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FDA Cracking Down on Underaged E-Cigarette Use

In a press release posted September 12th, 2018 by the Food and Drug Administration (FDA), the agency announced several details about enforcement actions for the e-cigarette industry. Dr. Scott Gottlieb, FDA Commissioner also released a statement regarding ongoing agency efforts.

Dr. Gottleib identified one issue regarding restricting sales and marketing efforts to teens. This was is a major component of the Deeming Regulations, however; minors continue to purchase the embargoed products. The mega-brands that command 97% of the industry, including Juul; Vuse; Blu; MarkTen XL; and Logic received warning letters and fines.

To date, more than 1,300 warning letters and fines made their way to retailers for selling Juul and other products to minors after a nationwide crackdown. Targets of the enforcement campaign included both brick-and-mortar and online retailers. This new crackdown comes after another wave of warning letters back in the spring. Online retailers present a complicated issue for the FDA, as it is easy to circumvent age requirements. Stores, online or not, face potential revocation of their ability to sell tobacco products.

Another part of the issue is that the FDA is closely researching a link between dessert, fruity, and candy-themed e-liquids and companies explicitly marketing them to kids. Finally, the FDA is closely examining manufacturers and distributors to ascertain whether these products entered the market after the deeming date of August 8th, 2016. Companies selling products introduced after that date would be required to file Pre-Market Tobacco Applications (PMTA).

Ongoing issues with e-cigarettes puts the FDA in a precarious situation. The FDA acknowledges that e-cigarettes are effective in helping smokers ditch harmful tobacco products like cigarettes and cigars, but the number of younger vapers is growing at an alarming rate. Commissioner Gottlieb previously commented on the increase in under-aged e-cigarette users and is considering adding new regulations for e-liquid flavors. The extent of new rules is unknown.

One of the best protections for e-liquid manufacturers and distributors is to create or implement processes and internal checks to both document ingredients, recipes, batches, and labels to proactively comply with future regulations. InstantGMP™ Vape comes built-in with features and workflows to do the heavy lifting for compliance and is non-disruptive to current production schedules. It is far easier to start using a system like InstantGMP™ Vape now than when new rules go live.

 

 

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