The U.S. Food and Drug Administration’s (FDA) Center for Tobacco Products (CTP) is tasked with regulating tobacco and nicotine products, including vapes and oral nicotine pouches. A recent Reuters article highlights how the FDA is fast-tracking reviews of these products under pressure from the White House, raising questions about the approval process and potential biases. One critical factor often overlooked is that the CTP is fully funded by tobacco user fees—fees paid by tobacco companies. This funding structure raises concerns about whether the FDA’s decisions may favor products from Big Tobacco over smaller manufacturers, even when the products are nearly identical in composition.

The FDA’s Funding Model: Tobacco User Fees

The CTP’s operations, including its review of products like vapes and nicotine pouches, are entirely funded by user fees collected from tobacco product manufacturers and importers. In 2024, these fees amounted to over $700 million, with the lion’s share coming from major tobacco companies like Altria, Reynolds American (a subsidiary of British American Tobacco), and Philip Morris International. These companies dominate the market for cigarettes, vapes, and newer products like nicotine pouches, giving them significant financial leverage within the CTP’s budget.

This funding model creates a potential conflict of interest. The CTP relies on Big Tobacco’s money to function, which could incentivize the agency to prioritize or fast-track approvals for products from these industry giants. Smaller manufacturers, who contribute less to the user fee pool, may face stricter scrutiny or slower review processes, even if their products are functionally identical to those of larger companies.

Identical Formulas, Unequal Treatment?

Vapes and nicotine pouches, whether produced by Big Tobacco or smaller brands, often use similar ingredients: pharmaceutical-grade nicotine, flavorings, and base materials like propylene glycol or vegetable glycerin for vapes, and fillers like cellulose for pouches. The manufacturing processes and safety profiles of these products are largely standardized across the industry. Yet, the FDA’s approval process seems to disproportionately favor products from major tobacco companies.

Does Big Tobacco Have a “Magic” Advantage?

The question arises: do tobacco companies possess some proprietary “magic” that makes their products safer for consumers? The answer is likely no. The safety of vapes and pouches depends on factors like ingredient quality, manufacturing standards, and proper labeling—none of which are exclusive to Big Tobacco. In fact, smaller manufacturers often source their nicotine and components from the same suppliers as larger companies, adhering to similar Good Manufacturing Practices (GMPs).

So why do Big Tobacco’s products seem to sail through the FDA’s approval process? The answer may lie in resources and influence. Major tobacco companies have the financial clout to fund extensive PMTA applications, including costly clinical studies and legal teams to navigate the FDA’s bureaucratic maze. They also have established relationships with regulators, built over decades of operating in the tobacco industry. Smaller companies, with limited budgets and fewer connections, often struggle to meet the FDA’s stringent requirements, even when their products are functionally equivalent.

 The White House Connection

The Reuters report suggests that the White House is pushing the FDA to expedite reviews of nicotine pouches, possibly to address public health concerns or political pressures surrounding vaping and youth nicotine use. While this could benefit consumers by increasing access to potentially less harmful alternatives to cigarettes, it also amplifies concerns about favoritism. Big Tobacco, with its well-funded lobbying efforts and significant contributions to the CTP’s budget, is better positioned to capitalize on this fast-tracking than smaller competitors.

A Question of Fairness

The FDA’s reliance on tobacco user fees creates a system where the biggest players in the industry hold disproportionate influence. While the agency claims to prioritize public health, the approval of products from major tobacco companies over those from smaller manufacturers raises questions about fairness and impartiality. If vapes and pouches are made with nearly identical formulas and components, why do some brands get a green light while others languish?

To ensure a level playing field, the FDA could consider diversifying its funding sources or implementing stricter transparency measures in the PMTA process. Until then, consumers and smaller manufacturers alike may wonder whether Big Tobacco’s deep pockets—and not some “magic” safety formula—are the real key to FDA approval.

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