Overview: We are seeking an expert in FDA compliance for dietary supplements to review the label design and packaging of our product. This project aims to ensure our packaging meets all regulatory requirements for the U.S. market, starting with one product with the potential to extend to others based on performance. Responsibilities: - Review current packaging and label design against FDA regulations to identify areas of non-compliance. - Advise on improvements to align with FDA standards and avoid classification as a drug. - Ensure that the product can be imported into the U.S. without compliance issues. - Validate Supplement Facts for correctness, including format, mandatory information, and graphic elements. - Assess and suggest modifications for net quantity, ingredients list, and structure/function claims to meet FDA guidelines. Requirements: - Proven experience in FDA compliance for dietary supplements, specifically within the U.S. market. - Familiarity with FDA labeling requirements, including net quantity, Supplement Facts, ingredients list, and claims. - Ability to provide actionable feedback and solutions for compliance issues. - Excellent communication skills, with the ability to explain complex regulations in understandable terms. Project Scope: The initial project will focus on one product. Success in this role could lead to additional projects covering more products in our portfolio. Our current labeling faces several compliance issues, including incorrect net quantity labeling, non-compliant Supplement Facts labeling (missing information, incorrect formatting), inappropriate ingredient listings, potential new dietary ingredient notification requirements, and more. We seek a professional who can address these concerns effectively.
Keyword: Product Review
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