February 16, 2020

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Tobacco Turmoil and the FDA's Regulatory Authority

FDA’s regulatory authority extended to all tobacco products

  • As covered previously, under the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Family Smoking Prevention and Tobacco Control Act of 2009 (Tobacco Control Act), FDA has the authority to regulate cigarettes, cigarette tobacco, roll-your-own tobacco, smokeless tobacco, and any other tobacco products that the Agency deems to be subject to the law.

  • On May 5, FDA pre-published its long-awaited Deeming Regulation, which will be published in the Federal Register on May 10, and become effective 90 days thereafter, on August 8, 2016.  The new rule will extend FDA’s regulatory authority to all currently unregulated “tobacco products”, including e-vapor and e-liquid products that contain tobacco-derived nicotine, cigars, hookah, and pipe tobacco.

  • Once effective, the newly covered products will be subject to the same Tobacco Control Act requirements that currently only apply to the regulated tobacco product categories noted above.  Most significantly,  FDA chose not to amend the “grandfather date” of February 15, 2007 for deemed products, which means that to remain on the market after the effective date, such products must be:

    • the subject of a Premarket Tobacco Application (PMTA) filed within 24 months of the effective date of the rule (i.e., by August 8, 2018);

    • the subject of a Substantial Equivalence (SE) Application filed within 18 months of the effective date (i.e., by February 8, 2018); or

    • the subject of an SE Exemption Request filed within 12 months of the effective date i.e., by August 8, 2017.

  • If FDA does not grant the product marketing authorization within 12 months following the above-noted deadlines, the product must be removed from the market.

    • To support an SE claim, a manufacturer must be able to identify a “valid predicate,” which is a tobacco product commercially marketed in the U.S. as of February 15, 2007, or a tobacco product previously found SE.  As previously covered by our e-vapor regulatory practice, this requirement is particularly concerning to the vapor industry; the sophisticated products currently marketed are vastly different to the rudimentary disposable models first introduced, and in any case, FDA has been able to identify only one e-cigar product that “may possible be able to serve as a valid predicate.”  If the SE pathway is foreclosed, a manufacturer’s only option is to pursue the much more onerous PMTA pathway.

    • A potential saving grace for industry remains: the Cole-Bishop Amendment, which, if approved, would change the “grandfather date” from February 15, 2007 to August 8, 2016, the effective date of the regulation.  For in-depth coverage of this amendment and its implications, click here.

  • Among other things, the final rule also requires pre-market authorization for deemed products that are not on the market as of August 8, 2016, prohibits the sale of “covered tobacco products” to individuals under the age of 18, and requires the display of health warnings on cigarette tobacco, roll-your own tobacco, and covered tobacco product packages and in advertisements.

© 2020 Keller and Heckman LLP


About this Author

Keller and Heckman offers global food and drug services to its clients. Our comprehensive and extensive food and drug practice is one of the largest in the world. We promote, protect, and defend products made by the spectrum of industries regulated by the U.S. Food and Drug Administration (FDA), the European Commission and Member States authorities in the European Union (EU) and similar authorities throughout the world. The products we help get to market include foods, pharmaceuticals, medical devices, veterinary products, dietary supplements, and cosmetics. In addition...