The AARC has been working with its partners in the anti-tobacco arena for years to convince the FDA to regulate e-cigarettes and other tobacco products.
Those efforts came to fruition on May 5, when the federal agency issued sweeping new regulations extending its authority over all tobacco products. Effective Aug. 8, this long-awaited, landmark rule gives the agency regulatory power over e-cigarettes and other electronic nicotine delivery systems, cigars, pipe tobacco, hookah, and more.
A Significant Step
According to the CDC, smoking is the leading cause of preventable disease and death in the United States and is responsible for 480,000 deaths per year in the U.S. It is also the primary cause of COPD, which is listed by the CDC as the third leading cause of death.
To carry out its role on behalf of respiratory patients and the respiratory therapists who treat them, the AARC has joined with like-minded organizations and patient advocacy groups in the Tobacco Partners Coalition. Headed by the American Cancer Society Cancer Action Network, the American Heart Association, the American Lung Association, and the Campaign for Tobacco Free Kids, the coalition has worked tirelessly to advocate for greater FDA regulation of tobacco products.
“We applaud the FDA for taking this significant step to protect the public health and for establishing restrictions that will help to protect our country’s vulnerable youth from the influence of the tobacco industry” says AARC President Frank Salvatore, MBA, RRT, FAARC. “Respiratory therapists know firsthand the devastating consequences tobacco products have on their patients’ quality of life, and this new ruling is an important step in helping to reduce tobacco consumption.”
Not A Moment Too Soon
The new rule is sorely needed. A 2015 National Youth Tobacco Survey released last month showed the use of e-cigarettes among high school students skyrocketed from 1.5% in 2011 to 16% in 2015. Moreover, a record-high three million middle and high school students used e-cigarettes, compared to just 1.6 million who smoked cigarettes. Cigar and hookah use also increased, according to the survey.
The new FDA rule aims to restrict youth access to these products by adding new prohibitions on retailers and manufacturers that have previously been unregulated. Key provisions include:
- Not allowing products to be sold to persons under the age of 18 (both in person and online).
- Requiring age verification by photo ID.
- Providing for federal enforcement and penalties against retailers who sell to minors.
- Not allowing the sale of covered tobacco products in vending machines (unless in an adult-only facility).
- Not allowing the distribution of free samples.
- Requiring all tobacco products containing nicotine to carry an addiction warning label and cigars to carry one of four other warnings as well.
- Prohibiting 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.
“The AARC has advocated alongside other organizations on behalf of patients everywhere to reach this important milestone,” adds Salvatore. “While the agency needs to do more to ban flavorings from e-cigarettes and to take stronger steps to prevent manufacturers from using their marketing tactics that appeal to kids and young adults, we believe the FDA is moving in the right direction.”
In the final rule, the FDA announced plans to extend the ban on flavors currently applicable to cigarettes to cigars as well, although additional rulemaking is necessary to complete that task. Unfortunately, the FDA left the door open with respect to specific actions it would take to prohibit flavors in e-cigarettes, such as gummy bear and cotton candy, which are particularly appealing to kids and young adults.
The AARC will continue to monitor the FDA’s actions in this area as well as other aspects of its rulemaking as the agency continues to refine its regulatory authority.
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