LABELING & CLAIMS EXPERTISE
proven experience reviewing 100’s of labels and analyzing 1000’s of claims for all kinds of FDA-regulated products
PET FOOD & ANIMAL FEED MASTERY
comprehensive knowledge of state and federal pet food registration and compliance requirements
COSMETICS COMPLIANCE EXPERTISE
expertise in cosmetic advertising, ingredient safety, and MOCRA compliance
DIETARY SUPPLEMENT EXPERTISE
strategic claims analysis and market entry guidance for supplement companies
DETENTIONS & PERMIT RESOLUTION
extensive experience securing product releases and negotiating complex import permits
MARKET ENTRY FACILITATION
strategic guidance for new companies entering FDA-regulated markets with confidence
Labeling & Claims Compliance Excellence
With over 15 years experience in product labeling and claims compliance, I protect your business from costly FDA detentions and import alerts, enforcement actions, FTC investigations, NAD cases, and consumer class-action lawsuits. My meticulous approach to label review and claims analysis helps companies develop effective advertising while minimizing regulatory risk. I provide comprehensive pre-market labeling and claims analysis to prevent regulatory issues, and when challenges arise, I have experience defending businesses and their marketing claims in FDA, FTC, and NAD proceedings. This dual expertise ensures your products reach consumers with maximum impact while maintaining complete compliance across all regulatory touchpoints.
New Market Entry & Import Success
I provide comprehensive guidance for companies entering FDA-regulated markets, focusing on proactive compliance to prevent costly regulatory issues. I expertly help companies navigate complex premarket and ongoing requirements, helping firms understand their regulatory obligations before launching products. My expertise also enables companies to develop impactful labeling and advertising strategies that drive sales while remaining within legal boundaries.
When challenges arise, my 15 years of hands-on experience is invaluable. I have successfully represented companies through FDA import detentions, import alert removals, Warning Letter responses, facility inspections, and Foreign Supplier Verification Program (FSVP) audits. This comprehensive background means I not only help companies avoid problems but also provide proven solutions when regulatory issues emerge, ensuring business continuity and market access.
Industries I serve
Food &
Beverage
- Importers and manufacturers
- Distributors and retailers
- Online platforms and brand owners
Dietary
Supplements
- Contract manufacturers and formulators
- New Product Development and Design
- Labeling & Advertising Claims Developers
Cosmetics &
Personal Care
- Cosmetics importers & manufacturers
- Social Media Marketers & Platform Sellers
- Product Formulators & Advertisers
Pharmaceuticals
& Medical Devices
- Drug manufacturers and importers.
- Medical device companies.
- Biotech and pharmaceutical startups.
We defend your
rights against
FDA so you can
focus on your
business
We know dealing with FDA can be difficult and challenging
You deserve expert advice at a fair price. When you partner with us, you leverage our decades of experience to get the better outcome quickly.