POMPANO BEACH, Fla.-- Writing in CSP at the end of July, very shortly before sweeping policy changes for the electronic-cigarette category were announced by the U.S. Food and Drug Administration (FDA), I said that compliance would remain key as a truly regulated vapor-product industry unfolds. Now that an intended approach for a new framework has been outlined by the FDA, we are able to provide more details on what this means for the category.
Styled as a “comprehensive regulatory plan to shift trajectory of tobacco-related disease [and] death,” Commissioner Scott Gottlieb’s statement reflected hopes of striking a balance between regulation and innovation of harm-reduction technologies while providing “clear guideposts” to the industry. No plans were announced to change the underlying provisions of the original deeming rule, including the grandfather date, but certain provisions that influence the category are addressed, including an extension for filing premarket tobacco application (PMTA) submissions to August 2022 for noncombustible products, and a promise of more clarity for the industry regarding the expected contents of those applications.
Important for retailers: Other deadlines set forth in the deeming rule remain unchanged, including requirements for mandatory health warnings on product packaging and advertisements. Other unchanged deadlines include those with regard to ingredient listings, health document submissions and removal of modified-risk claims. As always, being thorough and candid with your suppliers about compliance is an ideal way for retailers to protect themselves; responsible, compliance-focused partners such as Logic recognize this.
At the state and municipal levels, bills continue to be introduced across the country, covering excise taxes, flavor restrictions, place-of-use restrictions, couponing prohibitions and licensing and age-of-sale restrictions. This trend is unlikely to change, cementing the importance of retailers and suppliers engaging in the legislative process and partnering with compliance-forward suppliers.
As we have consistently done in the past, Logic continues to support scientific and evidence-based regulation of the vapor-product industry. We are encouraged by Gottlieb’s comments concerning a sensibly and fairly regulated market that potentially recognizes the continuum of risk and the public health potential for reduced-risk products, such as electronic nicotine delivery systems (ENDS), electronic cigarettes and innovative new technologies.
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