The FDA’s proposed deeming regulations issued earlier today purport to contain a number of relatively modest proposals for regulation of the newly “deemed” products — generally e-cigarettes, cigars and pipe tobacco. However, lost in the shuffle of the media commentary thus far is the proposal’s impact on tobacco companies’ ability to market new products, or even to continue to market products that are currently being sold.
The FDA proposes to apply the Tobacco Control Act’s premarket review requirements to the newly “deemed” products. This means that, as a general matter, companies must seek and obtain FDA approval before they can sell new products, or even make changes to existing products. This requirement would pose special problems for e-cigarettes and cigars in particular. E-cigarettes are relatively new to the domestic market, and product enhancements are common, and in the public interest. For cigars, a manufacturer’s ability to introduce new product lines, as well as make product changes based on tobacco growing variations, is viewed as critical to the industry.
The proposed regulation purports to acknowledge these issues by delaying premarket approval for two years after the regulations become effective. Companies can submit a premarket approval / substantial equivalence reports within that two-year period, and as long as they have done so, could continue to market the product until the FDA acts on the application.
But what happens then? First of all, the required showing could be extremely difficult. Companies must either show that: (1) the introduction of the new product is appropriate for the protection of public health; or (2) the product is identical to a product on the market in 2007, or that the differences between the new and so-called “grandfathered” products raise no new issues of public health.
Unfortunately, the FDA has determined that it lacks the authority to alter the so-called “grandfather” date of February 15, 2007, so comparison between a new and a ten-year-old product could be difficult. This is particularly true for e-cigarettes, which have only recently entered the domestic market, and which have changed substantially since their introduction around 2007. The lack of a change to the grandfather date would require that any products introduced after 2007, or changed since then, be subject to premarket review and the time-consuming FDA approval process. So although the proposed regulation would delay these requirements for two years, the requirements will be substantial and could be a significant barrier to market.