More insight - FDA CTP wants marketing data from Altria by July 30, 2010..

June 21, 2010 - As new U.S. Food & Drug Administration (FDA) regulations kick in this week, the FDA is already questioning one supplier's tactics after redesigning its packaging. Regulators demanded that cigarette maker Philip Morris USA (PM USA) turn over all market research material on Marlboro Lights, citing concern over an advertisement for the brand, reported Reuters. In a letter to PM USA parent company Altria Group Inc., the FDA said it was concerned about advertisements, or "onserts," attached to packs of Marlboro Lights.

A U.S. ban on promoting cigarettes as "light," "mild" or "low" takes effect on Tuesday, June 22, 2010. The ban is a key provision of a new federal law that gives the FDA authority to regulate tobacco products.

A PM USA onsert that drew FDA attention reads: "Your Marlboro Lights pack is changing. But your cigarette stays the same. In the future, ask for 'Marlboro in the gold pack'."

The FDA said, "By stating that only the packaging is changing, but the cigarettes will stay the same, the onsert suggests that Marlboro in the gold pack will have the same characteristics as Marlboro Lights, including any mistaken attributes associated with the 'light' cigarettes." It added, "Although the onsert includes some disclaimer language, Congress found that disclaimers have been ineffective in eliminating mistaken beliefs regarding 'low tar' and 'light' cigarettes."

(Letter to Philip Morris USA, Inc., Marketing Marlboro Lights Cigarettes with an Onsert..)

Directly related news briefs:
FDA CTR - demanding that PM USA turn over research on how consumers are reacting to changes in the Marlboro Lights package..;
U.S. Senators warn tobacco companies not to engage in misleading cigarette advertising..;
PMUSA store sign Marlboro 'New Look Same Famous Flavor"...

Richmond, Va.-based Altria must submit by July 30 all materials related to the marketing or sale of Marlboro Lights, including themes, creative recommendations and dissemination strategies, the FDA said. Altria spokesperson Bill Phelps said, "We received the letter...and we're reviewing it and we will respond."

Credit Suisse analyst Thilo Wrede said in a research note to investors, "We think that [PM USA] should be allowed to communicate packaging changes to its smokers, but the FDA request serves as a reminder that the regulatory pressure is maybe bigger than initially expected."

The FDA noted in a separate letter to retailers of tobacco that the "new legal restrictions apply only to manufacturers; they do not prohibit retailers from selling tobacco products with the descriptors 'light,' 'low,' 'mild,' or similar descriptors that were manufactured before June 22, 2010." (Letter to Retailers on Tobacco Products Labeled or Advertised with the Descriptors “Light,” “Low,” “Mild,” or Similar Descriptors)

"As the FDA acknowledges in the letter to retailers, there is no time limit for retailers to sell through their existing inventory of these tobacco products labeled with these descriptive terms. Retailers should simply continue to use good retailing practices of rotating stock which will reduce the length of time after June 22 that these tobacco products labeled with descriptive words remain on store shelves," said the National Association of Tobacco Outlets (NATO) in its most recent issue of NATO E-News.

Other tobacco regulatory activity: The U.S. Postal Service announced that it will no longer accept packages containing tobacco products starting June 29, 2010 thereby following its obligations under the Prevent All Cigarette Trafficking (PACT) Act. With only a few limited exceptions, the Postal Service will no longer be allowed to accept or transport packages containing cigarettes or smokeless tobacco products. The general mailability ban will extend to cigarettes, roll-your-own tobacco and smokeless tobacco. The prohibition does not include cigars. Other delivery services like FedEx, UPS and DHL are also no longer making cigarette shipments, which significantly limits the legal shipping options for online cigarette sellers. (U.S. PACT Law does effect June 29, 2010..

"Online sales are only a tiny fraction of the total tobacco sales in the U.S., but this event is another example for the increasing pressure on the industry from Washington," said Wrede.

And the FDA advisory panel will have its next meeting on menthol on July 15 and 16. At that meeting, the industry is expected to present its view on menthol and provide the data that was requested at the March meeting.

"We expect a much more intense debate about the industry's intentions for adding menthol to cigarettes, which could lead to a more general discussion of menthol's role in underage smoking initiation. We continue to see the underage initiation argument as the most promising angle of attack for proponents of a menthol ban," Wrede added.

Reference: FDA Takes Issue With 'Onserts'
Agency demands PM USA Morris marketing documents as "light" ban looms
, CSP Daily New, 6/21/2010.