ASAM Pleased FDA Announces Rule Extending Oversight of All Unregulated Tobacco Products

On Thursday, May 5, the Food and Drug Administration issued a long-awaited rule to establish oversight of electronic cigarettes (e-cigarettes), cigars, hookah and other previously unregulated tobacco products. This rule was issued under the Family Smoking and Prevention and Tobacco Control Act of 2009, which gave the FDA immediate regulatory authority over cigarettes, cigarette tobacco, smokeless tobacco and roll-your-own tobacco and authorized the agency to extend its jurisdiction to all other tobacco products.

It took nearly eight years to extend the key provisions of the 2009 law to e-cigarettes and other newly regulated tobacco products. These provisions:

• Prohibit sales to children under 18, require retailers to verify age for over-the-counter sales and provide for federal enforcement and penalties against retailers who sell to minors;
• Prohibit free samples;
• Restrict vending machine sales to adult-only facilities;
• Require all tobacco products containing nicotine to carry an addiction warning label and cigars to carry one of four warnings as well;
• Require disclosure of ingredients and documents related to health and authorize the FDA to request additional documents related to research and marketing;
• Prohibit the introduction of new or changed products without prior FDA review and scientific evidence demonstrating that allowing a product is “appropriate for the protection of public health”;
• Prohibit manufacturers from claiming a tobacco product is less harmful without first providing the FDA with scientific evidence supporting the claim and demonstrating that it will benefit public health as a whole, and not just individual tobacco users; and
• Authorize the FDA to set standards governing the content of tobacco products.

ASAM supports the implementation of this rule at a time when use of these previously unregulated tobacco products is on the rise. According to the government’s 2015 National Youth Tobacco Survey (NYTS) released last month, there has been a ten-fold increase in current e-cigarette use among high school students between 2011 and 2015 – from 1.5 percent to 16 percent. The evidence shows that e-cigarettes are now by far the most commonly used tobacco product among youth. However youth use of cigars is also a serious concern; the 2015 NYTS shows that high school boys now smoke cigars at a slightly higher rate than cigarettes – 11.5 percent for cigars and 10.7 percent for cigarettes.

While much has been done to reduce cigarette smoking among those under 18, the use of e-cigarettes has drastically increased and requires further regulation to protect kids from their harms. The marketing of e-cigarettes, especially around the more than 7,700 flavors that mimic sweets and candies, has been shown to be a significant factor in the rise of youth use of e-cigarettes. The FDA published research in the October 2015 issue of the Journal of the American Medical Association found that most youth, ages 12-17, who had ever experimented with tobacco started with a flavored product, including 81 percent of youth who had ever used e-cigarettes.

ASAM supports the implementation of this rule and extended FDA oversight of tobacco products and looks forward to continue working with federal agencies and other stakeholders to reduce tobacco use among youth and the general population as a whole.