FDA Reprimands Tobacco Company for Not Meeting Premarketing Filing Requirements

According to FDA, the RTF letter was issued (https://www.fda.gov/tobacco-products/ctp-newsroom/fda-issues-refuse-file-rtf-letter-jd-nova-group-llc) because the company’s applications for the products “lacked an adequate environmental assessment,” which must be prepared for each proposed authorization.

FDA required (https://www.fda.gov/tobacco-products/manufacturing/submit-tobacco-product-applications-deemed-tobacco-products) applications for e-cigarettes and other new tobacco products that were on the market as of August 8, 2016, to be submitted by September 9, 2020. By FDA’s definition, new tobacco products include (https://www.fda.gov/tobacco-products/manufacturing/submit-tobacco-product-applications-deemed-tobacco-products) any product that was not commercially marketed in the United States as of February 7, 2007, or any modification of a tobacco product where the modified product was commercially marketed in the United States after February 15, 2007.

“On August 8, 2016, all deemed tobacco products, including ENDS, cigars, hookah tobacco, pipe tobacco, nicotine gels, and certain dissolvables became subject to FDA’s tobacco authorities, including the premarket authorization requirements in the Federal Food, Drug, and Cosmetic Act," FDA said (https://www.fda.gov/tobacco-products/manufacturing/submit-tobacco-product-applications-deemed-tobacco-products). “All deemed tobacco products need to have authorization from FDA to be legally marketed.”

FDA’s RTF letter to JD Nova Group does not apply to all of the company’s product applications submitted by the September 9, 2020, deadline. In the RTF letter, FDA said (https://www.fda.gov/tobacco-products/ctp-newsroom/fda-issues-refuse-file-rtf-letter-jd-nova-group-llc) that the company may resubmit a complete application for the products at any time, but the products may not be marketed unless they receive a marketing granted order. FDA also said (https://www.fda.gov/tobacco-products/ctp-newsroom/fda-issues-refuse-file-rtf-letter-jd-nova-group-llc) JD Nova and retailers may not introduce the products or deliver them for introduction to interstate commerce in the United States.

ONS stands with FDA in the fight against tobacco, e-cigarettes, and vaping, and particularly marketing the products to minors. ONS’s position (https://www.ons.org/make-difference/ons-center-advocacy-and-health-policy/position-statements/e-cigarettes-and-vaping) is that FDA should regulate e-cigarettes and vaping liquids as soon as possible to protect underage users from adverse health effects and potential nicotine addiction. ONS also endorses the International Society of Nurses in Cancer Care (https://www.isncc.org/)’s position on tobacco (https://www.ons.org/make-difference/ons-center-advocacy-and-health-policy/position-statements/isncc-tobacco-position), which petitions that the prevention of tobacco use, prevention of exposure to secondhand smoke, and support for smoking cessation are valuable approaches for nurses to decrease tobacco-related health problems. ONS members can also access additional resources through the Society’s Vaping Learning Library (https://www.ons.org/learning-libraries/vaping).