By AMERICAN HEART ASSOCIATION NEWS
The Food and Drug Administration on Thursday released new rules that extend its regulatory authority to electronic cigarettes, cigars, cigarillos, pipe tobacco and hookah tobacco.
More than two years in the making, the new requirements prohibit the sale of these newly regulated tobacco products to Americans under 18, both in person and online, and require photo identification for purchase. In addition, such products can no longer be sold in vending machines accessible to minors.
The rules also require newly regulated tobacco products to include health warnings on product packages and advertisements.
In addition, manufacturers, importers and retailers of such products must:
- Get FDA approval for products that entered the market after Feb. 15, 2007
- Register manufacturing establishments
- Provide product listings to FDA
- Report all product ingredients
- Report all harmful and potentially harmful substances
The rules also restricts manufacturers from marketing their products as “light” or “mild,” unless authorized by the FDA.
Some of the requirements, such as barring sales to minors, take effect in 90 days. Other requirements have longer compliance deadlines, such as the ban on the use of misleading terms, which will not be enforced until one year after the final rules takes effect.
The FDA said manufacturers will have up to two years to submit a new product application and can continue selling their products during that time. Retailers may keep their products on the market for up to one additional year while the FDA reviews their application.
The tighter regulations were inspired by the sharp uptick in teen and adolescent use of alternative tobacco products such as e-cigarettes, said U.S. Department of Health and Human Services Secretary Sylvia Mathews Burwell. “As cigarette smoking among those under 18 has fallen, the use of other nicotine products, including e-cigarettes, has taken a drastic leap,” Burwell said in a news release, and “all of this is creating a new generation of Americans who are at risk of addiction.”
Data from the Centers for Disease Control and Prevention show that among the 4.7 million middle and high school students who used tobacco products in 2015, 3 million of them smoked e-cigarettes.
The new rules addressed flavoring, but stopped short of banning candy and fruit flavors. The FDA said it plans to issue a separate rule prohibiting characterizing flavors in cigars.
Health groups such as the American Heart Association welcomed the new regulations.
“Now, thanks to this new rule, more potential tobacco users will hopefully be steered clear from taking that first puff,” said AHA CEO Nancy Brown. But the agency must now act to ban candy and fruit flavors for all tobacco products, she said.
“Tough regulation is needed or tobacco companies will only continue to use cunning tactics and sweet flavors in an attempt to entice a new generation of kids to a lifetime of nicotine addiction,” Brown said.