Made in America. Trusted in global markets.

Yes. F.A.M.E. Complete — our enterprise tier — is specifically structured for international distributors and retail buying groups managing multiple SKUs across multiple markets. Dedicated VP-level account management, priority scheduling, and multi-market compliance documentation included. Contact partnerships@famehealthlabs.com to discuss.

Yes, and this is critical. Several ingredients approved by the FDA are prohibited or restricted in the EU, Canada, GCC and APAC. Certain botanicals, high-dose vitamins and novel ingredients face market-specific restrictions. Our formulation team reviews your formula against your target market's permitted ingredient lists before production begins. Getting this right at the formulation stage avoids costly re-work after launch. We tailor your formulation and documentation to your specific target markets from the outset. Regulatory requirements vary by market and product; we recommend working with a local regulatory consultant for country-specific registration.

TGA (Australia) and Medsafe (New Zealand) are among the most stringent supplement regulators globally. Our ISO 17025 COAs, GMP certification and stability data (ICH) align with TGA's Listed Medicine requirements. We provide the documentation package needed to support ARTG listing, formatted to align with TGA requirements. A TGA-registered sponsor handles the registration itself; we supply the manufacturing evidence they need. Regulatory requirements vary by market and product. We recommend working with a local regulatory consultant for country-specific registration.

Yes. GCC markets — Saudi Arabia (SFDA) and UAE (ESMA/MOH) — require Halal certification, CoFS and GMP compliance. We provide Halal-compliant flavor systems through F.A.M.E. Ingredients, GMP and ISO 17025 documentation, and CoFS support for Gulf market registration, with the documentation package formatted for GCC requirements. Contact our partnerships team at partnerships@famehealthlabs.com to discuss your specific target markets. Regulatory requirements vary by market and product. We recommend working with a local regulatory consultant for country-specific registration.

Yes. Since Brexit, the UK operates under its own FSA supplement regulations, separate from EU directives. UK-specific CoFS, label compliance and documentation support is available. Curí's ISO/IEC 17025 accreditation sits under the ILAC Mutual Recognition Arrangement, which UKAS is a signatory to, so accredited results are recognised in the UK. If you are entering both EU and UK simultaneously, we handle both documentation paths and format the package for each. Regulatory requirements vary; a UK regulatory advisor is recommended for product-specific notification.

EU supplement regulations differ significantly from FDA rules — under the EU Food Supplements Directive, permitted vitamins, minerals and maximum levels are tightly controlled. We manufacture to GMP standards, and Curí's ISO/IEC 17025 accreditation sits under the ILAC Mutual Recognition Arrangement, so accredited results are internationally recognised. We support stability testing (ICH), labeling compliance review, and CoFS documentation for EU registration, and we format the documentation package — COAs, CoFS, GMP certificates, stability data and labeling — for your EU market. Registration and notification requirements vary by country and product type; we recommend working alongside a qualified EU regulatory advisor for country-specific notification.

Yes — this is a core part of what we do. Manufacturing in our FDA-registered US facility gives international brands a compliant, credible US-made product with the certification stack American retailers and Amazon require. We guide you through the full process.

Yes. Beyond manufacturing, we support international product registrations, market-specific compliance documentation, and labeling requirements. Our certification stack — Health Canada, NSF, MOSA, SQF, GMP — opens doors across regulated markets.

Yes. Halal and Kosher-compliant flavor systems are available on request through F.A.M.E. Ingredients — essential for Middle East, Southeast Asian, and observant international markets. Let us know your target market and we'll confirm the certification path for your formula.

A Certificate of Free Sale confirms a product is legally sold in its country of origin — required by many countries to import supplements. We provide CoFS documentation support to help your products clear customs and registration in international markets.

Yes. Curí, our ISO 17025 accredited lab, issues a COA with every batch. It is accepted by many international buyers and regulators, but market-specific requirements vary — your regulatory consultant confirms what your market needs.

Yes. We hold Health Canada NHPD certification, so products manufactured here already satisfy Canadian market requirements. No separate facility, no re-manufacturing — your Canadian launch is supported from day one.