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An Update on FDA Tobacco Issues

On June 12, NATO representatives will meet with Dr. Lawrence Deyton, the director of the U.S. Food & Drug Administration's Center for Tobacco Products (CTP), in a stakeholder's meeting to discuss current tobacco regulatory issues. With this upcoming meeting, this article summarizes the current status of various FDA tobacco regulations and litigation.

State Inspections: Currently, the FDA has contracts with 37 states and the District of Columbia to conduct federal inspections of retail stores that sell tobacco products. These inspections involve trained state agency inspectors who inspect retail stores to ensure compliance with FDA tobacco regulations and to determine whether a minor is able to purchase tobacco products.

The states with a current FDA inspection contract include Alabama, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, Georgia, Hawaii, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, New Hampshire, New Jersey, New Mexico, North Carolina, Ohio, Oklahoma, Pennsylvania, Rhode Island, Tennessee, Texas, Utah, Virginia, Washington, Washington, D.C., West Virginia and Wisconsin.

According to the FDA website and as of April 30, 2012, the states under contract with the FDA have conducted 59,486 retail inspections with 2,594 warning letters issued to first time retail violations and 145 civil money penalty complaints (fines) have been issued to retailers for two or more inspection violations.

This means that 95.4% of all retailers inspected have passed the FDA's state inspections.

Retail Violation Reporting Form: Under its broad enforcement authority, the CTP is proposing to allow the general public to submit a report of a potential retail tobacco violation through a smartphone application, over the Internet, by telephone or by mail.

NATO and its members have objected to this proposal as being unauthorized, unnecessary and unfair. Congress authorized the FDA to contract with states and train state inspectors to conduct inspections on retail stores, but did not instruct the FDA to allow the untrained public to become involved in policing tobacco retailers and submitting reports about possible violations of the federal tobacco regulations. With three-fourths of the states now conducting FDA retail inspections and the agency working to contract with the remaining states, there is no need to allow the public to become involved in the enforcement of the tobacco regulations.

Also, this proposal may lead to inaccurate or even false reports being submitted to the FDA by members of anti-tobacco organizations that target specific retailers. The FDA rejected the concerns raised by NATO and its members about this proposed retail violation reporting form and has requested that the Office of Management and Budget authorize the use of the form by the public.

Menthol in Cigarettes: The FDA's Tobacco Product Scientific Advisory Committee (TPSAC) submitted its final report to the CTP regarding the impact of the use of menthol on the public health in March of 2011. In June of 2011, the CTP announced that the TPSAC's report had been reviewed and then submitted the agency's review of the menthol issue to an external peer review panel in July of 2011. This peer review panel is evaluating the agency's final review and the FDA will then publish its final menthol report in the Federal Register, which will be open to public comment.

There is no deadline date for a final report to be issued by the FDA to the public.

Regulation of Other Tobacco Products: Just last month, the FDA published an announcement on the Federal Business Opportunities website that the agency intends to issue a "deeming regulation" sometime during the summer of 2012 to cover other tobacco products. This means that the FDA plans to issue sometime this summer a proposed regulation covering other tobacco products such as cigars, cigarillos, e-cigarettes, hookahs and possibly other tobacco products. The extent of the proposed regulation is not known at this time, but will be published in the Federal Register when released by the CTP.

Cigarette Graphic Health Warning Litigation: Two lawsuits are pending against the FDA's requirement that cigarette manufacturers print color graphic health warnings on cigarette packages, cartons and advertisements.

The first lawsuit was filed in 2009 and a three judge panel of the U.S. Circuit Court of Appeals ruled on March 19, 2012 that the color graphic health warnings are commercial disclosures of important health-related information and, therefore are constitutional.

The second lawsuit was filed against the color graphic warning labels in August of 2011, just weeks after the FDA released the actual graphic warning pictures that were to be printed on cigarette packing and advertisements by September 2012. The federal district court judge hearing this second lawsuit issued a decision in late February finding that the color graphic warning labels were protected commercial speech and violated the U.S. Constitution. This decision was appealed and the U.S. Court of Appeals for the District of Columbia heard the case on April 10, 2012. A decision by the District of Columbia Circuit Court should be issued in the coming months.

With these lawsuits and appeals pending, the FDA announced that the enforcement of the graphic image health warnings will be delayed.

Published: Tuesday, May 29, 2012

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