FDA Requirements for Labels on Electronic Nicotine Delivery Systems

FDA Requirements for Labels on Electronic Nicotine Delivery Systems

Posted by Gina King on Jan 23rd 2020

If you’re a smoker, ex-smoker or have even seen smoking paraphernalia around, you’re probably familiar with the warnings that accompany most products. More recently, however, you may have seen these accompanying vaping devices and e-liquids too. That’s because last year, the FDA announced a list of requirements for labels on these products as well. We’re going to break down the how, what and why of these labeling requirements.

Why did the FDA announce new rules for labels on ENDS products?

In 2009, the Family Smoking Prevention and Tobacco Control Act was signed by President Obama. This regulation made several changes to the way that tobacco companies were allowed to package and market their products.

In 2016, the Food and Drug Administration or FDA announced that it would henceforth consider ENDS (Electronic Nicotine Delivery Systems) products to be under the umbrella of tobacco products and would extend its influence to regulate those as well.

A select minority of e-liquid and hardware companies were accused of employing labeling that was childlike and seemed to be intentionally so, in order to attract a younger audience. Additionally, a few brands also came under fire for making their packaging mislead customers into thinking it was a food product at first glance, rather than a vape one.

In order to curtail these practices by a few companies, the FDA made sweeping, industry-wide regulations in August 2018 so that children wouldn’t be attracted to these products for adults.

Who has to follow the labeling rules for ENDS products?

who has to put warnings on nicotine labels?

Anyone who manufactures, sells or advertises ENDS products must display a health warning on the packaging or advertised content. This means it must be present on billboards, in magazines, and on online stores as well. The warning must also be posted by online marketers, including affiliates that receive a commission, or influencers that are paid to post about a brand.

More importantly, the warnings must also be printed on hardware, like vaporizers and tanks, which don’t exactly count as nicotine products on their own. The rationale behind this is that they can be used with products that contain nicotine, and therefore must be regulated as well.

However, this extends only to the advertising of products and not, say, a store. So, a billboard advertising a vape store would not be required to have a health warning on it, as long as it doesn’t depict or mention specific brands or products.

What are the requirements for the nicotine health warning?

nicotine warning label

The warning must be capitalized and punctuated exactly as follows: “WARNING: This product contains nicotine. Nicotine is an addictive chemical.”
The warning must appear in the upper portion of the advertisement or packaging material.
The warning must occupy at least 20% of the area of the advertisement or 30% of the main panel(s) of product packaging.
The warning must be printed in a size 12 font or larger and should be scaled to fill up the warning ‘area’ as much as possible.
A legible font like Helvetica bold or Arial bold type or another sans serif font must be used.
The warning must use white text on a black background or black text on a white background and should contrast with design elements on the rest of the packaging or advertisement.
The warning must be capitalized and punctuated exactly as described in the regulations.
The warning must be centered in the warning area. It should also face the same direction as the rest of the text on the packaging or advertisement.
The warning must be surrounded by a rectangular border, at least 3-4mm in width that is the same color as the text of the warning statement.

And that’s the (far from) simple list! ENDS manufacturers and advertisers were given about a month (August 10th – September 10th, 2018) to fulfill these requirements, which is why vapers may have found themselves inundated with these warnings last year. What do you think about these regulations? Yay or nay? 

Veppo Vape Team

Gina King is the brand manager for Veppo, a family run brand offering select, tested, high quality vape pen vaporizers, e-liquid and e-cigars. Over the past 12 years, Veppo has provided more than 250,000 customers a friendly alternative to cigarettes.

Gina is a mother, writer, traveler and speaker and has been featured on HuffPost, Forbes, Elite Daily and more.



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