Insight is defined as an understanding or awareness of a subject. At the Food, Drug and Law Institute conference held this past October on Food and Drug Administration (FDA) tobacco regulations, Mitch Zeller, the director of the FDA’s Center for Tobacco Products, provided numerous insights on the agency’s strategic priorities for tobacco regulations.
Product Standards
Zeller considers product standards the single most powerful tool that Congress provided to the FDA to regulate tobacco products. Under the Family Smoking Prevention and Tobacco Control Act (the law that Congress passed to authorize the FDA to regulate tobacco products), a product standard is the power to ban, restrict or limit the allowable levels of ingredients in tobacco products or tobacco smoke. The FDA intends to develop strong product standards to improve public health that can withstand a legal challenge from the tobacco industry.
To date, the FDA has not finalized or issued any product standards. However, Zeller indicated that the FDA is exploring product standards in three specific areas, including addictiveness of tobacco products, the toxicity of tobacco products and the appeal of tobacco products. Scientific studies funded by the FDA are being conducted to develop and support product standards in these three areas. When new product standards are developed, the FDA will use the rulemaking process to publish the proposed standards and allow for public comments to be submitted in response to the standards. What do product standards mean for the industry? Based on the definition of a product standard, the FDA could propose, for example, standards that require lower nicotine levels or the removal of certain ingredients in tobacco products or constituents in tobacco smoke. These kinds of product standards could change the makeup of tobacco products so that the products on the market today would not be the same under a standard.
Nicotine Policy
The FDA is looking at nicotine differently, not as a drug, but how nicotine is being delivered to the individual. In other words, is nicotine being delivered as a nicotine-replacement therapy such as nicotine gum or patches, combustible tobacco products or electronic cigarettes? Zeller stressed that there is a continuum of nicotine risk, with combustible tobacco products containing the highest health risk and nicotine replacement therapy products on the other end of the health risk spectrum. He also emphasized that it is important to understand that people smoke for the nicotine but have health consequences from the smoke constituents and tar. This continuum of risk gives the FDA the opportunity to study a regulatory process for nicotine that may have less or more stringent regulations depending on the relative health risk posed by different products.
As a part of the FDA’s exploration of nicotine regulations, Zeller highlighted related actions that included finalizing the proposed deeming regulations (the FDA is reviewing 135,000 comments received from the public), working to determine how the regulation of nicotine therapy products will evolve, and considering options for an expedited premarket review of new tobacco products based on the principles of toxicity and risk.
Retail Compliance
The FDA has entered into contracts with either state agencies or private companies to conduct compliance checks on retailers in all 50 states to ensure that federal tobacco regulations are being followed. Over the past four years, retailers on average have successfully passed approximately 95% of compliance checks. The Family Smoking Prevention and Tobacco Control Act requires the FDA to conduct these inspections in the states each year. Since 2010, the FDA has paid out $133 million to state agencies and private companies for conducting these retail inspections.
Public Education
The main public education effort undertaken by the FDA is known as “The Real Cost” campaign. It uses TV commercials, social media and print ads to educate youth about the health consequences of tobacco use. The campaign will be conducted over several years, including research to determine if the messages result in a decrease in smoking among 12- to 17-year-olds.
The first TV commercials produced were taped on a c-store set and depicted a young male and a young female using body parts as part payment for a pack of cigarettes. NATO filed a formal complaint with the FDA requesting that the commercials be removed from TV and YouTube because of the false and negative depiction of retailers selling cigarettes in exchange for body parts. Although the FDA did not remove these commercials from TV or YouTube, the agency recently produced and is airing a new set of “Real Cost” ads, none of which depict a retail store setting. The FDA is also in the process of producing new TV ads that focus on youth use of smokeless tobacco products.
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