A new FDA rule asserts the agency’s authority over all tobacco products—including e-cigarettes, cigars, hookah tobacco, and pipe tobacco—and restricts the sale of these products to minors.
The final rule helps implement the Family Smoking Prevention and Tobacco Control Act of 2009 and will allow the FDA to “catch up with changes in the marketplace,” said Sylvia Burwell, Secretary of Health and Human Services. “As cigarette smoking among those under 18 has fallen, the use of other nicotine products, including e-cigarettes, has taken a drastic leap. All of this is creating a new generation of Americans who are at risk of addiction.”
A recent survey supported by the FDA and the Centers for Disease Control and Prevention shows current e-cigarette use among high school students has skyrocketed from 1.5% in 2011 to 16% in 2015 (a more than 900% increase) and hookah use has risen significantly. In 2015, 3 million middle and high school students were current e-cigarette users, and data showed high school boys smoked cigars at about the same rate as cigarettes. Additionally, a study by the FDA and the National Institutes of Health shows that in 2013–2014, nearly 80% of current youth tobacco users reported using a flavored tobacco product in the past 30 days—with the availability of appealing flavors consistently cited as a reason for use.
Under provisions of the new rule that take effect in 90 days:
The FDA’s actions will also help it prevent misleading claims by tobacco product manufacturers, evaluate the ingredients of tobacco products and how they are made, and communicate their potential risks. Manufacturers of all newly regulated products must show that they meet the applicable public health standard in the law and receive marketing authorization from the FDA, unless the product was on the market as of February 15, 2007. The tobacco product review process allows the FDA to evaluate important factors such as ingredients, product design, and health risks, as well as their appeal to youth and nonusers.
Under staggered timelines, the FDA expects that manufacturers will continue selling their products for up to two years while they submit—and an additional year while the FDA reviews—a new tobacco product application. The FDA will grant marketing authorization where appropriate; otherwise, the product will face FDA enforcement.
Smoking, the leading cause of preventable disease and death in the United States, is responsible for 480,000 deaths per year. The new rule marks the latest chapter in the decades-long quest by the federal government and the public health community to protect people from tobacco. Tobacco prevention and control efforts have saved at least 8 million lives in the last 50 years, according to the 2014 Surgeon General’s Report on the Health Consequences of Smoking. In 2009, Congress passed the bipartisan Family Smoking Prevention and Tobacco Control Act (TCA) giving the FDA authority to regulate the manufacturing, distribution, and marketing of tobacco products to protect the public health.
The FDA’s actions will subject all manufacturers, importers and/or retailers of newly regulated tobacco products to any applicable provisions, bringing them in line with other tobacco products the FDA has regulated under the TCA since 2009. These requirements include:
Source: FDA; May 5, 2016.