The deeming regulations that the U.S. Food and Drug Administration (FDA) is in the process of finalizing to regulate cigars, pipe tobacco, electronic cigarettes, dissolvables and hookah tobacco are just the first step in its long-term plan to propose and enact additional regulations on all tobacco products.
Since August 2014, when the public comment period on deeming regulations was closed, much attention has focused on when they will take effect. With about 135,000 comments submitted to the FDA on the regulations, the agency has publicly indicated that they should be finalized and become effective in the near future.
The FDA has also been clear in its commitment to base future regulations on scientific studies and data, and over the past five years it has spent $478 million to fund numerous scientific studies on tobacco products. The findings of these long-term studies will be used by the agency to draft new sets of proposed regulations on cigarettes, RYO tobacco, smokeless tobacco, cigars, pipe tobacco, e-cigarettes, vapor products, hookah tobacco and dissolvables.
What’s Being Researched
It’s important to understand the focus of FDA-funded research because the studies will form the basis for new regulations. As a part of its plan, the FDA has developed a set of research priorities, some of which include understanding the diversity of tobacco products, reducing addiction to tobacco products, investigating tobacco product marketing and examining e-cigarettes. Within each of these research priorities, the FDA has sponsored studies to compile a body of science that will be relied upon to draft future regulations.
The studies being conducted on the diversity of tobacco products focus on the ingredients, components and designs of new tobacco products; how nicotine and other addictive substances are delivered to the user; whether product labeling and marketing affect the number of people that use the product; and whether flavors influence the appeal of tobacco products to youth, increase initiation of tobacco products, cause individuals to use more than one tobacco product or decrease the rate of cessation.
Regarding the FDA’s research priority on reducing addiction to tobacco products, the studies investigate what constituents or ingredients in tobacco products besides nicotine increase addictiveness; the effect of lowering nicotine levels in tobacco products on the rate of tobacco use initiation; the use of more than one tobacco product, and the rate of tobacco cessation; and what level of nicotine in cigars and smokeless tobacco leads to dependence and addiction.
The FDA has the authority to reduce nicotine in all tobacco products, although it is prohibited from reducing the level of nicotine to zero.
In terms of tobacco product marketing, study topics include the effect of industry marketing of smokeless tobacco, menthol cigarettes and flavored tobacco products on youth and women; the role of point-of-sale advertisements on youth tobacco use initiation, continued use and cessation; and the effect of price promotions such as free or discount-priced products on consumer initiation of tobacco use.
Turning to e-cigarette research, the studies underway concentrate on the level of metals in e-cigarette aerosol/vapor; the nicotine levels and toxicity of e-cigarettes; the toxin exposure of individuals who smoke cigarettes and use e-cigarettes; the level of use of e-cigarettes by youth; and e-cigarettes as a gateway to other tobacco product use.
Today, there are no FDA-funded e-cigarette studies researching e-cigarettes as a smoking-cessation product because such research requires an Investigational New Drug (IND) application. However, compiling an IND is an involved process and the information needed from manufacturers, such as the ingredients in nicotine liquid, may not be available because many of the companies are located in foreign countries.
What Lies Ahead
Many of the currently funded studies will take several years to complete, and the FDA will likely not propose new tobacco regulations until the scientific studies are completed.
And how will the agency implement any new regulations? By proposing the adoption of tobacco product standards, which include the power to restrict or ban ingredients in tobacco products, tobacco smoke or vapor from e-cigarettes.
Product standards are a very powerful tool that the agency can use to further restrict and regulate tobacco products. One product standard already in effect is the ban on the sale of flavored cigarettes (with the exception of tobacco and menthol flavors).
Any proposed regulations, including new-product standards, must go through a public comment process that will lengthen the time frame for adopting regulations. This could be further extended if industry members turn to litigation as a means of opposing the implementation of new regulations.
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