Health Supplement Food

Congress defined the term' Dietary supplement ' in the Health Supplement Health Education Act of 1994 (DSHEA). Dietary supplement are foods that people need every day to maintain a healthy life (vitamins, minerals, co-enzymes, carbohydrates, fats, proteins, etc.)

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  FDA (Food and Drug Administration) Approval

  All Dietary Supplements are categorized as food and are subject to FDA control. Although the developer is responsible for its effectiveness or safety, unlike drugs, there is no procedure that requires FDA approval before marketing. (Except for newly developed raw materials) All Dietary Supplements include 'These statements has not been evaluated by the Food and Drug Administration. The phrase “This product is not intended to diagnose, treat, cure, or prevent any disease” must be displayed, and phrases using the name of a specific disease cannot be used in advertising or product packaging. Also, it is against the law to use the word FDA in advertising for commercial purposes, and the FDA will take strong sanctions.
  
  FDA approval from the Dietary Supplement is an import license approval, and all foods imported from foreign countries are tested for safety by investigating the experimental results that do not contain substances harmful to consumers such as heavy metal test, contamination test, bacteria test, and pesticide test. Is to license the import. This stability test is not directly conducted by the FDA and the results are not recognized, and the importer's documents are submitted for approval.

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  Good Manufacturing Practices (GMP)

  If you produce, label, and own dietary supplements that are imported or proposed to be imported into a U.S. state or territory, region of Colombia or the Puerto Rican Union, the current Health Supplement Good Practices Standard (DS CGMP) applies. Retail establishment establishments do not include warehouses or other storage facilities for retailers and other storage facilities that may be sold directly to individual customers.

  • 1. For labeler, DS CGMP regulations are as follows.
    • Meet 21 CFR 111.255 requirements to establish batch production records.
    • Other related requirements such as personnel, facilities and physical facilities and spaces, facilities and equipment, and status maintenance must be observed.

  Since the individual component steps start with the packaging process that has already been completed, there is no need to comply with the characteristics and weights or measurements of each component used in 21 CFR111.260(e) requirements.

  • 2. For Distributor, DS CGMP regulations are as follows.
    • The requirements for storage and distribution must be observed.
    • You must comply with those requirements, such as those for human resources, physical facilities and space.

  If your only customer is a manufacturer that processes dietary ingredients for the manufacture of dietary supplements, you are not subject to DS CGMP. However, by complying with DS CGMP regulations, you can encourage good governance. Companies that package dietary ingredients as simple dietary supplements or label packaged dietary ingredients are subject to DS CGMP regulations. This is because the company is a manufacturer of dietary supplements that are simply packaged or labeled without any additional processing.

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  Packaging and labeling of dietary supplements

  All details of the manufacturing process and steps that need to be controlled to ensure the quality of the dietary supplement must be indicated on the packaging and labeling as specified in the manufacturing record of the finished product of the dietary supplement.

  • Specifications of parts used in the manufacture of dietary supplements
  • Specifications for intermediate production
  • Label and packaging specifications for dietary supplements
  • Product specification for finished products of dietary supplements
  • Specifications for products received from suppliers for packaging and labeling as dietary supplements
  • Packaging and label specifications for dietary supplements that have been packaged and labeled

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  IGC’s Competency

  • IGC is contributing to the continuous development of customers by accurately evaluating the suitability of product certification through the technology and expertise accumulated over the years.
  • IGC has updated knowledge of a wide range of specific scope and legal requirements in major markets around the world, and provides the knowledge and services to support your entire global operations.
  • IGC offers a variety of certification related services in the food area.