In the June 2019 edition of SMOKESHOP Magazine, Troutman Sanders attorney Bryan Haynes discusses “The FDA’s New Catch-22.”  Haynes outlines the FDA’s threat to step up enforcement of premarket review requirements for “new tobacco products” while stalling on long-awaited guidance and regulations establishing the boundaries for industry submissions.

Read the article here.

 

The Federal Trade Commission (FTC) and the U.S. Food and Drug Administration (FDA) recently sent warning letters to four firms that manufacture and market flavored e-liquid products [Letters 1, 2, 3, 4]. According to the letters, the companies used social media “influencers” (individuals who promote a company’s product on social media websites in exchange for compensation) to promote their products.  Those promotional tweets and other postings on sites including Facebook, Instagram, and Twitter failed to include the requisite FDA warnings, prompting the FDA to declare the promoted products misbranded.
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On June 11, the FDA finalized its guidance for manufacturers submitting new tobacco product applications through the premarket tobacco application (PMTA) process for electronic nicotine systems (ENDS), including e-cigarettes, vaping devices and nicotine-containing e-liquids.  By way of background, when the FDA issued the Deeming Regulations asserting jurisdiction over ENDS in May 2016, it also issued a draft guidance for ENDS PMTAs.  The Agency had been promising to finalize that guidance as it proposes to move forward the deadline for these submissions.
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Senate Majority Leader Mitch McConnell (R-KY) recently announced that he, along with Senator Tim Kaine (D-VA), have filed a new, bipartisan bill in Congress to raise the nationwide legal age to purchase tobacco and vaping products from 18 to 21. The bill, currently titled the “Tobacco-Free Youth Act,” would require all states to pass laws raising the minimum age to purchase cigarettes, electronic nicotine delivery systems (ENDS) and other tobacco products to 21. The bill would compel each state to pass individual laws or risk losing substance abuse prevention and treatment funding.
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House Energy and Commerce Chair Rep. Frank Pallone, Jr. (D-NJ) and Rep. Donna Shalala (D-FL) recently introduced H.R. 2339, a comprehensive bill seeking to amend the Federal Food, Drug, and Cosmetic Act with respect to the sale and marketing of tobacco products. The legislation, currently titled the Reversing the Youth Tobacco Epidemic Act of 2019, is a broad bill that covers many of the legislative movements and trends seen in recent years concerning the sale and marketing of tobacco products. This bill reflects an attempt to combine the various issues into one comprehensive piece of legislation ostensibly intended to limit youth tobacco access.
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The cigar industry has found some official support for its challenge to the Deeming Regulations. That official support has come from the State of Arizona, whose Attorney General has filed a brief as amicus curiae, supporting the cigar industry’s position in Cigar Association of America, et al. v. FDA, et al., No. 18-5195 (D.C. Cir.).
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The Family Smoking Prevention and Tobacco Control Act requires the FDA to issue regulations that require color graphics depicting the health consequences of smoking on cigarette packages and in cigarette advertisements. As we previously reported here, on September 5, 2018, the U.S. District Court for the District of Massachusetts found that the FDA “unlawfully withheld” and “unreasonably delayed” the promulgation of a rule mandating color graphic warnings for cigarettes.
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In an August 2017 Guidance, the FDA gave companies an extension to comply with certain deadlines for premarket review submissions, including “substantial equivalence exemption requests (SE EX requests), substantial equivalence reports (SE reports), and premarket tobacco product applications (PMTAs).”
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In a March 2019 update to its guidance regarding “Extension of Certain Tobacco Product Compliance Deadlines Related to the Final Deeming Rule,” the FDA has extended the deadline for manufacturers of “Deemed Products” to report harmful and potentially harmful constituents (“HPHCs”) in their products.  “Deemed Products” are those that were first regulated by the FDA under the Deeming Regulations, and generally include e-cigarettes and other electronic nicotine delivery systems, cigars, pipe tobacco and hookah tobacco.
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