An overview of the regulatory resources available for the dietary supplement industry.
Definition and Purpose
A Supplements Regulatory Guide (SRG) serves as a valuable resource for the food and dietary supplement industry. It enables manufacturers and other stakeholders to navigate the regulatory landscape, meet legal requirements, and ensure the safety and integrity of supplement products.
Scope and Structure
The specific contents and structure of a supplement regulatory guide may vary depending on the country or region it pertains to, as regulations and requirements can differ significantly across markets.
A standard SRG typically covers the following key aspects of compliance:
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Definition and Classification: How food and dietary supplements are legally defined in that specific market.
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Ingredient Requirements: Permitted and prohibited substances, purity standards, and dosage limits.
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Labeling and Claims: Rules regarding mandatory label information and allowable health or nutritional claims.
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Good Manufacturing Practices (GMPs): Standards for production, storage, and handling.
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Safety and Reporting: Protocols for ensuring product safety and reporting adverse events.
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Testing and Quality Assurance: Required laboratory testing and QA procedures.
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Notification/Registration: Procedures for registering products with local authorities before sale.
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Import and Export: Regulations governing the movement of goods across borders.
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Enforcement and Penalties: Overview of regulatory bodies and potential penalties for non-compliance.