In April of 2020, the US Food and Drug Administration issued 10 warning letters to e-cigarette retailers marketing to minors , and this week a lawsuit was filed against major vape manufacturer Juul for marketing to youths who were not of legal age to vape and for downplaying the health risks of vaping.

Medical experts have accused Juul in particular of causing a “youth nicotine epidemic” by promoting their products using social media, sponsoring music festivals and hosting launch parties which appealed to young people. They also note that the company did not mention that the products were an alternative to cigarettes in their early marketing.

Here’s what you need to know about the new FDA regulations for vape products and how to ensure that your business is marketing responsibly.

The FDA has been working to reduce unauthorised electronic nicotine delivery systems (ENDS) and other tobacco products being sold to children and teenagers for the last few years by increasing the minimum age to buy tobacco products from 18 to 21, and launching a public health campaign and resources for schools to educate on the potential risks of youth use of vape products. 

They have also introduced the PreMarket Tobacco Application process to enforce marketing to ensure that the tobacco products on the market are sold in the interest of public health. Any manufacturer intending to introduce a new tobacco product to the market must submit an application to the FDA by September 9th, 2020 to show that its marketing strategy is in line with the new regulations.

An ENDS product can be seen as marketing to youth in the way it is designed and labelled, for example pod kits which look like products popular with children such as smart watches and fidget spinners, or packaging which looks like food and drink. 

Products which aren’t ENDS but are designed to hold vaping products, such as backpacks and clothing with pockets for pod systems, are also considered tobacco products which are targeting minors in their marketing.

In January of this year, a ‘ban’ on flavours of e-cigarette cartridge flavours popular with teenagers across the US sought to reduce the number of children and young people addicted to nicotine. Alex Azar, Health and Human Services Secretary said that “by prioritising enforcement against the products that are most widely used by children, our action today seeks to strike the right public health balance.” It is worth noting that FDA has not banned flavored ENDS which hold a Market Order under the PTMA pathway.

The first step is to make a PreMarket Tobacco Application to ensure that your products comply with Federal requirements. In order to have your PMTA approved, your business needs to make clear in its marketing that the product for use by youth and young adults (under the age of 21).

You can do this by setting out a marketing strategy which makes this explicit and ensuring that the design, labelling and advertising of your products shows that they are an alternative to traditional cigarettes for smokers and will not encourage youth or non-smokers to take up vaping. At Inter Scientific, we’re committed to working with responsible e-cigarette manufacturers to ensure that children and young adults are not targeted for sale.

To guide you through the process, we’ve created a road map for the PMTA using our extensive experience of the regulated ENDS category, which will reduce the risk of your application being rejected. Our goal is to simplify the process for you and assist you with every step along the way. Click here to learn more about how we can give your application the best chance of being approved.

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