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.


From the retailer’s perspective, the FDA’s policy of stifling new product introductions would seem to endanger the very existence of some smaller manufacturers, thereby increasing retailers’ dependence on, and vulnerability to, a few large manufacturers. The FDA’s current interpretation of its authority and mission under the Tobacco Control Act, and its resulting harm to small businesses, is perhaps one of the most troubling aspects of that law.

From the consumer’s viewpoint, the FDA is denying the consumer valuable information. For example, despite the difference in relative risks between a combustible product, on the one hand, and electronic nicotine-delivery system (ENDS) products, on the other, the consumer is denied that knowledge. Moreover, the regulatory regime is threatening to prevent adult consumers from gaining access to the products they have grown to know and love despite there being no science to establish youth interest in those products. For example, in the FDA’s zeal to address flavors in ENDS products, they could possibly ban something as adult-oriented as cherry-flavored pipe tobacco—simply because they either do not understand or because they don’t know how to regulate different products differently, or because they might consider it to be a meaningless distinction.

Manufacturers and retailers need to fight like hell. Support elected officials who support your business and the tobacco industry. Send them money, work a poll, tell your friends what is going on, and keep up with the latest legislative activity happening in your state by visiting the National Association of Tobacco Outlets website, natocentral.org. As a litmus test for any person seeking your support to elected office, you need to ask them how they feel about individual responsibility and freedom of choice. You must also read and watch the news, mass media and entertainment with a critical eye and understanding of the messages being conveyed in the guise of even-handed news. History may later reveal that the tobacco industry is the “canary in the coal mine,” meaning that the regulatory zest directed at our industry is just a harbinger of bad outcomes elsewhere in our society as a result of generally misguided policies.

Henry C. Roemer III is a business law attorney and partner at Finger, Roemer, Brown & Mariani LLP. He has extensive legal experience in tobacco and business transactional matters, and he represents tobacco companies in all aspects of compliance with federal, state and local matters.

This story first appeared in the May/June 2018 issue of Tobacco Business magazine. Members of the tobacco industry are eligible for a complimentary subscription to our magazine. Click here for details.