Global Dietary Supplement Regulation and Compliance Made Simple

Freyr ensures your Dietary supplements meet Regulatory standards worldwide—covering classification, labeling, claims, and approvals for safe, successful market entry.

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Understanding Dietary Supplements

Dietary supplements include a wide range of vitamins, minerals, herbal ingredients, probiotics, and products commonly marketed for sports nutrition. Depending on their composition and the Regulatory framework of each market, these products are intended to supplement the diet and support specific nutritional or physiological functions. They are not intended to diagnose, treat, cure, or prevent any disease.

Navigating these evolving Regulatory landscapes is critical to ensuring safety, consumer trust, and successful market access. Freyr offers full-spectrum Regulatory solutions tailored to the complex needs of manufacturers and marketers worldwide for

Classification of Dietary Supplements

Dietary supplements are classified into several categories based on their composition and intended use:

  • Infant Formula

    Vitamins and Minerals (VMS)

    Essential micronutrients necessary for various bodily functions, including immune support and metabolism.

  • Infant Formula

    Health Foods

    In Japan, products enriched with bioactive compounds are designed to promote overall wellness and prevent nutritional deficiencies.

  • Infant Formula

    Natural Health Products (NHPs)

    In Canada, this category, recognized in countries like Canada, comprises herbal medicines, probiotics, and homeopathic products.

  • Infant Formula

    Complementary Medicines

    In Australia, they include traditional, homeopathic, and herbal medicines used in alternative healthcare systems.

  • Infant Formula

    Sports Nutrition Products

    Supplements designed to enhance athletic performance, muscle growth, endurance, and recovery, including protein powders, amino acids, and energy boosters.

 

Dietary Supplement Claims and Compliance

Claims associated with dietary supplements are highly regulated to prevent misinformation. These include:

Health Claims: Statements linking a product to a health benefit (e.g., "Supports immune function").
Manages
Nutrient Content Claims: Claims about the presence of specific nutrients (e.g., "High in Vitamin C").
Manages notification via the SCPN online platform
Structure/Function Claims: Describe how a nutrient supports normal body functions (e.g., "Contributes to normal brain function").
Manages notification via the SCPN online platform
Disease Risk Reduction Claims: Statements about reducing the risk of certain diseases require substantial scientific evidence and Regulatory approval. In the EU, such claims must be authorized by EFSA and listed in the EU Register. These are known as Health Claims in the US and must be FDA-authorized.

 

 

global HAs

How Freyr Can Support

Freyr provides comprehensive Regulatory solutions to ensure dietary supplements compliance with global standards. Our services include:

  • Regulatory Intelligence and market entry strategy
  • Dietary supplement registration and approvals
  • Labeling and claims compliance for dietary supplements
  • Ingredient and formulation review for dietary supplement approval
  • Regulatory liaison and submissions
  • Post-market surveillance and compliance
  • Expert consulting for dietary supplement registration and approval

 

 

Why Choose Freyr

  • Proven experience in navigating Dietary Supplements regulations across multiple markets
  • Ensuring Dietary Supplements meet the highest safety and quality standards
  • Tailored regulatory strategies for different Dietary Supplements categories
  • End-to-end Regulatory services for Dietary Supplements market entry
global HAs

Partner with Freyr to ensure global dietary supplements regulatory compliance.

Navigate the complexities of dietary supplement regulations with Freyr’s expertise.

 

Get in touch with us today.