The AAFP recently joined 29 other organizations to bring its concerns about unregulated tobacco products to the highest level -- urging President Obama to halt years of delay and provide the leadership necessary to ensure the FDA has authority over all tobacco products.
The Academy signed on to a letter dated April 13(5 page PDF) asking the president to help finalize a proposed deeming rule that would classify as "tobacco products" currently unregulated products such as electronic cigarettes (e-cigarettes), some or all cigars, pipe tobacco, nicotine gels, waterpipe (hookah) tobacco and dissolvables, as well as future nicotine/tobacco products. The move would subject such products to FDA regulation under the 2009 Family Smoking Prevention and Tobacco Control Act (TCA).
The FDA issued the proposed rule in 2014. Then, about a year ago, HHS told Congress that the rule would be finalized by the end of last summer. Officials later said they understood the urgency to act quickly, but the rule is still not finalized.
"Every one of these delays comes with a cost to public health," the organizations told the president.
The TCA gave the FDA the authority to regulate the manufacturing, distribution and marketing of tobacco products, such as cigarettes, smokeless tobacco and roll-your-own tobacco.
The new deeming rule, once finalized, would require manufacturers of the currently unregulated products to register their products with the FDA and report the ingredients they use. It also would prevent the manufacturers from marketing new tobacco products until an FDA review and would ban the distribution of free samples. The rule would impose minimum age and identification restrictions. Finally, it would prevent manufacturers from making any direct or implied claims unless the FDA decided that the claims were supported by scientific evidence.
But for now, these products remain unregulated.
"There are no restrictions in place to protect public health against the risks these products pose, particularly to the health of our children," the organizations wrote.
For instance, the FDA cannot stop manufacturers of unregulated products from using fruit or candy flavors. The letter noted that e-cigarettes are available in more than 7,000 flavors, some of which clearly appeal to youth, such as cotton candy, gummy bear and bubble gum.
The organizations suggested that irresponsible marketing of unregulated products may have contributed to the rise in the use of e-cigarettes by young people. For instance, 2015 research from the CDC and the FDA found that between 2013 and 2014, the amount of high school students using e-cigarettes tripled from 4.5 percent to 13.4 percent.
The letter said the cigar industry also uses candy and fruit flavors to appeal to young people.
The organizations urged the president to finalize the "long overdue" regulation.
"This delay is serving the interests of the tobacco companies, which have a long history of using product design and marketing tactics to attract children to harmful and addictive products," they said.
The 30 organizations, which besides the AAFP include the American Lung Association, American Cancer Society Cancer Action Network and American Heart Association, asked the president to lead "prompt administration action to finalize this regulation in the interest of public health and especially for the protection of our children."
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