By: Mitch Zeller, J.D.
This month, for the first time, FDA will be able to help protect the public, and especially kids, from the dangers of all tobacco products.
For years, it has been illegal under federal law to sell cigarettes and smokeless tobacco to minors. Under a rule finalized in May, federal law now prohibits retailers from selling e-cigarettes, hookah tobacco or cigars to people under age 18.
- It will become illegal nationwide to sell cigars, hookah tobacco, and e-cigarettes to anyone under age 18 and retailers will need to check photo ID of anyone under age 27.
- Retailers will not be allowed to give away free samples of newly deemed tobacco products.
- Retailers will not be allowed to sell cigars, hookah tobacco, and e-cigarettes in a vending machine where anyone under age 18 has access at any time.
In 2009, the President signed the Family Smoking Prevention and Tobacco Control Act into law, giving FDA the authority to regulate cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco. But cigar, hookah tobacco and e-cigarette markets remained unregulated, creating a market environment I have equated in the past to the Wild, Wild West.
While there has been a significant decline in the use of traditional cigarettes among youth over the past decade, their use of other tobacco products continues to climb – putting a new generation of kids at risk of addiction. E-cigarette use, for example, skyrocketed from 1.5 percent in 2011 to 16 percent in 2015 (an over 900 percent increase) among high school students; and hookah use also increased significantly. And every day, more teenage boys try a cigar than try a cigarette.
That’s why this historic rule is so important. It enables FDA to regulate all tobacco products except accessories – improving public health and protecting future generations from the dangers of tobacco.
In addition to restricting youth access to tobacco products, FDA will now be able to review new tobacco products not yet on the market, prevent misleading claims and help better provide consumers with information to make informed decisions about their tobacco use. This means tobacco product manufacturers will be required to register and list their products with FDA. And all newly regulated products will need to get a marketing order from FDA, unless they are grandfathered (were sold in the U.S. as of February 15, 2007.) Manufacturers will also be required to report ingredients and harmful and potentially harmful constituents in their products.
Under these public-health based regulations, tobacco product manufacturers seeking a marketing order from FDA must now demonstrate what is actually in these products, and how these products impact the health of those who use them – important rules to be expected for products that expose consumers to known or potential health risks.
To assist companies in making the transition to an FDA-regulated marketplace, we have published several guidance documents to help businesses, big and small, meet these new requirements. We also continue to offer webinars for retailers and manufacturers and support from our Office of Small Business Assistance.
This historic final deeming rule is a major public health step forward. We believe by restricting youth access to additional tobacco products such as cigars, hookah, and e-cigarettes and by scientifically reviewing these products, we will reduce the public health toll of tobacco use, which remains the leading cause of preventable disease and death in the country and the world – and keep our kids tobacco-free.
Mitch Zeller, J.D., is the Director of FDA’s Center for Tobacco Products