By the American Lung Association
You may have heard that the U.S. Food and Drug Administration (FDA) recently finalized a rule that gives the agency authority over all tobacco products, including cigars, pipe tobacco, hookah and e-cigarettes. Federal rules can be complex and hard to understand. Here’s what it means, when it starts and how it aims to protect public health.
This new, final rule – which is often called the “deeming” rule—gives FDA legal authority to regulate the sales, marketing and manufacturing of all tobacco products, including cigars, pipe tobacco, hookah and e-cigarettes. Before this rule, these unregulated tobacco products could be sold with almost no oversight or protections in place for kids or the public health. There was no review of the ingredients in the products, how they were made, or any potential dangers to health. Under this new rule, the FDA will take further steps to protect Americans from the dangers of previously unregulated tobacco products including ensuring all tobacco products have health warnings, and sales to kids under 18 are prohibited.
What the new rule does
Cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco products have all been under FDA’s authority since 2009, when President Obama signed the Family Smoking Prevention and Tobacco Control Act.
This new rule does much to complete the process started in 2009. It extends the FDA’s regulatory authority to all tobacco products, including e-cigarettes, all cigars (including so-called “premium” cigars), hookah tobacco, pipe tobacco, nicotine gels and dissolvable tobacco products. It will require health warnings on cigarette tobacco, cigars and certain newly regulated tobacco products and prohibits free samples.
It also requires that manufacturers of newly regulated tobacco products that were not on the market as of February 15, 2007, show that these products meet what is referred to as the public health standard set by the law. Within three years, these manufacturers will also have to receive authorization from the FDA to sell their products or they will no longer be allowed to be sold. This tobacco product review process allows the FDA to evaluate important factors such as ingredients, product design and health risks, as well as products’ appeal to kids and non-users.
The new rule also restricts youth access to newly regulated tobacco products by not allowing products to be sold to kids younger than 18 (photo ID required) and prohibiting tobacco products to be sold in vending machines in facilities open to people under 18.
The final rule allows the FDA to further evaluate the health impact of these products on both users and non-users. It also lets the FDA regulate the products based on the most current scientific knowledge.
What’s the timeline?
On August 8, 2016 – the FDA will begin to enforce these rules on the newly-covered products:
- No free samples
- No unproven health claims
- No vending machine sales, except in adults-only establishments
To report violations of the new tobacco regulations, email CTPCompliance@fda.hhs.gov.
Other provisions will be phased in over time. For example, manufacturers may continue selling their products for up to two years while they submit a new tobacco product application and an additional year while the FDA reviews the application. FDA has created a whole chart with timelines here.
How will it help?
It will help prevent young people from starting to use tobacco, and help consumers better understand the risks of using these products. It will also prevent new tobacco products from being marketed unless a manufacturer demonstrates that the products meet certain public health standards.
Regulated does not mean “safe”
It’s important to note that FDA regulation of these products does not mean they are safe to use. More than 50 years ago, the U.S. Surgeon General released a report detailing the adverse health effects of smoking. Today, tobacco use is still the leading cause of preventable illness and death in the United States. There are close to half a million tobacco-related deaths in America each year. If you or someone you know would like to quit smoking, we have tools to help. If you would like to help the American Lung Association continue its fight to protect kids from tobacco products, learn how to get involved.