On May 5, 2016, the FDA published a final rule, extending the Agency’s authority to all tobacco products, including, but not limited to, e-cigarettes, cigars, and hookah and pipe tobacco. This rule, which further implements the Family Smoking Prevention and Control Act of 2009, will allow “the FDA to improve public health and protect future generations from the dangers of tobacco use.”
According to the FDA, “the term ‘tobacco product’ means any product made or derived from tobacco that is intended for human consumption, including any component, part, or accessory of a tobacco product. This includes, among other products, cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco.” The final rule applies to all products meeting this definition. Accessories of the newly deemed tobacco products are not subject to the regulations set forth in the Agency’s rule. Furthermore, the rule also serves to “establish specific restrictions that are appropriate for the protection of the public health for the newly deemed tobacco products.”
Over the past decade, the rate of traditional cigarette use among youth has significantly declined. However, the rate of use for other types of tobacco products has continued to increase among this population. According to the Agency, “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 percent in 2011 to 16 percent in 2015 (an over 900 percent 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.” In addition, another study conducted in 2013-2014 [by FDA and the National Institutes of Health (NIH)] shows that, when asked, nearly 80% of current youth tobacco users admitted to using flavored tobacco products within the past 30 days. Furthermore, these individuals cited the availability of appealing flavors as one of the leading reasons for use.
Prior to last week’s final rule, there were no federal laws prohibiting the sale of e-cigarettes, hookah tobacco, or cigars to children under the age of 18. With the new regulations in place, that is going to change. The FDA’s final rule, which goes into effect on August 8, 2016, contains provisions aimed at restricting youth access, including:
While the following list is not all-inclusive, some of the requirements of the final rule include:
The final rule will take effect on August 8, 2016. However, in its press release, FDA notes that, under staggered timelines, it “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 issue an order granting marketing authorization where appropriate; otherwise, the product will face FDA enforcement.”
June 1, 2016
On May 10th the Food and Drug Administration (FDA) published a final rule expanding regulation to a range of products that meet the statutory definition of a “tobacco product,” including...
February 18, 2016
FDA’s Center for Tobacco Products (CTP) is seeking up to six regulated tobacco manufacturers to participate in a voluntary pilot program to help evaluate a potential new eSubmission portal (CTP...
August 25, 2022
FDA - Tobacco Products: Principles for Designing and Conducting Tobacco Product Perception and Intention Studies. August 2022 This final guidance is intended to help applicants (or “you”) design and...