The administration has requested a budget authorization to strip down the Food and Drug Administration Center for Tobacco Products. President Donald Trump, apparently, has the vision to create a new tobacco agency that isn’t an administrative monstrosity like the FDA.
There’s no chance that the administration will get their request from Congress. No lawmaker in their right mind would consider breaking down the FDA.
Between hiring alarmist health officials and treating vaping as a crime in some instances, Trump has no better strategy but to upend the entire public health administrative state with an off-handed idea.
You’d expect the administration to lobby for legislation that could make the premarket tobacco applications (PMTA) process more palatable for companies who cannot afford the costs of the initial rule. But, no. It’s Trump.
FDA is the only agency tasked by the Tobacco Control Act to enforce tobacco regulations. This includes the enforcement of the PMTA regulatory pathway, which is additionally mandated under existing legal rulings that require the responsible authorities to stop dragging their feet.
That said, Congress has the authority to change the responsibility of an agency. Legislative battles, in this case, could persist for months—even years. It would be very expensive to transition existing workforces over to a new entity. Much of this must, also, be done with congressional approvals.
There is a risk of further complicating the approval process for vape and other companies, too. A new tobacco regulatory agency could diminish product options for consumers who choose to use products like e-cigarettes for risk-reduction purposes. So, why would Trump propose a new agency?
Following the announcement, I conducted an informal sampling of several people—all representing the industry, public health, drug harm reduction, academia, and advocacy. Most believe that the administration’s proposal has no chance of passing Congress. A few respondents were more optimistic that this could be a sign that Trump’s health officials are trying to appeal to small vape companies. Two people had no real opinion on the matter.
Trump’s proposal is based on two potential schools of thought, according to the overwhelming majority of respondents. Both, are merely generalized opinions about how the sampled individuals perceived the idea of Trump creating a new tobacco regulatory agency.
First, one belief is that Trump is trying to score political points with vaping consumers who vote Republican. After an uncertain period of regulation, the president and his political and policy teams may be looking to secure votes to pad the results of a potential win in November’s election. He may also have no expectation that the proposal will pass the congressional budget committees.
Second, the president and his domestic policy council may honestly think that the creation of a new tobacco agency will simplify the regulatory process and potentially save millions in tax dollars and protect, both, public health and product access for adults. These are only assumptions, though.
A new agency counters Trump’s promise to control federal spending. The Congressional Budget Office expects the U.S. government’s public debt will reach $18 trillion by the end of 2020. The debt will exceed $31 trillion by 2030, based on these projections. The federal government’s budget deficit, this year, will likely exceed the standard $1 trillion thresholds, even in a healthy economy. Where would the money for this new tobacco agency come from? Higher user fees on tobacco and vape companies? Higher taxes on consumers? Who knows.
Forming an entirely new agency is nothing more than a pipedream from an administration who has no true allies on either side of the nicotine rights discussions between the growing class of stakeholders. Congress should vote down this proposal for a new tobacco agency, based on a litany of countless arguments that all negate the purpose of growing inefficient bureaucracies. The administration needs to consider options that could allow for the simplification of the existing PMTA regulatory pathway, albeit limited options besides proposing new legislation.