Documents Tab – Jumroll.com
The Documents tab on Jumroll.com is your comprehensive guide to understanding all the crucial documents necessary for health product approval in the United States. Ensuring product safety and efficacy is paramount for us, and we believe in the importance of transparency and clear communication about this process. Here, you’ll find a list of the main documents a health product must possess to be legally approved for sale in the USA.
Product Identification
- Product Label: The product label must include the name of the product, list of ingredients, quantity, dosage, directions for use, and any precautionary information. This also extends to any labeling used in the advertising of the product.
Quality Assurance
- Certificate of Analysis (CoA): A document issued by Quality Assurance that confirms that a regulated product meets its product specification. It contains the actual results obtained from testing performed as part of quality control.
Regulatory Compliance
- Food and Drug Administration (FDA) Approval: If a product is classified as a drug, it must have FDA approval to be marketed. This means it has undergone rigorous testing and been found safe and effective for its intended use.
- Dietary Supplement Health and Education Act (DSHEA) Compliance: If a product is classified as a dietary supplement, it must comply with DSHEA, which requires proper labeling and prohibits marketing the product for the treatment of disease without FDA approval.
- Good Manufacturing Practices (GMP) Certificate: This certifies that a product has been manufactured in a facility that meets FDA’s GMP regulations, ensuring the quality and safety of the product.
Research and Development
- Clinical Trial Results: Health products must provide evidence of safety and efficacy. This is usually done through clinical trials. The results must be documented and available for review.
Safety Documentation
- Material Safety Data Sheet (MSDS): This document provides information about a product’s physical and chemical properties, including potential hazards and safety precautions.
We at Jumroll.com are committed to ensuring that all products sold through our platform meet these essential criteria. Through our Documents tab, we aim to provide clarity and assurance that you are buying quality, reliable, and legal health products.