Browse Supplements & Health Food OEM and contract manufacturers in Japan. Find manufacturing partners for private label and contract production. Filter by small lot options and sample availability. Free consultations available.
Not sure which manufacturer is best for you?
OEM JAPAN's team provides free consultation support. We will guide you to manufacturers that match your requirements.
Not sure which manufacturer is best for you?
OEM JAPAN's team provides free consultation support. We will guide you to manufacturers that match your requirements.
Key regulations and requirements for importing Supplements & Health Food from Japan
Dietary supplements in the US are regulated under DSHEA (Dietary Supplement Health and Education Act of 1994). Products must comply with FDA's Current Good Manufacturing Practices (cGMP) and may require a New Dietary Ingredient (NDI) notification. Health claims are strictly regulated.
Ensure the product does not contain ingredients classified as pharmaceuticals in Japan. Export requires confirmation that the product meets the destination country's supplement definition.
Ministry of Health, Labour and Welfare (MHLW)
Manufacturing facilities must be registered with FDA and comply with 21 CFR Part 111 (cGMP for dietary supplements). FDA may conduct inspections.
Not sure which manufacturer is best for you?
OEM JAPAN's team provides free consultation support. We will guide you to manufacturers that match your requirements.
Food and Drug Administration (FDA)
If a dietary ingredient was not marketed in the US before October 15, 1994, an NDI notification must be submitted to FDA at least 75 days before marketing.
Food and Drug Administration (FDA)
Must include a 'Supplement Facts' panel (not Nutrition Facts), listing serving size, active ingredients with daily values, and other ingredients. Structure/function claims require FDA notification and disclaimer.
Food and Drug Administration (FDA)
Dietary supplements cannot claim to diagnose, treat, cure, or prevent any disease. Only structure/function claims are permitted (e.g., 'supports immune health'), and these require the disclaimer: 'This statement has not been evaluated by the FDA.'
Some ingredients common in Japanese supplements may not be permitted in the US. For example, certain botanical extracts may require NDI notification, and some ingredients may be classified as drugs rather than supplements.
6-12 months (NDI notification review takes 75+ days, cGMP audit, labeling compliance)
Importing dietary supplements (health foods) into China is one of the most challenging regulatory processes. Products claiming health benefits require SAMR 'Blue Hat' (保健食品) registration, which can take 2-5 years. Alternatively, some vitamin/mineral supplements can use the simplified filing (备案) process.
Determine whether the product is classified as a regular food, health food (保健食品), or new food ingredient in China. This classification dictates the entire regulatory pathway.
Ministry of Health, Labour and Welfare (MHLW)
Products making health function claims must undergo SAMR registration, including product testing at designated Chinese labs, clinical trials (for certain claims), and expert review. The 'Blue Hat' logo must appear on the label.
State Administration for Market Regulation (SAMR)
Imported vitamin and mineral supplements using ingredients from the approved filing list can use the simplified filing process (typically 3-6 months), avoiding the lengthy registration process.
State Administration for Market Regulation (SAMR)
Manufacturing facility must be registered with GACC in addition to the product-level registration/filing.
General Administration of Customs of China (GACC)
Blue Hat registration for imported health foods typically takes 2-5 years and costs $50,000-$200,000+. Many Japanese supplement companies choose to reformulate as 'regular foods' without health claims to avoid this process.
If the supplement contains ingredients not previously approved for use in China, a separate 'New Food Ingredient' approval must be obtained from the National Health Commission (NHC), adding another 1-2 years.
Filing route: 6-12 months | Registration (Blue Hat): 2-5 years
This information is provided for reference purposes only and does not constitute legal advice. Regulations may change. Please consult with qualified trade compliance professionals for your specific situation.