The rules also mark the first time federal law has prohibited retailers from selling e-cigarettes, hookah tobacco, or cigars to people younger than 18 years old.
The rules are aligned with a 2009 law allowing the FDA to take action against the health risks posed by tobacco, according to a statement by the agency.
"We have more to do to help protect Americans from the dangers of tobacco and nicotine, especially our youth," stated U.S. Department of Health and Human Services Secretary Sylvia Burwell. "As cigarette smoking among those under 18 has fallen, the use of other nicotine products, including e-cigarettes, has taken a drastic leap. All of this is creating a new generation of Americans who are at risk of addiction."
E-cigarettes: Alarming growth among students
Smoking causes almost 500,000 deaths annually, according to the FDA. E-cigarette use among high school students has increased from 1.5% in 2011 to 16% in 2015, and hookah use has grown significantly, according to a new study in Morbidity and Mortality Weekly Report (April 15, 2016, Vol. 65:14, pp. 361-367).
“We have more to do to help protect Americans from the dangers of tobacco and nicotine, especially our youth.”
— Sylvia Burwell, secretary, U.S. Department of Health and Human Services
About 3 million middle and high school students used e-cigarettes in 2015, the FDA reported. High school boys smoked cigars at about the same rate as cigarettes, the report noted.
In 2013-2014, almost 80% of youth tobacco users reported using a flavored tobacco product in the past month, and they cited the appealing flavors as reasons, according to a joint study by the FDA and the U.S. National Institutes of Health. Their popularity is mainly due to flavored products and targeted marketing to youth.
The rules aimed at restricting youth access to tobacco products take effect in August and include the following:
- Tobacco products cannot be sold to anyone younger than 18 years (in person or online).
- Buyers' age must be verified with a photo ID.
- Tobacco products cannot be sold in vending machines, save in adult-only venues.
- Free samples may not be distributed.
Tobacco product manufacturers have two years to submit new applications to market their products and an additional year while the FDA reviews their new product application. Manufacturers that lack FDA approval will be subject to enforcement. Some of the new requirements are listed below:
- Tobacco product manufacturers must register and list their products with the FDA.
- Manufacturers must disclose ingredients in their products, including those that are harmful or potentially harmful.
- Premarket review and approval of new tobacco products are required.
- Manufacturers must include health warnings on packages and ads.
- Tobacco products marketed as "light," "low," or "mild" may not be sold unless approved by the FDA.
The rules will prevent misleading claims by tobacco product manufacturers while allowing the agency to evaluate what's in tobacco products, how they're made, and publicize the risks of using them, the FDA said.
Additionally, manufacturers must show that their products adhere to public health standards, and they must get the FDA's approval to sell them, except for products sold on the market before February 15, 2007.
The FDA can now evaluate factors such as ingredients, the design of products, health risks, and if they are specifically aimed at young people and those who don't use tobacco currently.
"As a physician, I've seen firsthand the devastating health effects of tobacco use," stated FDA Commissioner Robert Califf, MD. "It is the FDA's job to reduce tobacco-related diseases and deaths."
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