A Look at Pending Regulations

By
Thomas A. Briant, Executive Director

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It has been more than two years since the enactment of the Family Smoking Prevention and Tobacco Control Act that authorized the Food and Drug Administration to regulate cigarettes, roll-your-own tobacco and smokeless tobacco products. While the FDA has implemented various tobacco-related regulations since the law took effect, there are several significant regulatory matters that remain under consideration or are subject to litigation.

These regulatory matters include retail training program standards; a retail violation reporting form; the use of menthol in cigarettes; the graphic image cigarette health-warning labels; and potential cigar and pipe tobacco regulations.

Retail Training Standards

Under the FDA law, a retailer has the option of implementing a clerk training program. If a retailer uses an “approved training program,” then the retailer is subject to lower fines if a tobacco regulation is violated. The FDA has issued a “guidance” document, which is the agency’s current thinking on the various elements of a clerk training program; but the FDA law states that the agency must develop “standards” to determine what is an “approved training program.”

While it does not have the force and effect of law, the guidance document recommends teaching clerks the following: the minimum legal age to purchase tobacco products; how to request photo identification of customers under 27; and the health impact of tobacco, including the estimated number of deaths caused by tobacco each year, along with the medical costs and lost productivity due to smoking. Also, the guidance suggests that retailers pay an employee who passes a compliance check a cash bonus or provide paid time off.

However, the guidance document is not the same thing as the set of training program standards that the FDA must develop. During a FDA Retailer Stakeholder meeting held last August, FDA staff indicated to retail attendees that the training program standards are being finalized, which may include some of the elements contained in the guidance document. This means that a retailer will not know if its training program is an approved program until the set of standards is issued. Moreover, the FDA will not certify any existing training program such as We Card as being approved once the standards are issued. That determination will need to be made by each retailer.

Violation Form

In late August, the FDA published a notice seeking public comments on a proposal to allow consumers and other stakeholders (such as anti-tobacco organizations) to submit reports to the agency about potential retailer violations of the tobacco regulations. This proposal would allow these violation reports to be filed by telephone, over the Internet, through a smartphone application or by mail. The FDA estimates that 1,000 citizens will file reports of retail tobacco regulation violations each year for the next three years.

More than 20 sets of comments were submitted in response to this proposed violation reporting form, and only a few of the comments supported the use of the form. The comments opposing the use of the form pointed out that the FDA law did not direct the agency to issue such a violation reporting form; the FDA is already contracting with state govern-ment agencies to conduct retail compliance inspections; the public may not have the necessary knowledge to determine what is and is not a violation; and various organizations may file inaccurate or even false reports to target a specific retailer.

The FDA is in the process of reviewing the comments submitted about the violation reporting form. Once the FDA finalizes its review of the comments, the Office of Management and Budget will also seek public comments on this proposed form because taxpayer time is involved in completing the form and submitting the report to the FDA.

Menthol Update

The FDA’s Tobacco Product Scientific Advisory Committee (TPSAC) studied the use of menthol in cigarettes and issued a report and set of recommendations March 18, 2011. The TPSAC report concluded, among other things, that the evidence does not indicate increased disease risks in smokers of menthol cigarettes compared to nonmenthol cigarettes; the removal of menthol cigarettes from the marketplace would benefit the public health in the United States; and a potential exists for a black market if a ban on menthol cigarettes is implemented.

Tobacco industry manufacturers and the three nonvoting industry members of the TPSAC compiled an industry viewpoint report in response to the TPSAC’s conclusions on menthol cigarettes. The industry’s report stated, in part, that the scientific data demonstrates no difference in disease, initiation, cessation or dependence between menthol and nonmenthol cigarettes; there is no scientific basis to support the regulation of menthol cigarettes any differently than non-menthol cigarettes; and that a ban on menthol cigarettes would result in a dramatically larger illegal cigarette market than exists now.

The FDA has conducted an initial review of the TPSAC and industry reports, but it has not taken any official action. Under the FDA law, there is no timetable or requirement that the FDA adopt any regulations regarding menthol in cigarettes.

Graphic Warnings

On June 22, 2011, the FDA published a Final Rule requiring nine text warnings and graphic images to be printed on the top 50% of the front and back of cigarette packages, the left 50% of the front and back of cigarette cartons, and the top 20% of all printed cigarette advertisements. The new text and graphic-image warning labels were to take effect Sept. 22, 2012.

However, a federal lawsuit filed by five tobacco manufacturers challenging the constitutionality of the graphic warning images resulted in a court decision Nov. 7, 2011, granting a temporary injunction against the implementation of the new warnings. The federal judge determined that the tobacco manufacturers would likely prevail in the lawsuit because the First Amendment to the U.S. Constitution protects free speech, including commercial speech such as advertising. Also, the judge determined that the images were unconstitutionally “compelled speech” because the text and graphic images were designed to compel the manufacturers to “speak” to consumers so that they would quit or never start smoking, rather than to just simply provide factual health information.

The FDA has appealed the temporary injunction ruling to the U.S. Circuit Court of Appeals, and a group of 24 state attorneys general have filed a “friend of the court” brief with the appeals court in support of the government’s graphicimage labels.

The court decision not only issued an injunction against the FDA’s cigarette text and graphic-image warnings, but it also imposed a stay on the implementation of the health-warning regulations until 15 months after a final ruling on the merits of the claims in the lawsuit. This means that while the case is on appeal, the manufacturers will not be required to place the graphic images on cigarette packaging or in cigarette advertisements.

Cigars and Pipe Tobacco

The FDA law allows the agency to extend tobacco regulations to other tobacco products, including cigars and pipe tobacco. On April 25, 2011, the FDA issued a letter stating its intent to propose regulations on other tobacco products such as cigars and pipe tobacco. The letter went on to state that these regulations would include general controls, such as company registration, product listing, ingredient listing, good manufacturing practice requirements, user fees for certain products, and premarket review requirements for new tobacco products and modified-risk tobacco products.

Industry trade groups representing cigar and pipe tobacco manufacturers have made presentations to FDA staff on the uniqueness of these tobacco products, and the agency has not yet issued any proposed regulations for these tobacco products. 

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