At the 2015 NATO Show, held in April, Mitch Zeller, the director of the FDA’s Center for Tobacco Products (CTP), updated attendees on current and pending tobacco regulations.
Key highlights from Zeller’s presentation include:
Protect the Public Health: The federal law authorized the FDA to adopt tobacco regulations that are “appropriate for the protection of the public health.” To do so, Zeller said the FDA will use its regulatory authority to restrict the marketing and distribution of tobacco products; decrease the harm of tobacco products; ensure industry compliance with federal regulations; and conduct or sponsor scientific studies to be used to support new regulations in the future.
Restrictions on FDA Authority: While the FDA was granted broad authority to regulate tobacco products, Congress did not give the FDA the power to establish clean indoor-air policies; regulate the growing of tobacco; reduce nicotine in tobacco products to zero (although the FDA could presumably reduce nicotine levels to as near to zero as possible); ban outright the sale of cigarettes, roll-your-own tobacco, smokeless tobacco, cigars, pipe tobacco, e-cigarettes and hookah tobacco; or raise the legal age to purchase and use tobacco beyond 18.
Deeming Regulations: The FDA has set a goal of finalizing the first new set of tobacco regulations, known as deeming regulations, by June 30, 2015. These deeming regulations would apply to cigars, pipe tobacco, e-cigarettes, hookah tobacco, nicotine gels and dissolvable products. Specifically, the regulations would require, among other things, that manufacturers of the deemed products register their products with the agency and file an ingredient list for each product; be barred from using descriptive words such as “low” and “mild” to describe a tobacco product; set a national minimum age to purchase and use these tobacco products at age 18; mandate a new health warning on these products that says the products contain nicotine and that nicotine is addictive; and prohibit retailers from giving out free samples of the deemed products.
Continuum of Risk: The FDA has formulated a “continuum of risk,” which is essentially an acknowledgement that different kinds of products contain nicotine and that these products have different health consequences or benefits. On one end of the continuum are combustible products such as cigarettes, and on the other end are nicotine replacement products such as nicotine patches and gum. The FDA may consider imposing less restrictive regulations on tobacco products that are nearer the end of the continuum that contains nicotine-replacement products and more restrictive regulations on combustible tobacco products.
Product Standards: In his presentation, Zeller said the law granting the FDA the authority to regulate tobacco products has a very powerful tool known as product standards. A product standard is a regulation that limits or bans the allowable levels of ingredients in tobacco products or tobacco smoke. The FDA is conducting studies to support new product standards in the areas of addiction, toxicity and appeal.
For example, a product standard relating to addiction could be a limitation on the level of nicotine allowed in any tobacco product.
A standard in the area of toxicity could be a mandate to remove a particular ingredient from a tobacco product that has been scientifically determined to be harmful to human health. Also, a product standard regarding appeal could be a ban on certain flavors used in various tobacco products.
Minimum-Age Report: As required under the Tobacco Control Act, the FDA contracted with the Institute of Medicine (IOM) to conduct a study on whether increasing the legal age to purchase tobacco would have an effect on the public health. The IOM investigated raising the legal age to 19, 21 and 25; it concluded that raising the legal age to 21 would have the most effect from a public health standpoint. While the FDA does not have the authority to raise the legal age to purchase tobacco products, the Tobacco Control Act requires the FDA to submit a report to Congress on the outcome of the study. This report should be submitted to Congress in the next several months. Only Congress has the authority to raise the national minimum age for purchasing tobacco products.
User Fees: The CTP is funded entirely through tobacco manufacturer user fees based on the market share of each company, Zeller said. Only the FDA can spend the user fees collected from the tobacco industry. By 2019, the annual user fees payable to the FDA will total $712 million each year; that amount will remain the same in perpetuity.
Compliance Inspections:Over the past four years, the FDA has contracted with virtually every state to conduct compliance inspections on retailers that sell tobacco products. The state agencies under contract with the FDA have conducted more than 400,000 inspections, and retailers on average have successfully passed the inspections 95% of the time.
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