Now’s the Time to Speak Up: Tell HHS the PMTA Process Needs Reform

In a bold move, the U.S. Department of Health and Human Services (HHS) has issued an open call for ideas to eliminate regulations that may be harming, rather than helping, the American healthcare system. This is a rare opportunity for consumers, small business owners, public health advocates, and medical professionals to influence federal policy — and it’s a perfect moment to shine a spotlight on the broken PMTA (Premarket Tobacco Application) process. 

What’s the Problem with the PMTA Process? 

The PMTA process — the FDA’s pathway to authorize vaping and nicotine alternatives — was intended to ensure product safety. But in practice, it has been an expensive, inconsistent, and often impenetrable system that has driven small businesses out of the market and blocked access to smoke and ash free nicotine alternatives.  

Thousands of flavored vapor products that adult consumers rely on were removed or denied, while only a handful of products — mostly from Big Tobacco companies — have made it through. That’s not public health progress; that’s regulatory failure. 

Here’s How You Can Help 

You can submit your comments directly to HHS at regulations.gov/deregulation. When you do, be clear, constructive, and compelling. Below are some bullet points to help craft an effective submission: 

🔧 What to Include in Your PMTA Reform Suggestion 

• Start with a personal story 
  Explain how access to vaping or reduced-risk products helped you or someone you love. Personal narratives add weight and relatability to policy feedback. 
• Point out the problem 
  Describe how the PMTA process has created barriers to innovation, driven small businesses out of the market, and limited access to effective smoke-free cigarette alternatives.  
• Highlight the burden 
  Note how costly, time-consuming, and unclear the application process is — particularly for small manufacturers — and how this has disproportionately benefited major tobacco companies. 
• Call for science-based authorization 
  Urge the FDA to authorize a broader range of flavored and open-system products backed by real-world data and independent research. 

Propose practical reforms 
Suggest: 

• A streamlined PMTA pathway for products with real-world appeal to current combustible tobacco consumers.  
• Clear and consistent guidance for applicants 
• Timely and transparent review timelines 
• FDA collaboration with public health experts and consumer advocates, not just major corporations 

Keep your tone respectful and solutions-oriented 

Regulatory agencies are more likely to consider thoughtful, respectful feedback than rants or accusations. 

🗣️ How to Submit 

Go to: regulations.gov/deregulation 
Search for or reference HHS’s request for regulatory feedback. Paste your comment and hit “Submit.” 

Let’s Make America Healthy Again  

HHS says they're listening. Now let’s give them something powerful to hear. This is our chance to advocate for fairer regulations, superior alternatives, and a public health system that actually prioritizes saving lives — not protecting outdated processes or monopolies. 

If you've ever said “why don’t they just fix it?” — this is your moment.