Help Fix the FDA’s Broken PMTA Process — And Protect Your Business
The U.S. Department of Health and Human Services (HHS) just sent out a call that every vape industry stakeholder should hear loud and clear:
“If you know a regulation that’s making our health system worse, not better — tell us.”
➤ Submit here: regulations.gov/deregulation
This is your chance to speak directly to federal regulators about one of the most harmful and misguided processes affecting our industry today: the FDA’s Premarket Tobacco Application (PMTA) system.
As it stands, the PMTA process is not working for small businesses, consumers, or public health. And this is the moment to demand change.
🚨 Why Your Business Needs to Comment
The current PMTA framework:
- Favors Big Tobacco while wiping out small and mid-sized manufacturers
- Has banned tens of thousands of flavored vape products that adult consumers depend on
- Stifles innovation, imposes million-dollar compliance burdens, and delivers no regulatory clarity
- Is turning once-thriving vape shops into collateral damage in a war they were never meant to fight
- If you're a shop owner, manufacturer, distributor, or wholesaler who’s been affected by this process, now is the time to put it on the record.
🛠 How to Craft an Effective Business-Focused Comment
Use these ideas to write a powerful and professional submission:
Describe how the PMTA process has harmed your business
- Did you have to pull products from shelves?
- Lose suppliers?
- Lay off staff?
- Delay product development?
- Outline the financial and operational burden
- Detail how the cost, complexity, and uncertainty of PMTA have created barriers only major corporations can navigate.
- Advocate for practical reforms, such as:
- A tiered PMTA system for small manufacturers
- Clear timelines and criteria for review
- Recognition of real-world evidence and international regulatory approvals
- Protection for open-system and refillable devices with strong consumer demand and safety records
- Explain how reform benefits public health and small businesses
- The current process is reducing access to smoking alternatives, pushing consumers to illicit markets, and killing compliant companies.
Be professional and solutions-oriented
The goal is to inform and influence—not to vent. Be firm, factual, and forward-thinking.
📩 Where to Submit
👉 Submit your comment at regulations.gov/deregulation
Type or paste your letter, and be sure to hit "Submit."
🔊 Speak Now—Or Risk Losing More Than Products
Regulatory reform won’t happen unless the small businesses and entrepreneurs being impacted most speak up.
You don’t need a lawyer or a lobbyist to make your voice heard. You just need 5 minutes, a keyboard, and your truth.
Protect your future. Shape the conversation. Tell HHS how the PMTA process is hurting small businesses and propose a better way forward.
Let’s fix this—before they finish phasing us out.
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