FDA Takes Stronger Oversight Role of Tobacco Products

September 02, 2019 by Alec Stone MA, MPA, Former ONS Director of Government Affairs and Advocacy
alec stone
Alec Stone MA, MPA, ONS Public Affairs Director

As the youth smoking epidemic persists (https://voice.ons.org/advocacy/surgeon-general-declares-youth-vaping-an-epidemic) and illnesses related to vaping (https://voice.ons.org/advocacy/ama-medicare-expansion-vaping-pulmonary-disease-nursing-shortage) make the headlines, the U.S. Food and Drug Administration (FDA) is searching for solutions to combat the growing impact of new tobacco and nicotine products. After weeks of public outcry, FDA has doubled down on its regulatory stance, issuing several statements—including new warning letters to large tobacco companies (https://www.fda.gov/news-events/press-announcements/fda-notifies-four-companies-remove-44-flavored-e-liquid-and-hookah-tobacco-products-market-not)—to reinforce its commitment to aggressive oversight and regulation of new tobacco products.

The most recent FDA warnings target four companies, calling for 44 flavored e-liquid products to be removed from the market for lack of authorization. Flavored vaping products have come under harsh scrutiny, no small part because of recent congressional testimony from large vaping manufacturers like Juul (https://voice.ons.org/advocacy/house-committee-examines-juuls-role-in-the-youth-smoking-epidemic) and the potentially predatory marketing tactics they use to target underage consumers.

“Today’s actions make clear that we will continue to keep a close watch on whether companies are breaking the law and will take swift steps when violations are found. Our work in this area has already resulted in a number of companies removing products from the market,” Acting FDA Commissioner Ned Sharpless, MD, said (https://www.fda.gov/news-events/press-announcements/fda-notifies-four-companies-remove-44-flavored-e-liquid-and-hookah-tobacco-products-market-not). “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 products. We are committed to tackling the troubling trend of youth e-cigarette use by continuing to use all available regulatory tools to ensure these products aren’t being marketed to, sold to, or used by kids.”

After U.S. senators chastised FDA’s lack of earlier efforts (https://voice.ons.org/advocacy/durbin-calls-out-fda-medicare-for-all-support-cancer-mortality-drops) to restrict vaping and e-cigarette products from being marketed and sold to children, Congress is now considering several bills that codify a national purchase age for tobacco-related products (https://voice.ons.org/advocacy/tobacco-21-gets-federal-boost) to 21 years old, regardless of existing state laws. The movement to combat youth smoking has grown to encompass several federal agencies, along with numerous advocacy groups like the Campaign for Tobacco Free Kids (https://www.tobaccofreekids.org/), in which ONS is actively involved (https://www.ons.org/make-a-difference/advocacy-policy/coalitions).

FDA’s compliance letters and oversight guidelines have become stricter and the agency’s actions are encouraging to public health advocates interested in seeing a firmer hand to regulate Big Tobacco’s sway on the market. ONS advocates are vital to the vaping conversation (https://voice.ons.org/stories/providing-expert-testimony-in-the-virginia-state-senate) and provide expert testimony at all levels of government. Consider joining your voice and expertise to the ONS advocacy effort (https://voice.ons.org/advocacy/get-involved).


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