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Nutraceutical Regulations and Registration in Hong Kong (FEHD)

Hong Kong stands out as a dynamic hub in Asia's health supplement market. The trend of consumers embracing a diverse range of dietary supplements for their well-being is on the rise. While vitamin-centric health supplements enjoy wide popularity. In 2022, around 79% of people in Hong Kong took nutritional supplements to improve and strengthen their immune systems. In the meantime, 27% used dietary supplements to improve their skin, hair, and nails. In contrast, a slightly lower proportion of 58% among respondents aged 54 and above acknowledged using such supplements. Moreover, a significant 79% of Hong Kong's populace turned to nutritional and dietary supplements last year to enhance and fortify their immune systems. Concurrently, 27% opted for dietary supplements to enhance the health of their skin, hair, and nails.

Market trends in nutraceuticals and dietary supplements in Hong Kong.

By 2030, it is anticipated that the Hong Kong Nutrition and Supplements market will reach a value of $1.26, growing at a CAGR of 9.5% during 2022-2030. Local players like Vita Green Health, and Right EA Trading lead, buoyed by government efforts, rising health awareness, and robust regulations. The market segments encompass Type, Product, application, and Distribution Channel.

Nutraceutical regulation in Hong Kong

This article outlines the Nutraceutical regulations and registration in Hong Kong (FEHD)

Hong Kong’s Health Authority and legal representation.

The regulation of nutraceuticals and dietary supplements in Hong Kong falls under the purview of several government agencies, primarily the Food and Environmental Hygiene Department (FEHD) and the Department of Health (DOH). These agencies collaborate to ensure that nutraceutical and health supplement products entering the market are safe, accurately labeled, and approved by food regulation organizations.

Hong Kong dietary supplement Registration process

  • Preparation and Documentation: Before initiating the registration process of nutraceutical and dietary supplements, the manufacturer or distributor must gather all necessary documentation, including detailed information about the product's composition, intended use, safety data, labeling, and packaging. This documentation forms the basis for the application.

  • Submission of Application: The applicant submits the completed application and supporting documents to the relevant authority, which is typically the Food and Environmental Hygiene Department (FEHD) in Hong Kong.

  • Review and Evaluation: The FEHD reviews the submitted application and documents to ensure that the product complies with Hong Kong's regulations and standards for nutraceuticals compliance. This evaluation process includes assessing the safety of ingredients, potential health claims, and dietary supplement labeling accuracy.

  • Product Testing: In some cases, the FEHD may request samples of the product for laboratory testing to verify its composition, quality, and safety. GMP compliance for nutraceuticals in HK-This step is especially important for products containing novel ingredients or those with potential health risks.

  • Label Review Nutraceutical Hong Kong: The authorities scrutinize the product's labeling and packaging to ensure that it provides accurate and clear information for consumers following Nutraceutical packaging regulations Hong Kong.

  • Approval and Registration dietary supplements Hong Kong: A registration number is assigned to the nutraceutical product, indicating that it has met the regulatory requirements and can be legally marketed in Hong Kong.

  • Ongoing Compliance: After registration, manufacturers and distributors are responsible for maintaining compliance with the regulations.

Documents required for the nutraceutical registration process in Hong Kong.

  • Product Information: Product name, brand, and description. Intended use and purpose of the product.

  • Ingredients and Formulation- dietary supplement Hong Kong: Comprehensive list of all ingredients, including botanicals, vitamins, minerals, and other bioactive compounds.

  • Labeling and Packaging: Details of all text on the label, including nutritional information, health claims, and usage instructions.

  • Certificate of Analysis (COA): COA for each ingredient and the final product, indicating purity, potency, and absence of contaminants.

  • Safety Data and Scientific Evidence: Scientific studies, clinical trials, or research supporting the safety and efficacy of the product's ingredients and health claims.

  • Manufacturing and Quality Control: Details of the manufacturing process, including quality control measures and Good Manufacturing Practices (GMP) compliance.

  • Adverse Event Reporting: Records of any adverse events reported from other markets, if applicable.

  • Authorization Letter: A letter authorizing a local representative or distributor to act on behalf of the manufacturer.

Fess associated to register of nutraceutical registration Hong Kong.

Approximate Range- HKD 2,000 to HKD 10,000 (or more) per product

Timeline for product registration and approval in Hong Kong.

1. Initial review and document check- 2 to 3 months.

2. Safety and efficacy assessment- 3 to 6 months.

3. Registration approval- 1 to 2 months.



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