Lowey Calls on FDA to Remove Illegal Vaping Products from the Market and Redouble Efforts to End E-Cigarette Epidemic
The UWELL Amulet Watch Style Pod System, pictured below, is being sold to the public without an FDA marketing authorization
WASHINGTON, DC – Congresswoman Nita Lowey (D-NY17/Rockland-Westchester), Chairwoman of the House Appropriations Committee, today sent a letter to the U.S. Food and Drug Administration (FDA) Acting Commissioner Dr. Ned Sharpless urging FDA to redouble its efforts to promptly remove illegal vaping products from the market.
On Friday, federal health officials announced that at least 193 individuals in 22 states, mostly teens and young adults, have been hospitalized with vaping related respiratory illnesses, and that to date, there has tragically been at least one fatality. With this new information and the 78% increase in high schoolers using e-cigarettes between 2017 and 2018, Lowey urged FDA to concentrate efforts on removing products that are easily hidden from parents and teachers in order to curb the e-cigarette epidemic and prevent students from getting hooked on nicotine.
“If a teen can do a simple online search to find vaping products that could easily be hidden from parents and teachers, then FDA can similarly search out these products and bring enforcement actions,” Lowey wrote. “The FDA must do much more to address the public health emergency of e-cigarettes as a new generation is getting hooked on nicotine, which can lead to a lifetime of health challenges, and as vaping related illnesses are urgently threatening the health and safety of Americans of all ages.”
Lowey highlighted the UWELL Amulet Watch Style Pod System, which is designed to look “Apple-esqe” and is easily concealable as a vaping device. Under federal law, new tobacco products, including e-cigarettes and other vaping devices, that are introduced or modified after the August 8, 2016, deeming date, cannot be marketed without authorization from the FDA. Advertisements published on behalf of the UWELL Amulet Watch Style Pod System that were posted to YouTube on July 2, 2019, repeatedly refer to the product as brand new. As a result, Lowey has called for aggressive enforcement and for FDA to immediately remove the product from the market.
Lowey has been a strong advocate for tough regulations of e-cigarettes. As Chairwoman of the House Appropriations Committee, she has consistently opposed tobacco-industry efforts to weaken FDA’s enforcement of the Family Smoking Prevention and Tobacco Control Act and recently included an increase of $40 million for the Office on Smoking and Health in the House-passed spending bill for Fiscal Year 2020.
The full text of the letter is below. A PDF copy is available here.
Dear Acting Commissioner Sharpless:
At least 193 individuals in 22 states, mostly teens and young adults, have been treated for vaping related lung illnesses in recent weeks. On Friday, health officials in Illinois announced that one of these patients had lost his life from what doctors believe are respiratory illnesses caused by vaping. This tragic news underscores the failure of the federal government to protect the public against the harms of vaping.
The U.S. Food and Drug Administration (FDA) is charged with protecting consumers. I believe that you and I share a mutual goal of protecting young people from the dangers of nicotine addiction. Yet, I continue to be frustrated by FDA’s slow-walking of enforcement actions for tobacco products that violate federal law. Actions to date simply are not enough to combat this epidemic.
Earlier this month, FDA issued warning letters to four companies for illegally selling products without required marketing authorizations. Your own statement issued with the warning letters stated, “The marketing of illegal tobacco products is particularly concerning given the epidemic of youth vaping that we’re facing, which we know has resulted in part from irresponsible practices of manufacturers, importers and retailers who have targeted kids in their marketing of these practices.”
In the weeks since that announcement, a number of concerning tobacco products have been brought to my attention. Given the vast number of vaping products available online, FDA clearly must redouble its efforts to promptly remove illegal products from the market. If a teen can do a simple online search to find vaping products that could easily be hidden from parents and teachers, then FDA can similarly search out these products and bring enforcement actions.
One of these troubling products is the UWELL Amulet Watch Style Pod System, sold online through Element Vape and advertised on Facebook and YouTube. A screenshot of Element Vape’s Facebook advertisement is enclosed. The manufacturer’s YouTube video advertises the UWELL Amulet Watch Style Pod System as “Apple-esqe” and highlights that users can “easily take the pod, throw it in your pocket, and you have a tiny little device at your every need.” The video, published on July 2, 2019, repeatedly refers to the product as brand new, which without an FDA marketing authorization order would violate federal law. With students nationwide preparing to start a new school year, this product raises alarms as it could be easily disguised and used by teens throughout the school day. FDA should immediately remove the device from the market.
The FDA must do much more to address the public health emergency of e-cigarettes as a new generation is getting hooked on nicotine, which can lead to a lifetime of health challenges, and as vaping related illnesses are urgently threatening the health and safety of Americans of all ages. I urge you to bring aggressive enforcement actions against illegal products such as the UWELL Amulet Watch Style Pod System and to swiftly remove it from the market.
Nita M. Lowey
Member of Congress
CC: Secretary of Health and Human Service Alex Azar