REGULATORY & LABEL COMPLIANCE
The regulatory landscape for pet probiotics and microbiome products shifted dramatically. The FDA-AAFCO MOU expired. The AFIC process launched. Warning letters started landing. And suddenly, companies that thought they were fine... weren't.
I help animal health companies get their products, labels, claims, and marketing materials into full compliance, before they receive a warning letter.
THE PROBLEM!
What changed and why it matters?
The FDA-AAFCO Memorandum of Understanding expired and the new Animal Food Ingredient Consultation (AFIC) process went into effect. How pet probiotic and microbiome products are evaluated, labeled, and marketed in the US were changed.
Words like "treats," "prevents," or "cures" still on your label? Bad news! That's not a supplement anymore but an unapproved drug in FDA's eyes. And... they are paying attention.
Major retailers are now requiring compliance verification before stocking products. If your labels, website, or marketing materials haven't been reviewed since these changes... you're operating on borrowed time.
What I Do
Full Compliance Audit
​I review everything — product labels, ingredient lists, website claims, marketing materials, social media content, even sales training decks.
You get a detailed report identifying every compliance risk, specific recommendations to fix each one, and compliant alternative language you can use immediately.
Claims Review & Rewrite
Your marketing team wants to say "treats digestive issues." FDA says that's a drug claim.
I find the sweet spot: language that's compelling, accurate, and compliant.
Example?
"Cures anxiety" → "Helps maintain calm behavior"
AFIC Submission Support
The new Animal Food Ingredient Consultation process requires careful, strategic preparation.
I help you build a complete submission that CVM will accept, from pre-submission planning through documentation, safety data compilation, and response management.
Regulatory Retainer
Regulations change.
Warning letters get issued.
New guidance shows up.
A monthly retainer gives you priority access for regulatory questions, review of new labels and claims before launch.
Get monthly regulatory update briefings, and alerts for relevant FDA actions.
WHY ME?
Why Companies Trust Me With This...
I've been launching products for the last 15 years through regulatory pathways across multiple countries.
I hold a DVM and a PhD in Microbiology, I understand both the science behind your product and the regulatory language it needs to survive.
I've worked with FDA-CVM submissions, USDA processes, EU registrations, and APAC markets.
I know what reviewers actually look for because I've been a reviewer myself.
And I do this work because I believe compliant products are better products
