This annual article focuses on the big picture of tobacco legislation and regulations on the federal, state and local levels. So far, 2014 has proven to be even more demanding and complex than 2013 was because of the proposed tobacco deeming regulations from the Food and Drug Administration (FDA) and the significant increase in both the number and scope of proposed local tobacco ordinances.
FDA Deeming Regulations
In April, the FDA released for public comment a set of proposed deeming regulations that would extend the agency’s regulatory authority to other tobacco products.
The FDA proposed two deeming regulatory options. Option 1 would extend regulations to all other categories of tobacco products, including cigars, pipe tobacco, electronic cigarettes, nicotine gels, hookah tobacco and dissolvables. Option 2 would extend the FDA’s regulatory authority to all of these categories of tobacco products, except premium cigars.
Specifically, the FDA’s proposed deeming regulations would adopt the following regulations:
1. Manufacturers would register each of their tobacco manufacturing facilities with the FDA, submit a product list and list of ingredients, and report any harmful and potentially harmful constituents.
2. Modified-risk descriptors such as “light,” “low,” and “mild” could not be used to describe a regulated tobacco product.
3. No free samples of the deemed tobacco products would be allowed.
4. For newer tobacco products that were not on the market as of Feb. 15, 2007, those manufacturers that submit a premarket tobacco application (PMTA) to the FDA within 24 months following the effective date of the final deeming regulations could continue to market the products unless and until the FDA responds to the application.
5. The minimum age to purchase deemed tobacco products would be 18 years old.
6. A new health warning would need to be placed on all deemed tobacco products, on all cigarette tobacco, roll-your-own tobacco packaging, and all manufacturer and retailer advertisements for these deemed tobacco products. This warning would read: “WARNING: This product contains nicotine derived from tobacco. Nicotine is an addictive chemical.”
7 . While the proposed deeming regulations do not ban flavors for the deemed tobacco products, the FDA requested comments on factors it should consider in determining whether a particular tobacco product such as a little cigar or other non-cigarette tobacco product could be characterized as a “cigarette,” and thus subject to the current cigarette flavor ban.
The deeming regulations are important not only for what regulations are proposed, but also for what regulations were not proposed. For example, the deeming regulations do not propose banning flavors in the deemed products. Also, retail self-service displays of the deemed products are not prohibited. In addition, the deeming regulations ban neither the Internet sale of the deemed products nor the advertising of these tobacco products.
The period of time for the public to submit comments to the FDA on the deeming regulations ended Aug. 8, and more than 81,000 individual comments were submitted to the agency. According to federal law, the FDA must now review each of the comments, determine if any proposed regulations need to be revised, submit the final deeming regulations to the White House Office of Management and Budget for a final review, and then issue the final rule. This process is estimated to take 12 to 18 months.
CONTINUED: FDA Menthol Update
FDA Menthol Update
In July, a federal judge issued a ruling in a lawsuit brought by Lorillard Tobacco Co. and R.J. Reynolds Tobacco Co. against the FDA that requires the agency to appoint new members to the FDA’s Tobacco Product Scientific Advisory Committee (TPSAC) and prohibits the agency from using the report prepared by the TPSAC, which focused on the use of menthol in cigarettes.
The judge based his decision on a finding that three TPSAC members had financial conflicts of interest because they were paid expert witnesses against tobacco companies in tobacco litigation, and they received consulting fees paid by pharmaceutical companies that marketed nicotine-replacement-therapy products.
As part of the ruling, the judge also found that these conflicts of interest tainted the menthol reported compiled by the TPSAC, making the report unusable by the FDA. If the FDA does not appeal the court ruling, the agency’s efforts to propose any regulations on the use of menthol in cigarettes could be postponed while new TPSAC committee members are appointed and additional scientific review of research on menthol is conducted.
State Tobacco Issues
Although 23 state legislatures considered legislation this year to increase or cigarette and tobacco product tax rates, so far only Vermont has enacted a 13-cents-per-pack cigarette tax increase and a weight-based tax of $2.29 per ounce on moist snuff and smokeless tobacco.
Those states that considered but did not pass a cigarette or tobacco tax increase include Alabama, California, Florida, Hawaii, Kansas, Kentucky, Maine, Maryland, Mississippi, Nebraska, Oklahoma, Oregon, Rhode Island, Tennessee, West Virginia, Wisconsin and Wyoming. Several states with tax increase bills still pending include Massachusetts, New York, Ohio and Pennsylvania.
Bills to assess a new tax on e-cigarettes were proposed but not enacted in Hawaii, Indiana, Kentucky, New Jersey, Oklahoma, Oregon, Rhode Island, South Carolina, Vermont and Washington.
North Carolina enacted a tax of 5 cents per milliliter of liquid nicotine solution used for electronic vapor products. Minnesota is the only other state that currently taxes e-cigarettes, with a rate of 95% of the wholesale cost.
Those states with a proposed e-cigarette tax still pending include Michigan (a tax of 15 cents per 1.5 milliliters on the nicotine solution in vapor products including electronic cigarettes), New York (a 75% tobacco products excise tax on e-cigarettes) and Ohio (a proposal to assess the state’s $1.85 per pack cigarette tax on e- cigarettes).
Local Level
As of the end of July, 92 cities and counties in 16 states had considered or proposed restrictions on tobacco products. These included prohibiting tobacco product coupon redemption; outlawing promotionally priced tobacco products such as a buy-one-get-one free package; limiting or reducing the number of retailers allowed to obtain licenses to sell tobacco products; banning flavored tobacco products; and raising the legal minimum age to purchase tobacco to either 19 or 21 years old.
Most recently, there have been proposals to ban the display of tobacco products from the public view, prohibit tobacco advertising, and ban the sale of electronic cigarettes and other smokeless tobacco products such as snus and nicotine tablets or lozenges. These proposals have been defeated because bans on tobacco product displays or advertising violate the First Amendment protections afforded to product advertising, and the outright bans on the sale of e-cigarettes were met with consumer and retail opposition.
Conclusion
In the past, the greatest threat to tobacco products was a tax increase. Today the number and different kind of proposed regulations and restrictions on tobacco products at all levels of government have dramatically changed the legislative and regulatory landscape for tobacco products. To protect the right to sell tobacco products, the entire industry needs to continue its efforts to monitor and respond to these threats that would otherwise seek to severely restrict or outright ban the sale of legal tobacco products to adults.
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