August 19, 2019

August 19, 2019

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FDA Extends Regulatory Authority Over All Tobacco Products, Including E-Cigarettes, Cigars and Hookahs

The U.S. Food and Drug Administration (“FDA”) today issued historic final rules that extend the statutory definition of "tobacco products" to e-cigarettes, pipe tobacco, dissolvables, cigars, and “novel and future products.” The new rules go into effect on August 8, 2016, and warrant immediate attention by these billion dollar industries. 

By deeming that e-cigarettes, pipe tobacco, dissolvables, cigars, and "novel and future products" meet the statutory definition of a "tobacco product," impacted industries are now subject to the same regulatory regime as cigarettes, roll your own tobacco, and smokeless tobacco. Whether your product is currently on the market or in product development, manufacturers of the foregoing products will be subject to, at minimum, the following regulatory guidelines:

Every manufacturer, importer and retailer of these products must follow applicable provisions related to tobacco products under the Federal Food, Drug and Cosmetic Act ("FDCA") and all FDA regulations;
Enforcement actions by FDA, including adulteration and misbranding charges;
Registration and listing requirements with FDA;
Reporting ingredients to FDA, including Harmful and Potentially Harmful Constituents ("HPHCs");
Requiring premarket review and authorization of new tobacco products;
Health warning placement on all product label and labeling;
Removal of modified risk tobacco claims, such as "light," "low," "mild," unless authorized;
Banning of flavors; and
Significant restrictions on youth access to these products.

The FDA’s radical expansion will now require all affected industries to incur significant new costs to bring new products to market and keep existing ones on the market. These new expenses include researching, testing, corresponding, challenging, and navigating a complex FDA regulatory framework, while trying to stay competitive. Some analysts predict the premarket review and authorization process could cost some industry actors between $2 million and $10 million dollars. 

 

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About this Author

Laura A. Bentele, Litigation Attorney, Armstrong Teasdale, Law firm
Associate

Laura Bentele is an associate attorney in the Litigation group practicing in the areas of complex commercial litigation and white collar criminal defense. To achieve optimal outcomes, Laura anticipates clients’ strategic and practical business considerations. Committed to effective case management, she is versed in all phases of discovery, trial preparation and negotiation of settlements with opposing counsel. Laura strives to maintain open avenues of communication to ensure that clients receive representation that meets their business needs.

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Ryan Fournier, International Attorney, Armstrong Teasdale Law Firm
Associate

Ryan, a member of the firm’s International practice group, represents domestic and foreign companies of all sizes on a wide range of international law matters. These include: U.S. Customs and Border Protection laws and regulations; the Foreign Corrupt Practices Act; compliance reviews and audits; licensing and compliance matters involved in the export of U.S. products under the Export Administration Act and Regulations (EAA/EAR); the Arms Export Control Act and Regulations (AECA/ITAR); Foreign Assets Control Regulation; free trade agreements; sanctions programs; boycott and anti-boycott regulations; and the denied and debarred persons lists. 

 

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Scott Kozak, Agriculture, Food and Health and Securities Regulation, Armstrong
Partner

Scott Kozak is the founder and co-founder of two of the firm's practice groups:  Agriculture, Food and Health and Securities Regulation and Litigation. He is also a member of the firm’s Complex Commercial Litigation team. A skilled trial lawyer, he focuses on, securities, products liability, toxic tort, complex commercial and environmental litigation. 

Products Liability. Scott has handled a wide range of products liability cases and as a member of the Agriculture, Food and Health group, defends...

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