The Food and Drug Administration (FDA) has issued a final rule to expand its authority to regulate tobacco products, including electronic nicotine delivery systems (ENDS), cigars, hookah tobacco, pipe tobacco, and nicotine gels. This rule considers that all products that meet the legal definition of “tobacco product”, except for the accessories of new tobacco products, are subject to the Federal Food, Drug and Cosmetic Act (the FD&C). The FD&C, as amended by the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act), gives the FDA the authority to regulate cigarettes, smoking tobacco, rolling tobacco, smokeless tobacco, and any other tobacco product that the Agency deems subject to the law. The FDA's latest rule prohibits the sale of “covered” tobacco products to people under 18 and requires health warnings to be displayed on smoking tobacco, roll-up tobacco, and covered packages of tobacco products and advertisements.
This action is taken to reduce deaths and illnesses caused by tobacco products. The Tobacco Control Act also prohibits candy and fruit-flavored cigarettes that appeal to children, sets a federal minimum legal age for selling (now 2 years), and restricts the industry's marketing and sales tactics aimed at children. It also prohibits companies from making false or misleading claims that a tobacco product is less harmful than others. The FDA requires tobacco companies to disclose information about their products, including harmful ingredients, to the Agency.
It also requires that new tobacco products receive marketing authorization from the FDA to prevent the introduction of products that are more harmful, addictive, or attractive. The FDA can order the reduction or elimination of harmful ingredients and additives in tobacco products to protect public health. Additionally, it requires bigger and bolder graphic health warnings on cigarettes. This rule subjects all recently considered products to the requirements of the Tobacco Control Act, including manufacturer registration, ingredient notification and pre-marketing review of new tobacco products (those marketed or modified as of February 15, 2020) and risk or exposure reduction statements.
It also prohibits free samples, established a national minimum age for the sale of all tobacco products, required age verification in face-to-face transactions, restricted the sale of vending machines, and required health warnings. Despite this rule being a fundamental first step towards comprehensive regulation of all tobacco products, both it and the FDA measures that result from it have been subject to ongoing litigation. The FDA has not been able to exercise its full scope of authority to regulate tobacco products due to lawsuits filed by e-cigarette manufacturers challenging the MDOs. It is critical for public health that the FDA eliminates illegal products from the market and ensures that only products authorized by the FDA are allowed on the market.
Campaigns for Tobacco-Free Kids is a non-profit organization working towards a smoke-free future without accepting funding from either government or the tobacco industry.