follow new rules on age limits and marketing. The FDA gave two years to comply with the labeling laws.

In May of 2017, the agency extended the deadline for companies to get FDA-approval to sell their tobacco products. All e-cig companies have until August 2020 to receive the green light from the FDA to sell their goods.

Will New Rules Change Anything?

Do you support warning labels on nicotine products, like e-juice and pre-filled cartridges? How about non-nicotine products like no-nic e-juice? So how these regulations will affect everyone is still an open question. It is too early to say what effect these new labeling rules will have on the industry. No industry likes regulations, but the FDA seems intent on making up for lost time with these new guidelines.

The e-cig industry is not doing itself any favors either. A 2016 study found that from both online and offline sales of e-juice, 53.9% of bottles had some warning label. The study did conclude that in other areas, like stopping sales to minors, online sellers of e-juice were doing a poor job. Hence, the need for more FDA rules.

Warning labels are not all that must be included on new tobacco products. The new labels must also carry information on:

  1. The name and address of the tobacco producer
  2. The quantity of the contents in terms of weight, measure, or number
  3. How much of the tobacco comes the US and how much comes from overseas
As of yet, vape companies have stayed silent on the subject of the new labels. There is not much vape companies can do, except comply. Maybe they see new labels and rules on advertising as only one battle in the broader war. If that be the case, then they are saving their fight for 2020, when their very lives will be on the line.

Published: August 7, 2018Updated: August 7, 2020

Jeffrey Buckley

I was a smoker for over 25 years. In this time I also earned my medical degree with a specialization in addiction treatment and counseling. That period has led me to vaping, my interest started around 2011. I’m fighting the tide of hysteria and dis-information around vaping that emanates from various fronts legislative, cultural and scientific. Having scientific councils support, I’m happy to contribute my thoughts, articles, and expertise.


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