sestovic/iStock(WASHINGTON) — The Food and Drug Administration has proposed a new rule that outlines the process for tobacco companies to apply to sell e-cigarettes and vape products, as the number of vaping-related illnesses tracked by the Centers for Disease Control continues to increase.
The FDA has warned e-cigarette companies that they are illegally marketing products by selling them without going through the agency’s “premarket review” process, where the FDA evaluates information about the product to determine if it is appropriate for public health to have the product on the market.
The rule is not the enforcement plan discussed by the president and other officials that they say would effectively ban flavored e-cig or vaping products, but the FDA will likely use these requirements to take products off the market that don’t have the proper approvals. An agency spokesperson said the FDA had authorized no e-cigarette or vaping products currently on the market under this requirement.
The FDA, which regulates tobacco products, has been looking at the rules around e-cigarettes and vaping products since officials began raising concerns about rapidly growing e-cigarette use among young people, but the newly proposed rule would apply to any new form of tobacco product.
“This proposed rule follows our announcement last week that we intend to finalize a compliance policy in the coming weeks that would prioritize enforcement to clear the market of unauthorized, non-tobacco-flavored e-cigarette products,” Acting FDA Commissioner Ned Sharpless said in a statement. “These important regulatory actions are part of our ongoing oversight of e-cigarettes and other tobacco products that is critical to our public health mission and, especially, to protecting kids from the dangers of nicotine addiction and tobacco-related disease and death.”
The rule proposed Friday would add more detail to the requirement that tobacco companies submit information to the FDA about the health and safety of new tobacco products so the agency can decide if they should be sold and whether any additional restrictions are warranted.
The rule says the FDA will evaluate the marketing plans for specific electronic tobacco products to look at the potential for young people to access the product.
The FDA does have the authority to restrict companies marketing tobacco products to limit exposure of young people to the products, including blocking radio or television ads and requiring online and social media advertising to be targeted to adults.
In previous guidance to tobacco companies applying to sell e-cigarettes, the FDA only recommended they share marketing materials and demographics of the customer base. The FDA has required changes to marketing when it has approved new products in the past.
“FDA also recommends sharing your marketing plan to enable FDA to better understand the potential consumer demographic,” the agency says in guidance to companies released in June.
The new rule would add the marketing plan and information about how the company will avoid youth exposure to the product as part of the product application.
But the agency also said it did not plan to enforce requirements that all new e-cigarette or tobacco products have approval from the FDA to put those products on the market. That has recently shifted, and the FDA has warned companies that they can’t describe their product as safer than traditional cigarettes without their approval.
“FDA does not, at this time, intend to enforce these requirements for components and parts of deemed products that are sold or distributed solely for further manufacturing into finished tobacco products, and not sold separately to the consumer,” FDA said in the June document.
Lawmakers are expected to press officials from the FDA on the agency’s past approach to e-cigarettes, saying the lack of enforcement contributed to the current public health crisis. Members of a new bipartisan “End Youth Vaping” caucus said Thursday they plan to pursue legislative responses to the crisis like taxing e-cigarette products or raising the legal age to purchase tobacco if they aren’t satisfied with the administration’s response.
“The recent surge in the vaping related illnesses shows that we are desperate for more federal regulation of these dangerous products, Congress simply cannot afford to sit back and watch as these companies keep operating as if nobody is paying attention,” Rep. Diane DeGette, D-Colo., said Thursday.
“It’s frankly unfortunate that it takes so many people to get sick and even die across this country before we really pay the attention that we should. We need to get these products out of the hands of our kids, and we need to do it now.”
DeGette is the vice chair of the House Energy and Commerce Committee, which has a hearing on public health concerns around e-cigarettes next week. A House Oversight subcommittee also has a hearing scheduled on the outbreak of vaping-related illnesses.
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