SS June 2016

Issue link:

Contents of this Issue


Page 27 of 55

O n May 5, the U.S. Food & Drug Administration (FDA) released the long-awaited deeming regu- lations, which now subject e-cigarettes, pipe tobacco, cigars, and all other tobacco products to the FDA's tobacco regulatory authority. Manufacturers, distributors, and retailers of these products will now be subject to a host of regulatory require- ments and prohibitions, from mandatory testing, registration, and product listing to a ban on free samples. For many com- panies, these requirements—while oner- ous—are tolerable. The FDA's premarket review re- quirements, however, are a different story. These requirements will, at a min- imum, impose substantial additional costs on the regulated businesses. The worst case scenario is that a company may no longer be permitted to market all or certain of its products. PREMARKET REVIEW OF CURRENTLY-REGULATED PRODUCTS The FDA has been conducting premarket review of cigarettes, cigarette tobacco, and roll-your own tobacco for a little over five years, since March 22, 2011. That is because the Tobacco Control Act estab- lished a limited "provisional" window— between February 15, 2007 and March 22, 2011—for companies to provisionally introduce new products. These provi- sional products could continue to be sold pending the FDA's review as long as the manufacturer submitted a "substantial equivalence" report by March 22, 2011. Products that were introduced before February 15, 2007 (and unchanged since then) are "grandfathered" and not sub- ject to premarket review. Under this premarket review regime, many products—and perhaps most cig- arettes sold in the United States—are grandfathered and therefore exempt from scrutiny. The provisional window also saw many products introduced pri- or to March 22, 2011, with the vast ma- jority of substantial equivalence reports submitted shortly before the deadline. Manufacturers seeking to introduce new products after March 22, 2011 must ob- tain FDA pre-approval before the prod- ucts can be sold. As a result of this provisional win- dow, substantial equivalence remains by far the preferred pathway. The vast majority of submitted and approved ap- plications have been pursued under this pathway. By way of comparison, the FDA has approved only one application under the "exemption from substantial equiva- lence" pathway. The FDA has approved only eight products under the premarket tobacco application (PMTA) pathway and those were similar snus products manufactured by the same company. The legal burden for a PMTA is also higher. In contrast to the substantial equivalence pathway—where the appli- cant must show that the differences be- tween a new and grandfathered product do not "raise different questions of public health"—the PMTA applicant must show that the introduction of the product is "ap- propriate for the protection of the public health." The exemption from substantial 28 SMOKESHOP June 2016 REGULATION FOCUS > FDA Deeming Regulations: Will Premarket Review Crush New Products? The reality of introducing new cigars, pipe tobaccos, and vaping products—and keeping certain currently available ones on the market—has completely changed. It's a tough road ahead and could render the market unrecognizable. >BY BRYAN M. HAYNES

Articles in this issue

view archives of Smokeshop - SS June 2016