Since its inception, the vaping industry has grown massively and become increasingly popular over a very small window of time. With that, everyone within the business, including manufacturers, vape shops, and online sellers, has been subject to continuously changing rules, regulations, confusion, and misinformation. As everyone struggles to keep up, FDA regulations continue to be developed, revised, and enforced to balance the great demand for these products with public safety. We cannot stress enough how much these rules and regulations continue to change, so it’s essential to do all we can to stay informed.
Here are just a few of the ways FDA regulations continue to affect everyone throughout the entire vaping industry.
Restricted youth access
A large part of FDA regulations around E-cigarettes and vaping products are aimed at keeping them out of the hands of our youth. In mid-2016, it became illegal to sell these products to anyone under the age of 18. This includes the legal responsibility to verify the seller’s age using photo ID. Other regulations at play here include prohibiting free samples and vending machine sales outside of adult-only facilities. While it’s illegal to sell and market vaping products to minors under the age of 18, other states have different minimum ages of 19 or 21, and they may also have exceptions for those who serve in the military. It’s up to sellers, including online retailers and vape shops, to stay informed. The FDA has guidance materials available to ensure people are informed, and these include information on how they can ensure they are in compliance with the rules.
Retailer and manufacturer inspections
Stakeholders within the vaping industry, including manufacturing facilities and vape shops, should be aware that the FDA regularly visits and inspects these businesses to ensure FDA regulations are being complied with. On these visits, they also look to ensure businesses are not marketing vaping products without premarket authorization, and of course, that they’re doing everything in their power to restrict minor access to these products. The first warning letter that occurred as a result of violations was sent to a seller in 2018. Among the issues outlined were the sale of products that had not yet met pre-market authorization, and the labeling and/or advertising issues that were not compliant with FDA regulations.
More manufacture responsibilities
As they work to learn more and keep up with a rapidly growing industry, FDA regulations continue to be developed. They are typically based on acquiring, and imparting, more information for the industry and the public. Vaping products, including e-cigarettes, have many of the same regulatory and legal requirements as those the tobacco industry operates under today, as well as some that are unique to the vaping industry. Since 2019, vape product manufacturers must meet several requirements, including registering their business and submitting product lists, labeling, and advertising; submitting tobacco health documents and ingredient lists; and including warning labels on all packaging and advertising that the product contains nicotine, and that it is addictive. Many of the FDA regulation guidelines have been revised or newly written for those businesses who are looking to keep up as rules continue to change and regulations continue to be developed.
In mid-2016, vaping products were placed amongst the same FDA regulations as tobacco-containing nicotine products, including premarket authorization. This ultimately led to the FDA requiring Pre-Market Tobacco Applications (PMTAs) for all vaping products that were introduced to the market after February 15th, 2007. Submitting PMTAs is extremely expensive and time-consuming. To the vaping market, the announcement was essentially a death sentence. The application deadline was delayed by the FDA until August of 2022, giving the industry more time to react and prepare. However, that extension was overturned, with the final filing deadline in September of last year and the industry once again struggling to adapt. With that, the FDA has one year to respond to all the applications submitted, and the industry is awaiting market authorization.
With all of this, it’s clear to see that the FDA regulation changes that are constantly coming at the vaping industry aren’t going anywhere soon. We must do our part to stay on top of the information that affects us all. PMTAFiled is your go-to source for all changing policies that affect the industry. We do all the research so you don’t have to. We will continue to update you on PMTAs that have been filed, application statuses and FDA acceptance letters, and breaking PMTA news alerts.