Earlier this month, FDA issued advance notice of proposed rulemaking (ANPRM) to obtain information related to the regulation of non-face-to-face sale and distribution of tobacco products and the advertising, promotion, and marketing of tobacco products.

In June, we reported that National Tobacco Company (“NTC”), the nation’s fourth largest producer of roll-your-own tobacco products, including the popular Zig-Zag brand, had filed a lawsuit against the District of Columbia challenging the constitutionality of the city’s statutory ban on cigar wrappers.

Earlier this month, FDA issued draft guidance addressing substantial equivalence of new tobacco products.  In doing so, FDA provided tobacco manufacturers with much needed guidance on FDA’s “current thinking” on this subject.  Comments on the draft guidance are due by November 8, 2011.

Effective June 2010, FDA issued advertising and marketing restrictions under the Tobacco Control Act.  Among those requirements is a provision prohibiting tobacco manufacturers, distributors and retailers from “sponsoring” any “athletic, musical, artistic, or other social or cultural event, or any entry or team in any event” in the brand name, logo or selling message of any cigarette or smokeless tobacco brand.”

In August of last year, Musser’s Inc. t/d/b/a Genuine Tobacco Co. (“Genuine Tobacco”) filed a lawsuit in the Eastern District of Pennsylvania challenging the constitutionality of certain provisions of the Prevent all Cigarette Trafficking Act (the “PACT Act”). Genuine Tobacco operates two “brick and mortar stores” in Pennsylvania, as well as an online retail store that sells tobacco products through the Internet and telephone to consumers throughout the country.