If you’ve been following our journey to bring the Ramedica Herbal Wonder Balm back to the US, you’ll know we’ve faced more than a few twists and turns.
In our previous update and video we shared how we were preparing to pay the OMUFA fee — the FDA’s mandatory registration fee for over-the-counter drug facilities — so we could bring our balm back into the U.S. market.
But as of this week, here’s what’s changed.
1. Our Manufacturer Can’t Start Until September
We’ve just been informed that production, scheduled for this month, won’t begin until September. That means the earliest we can start shipping the balm is October — a full three months later than planned.
2. We Can’t Pay the OMUFA Fee Until August
In addition, we discovered that the OMUFA fee for 2025 can’t be paid right now — the payment window for this fiscal year closed on June 2, 2025. Our regulatory consultant failed to mention this, despite our proposed market date being July 1 and our final labels just being approved.
Around here, we’ve unofficially started calling it the F-Delay — for obvious reasons. 😅
Why that critical detail wasn’t flagged earlier? I truly have no idea.
But here’s what I do know…
The Silver Lining (Yes, There Is One)
After 3 years of navigating changing regulation, production — and a lifetime of healing work — I’ve learned this truth over and over: things rarely go as planned. And the more you resist the chaos, the more it persists.
So yes, this delay is frustrating. Yes, I’m disappointed. And yes, I wish we could get our balm into your hands right now.
But had we gone ahead with production this month as scheduled, the balm would’ve been sitting in our warehouse for weeks, unable to legally cross U.S. borders until October 1.
Man Plans — God Laughs
The truth is, I can’t change FDA deadlines or manufacturing setbacks. All I can do is choose how I respond.
I choose honesty.
I choose transparency.
I choose to keep showing up, even when it’s hard.
Because you deserve to know what’s happening behind the scenes. And if you’ve been cheering us on — waiting patiently for your order, or planning to place one — thank you for sticking with us through this rollercoaster.
We’re still on track to legally ship the balm starting October 1 — and if you’d like to reserve your jar now, backorders are open.
This ensures you’ll be first in line as soon as we’re cleared to ship.
We’ll keep you updated every step of the way.
Stay tuned — we’re not giving up.
With deep gratitude,
Jaime
CEO, Ramedicare
