TOB_Magazine

[ 88 ] TOBACCO BUSINESS [ MAY / JUNE | 18 ] The FDA vs. Innovation It’s a case of the government not only taking on businesses, but also attacking the one thing that has united tobacco manufacturers, retailers and consumers: innovation. I Innovation for tobacco businesses, as it relates to the U.S. Food and Drug Administration’s (FDA) regulation of tobacco products, is finding ways to operate successfully in the regulatory environment. For example, one form of innovation is identifying a “grandfathered” product (i.e., those on the market on or before the Feb. 15, 2007, predicate date) and identifying the potential of that product for longer-term success in the market. Innovation also means the recognition by manufacturers of the importance of being actively involved in the political and regulatory process. Although the 2016 presidential election produced perhaps less relief than one might have hoped, at the very least it raised the hope that the FDA would actually give some weight to sound science in its decision-making. For retailers, innovation means staying abreast of developments in regulations and being engaged and vocal with federal, state and local elected representatives about misguided policies being developed relating to tobac- co. Until the most recent presidential election, the FDA—through its restrictive interpretation of substantial equivalence—has made attempts to completely halt innovation by slowing the introduction of new products to the market. In the opinion of many, the FDA did this with the full knowledge that any industry that is not allowed to innovate will surely die. ➤ LEGAL COLUMN [ HENRY C. ROEMER ]