New FDA Commissioner Heidi Overton: What Her Confirmation Means for Vaping's Future — and Why Your Voice Matters Now
Bottom line: Heidi Overton's Senate confirmation hearing took place on September 24, with flavored e-cigarettes emerging as a flashpoint — just one day after the Wall Street Journal reported the Trump administration plans to speed up vape authorizations. The Makary resignation showed that an FDA commissioner's position on flavored products directly shapes policy. Right now — during this transition window — public comments to the FDA carry real weight, and you should consider submitting yours regardless of which side you're on.
FDA-Authorized Products
FDA Commissioners Under Trump
Months for PMTA Review
Who Is Heidi Overton?
On September 24, 2026, the Senate HELP Committee held its confirmation hearing for Dr. Heidi Overton, President Trump's nominee to serve as Commissioner of Food and Drugs. Nominated on August 19, 2026, Overton brings a background that blends medical training with White House policy experience — a combination that has drawn both support and scrutiny.
Her professional path includes a surgical residency at Johns Hopkins Hospital and a role as Deputy Director of the White House Domestic Policy Council. In announcing her nomination, President Trump cited her focus on "faster cures, American innovation, clinical trial reform, and lower drug prices." What he did not detail was her position on tobacco and nicotine regulation — the policy area that has proven to be the most politically charged for recent FDA commissioners.
As of her confirmation hearing, Overton had not publicly laid out a detailed position on vaping or nicotine pouch regulation. This silence, combined with the rapid pace of regulatory change at the FDA's Center for Tobacco Products (CTP), is precisely why her confirmation matters so much for anyone who uses, sells, invests in, or advocates around vaping products.
Senator Bill Cassidy (R-La.) has already raised concerns about her management experience and her role in vaccine policy during prior government service. But for the vaping community, the bigger question is simpler: what direction will she take on flavored e-cigarettes, PMTA processing speed, and enforcement priorities?
In plain terms: We don't know exactly where Overton stands on vaping yet. That's exactly why this moment matters — her policy direction will be shaped during the early months of her tenure, and that's when public input can have the most influence.
The Makary Lesson: Why the FDA Commissioner's Position Matters
To understand how much an FDA commissioner shapes vaping policy, look no further than what happened to Overton's predecessor, Dr. Marty Makary.
According to a September 23, 2026 Wall Street Journal report by Liz Essley Whyte and Laura Cooper, Makary "clashed with the White House over flavored tobacco products before resigning under pressure." CBS News further reported that Makary was reluctant to approve fruit-flavored e-cigarettes and faced pressure from the administration to move faster on authorizations.
The timeline tells the story:
| Date | Event | Significance |
|---|---|---|
| May 6, 2026 | FDA authorizes Glas Inc. fruit-flavored vapes (blueberry, mango) | FIRST first fruit-flavored e-cigarette authorization in FDA history |
| May 8, 2026 | FDA issues enforcement priority guidance | Allows most tobacco products to be sold after application filing, before full scientific review |
| May 12, 2026 | Dr. Marty Makary resigns as FDA Commissioner | Reportedly under pressure over flavored product disagreements with the White House |
| May 2026 | Kyle Diamantas becomes acting FDA Commissioner | Steers CTP through the transition period |
| June 30, 2026 | FDA grants MRTP orders for 20 ZYN nicotine pouch products | FIRST first modified-risk tobacco product orders for nicotine pouches |
| Aug 28, 2026 | FDA authorizes JUUL2 | Major brand returns to authorized market with age-verification tech |
| Sep 23, 2026 | WSJ reports FDA plans to speed up authorizations | Administration plans to revisit 2021 PMTA rule to simplify requirements |
The lesson here is unambiguous: the FDA commissioner's personal position on flavored tobacco products directly affects what products reach the market. Makary's resistance to fruit-flavored authorizations didn't stop the policy from changing — but it reportedly cost him his job. Overton will face the same cross-pressures: the administration pushing for faster approvals of "less harmful" products, public health groups pushing back, and lawmakers on both sides raising concerns.
How she handles those pressures will define vaping regulation in America for the next several years.
Bipartisan Pushback and Legal Challenges
It's not just public health advocates who are concerned about the FDA's recent direction on flavored products. Lawmakers on both sides of the aisle have objected, as the Wall Street Journal reported. This isn't a simple partisan divide — it's a broader debate about whether the FDA is striking the right balance between adult access and youth prevention.
Quote: "That only makes vaping more attractive to young people." — Sen. Susan Collins (R., Maine), speaking at a Senate hearing earlier this month about FDA's approval of blueberry and mango-flavored products (WSJ, Sept. 23, 2026)
Senator Collins is a Republican — which makes her criticism notable in an era where the issue often falls along predictable partisan lines. On the Democratic side, Senators Dick Durbin, Elizabeth Warren, and Richard Blumenthal have been vocal critics of the FDA's recent flavored product authorizations, sending letters demanding answers and calling for policy reversals.
Meanwhile, the legal challenges are mounting. Campaign for Tobacco-Free Kids and other public health groups have sued the Trump administration over the May 2026 enforcement guidance, arguing that the FDA violated federal law by making a major policy change without giving the public a chance to comment.
Why this matters for you: The Campaign for Tobacco-Free Kids lawsuit is built around the argument that the public was excluded from the policy process. That argument — if it gains traction in court — validates the importance of public comment. It also suggests that the FDA may need to open formal comment periods on these changes, creating a direct opportunity for adult vapers and consumers to make their voices heard.
If you're someone who uses vaping products as an alternative to smoking, or if you're concerned about youth access, this is not a moment to sit on the sidelines. The policy is being shaped right now — and the people making it need to hear from the people most affected by it.
What's on Overton's Vaping Agenda
If confirmed, Overton will inherit a CTP that's moving faster on product authorizations than at any point in the PMTA era. Here's what's already on the table — and what could accelerate under her watch:
Accelerated Authorization Push
The Wall Street Journal reported on September 23, 2026, that the Trump administration plans to announce in the coming days that it will revisit the 2021 rule that outlined scientific evidence requirements for new tobacco applications. The goal, according to people familiar with the matter, is to add "more flexibility for companies to get more products authorized" — potentially by simplifying requirements for scientific studies and speeding review times.
The 95 Authorized Products and Counting
As of September 2026, the FDA has authorized approximately 95 tobacco products from 11 companies, including:
- 45 e-cigarette / vaping products
- 30 nicotine pouch products
- 10 heated tobacco products
- 8 snus products
- 2 cigarette products
The second Trump administration has authorized multiple nicotine pouch products and allowed some to be marketed as less harmful for smokers than traditional cigarettes — a significant shift from the first term, when the FDA banned fruit-flavored vapes to curb teen use.
Industry Engagement
The Vapor Technology Association (VTA), an industry trade group, has been invited to meet with HHS Secretary Robert F. Kennedy Jr. — another signal that the current administration is willing to engage directly with the vaping industry on policy direction.
Why Your Voice Matters Right Now
You might be thinking: "I'm just one person. Can my comment really make a difference?" The short answer is yes — especially right now, and here's why.
The May 2026 enforcement guidance that allowed products to stay on the market during review is currently being challenged in court specifically because the FDA didn't provide a public comment period before making the change. If the courts agree, the FDA will likely need to open a formal comment period — and that's when individual voices add up.
But you don't have to wait for a court order. The FDA regularly accepts public comments on proposed rules, draft guidances, and policy changes through regulations.gov. Multiple dockets related to tobacco products are active or have recent comment periods, and agencies do read and consider the comments they receive — particularly when those comments contain personal experience, specific data, and thoughtful policy analysis.
Real-world precedent: When the FDA first proposed its PMTA framework, thousands of public comments came in from adult vapers, public health groups, and industry — and the final rule reflected some of those inputs. Comment periods aren't just symbolic; they're a legally required part of the rulemaking process, and agencies must respond to significant comments.
Here's what makes this moment uniquely important:
- New commissioner = fresh start. Overton will be setting her own priorities and direction. Early input can shape those priorities before positions harden.
- Policy is in motion. The accelerated authorization plan, the May enforcement guidance, and the flavored product approvals are all actively being debated and litigated. Your voice enters the conversation while decisions are still being made.
- Both sides are organizing. Public health groups are submitting comments, industry groups are submitting data, and state attorneys general are weighing in. If adult vapers and consumers don't participate, the policy debate only hears from organized interests — not the people most directly affected.
Whether you support the current direction or oppose it, your perspective deserves a place in the record. The FDA regulates products that affect millions of adults who use them as an alternative to smoking — and millions more who could be put at risk by youth access. Both perspectives matter, and both deserve to be heard.
How to Submit Your Comment to the FDA
Ready to participate? Here's a practical guide to submitting an effective public comment.
Step 1: Go to Regulations.gov
Navigate to regulations.gov, the federal government's online portal for public comments on agency rules and proposed policies.
Step 2: Find the Right Docket
Search for FDA dockets related to tobacco products, e-cigarettes, or the specific policy you want to comment on. Look for dockets that are still accepting comments — the site clearly shows open/closed status. Key docket categories to watch for:
- Tobacco product premarket applications (PMTA) draft guidances
- Enforcement priority updates
- Harmful and potentially harmful constituent (HPHC) lists
- Modified risk tobacco product (MRTP) applications
Step 3: Write an Effective Comment
The most impactful comments share several qualities:
- Personal but specific. If you're an adult who switched from smoking to vaping, share your experience — but ground it in specifics (how long you smoked, what helped you switch, how your health changed). Vague anecdotes carry less weight than detailed narratives.
- Data-informed. If you can cite specific studies, FDA data points, or population-level evidence, do so. Comments that engage with the evidence base are taken more seriously.
- Policy-focused. Address the specific policy or guidance in the docket, not a general rant about the FDA. Tell the agency what specific change you want and why.
- Rational tone. Emotional language can be authentic, but comments that come across as angry or abusive tend to be dismissed. Stay measured and constructive.
Step 4: Submit and Save a Copy
Follow the site's instructions to submit. Most dockets allow anonymous submission, though you'll need to provide basic information. Save a copy of your comment and the confirmation for your records — comments are publicly visible, so don't include personal information you wouldn't want posted online.
Important: This article is for informational purposes only and does not constitute legal advice. Always review the specific rules and requirements of each docket before submitting. If you're unsure about what to say or how to frame your comment, consider working with a consumer advocacy organization that can provide guidance.
What This Means for Different People
Adult Vapers Who Switched from Smoking
What's at stake: Access to flavored products that helped you switch, and the pace at which new harm-reduction products become available.
Action: Share your switching story with the FDA during relevant comment periods. Personal accounts from former smokers carry real weight in harm-reduction debates. For related reading, check out our guide to what research really says about vaping and lung health.
Parents Concerned About Youth Access
What's at stake: Flavored products that could appeal to kids, and enforcement against illegal disposable vapes that often reach minors.
Action: Submit comments supporting stronger enforcement against unregulated products and youth access prevention measures. Your voice as a parent matters in the policy debate.
Vape Shop Owners and Industry Professionals
What's at stake: The speed of PMTA authorizations, the scope of enforcement actions, and the overall regulatory clarity of the market.
Action: Submit detailed, data-backed comments about the business impact of current policy. Trade associations can also amplify your voice. Stay informed with our market analysis of top brands and trends.
Public Health Advocates
What's at stake: The evidentiary bar for product authorization, the role of flavors in youth initiation, and the balance between adult access and prevention.
Action: Submit rigorous, evidence-based comments engaging with the specific scientific and regulatory questions in each docket. High-quality public health analysis strengthens the record and improves final policies.
Frequently Asked Questions
Who is Heidi Overton?
Heidi Overton, MD, PhD, is President Trump's nominee to lead the FDA. A former Johns Hopkins surgery resident and White House Domestic Policy Council deputy director, she was nominated on August 19, 2026, with her Senate HELP Committee confirmation hearing held on September 24, 2026.
Why did Marty Makary resign as FDA commissioner?
Dr. Marty Makary resigned on May 12, 2026, reportedly under pressure after clashing with the White House over flavored tobacco product approvals. CBS News reported Makary was reluctant to approve fruit-flavored vapes against administration wishes.
What does Heidi Overton think about vaping?
As of her confirmation hearing, Heidi Overton had not publicly stated a detailed position on vaping or nicotine pouch regulation. Her policy direction on flavored e-cigarettes and PMTA processing is expected to emerge during and after the confirmation process.
How can I submit a public comment to the FDA about vaping?
You can submit public comments to the FDA through regulations.gov by searching for relevant FDA dockets. Comments can often be submitted anonymously. Focus on personal experience, data, and policy impacts rather than emotional arguments for greatest effect.
What is the FDA's May 2026 enforcement guidance?
Issued in May 2026, the FDA enforcement guidance allows most tobacco products to be sold legally after companies have filed applications but before they have received a complete scientific review. Public health groups including Campaign for Tobacco-Free Kids have sued over this guidance, arguing the FDA violated federal law by not providing public comment opportunity.
How many FDA-authorized vaping products are there?
As of September 2026, the FDA has authorized approximately 95 tobacco products from 11 companies, including 45 e-cigarette/vaping products, 30 nicotine pouch products, 10 heated tobacco products, 8 snus products, and 2 cigarette products.
Will Overton speed up or slow down vape approvals?
It is too early to predict with certainty. However, the Wall Street Journal reported on September 23, 2026, that the Trump administration plans to speed up authorization processes by revisiting 2021 rules and simplifying scientific study requirements. Overton will oversee implementation of these changes if confirmed.
What is the PMTA process?
PMTA (Premarket Tobacco Product Application) is the FDA process through which new tobacco products must demonstrate they are "appropriate for the protection of the public health" to receive marketing authorization. Congress mandated a review period of approximately six months, though in practice reviews have taken significantly longer. To learn more about the terminology, check our PMTA glossary entry.
We Want to Hear From You
The future of FDA vaping policy is being written right now — and your perspective matters. We'd love to hear your thoughts:
- Do you plan to submit a public comment to the FDA? Why or why not?
- What's the single most important thing the new FDA commissioner should understand about vaping?
- Has your state changed its vape laws in ways that affected you?
- Do you think public comments actually make a difference, or is the process just symbolic?
Quick poll: Which of the following do you think is most important for the new FDA commissioner to prioritize?
- Speeding up PMTA reviews so more products can reach adult smokers
- Stricter enforcement against illegal disposable vapes and youth access
- Maintaining a high evidentiary bar for all product authorizations
- More public comment opportunities and transparent rulemaking
Share your answer and your story — we read every comment, and your perspective helps shape our coverage.
FDA Regulatory Notice: As of September 2026, approximately 95 tobacco products from 11 companies have received FDA PMTA marketing authorization. The majority of vaping products on the market have not received FDA authorization, and their legal status varies by jurisdiction.
State Law Notice: Several states, including California, New York, New Jersey, Rhode Island, and Washington, DC, maintain flavor bans or other restrictions on vaping products. Always check your local laws before purchasing or selling tobacco products.
Sources & Further Reading
- Essley Whyte, L. & Cooper, L. (2026, September 23). "U.S. Regulators Plan Major Move to Speed Authorizations of Vapes, Tobacco Pouches." The Wall Street Journal. — WSJ.com
- U.S. Senate Committee on Health, Education, Labor & Pensions. (2026). "Nomination of Heidi Overton to be Commissioner of Food and Drugs." Senate HELP Committee. — help.senate.gov
- CBS News. (2026, May 12). "Marty Makary out as FDA commissioner." — cbsnews.com
- U.S. Food and Drug Administration. (2026, May 6). "FDA authorizes additional electronic nicotine delivery systems." FDA Tobacco Products. — fda.gov
- U.S. Food and Drug Administration. (2026, August 28). "FDA authorizes JUUL2 electronic nicotine delivery system." FDA Tobacco Products. — fda.gov
- Campaign for Tobacco-Free Kids. (2026). Lawsuit challenging FDA May 2026 enforcement guidance. — tobaccofreekids.org
- Durbin, D. (2026). "Durbin Urges HHS Secretary Kennedy to Intervene and Push Back on FDA Allowing Flavored Vapes That Harm Our Children." Senator Durbin Press Office. — durbin.senate.gov
- U.S. Food and Drug Administration. "Enforcement Priorities for Tobacco Products." FDA Tobacco Products. — fda.gov
- Regulations.gov. Federal eRulemaking Portal. — regulations.gov
- U.S. Food and Drug Administration. "CTP's PMTA Process." FDA Tobacco Products. — fda.gov
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