What Do You
Want to Make?

Start with your product category, formulation, packaging, order quantity, and sales markets. Compare each proposed facility against those requirements. Ask about sample development, relevant credentials, production documentation, and responsibilities. A useful proposal makes both the scope and the assumptions clear.

Compare production capability, minimum quantities, sampling, packaging availability, freight, import responsibilities, and reorder timing. The lowest unit price may not produce the lowest landed cost. Evaluate domestic and overseas options against the same product specifications.

Review the specific site and the product it will make. Ask which relevant certificates cover that location and process, what documentation will be available, and how samples will be approved. For U.S. food or supplement imports, establish who handles applicable foreign-supplier verification responsibilities; duties vary with the product and importing arrangement.

Learn more: FDA foreign supplier verification

Ask about experience with your product category, manufacturing process, ingredient specifications, and proposed packaging. Review relevant certificates and clarify testing, traceability, and production documentation. For botanical products, identify the ingredient specifications early. Apply these checks to the proposed supplier regardless of country.

Yes, subject to meeting the destination market’s requirements. Korean manufacturing origin does not establish U.S. or EU compliance. Review formulation, claims, labeling, safety documentation, and applicable registrations or notifications for each market. U.S. registration and EU market-entry requirements are different.

Learn more: FDA cosmetics registration · EU cosmetics framework

No. Manufacturing location does not establish authorization for another market. Review the product against applicable U.S. requirements, including classification, formulation, claims, and labeling. FDA does not provide premarket approval for dietary supplements. Cosmetic registration is also distinct from approval.

Learn more: FDA supplement questions · FDA cosmetics registration

First confirm whether the product is classified as a natural health product. These products require licensing before marketing. Commercial importers need the relevant site licence, with the foreign manufacturing site listed on it. A manufacturing certificate does not replace Canadian product and import requirements.

Learn more: Health Canada importing requirements

Confirm the product’s classification, ingredients, and labeling requirements. Manufacturers and importers must notify Health Canada within ten days after first sale. Notification is distinct from approval and does not replace the other requirements that apply to the product.

Learn more: Health Canada cosmetic notifications

Plan for an EU responsible person, a cosmetic product safety report, and notification through the Cosmetic Products Notification Portal, alongside the other applicable requirements. Treat the UK and other non-EU European markets separately when planning your launch.

Learn more: EU cosmetics framework

Do not assume one launch process covers every country. EU food supplement rules provide a shared framework, but individual member states may require notification to their competent authorities. Check each intended market before finalizing your launch plan.

Learn more: EU food supplements

No. FDA registration is not product approval. FDA does not approve dietary supplements, and cosmetic registration or listing does not mean a facility or its products are FDA approved. FDA does not issue certificates verifying cosmetic registration or listing compliance.

Learn more: FDA supplement questions · FDA cosmetics registration

GMP means good manufacturing practice. Its requirements depend on the product category. For U.S. dietary supplements, 21 CFR Part 111 is a key framework. If a supplier claims third-party GMP certification, ask which standard, facility, and activities its certificate covers.

Learn more: FDA supplement GMP

Not necessarily. A facility certified to NSF/ANSI 455-2 is different from a finished product certified under an NSF product program. Ask which certificate applies to the proposed facility and whether your specific product is separately certified.

Learn more: NSF/ANSI 455-2

Ask what the claim describes. A test report relates to the sample and tests reported. Eurofins also offers named GMP certification programs with defined requirements. Request the actual report or certificate and review its scope; a claim should not be broader than its documentation.

Learn more: Eurofins GMP program

ISO 22716 addresses cosmetic manufacturing practices. ISO/IEC 17025 addresses laboratory competence. Review the manufacturing certificate for the proposed facility and laboratory accreditation scope for the relevant tests. Neither is universal authorization to sell a product.

Learn more: ISO 22716 · ISO/IEC 17025

Define product specifications, supplier and site review, sample approvals, appropriate testing, documentation, and release responsibilities. Identify who performs each activity and how changes or results outside the agreed specifications are handled. Required detail depends on the product and intended markets.

Request the agreed specifications, approved samples, proposed testing scope, relevant facility certificates, and production terms. Clarify which batch and test documents will be supplied later, who reviews them, and what must happen before release. Not every document is applicable or available at the same stage.

Do not assume so. Classification, ingredients, claims, labeling, and market-entry requirements need review for each destination. Establish intended markets before finalizing your formula and packaging so differences can be addressed during development.

Learn more: EU cosmetics framework · Health Canada cosmetic notifications