On the heels of FDA’s surprising determination that dissolvable tobacco products, such as Star Scientific’s Stonewall and Ariva and R.J. Reynolds’ Camel “Orbs,” are not considered smokeless tobacco products currently subject to regulation under the Tobacco Control Act, the FDA’s Tobacco Products Scientific Advisory Committee convened its first meeting to evaluate these products.

We have previously written about New York’s recent effort to collect taxes for cigarette sales on Native American reservations.  We have also written about the ongoing arbitration between the states and the major tobacco companies regarding allegations that the states have not “diligently enforced” their state escrow statutes. 

On July 26, the Massachusetts Appeals Court upheld a lower court’s dismissal of a lawsuit filed by RYO Cigar Association, Inc. (“RYO”) and New Image Global, Inc. (“New Image”) seeking an injunction against enforcement of a regulation issued by the Boston public commission banning the sale of cigar wraps in Boston.

At least one issue is resolved.  The Food & Drug Administration (“FDA”) will regulate electronic cigarettes (“e-cigarettes”) as tobacco products and not as drug-delivery devices.  Yet, many other issues remain unresolved as a result of the FDA’s decision, including the taxation of e-cigarettes.

The Federal Trade Commission issued a report last week regarding the amounts spent by tobacco companies on advertising and promotion in 2007 and 2008.  Perhaps not surprisingly, the amount spent on advertising and promotion by the largest cigarette companies declined by 13% between 2006 and 2007, and another 8% between 2007 and 2008.

FDA recently issued draft guidance regarding how a manufacturer can establish that its tobacco product was commercially marketed in the United States as of February 15, 2007, thus exempting the product from the onerous premarket requirements of the Tobacco Control Act (“TCA”).  The guidance first explains that FDA interprets the phrase “as of February 15, 2007” as meaning that a tobacco product was commercially marketed – not in test markets – in the United States on February 15, 2007.

A significant provision of the Family Smoking Prevention and Tobacco Control Act is the requirement for tobacco manufacturers to operate in compliance with current good manufacturing practices (cGMP).   One good approach to understanding these requirements is to read the underlying regulations.  For finished pharmaceuticals this is 21 CFR Part 211.

Several years ago, the state of California filed suit against Native Wholesale Supply Company (“NWS”) for allegedly violating California’s MSA, cigarette fire safety, and unfair competition laws.  NWS, a tribally-chartered corporation headquartered in New York, sells and distributes cigarettes manufactured by the Canadian tribally-owned corporation Grand River Enterprises Six Nations.  In California, NWS primarily sells these cigarettes to Big Sandy Rancheria.  Big Sandy – or other Indian retailers in California to which Big Sandy directs NWS to transport Grand River cigarettes – then sells the cigarettes to the California general public.  Since late 2003, NWS has delivered over 325 million cigarettes, worth nearly $12 million, to California.