Merkley Leads Push for FDA to Close Synthetic Nicotine Loophole Being Used to Target Teens

Oregon’s U.S. Senator Jeff Merkley is leading a group of nine senators in pushing the U.S. Food and Drug Administration to crack down on synthetic nicotine. Vaping manufacturers have reportedly been switching to synthetic nicotine to sidestep the FDA’s regulatory process for tobacco products and to continue to ensnare teens with sweet flavors that the industry has used to hook a new generation on nicotine products.

Merkley was joined by U.S. Senators Tim Kaine (D-VA), Elizabeth Warren (D-MA), Sherrod Brown (D-OH), Edward J. Markey (D-MA), Richard Blumenthal (D-CT), Tammy Baldwin (D-WI), Tina Smith (D-MN), and Amy Klobuchar (D-MN).

“As the Food and Drug Administration continues to process pre-market tobacco product applications for deemed new tobacco products, we are deeply alarmed by reports that manufacturers are switching to synthetic nicotine in order to skirt required pre-market reviews and continue marketing their nicotine-containing products,” the senators wrote in a letter to FDA Commissioner Janet Woodcock. “We write to urge your agency to act without delay to ensure that these products do not evade regulatory oversight by using the authority granted by Congress through the Federal Food, Drug and Cosmetic Act to regulate synthetic nicotine products as drugs.”

“We are particularly concerned that manufacturers’ use of synthetic nicotine will undermine efforts to reduce the continued popularity of youth vaping,” they continued. “For example, Puff Bar markets Lychee Ice, Banana Ice, Blue Razz, Strawberry Banana, and other fruit flavors which have been shown to attract youth to vaping. The original Puff Bar devices are also priced as low as $12.00 per e-cigarette device and come in colorful designs, making these products even more appealing to youth and young adults. Similarly, oral nicotine products containing synthetic nicotine also are marketed in fruit and candy flavors that appeal to youth and are marketed as ‘convenient’ and ‘discreet’ alternatives.”

FDA data released in September showed that more than 2 million middle and high school students currently use e-cigarettes. Of those children and teens, eight in 10 report that they prefer flavored products, with fruit flavors being the most popular on the market.

The lawmakers asked for answers to the following questions within the next 30 days:

1.  What steps is the FDA taking to ensure that manufacturers of tobacco products do not claim to have switched to use synthetic nicotine as a means to stay on the market after receiving a marketing denial order (MDO) from your agency?

2. On March 2, 2021, an FDA spokesperson said the FDA was aware of Puff Bar’s transition to synthetic nicotine and noted an ongoing investigation. In the more than seven months since that statement, what actions has FDA taken to investigate whether Puff Bar products are in violation of the drug or tobacco product provisions of the FDCA?

3.  What additional authorities or resources would be helpful for FDA to regulate synthetic nicotine as a tobacco product?

The senators’ letter is supported by the American Lung Association, American Heart Association, Campaign for Tobacco Free-Kids, American Academy of Pediatrics, American Cancer Society Cancer Action Network, and Parents Against Vaping E-Cigarettes.