The Trump administration wants to fundamentally change the way the US government regulates tobacco and e-cigarette products, and the plan to move regulatory authority out of the US Food and Drug Administration is being met with strong condemnation from the public health community.
The plan is laid out in a small note in the Trump administration's $4.8 trillion budget proposal released on Monday. The proposal would shift the oversight of tobacco products out of the FDA and create a new agency under the US Department of Health and Human Services.
The budget plan essentially serves as a statement of priorities for the President ahead of the 2020 election, but like any budget proposed by the White House, the 2021 plan must be passed by Congress. And with a Democrat-controlled House of Representatives and a Republican-controlled Senate, what ultimately gets passed may bear little resemblance to what the President has proposed.
"A new agency with the singular mission on tobacco and its impact on public health would have greater capacity to respond strategically to the growing complexity of new tobacco products," the budget says, adding that the director of this agency would be confirmed by the Senate.
"In addition, this reorganization would allow the FDA Commissioner to focus on its traditional mission of ensuring the safety of the Nation's food and medical products supply."
But health and policy experts swiftly criticized the proposal.
"This is an effort plain and clear to install the tobacco industry as the wolf in the hen house," said Erika Sward, assistant vice president of national advocacy for the American Lung Association.
"There's no need to do this," said Eric N. Lindblom, senior scholar at the O'Neill Institute for National and Global Health Law at Georgetown Law.
If the Trump administration wanted better tobacco control, Lindblom added, it could support the FDA to do that now. Instead, the proposal echoes previous statements by the head of the White House Domestic Policy Council, Joe Grogan, suggesting that the FDA's tobacco-related regulatory activities were a "huge waste of time."
Moreover, appointing a Senate-approved director to the proposed HHS agency could "greatly politicize its management and activities," according to Lindblom, who is also the former director of the FDA Center for Tobacco Products' Office of Policy.
The new proposal may also require legislation to amend the Tobacco Control Act, "which would open the door to all sorts of other mischief," Lindblom said.
The Tobacco Control Act, signed into law by President Obama in 2009, gave the FDA regulatory authority over tobacco products, creating the Center for Tobacco Products and funding regulation efforts through fees on tobacco companies. In 2016, the FDA expanded its authority to all tobacco products -- including e-cigarettes.
The Center for Tobacco Products' mission is to "make tobacco-related death and disease part of America's past, not America's future," according to its website. Smoking remains the leading cause of preventable death, according to the US Centers for Disease Control and Prevention, and more than 16 million Americans live with some smoking-related disease.
The Center for Tobacco Products has been under increasing scrutiny for how it regulates e-cigarettes amid several major public health threats, such as growing rates of vaping among youth and a national outbreak of vaping-related lung injury.
Recently, the FDA released a new enforcement policy that targeted a number of flavored vaping products for removal from the US market. The agency is also tasked with reviewing premarket applications for all vaping products to stay on shelves, after a submission deadline in May.
But the agency has faced criticism for allegedly softening its stance on flavored vaping products under industry pressure. And experts suggested Monday that the new proposal on tobacco oversight could be no different.
"This unfortunately comes from an administration that has repeatedly placed the needs of the tobacco industry on equal footing with public health," Mark Schoeberl, the American Heart Association's executive vice president of advocacy, said in a statement Monday.
"The administration should instead focus on more meaningful efforts to end youth tobacco use and nicotine addiction," Schoeberl added. "That starts with ensuring the FDA exercises the authority it has been granted to protect public health."
Matt Myers, president of the Campaign for Tobacco-Free Kids, said he personally worked for 10 years to push the bill that created the Center for Tobacco Products within the FDA. He said it was key to root meaningful regulatory power in the FDA -- "one of the most credible agencies" -- that would insulate the agency from political pressure. This Trump proposal, he said, will undo the agency's decades worth of work on tobacco regulation at the "worst possible time."
"What the FDA does with e-cigarettes over the next 12 months means we either have a youth vaping epidemic that will be with us for decades to come or they could take decisive action now," Myers said. Restructuring now would shift the focus to creating a new agency, not protecting public health. "This is the wrong policy at the absolute wrong time if you care about public health and kids."