Enterprise Supplement Brand: EU Compliance for American Brand

This established supplement brand had built a $45M US business over 12 years but faced saturating domestic growth. European expansion offered the next chapter—but EU supplement regulations differ significantly from FDA requirements.

Their US formulas contained ingredients prohibited under EU Novel Foods regulations. Certain vitamin forms weren't permitted, and maximum dosage limits meant reformulating best-selling products. Label requirements included translations, EU-responsible person designation, and different claim substantiation standards.

Previous attempts at EU entry with other manufacturers resulted in rejected shipments and regulatory fines. They needed a partner who truly understood multi-market compliance.

Build Your Own Brand's international regulatory team conducted a comprehensive portfolio analysis, identifying which products could translate directly vs. which needed reformulation for EU compliance.

We reformulated 28 products using EU-permitted ingredient forms while maintaining efficacy profiles. Our European regulatory affiliate managed Novel Foods notifications, EFSA claims substantiation, and country-specific registrations for all 12 target markets.

We established EU-compliant production runs with multilingual labeling, appointed responsible persons in each market, and created documentation packages satisfying import requirements—eliminating the customs issues that plagued their previous attempts.

The brand launched in 12 European markets in Q3 2025 with zero customs rejections—a stark contrast to their previous failed attempts. First-year international revenue reached $12.4M, representing 27% of total company revenue.

The EU business achieved profitability by month 8, faster than projected. They have since expanded their international partnership with Build Your Own Brand to include Health Canada compliance for Canadian entry and TGA registration for Australia.