The specific requirements of the U.S. market for U.S. FDA certification for collagen include the following aspects:
Safety assessment: Collagen products must undergo strict safety assessment, including acute toxicity test, long-term toxicity test, teratogenicity test, reproductive toxicity test, etc., to prove that the product is safe and harmless to the human body.
Component analysis: Applicants are required to provide a detailed component analysis report, including key indicators such as molecular weight, purity, amino acid composition and other key indicators of collagen, as well as possible impurities and contaminants.
Production process and quality control: Applicants need to provide detailed production process flow charts and quality control documents, including regulations on raw material procurement, production process, quality control standards, storage and transportation, etc. These documents need to prove that the product's manufacturing process and quality control meet the requirements of the U.S. FDA.
Labels and instructions: The labels and instructions of collagen products need to comply with the regulations of the US FDA, including information on product names, ingredient lists, usage methods, precautions, etc. This information must be true, accurate, and easy to understand in order to protect the rights and interests of consumers.
Clinical trials: If a collagen product needs to be tested in humans, then a clinical trial that meets the requirements of the US FDA is required. Clinical trials need to be approved by an ethics committee and designed and conducted in accordance with FDA regulations.
Continuous supervision: After obtaining the US FDA certification, applicants also need to accept continuous supervision from the FDA, including regular product quality spot checks, production site inspections, and other aspects of supervision and inspection. If non-compliance is found, the FDA will propose corrective measures and impose corresponding penalties.