With Congressional Repeal Risk, the FDA Finalizes Rules on Tobacco Product Use
As we previously wrote, in 2016 manufacturers, distributors, and retailers of e-cigarettes and other electronic nicotine delivery systems (ENDS) began to fall under FDA regulation. In Monday’s Federal Register, the FDA issued a final rule providing that products of this kind, when used as drugs, devices, or combination products (the “Final Rule”), are excluded from the federal regulatory definition of “tobacco products.” In other words, the agency has now formally clarified that even products made or derived from tobacco may be regulated as medical products if they are intended for use in a manner that fits the legal definition of a “drug” or “device.”
At the same time, the FDA’s effort to impose additional requirements and restrictions on tobacco-derived products comes amid a broader and more aggressive regulatory approach toward products such as ENDS. Notably, although this Final Rule could have far-reaching implications for the marketing of tobacco products, drugs, and medical devices, Congress’s recently passed “Midnight Rules Relief Act” could eliminate the rule before it takes effect (before February 8, 2017).
Specifically, the House of Representatives recently passed the Midnight Rules Relief Act of 2017, largely along party lines. If it is ultimately passed by the Senate and signed into law by President Trump, the bill would amend the Congressional Review Act (CRA) to allow Congress to bundle multiple regulations together in a single disapproval vote, thereby overturning them. While the CRA requires only a simple majority for passage, current law requires Congress to review regulatory disapproval resolutions one at a time. Under the proposed bill, regulations at risk of being overturned would include those submitted to Congress for review within the most recent 60 legislative days, including rules dating back as early as May 2016. As a result, this effort would affect not only the Final Rule relating to newer tobacco-related products, but also many other FDA regulations.
The House’s rapid push for potential regulatory reform was driven by a report issued by the “Freedom Caucus,” which called for more than 200 rules to be repealed under the Congressional Review Act (the caucus’s “wish list” included the Deeming Rule). House Republicans are eager for a large-scale rollback of regulations, and all potentially affected stakeholders should take that enthusiasm seriously. However, the Senate’s 60-vote threshold remains an obstacle, and Senate Majority Leader Mitch McConnell has remained silent on this particular legislation.
Over the past year or so, House Republicans have also highlighted the negative economic impact of the final food rule and other tobacco regulations issued by the FDA. In addition, Tom Price (R-GA), the nominee for Secretary of Health and Human Services, has in the past opposed tobacco regulation, and he could support sending the rule and newer tobacco product regulations back for redrafting under the new leadership of the Trump administration.
Congress has a full agenda in 2017, and it is far from certain that it will move quickly to overturn a broad group of regulations through disapproval. That said, the House has already sent an early signal that it intends to accelerate the rollback process, which should begin immediately after President Trump takes office. We will continue to monitor these legislative and administrative developments and keep readers informed.
