The global dietary supplement market is growing rapidly, but so is the complexity of regulatory compliance. Selling supplements in the United States, European Union, Australia, or the United Kingdom requires navigating different legal frameworks, certification requirements, and labeling standards. United States: FDA and DSHEA Under the Dietary Supplement Health and Education Act (DSHEA) of 1994, …
The global dietary supplement market is growing rapidly, but so is the complexity of regulatory compliance. Selling supplements in the United States, European Union, Australia, or the United Kingdom requires navigating different legal frameworks, certification requirements, and labeling standards.
United States: FDA and DSHEA
Under the Dietary Supplement Health and Education Act (DSHEA) of 1994, new dietary ingredients (NDIs) require an NDI notification submitted to the FDA at least 75 days before marketing. Manufacturers must follow 21 CFR Part 111 (cGMP), conducting identity testing, purity testing, and batch-level quality control. Dongying Zuoning Biotechnology holds FDA Facility Registration No. 129984999556.
European Union: EFSA and Novel Food
In the EU, food supplements comply with Directive 2002/46/EC. All health claims require authorization from the European Food Safety Authority (EFSA) only approved claims on the EU Register can be used. Novel Food Regulation (EU) 2015/2283 applies to ingredients not consumed significantly in the EU before 1997. A responsible person in the EU is required for each market.
United Kingdom: UK MHRA
Post-Brexit, the UK regulates supplements under the Food Safety Act 1990 and FSA guidelines. Nutrition and health claims must comply with the UK-specific Register of Approved Health Claims. Natasha’s Law applies to prepacked for direct sale (PPDS) products.
Australia: TGA
Australias Therapeutic Goods Administration (TGA) takes a stricter approach: Listed Medicines (AUST L) for lower-risk products with pre-approved ingredients, and Registered Medicines (AUST R) for higher-risk products requiring full efficacy documentation. Products must be correctly listed or registered before import.
Canada: Health Canada
Each supplement requires a Health Canada NPN (Natural Product Number), manufacturers need a Site License, and production must comply with Natural Health Product GMP requirements.
Good Manufacturing Practice (GMP): The Foundation
Regardless of target market, GMP is the universal quality standard. Dongying Zuoning Biotechnology holds GMP, ISO 9001:2015, and ISO 22000 and HACCP certifications.
Certifications Your Manufacturer Should Have
GMP Certificate | ISO 9001:2015 | ISO 22000/HACCP | FDA Facility Registration | Third-Party Lab Testing | Halal/Kosher (if targeting Muslim or Jewish markets)
Export Documentation Package
Essential documents for every export order: Certificate of Free Sale (CFS), Certificate of Origin, Certificate of Analysis (CoA), Bill of Lading/Commercial Invoice, and Ingredient Specification Sheets.
Partner with a Compliant Manufacturer
Email: wade@zuoningbio.com | Phone: +86 187 5469 6289 | Website: www.zuoningbio.com
