In the ever-evolving landscape of the food supplements industry, ensuring regulatory compliance is a critical aspect of business success. Strict adherence to regulatory standards not only guarantees product safety but also fosters consumer trust. The Product Compliance Institute provides comprehensive support to businesses navigating the complexities of this sector. Here’s an overview of key considerations and practices for regulatory compliance in the realm of food and dietary supplements:

Regulatory Framework:

• Familiarize yourself with local, regional, and international regulations governing food supplements.
• Stay updated on amendments and revisions to ensure ongoing compliance.

Ingredient Approval:

• Verify that all ingredients used in your supplements are approved for use in food products.
• Conduct thorough assessments of ingredient safety and efficacy before incorporating them into formulations.

Labeling Requirements:

• Ensure accurate and clear labeling of all components, including active ingredients and nutritional information.
• Comply with guidelines on health claims, avoiding misleading statements or unverified assertions.

Good Manufacturing Practices (GMP):

• Implement and uphold GMP standards to guarantee the quality, safety, and consistency of your products.
• Regularly audit and update manufacturing processes to align with the latest GMP guidelines.

Documentation and Record-Keeping:

• Maintain comprehensive records of all aspects of production, from ingredient sourcing to final product distribution.
• Establish a robust documentation system to facilitate traceability and accountability.

Quality Control Testing:

• Conduct rigorous testing for contaminants, purity, and potency to ensure product safety and efficacy.
• Establish protocols for routine batch testing and third-party verification.

Regulatory Audits and Inspections:

• Be prepared for regulatory audits by maintaining organized records and documentation.
• Address any identified non-compliance issues promptly and implement corrective actions.

Adverse Event Reporting:

• Establish a system for monitoring and reporting adverse events related to your supplements.
• Comply with reporting requirements to regulatory authorities in a timely and transparent manner.

International Market Considerations:

• Research and comply with regulatory requirements in target international markets.
• Obtain necessary certifications and approvals for each market to facilitate global distribution.

Continuous Monitoring and Adaptation:

• Regularly assess and reassess your compliance strategies to accommodate changes in regulations.
• Foster a culture of continuous improvement to stay ahead of emerging compliance challenges.

Industry Collaboration and Networking:

• Engage with industry associations and regulatory bodies to stay informed about industry trends and upcoming changes.
• Participate in forums and conferences to exchange insights with peers and regulatory experts.

Examples of various regulations affecting dietary supplements worldwide:

• Turkey: Regulation on Food Supplements
• Taiwan: Regulations for Application of Health Food Permit (Draft)
• Panama: Resolución Ministerial “Que establece la reglamentación para la inscripción de Suplementos Vitamínicos, Dietéticos y Alimenticios con Propiedades Terapéuticas” (Ministerial Resolution establishing the regulations for the registration of vitamin, dietary and food supplements with therapeutic properties).
• Brazil: Lists of constituents, limits of use, health claim, and labelling for food supplements
• Philippines: Guidelines for the Classification of Vitamins and Minerals for Food/Dietary Supplements under Processed Food Product Repealing the Provisions for Food in the Office Order No. 22 s. 1991 entitled “Guidelines for the Classification of Vitamins and Minerals as Drug or as Food”
• Vietnam: National technical regulation on maximum level contaminants in health supplements.
• EU: Directive 2002/46/EC on food supplements

Do not hesitate to contact us directly to talk about your challenges regarding the global regulatory compliance for dietary supplements.