FDA Takes Positive Step to Address Illegal Sales of Kid-Friendly E-Cigarettes – Agency Follow-Up Is Critical

Statement of Matthew L. Myers, President, Campaign for Tobacco-Free Kids
October 12, 2018

WASHINGTON, DC – The U.S. Food and Drug Administration today has taken a very positive step to address the proliferation of kid-friendly electronic cigarettes by sending letters to 21 e-cigarette companies seeking information about whether more than 40 of their products are being illegally marketed without required FDA review and authorization.

Current federal law and regulations prohibit the introduction of new or changed e-cigarette products after August 8, 2016, without prior FDA review and authorization, but until now, e-cigarette manufacturers have routinely ignored the law and the FDA has failed to take any meaningful action to enforce the law. The result: the marketplace has been flooded with new e-cigarette products with no federal oversight. The FDA’s letters require companies to provide evidence within 30 days that their products were on the market as of August 8, 2016, and have not been modified since that date. While Juul Labs, maker of the Juul e-cigarettes that have become wildly popular with kids, did not receive a letter, the FDA stated that it sought similar information from Juul during a recent on-site inspection of the company’s headquarters.

While today’s FDA actions are an important step forward, the agency’s follow-up is even more critical. The FDA must hold these companies’ feet to the fire by strictly enforcing its 30-day deadline and requiring the companies to provide strong and objective proof that their products were on the market in their current form as of August 8, 2016. If the companies fail to do so, the FDA must take immediate action to force the products off the market. As detailed in an August letter to the FDA by the Campaign for Tobacco-Free Kids and other leading health organizations, our own investigation and manufacturers’ public statements show that many of the products in question were not on the market as of August 8, 2016.

In our August letter, we urged the FDA to stop the sales of new e-cigarettes that have been illegally introduced in recent months without the agency’s authorization, including numerous products similar to Juul in their appearance and delivery of high doses of nicotine. Our letter stated that “manufacturers of e-cigarette products have introduced new products at an alarming pace in total defiance of law, with no apparent concern for FDA enforcement.” Earlier this year, our organizations also urged the FDA to remove from the market Juul flavors such as mango and cucumber that appear to have been introduced after August 8, 2016.

U.S. Sen. Dick Durbin (D-IL) and 13 other U.S. senators have also urged the FDA to enforce the legal requirement for prior agency review and authorization before new products enter the market.

In addition to today’s actions against these specific products and manufacturers, the FDA must vigorously enforce the pre-market review requirement for all new or changed tobacco products and require all products now on the market to provide detailed information about the product and when it entered the marketplace. The FDA should also reverse its decision to delay until 2022 an agency review of e-cigarettes that were on the market as of August 8, 2016.

The legal requirement for FDA review and authorization before new products enter the market is one of the FDA’s most important tools to stop the introduction of products that appeal to kids, rather than dealing with these products after the fact – and after they are have become popular with kids, as in the case of Juul. Today’s FDA action is an important and overdue first step in enforcing this requirement, but it is only a first step.