Could the FDA Finally Authorize Flavored Vapes? A Shift in Tone Suggests Change Ahead

For years, the U.S. vaping community has been caught between two opposing forces. On one hand, growing evidence supports vaping as a harm reduction tool for adult smokers. On the other, the Food and Drug Administration (FDA) has maintained a restrictive stance that limits access to flavored e-liquids and creates confusion across the market.

Recent comments from a top FDA official may signal that change could finally be on the horizon.

A New Message from the FDA
During a recent Food and Drug Law Institute (FDLI) tobacco and nicotine policy conference, Bret Koplow, Acting Director of the Center for Tobacco Products (CTP), made comments that caught the attention of both regulators and advocates.

According to an X (Twitter) thread by longtime tobacco control leader Cliff Douglas, Koplow expressed support for “promoting a tobacco harm reduction approach to reduce cigarette smoking.” Even more notably, Douglas reported that Koplow supports “the potential for increasing the range of flavored e-cigarettes that could be authorized for sale.”

This marks a striking departure from the FDA’s previous position. To date, the agency has authorized only a small handful of vaping products, all in tobacco or menthol flavors. No bottled e-liquids have been approved, leaving most of the vaping market in regulatory limbo.

The Reality of the FDA’s Authorizations
The current list of FDA-authorized products is astonishingly short. The few approved devices are limited to closed systems like the JUUL, with tobacco and menthol pods only. During previous administrations, the FDA repeatedly promised a streamlined process for evaluating products. Yet in practice, that promise has never materialized.
Tens of thousands of Premarket Tobacco Product Applications (PMTAs) have been submitted by manufacturers seeking authorization, but most have received Marketing Denial Orders (MDOs) or have been left waiting indefinitely for a decision.

A “Remarkable Change” in Tone
According to Douglas, Koplow’s remarks represented a “remarkable change in tone.” For the first time, an acting FDA director appeared open to the idea that flavored vapes might have a legitimate place in a regulated marketplace.

Douglas added that Koplow emphasized the importance of a “legal marketplace” made up of authorized, reduced-risk products, supported by strong enforcement against illicit sales. However, he cautioned that this vision can only succeed if the FDA streamlines and simplifies its review process.

Without significant reform, Douglas warned, the unregulated gray market will continue to flourish, undermining public health goals.

Cautious Optimism Among Consumers and Businesses
While many see Koplow’s comments as a positive sign, experienced advocates are treating the development with cautious optimism. The vaping industry has heard similar promises before.

Previous administrations talked about reforming the authorization process, but the results have been disappointing. Instead of approving responsible manufacturers, the FDA has denied or ignored most applications, effectively closing the door on innovation.

Until the agency follows through with policy changes, these new remarks remain words on paper rather than a concrete shift in practice.

Contradictions from FDA Commissioner Martin Makary
Koplow’s comments also stand in stark contrast to the position of FDA Commissioner Martin Makary, who has taken a far more aggressive stance toward vaping.

Makary has often made misleading statements about youth vaping trends and the role of small vape shops. During his Senate confirmation hearing, he promised to use “people with guns” to crack down on illegal vape sales. Since taking office, he has indeed followed through on that threat.

His actions include high-profile raids on vape distributors and retailers across multiple states, as well as expanded border enforcement targeting shipments from China.

From Campaign Promises to Crackdowns
During his presidential campaign, Donald Trump promised to “save vaping.” Yet since taking office, his administration’s FDA has issued at least 40 Marketing Denial Orders against U.S. companies producing e-liquids and vape hardware.

The agency has stopped publishing a public list of MDOs, making it difficult to track the full extent of these denials. This lack of transparency has deepened mistrust within the vaping community.

What began as a campaign to eliminate unauthorized disposable vapes has expanded into a broader war on all vaping products, including refillable tanks and mods used by adult consumers.

Widening Enforcement Actions
In September, Makary approved coordinated raids in seven states involving the FDA, Bureau of Alcohol, Tobacco, Firearms and Explosives (ATF), and U.S. Marshals. Officials seized more than 2.1 million vaping products, including not only imported disposables but also American-made bottled e-liquids that were still awaiting FDA review.

The FDA justified these actions by labeling the products “illicit,” even when some had valid PMTAs pending. The message was clear: enforcement would continue regardless of whether companies were following the legal process.

The Consequences of Overreach
For small vape manufacturers, these enforcement actions have been devastating. Many have been forced to shut down, leaving adult consumers with fewer safe and regulated choices.

Public health experts warn that the crackdown could have unintended consequences. By making legitimate products harder to access, the FDA is driving consumers toward unregulated sources or back to combustible cigarettes.

Instead of reducing harm, this approach risks reversing years of progress in smoking cessation.

A Rational Voice at Last
Koplow’s comments offer a refreshing contrast. By acknowledging that harm reduction has a place in tobacco policy, he is aligning with scientific evidence rather than fear-driven narratives.

Studies from organizations such as Public Health England and the Royal College of Physicians have consistently found that vaping is significantly less harmful than smoking. In countries like the United Kingdom, regulators actively encourage adult smokers to switch to vapes, and the results speak for themselves.

Smoking rates in the UK have dropped to record lows, largely due to vaping’s role as a cessation tool.

The Role of Flavors in Harm Reduction
Critics often claim that flavored e-liquids are designed to attract youth, but research and real-world data tell a different story. Adults overwhelmingly prefer non-tobacco flavors when switching to vaping.

A 2023 survey by CASAA (Consumer Advocates for Smoke-free Alternatives Association) found that more than 85 percent of adult vapers use fruit, dessert, or beverage flavors. These options help create a clean break from the taste of cigarettes, reducing the likelihood of relapse.

When only tobacco or menthol flavors are available, many vapers report a higher risk of returning to smoking. Restricting flavors may therefore undermine the very goal of public health policy: helping people quit cigarettes for good.

Reforming the PMTA Process
If the FDA wants to create a truly effective harm reduction strategy, reforming the PMTA process must be a top priority.

The current system is so complex and expensive that only large corporations can afford to participate. Small and mid-sized companies, which drive innovation in flavors and devices, are effectively locked out.

A reformed PMTA process should focus on:

Simplified data requirements that still ensure safety and quality.
Clear guidelines for what constitutes sufficient evidence of reduced risk.
Faster review timelines to prevent small companies from collapsing while waiting for decisions.
Transparency and communication between the FDA and applicants.

Creating a fair and efficient process would benefit consumers, businesses, and regulators alike.

The Balance Between Enforcement and Innovation
Douglas rightly noted that a “legal marketplace” cannot exist without a viable pathway for legal products. Excessive enforcement, without meaningful authorization, simply creates a black market.

The FDA should focus on empowering responsible manufacturers rather than punishing them. By collaborating with the industry, the agency can ensure quality control, accurate labeling, and age verification standards that protect both consumers and youth.

Political and Public Health Implications
Any change in FDA policy will inevitably face political challenges. Misconceptions about vaping remain widespread, fueled by years of media panic and lobbying from competing industries.

However, public sentiment may be shifting. As more evidence emerges and other countries demonstrate success with harm reduction models, U.S. policymakers may find it harder to ignore the benefits of a balanced approach.

If the FDA genuinely embraces a harm reduction strategy, it could redefine its role from an enforcer to a facilitator of better health outcomes.

What FDA Approval of Flavored Vapes Could Mean
If flavored vape products begin receiving FDA authorization, several major changes could follow:

Smokers would gain safer alternatives supported by science and regulation.
Small businesses could re-enter the market without fear of arbitrary shutdowns.
Public health outcomes could improve, as fewer adults relapse to cigarettes.
Illicit markets would shrink, replaced by transparent, compliant manufacturers.

The key to success lies in timely action. Every delay allows misinformation to spread and more adult smokers to miss out on harm-reduction opportunities.

The Bottom Line
Bret Koplow’s remarks may represent the first genuine sign of progress from within the FDA in years. By acknowledging that flavored vapes can play a role in reducing cigarette use, he has opened the door for a more science-driven, compassionate regulatory approach.

The next step is for the FDA to match words with action. Reforming the PMTA process, approving a wider range of flavored products, and supporting responsible manufacturers could transform vaping policy in the United States.

Flavored vapes are not the enemy. They are one of the most effective tools for helping smokers quit, and when regulated properly, they can save lives.

The FDA now faces a choice: continue the cycle of enforcement and confusion, or embrace a future built on evidence, transparency, and genuine harm reduction.