Food Supplement
Food supplements, also known as dietary supplements, are products taken orally that contain dietary ingredients intended to supplement one’s diet. They come in various forms such as pills, capsules, tablets, powders, or liquids.
They are intended to complement the diet and provide essential nutrients, such as vitamins, minerals, amino acids, fatty acids, or other substances like enzymes and probiotics.
In many countries, food supplements are regulated as a category of food rather than drugs. This means they are not subjected to the same rigorous testing and approval process as pharmaceutical drugs. However, reputable manufacturers follow Good Manufacturing Practices (GMP) to ensure quality and safety.
Food supplements, or dietary supplements, are orally consumed products that help fill nutritional gaps by providing key nutrients such as vitamins, minerals, amino acids, fatty acids, and probiotics. Available in capsules, tablets, powders, and liquids, these supplements support overall health. Although often regulated as food rather than medicine, trusted manufacturers follow Good Manufacturing Practices (GMP) to ensure safety and quality.
Overview on Registration Process
Determine the Appropriate Authority
The first step involves identifying the government agency responsible for regulating food supplements in your country, typically falling under the jurisdiction of the Ministry of Health (MoH) or a dedicated food safety authority. Examples include:
- USA – Food and Drug Administration (FDA)
- South Korea – Ministry of Food and Drug Safety (MFDS)
- Canada – Health Canada
- Saudi Arabia – Saudi Food and Drug Authority (SFDA)
In some regions, food supplement regulation is under the purview of a food safety authority, examples being:
- EU – European Food Safety Authority (EFSA)
- UK – Food Standards Agency (FSA)
- India – Food Safety and Standards Authority of India (FSSAI).
- Australia – Therapeutic Goods Administration (TGA) and Food Standards Australia New Zealand (FSANZ).
License Application
Once you know the regulatory body, you’ll need to notify the regulatory body or apply for a license or registration depending on thejurisdiction. This typically involves filling out an application form and submitting required documents.
Documentation
The specific documents required will vary, but they may generally include:
- Technical Files: Generally, include:
- Product Information: Details including name, description, ingredients, and formulation.
- Manufacturing Information: Details of the manufacturing process and facility.
- Quality Control Documentation: Certificates of analysis and laboratory test results, including GMP (Good Manufacturing Practices) certificates and HACCP documentation.
- Nutritional Information: Nutritional composition analysis.
- Labeling and Packaging Information: Samples or drafts of the product label and packaging.
- Ingredient Safety Documentation: Safety data for all ingredients.
- Product Samples: Samples for testing and evaluation.
- Business Licenses: Business licenses and registrations.
- Legal Documents: Power of attorney or authorization letters if applicable.
Authorized Representative
Generally, Authorized Representatives are required in case of selling food supplements in foreign countries to maintain communication and supporting foreign manufacturers with local requirements such as vigilance, compliance as per the ministry of health requirements or regulations.
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