In a major regulatory development, FDA has officially granted Marketing Granted Orders (MGOs) to five JUUL products — marking the first authorization of an ENDS product in over a year, and signaling a potential shift in how the agency evaluates harm reduction tools.

To unpack the significance of this milestone, Alan Zhao at 2FIRSTS sat down with ARAC’s leadership team — Dr. Jessica Zdinak (CEO & Chief Research Officer) and Samuel C. Hampsher-Monk (VP, Global Regulatory Strategy & Client Operations) — for an exclusive interview on what this means for the industry.

Key Takeaways:

• APPH in Action: JUUL’s data demonstrated that adult switching — not just clinical cessation trials — was key to authorization.

• Switching Studies Take Center Stage: Real-world evidence of adult smokers moving away from combustibles is now essential.

• Regulatory Efficiency May Be Emerging: The current FDA leadership seems committed to streamlining PMTA reviews.

• Non-Tobacco Flavors? Still Uncertain. But strong behavioral data may offer a clearer path forward.

• What This Means for You: Companies without rigorous, real-world switching evidence may face continued denials.

ARAC has long advocated for the importance of behavioral science in evaluating harm reduction. This reaffirms that switching studies are not just valuable — they’re vital.

📍 Read the full interview here.