Received an FDA Warning Letter? You Have 15 Days to Respond.
Don’t panic—and don’t go it alone. A misstep here can lead to product seizures, import holds, or even a shut-down. We help cosmetic and wellness brands respond fast, fix the issue, and move forward with confidence.
What You’re Up Against
An FDA Warning Letter isn’t just a slap on the wrist. It’s a formal notice of serious violations—and it’s public. If left unanswered or handled poorly, it can derail your entire operation.
STAYING AWARE
Common Triggers & FDA Issues
Unapproved drug claims on cosmetics.
Improper labeling or ingredient declarations.
Manufacturing or GMP violations.
Repeat findings from an FDA 483.
URGENCY MATTERS
Resolve Quickly or You Risk:
Product recalls.
Import refusals.
Loss of retail partners.
Damage to your brand’s reputation.
You’re Not Alone.
We’ll Guide You Through It.
At Bustos Law Group, we’ve helped dozens of cosmetic, supplement, and wellness brands navigate the FDA’s toughest scrutiny. We know the process, the language, and how to get your business back on track fast.
Fast & Reliable Response Time
We act fast—because 15 days means every hour counts.
Experts In FDA Legal Support
We understand the unique regulatory challenges in beauty & wellness.
Small, Responsive Team
You won’t get passed around. You get direct attorney access.
High Client Satisfaction & Retention
Our clients stick with us for ongoing guidance—and for good reason
Here's The Plan
Send Us Your Warning Letter
We’ll review your situation and highlight critical response points.
Get a Response Strategy
We draft your official response and help you resolve the underlying issue.
Protect & Prevent
We work with you to implement compliance measures so you avoid future enforcement.
