The Trump administration’s budget proposal for the new fiscal year includes a plan that would spin out the Center for Tobacco Products as a separate agency from the Food and Drug Administration, according to The Hill. Presently, the FDA regulates all tobacco products in the United States along with foods, prescription drugs and over-the-counter medications.

The Family Smoking Prevention and Tobacco Control Act of 2009 gave the FDA the authority to regulate tobacco products. In the years since, however, the nature of the tobacco industry was transformed by the advent of vaping products and e liquid. While the total number of tobacco products on the market once numbered in the dozens – and most of those were grandfathered by the Tobacco Control Act – there are now hundreds of vaping products on U.S. shelves being sold without approval, and the FDA needs to receive and begin processing pre-market applications for those products by May.

The FDA has repeatedly stated that it lacks the resources to promptly process pre-market applications for vaping products while handling all of its other duties.

Why Has the Trump Administration Proposed a New Tobacco Control Agency?

According to the administration’s budget proposal, the reasons for spinning out the Center for Tobacco Products into a separate agency are twofold.

• The creators of the Tobacco Control Act didn’t envision how the tobacco industry would change in the future. Vaping is an extremely complex issue, and a separate agency would have its own budget and resources for handling that.
• The core mission of the FDA is to regulate and ensure the safety of foods and medications. When one really thinks about it, the addition of tobacco product regulation to the FDA’s existing duties isn’t entirely logical; tobacco products don’t promote health. In the words of White House Domestic Policy Council head Joe Grogan, tobacco products have “no redeeming qualities,” and tasking the FDA with regulating those products is a “huge waste of time” for an agency created for the promotion of public health.

How Has Vaping Increased the Complexity of Tobacco Regulation?

When the Family Smoking Prevention and Tobacco Control Act of 2009 was signed into law by President Obama, the tobacco industry was very different from today. No one could have anticipated how the industry would change in the coming decade. The reasons for the complexity surrounding tobacco regulation in 2020 are as follows:

• The Tobacco Control Act established a grandfather date of 2007 for existing tobacco products, allowing those products to remain on the market with a handful of changes:
  • Descriptive terms like “Light” and “Ultra-Light” were no longer allowed because those terms implied that those products were less harmful.
  • Flavored cigarettes – apart from menthol – were no longer allowed.
• Companies couldn’t bring new tobacco products to the market without first submitting applications to the FDA proving that those products were beneficial to public health and wouldn’t encourage new nicotine uptake. Effectively, the law made it illegal to release a new combustible cigarette brand in the United States; no combustible cigarette benefits public health.
• Vaping didn’t achieve mainstream popularity until after the signing of the Tobacco Control Act.
• In 2016, the FDA announced that it deemed vaping products to be tobacco products and would regulate them as such under the provisions of the Tobacco Control Act.
• No vaping product currently sold in the United States was available in 2007. Therefore, every vaping product on the market is an unapproved “new tobacco product” requiring a pre-market application.

When the Tobacco Control Act was signed into law, lawmakers expected that the FDA would receive new tobacco product applications only rarely. Instead, the agency may have to process hundreds of new product applications in 2020. It’s an enormous burden that the FDA isn’t equipped to handle.

Expert Opinions on Trump’s Tobacco Control Proposal

Some experts believe that the FDA is already doing a well enough job of regulating tobacco and vaping products and have applauded the agency’s efforts to ramp up its capabilities in advance of the May 2020 pre-market application deadline for vaping products. Recently departed FDA head Scott Gottlieb – a vocal proponent of vaping’s potential as an agent for tobacco harm reduction – stated that he found tobacco regulation an extremely productive use of his time when he was the agency’s commissioner.

Some also believe that keeping the authority to regulate tobacco products within the FDA is the right decision because the agency is theoretically insulated from outside political pressure. Creating a separate agency for tobacco regulation, those people say, gives tobacco companies a potential opportunity to meddle.

At the time of writing, no one from the vaping industry has commented about the budget proposal. The reason for the silence from the industry may be the fact that the organizational realignment wouldn’t fundamentally change anything about the way in which the government regulates the vaping industry. Pre-market applications for all vaping products will still be due by May 2020, and those applications will still be too expensive for most of the industry’s small businesses to put together. The realignment wouldn’t solve the core problem with vaping product regulations in the United States: Applying the same rules to both vaping products and tobacco products simply doesn’t make sense.

Will the Trump Administration’s Budget Proposal Pass?

The idea of creating a new government agency for tobacco product regulation is just one section of the Trump administration’s proposed $4.8 trillion budget for the upcoming fiscal year, and the budget requires approval from the House of Representatives and the Senate before it can be enacted. Since the Democratic party controls the House of Representatives, it is extremely unlikely that the proposed budget will be passed in its current form. In particular, the idea of creating a new tobacco control agency seems to have little support among lawmakers.

The Tobacco Control Act presents an additional challenge in the implementation of the Trump administration’s budget proposal. Since the law tasks the FDA with the job of regulating tobacco products, an amendment to the law would likely be necessary before that responsibility could legally be transferred to another government agency.