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Chitin and Chitosan Compliance: Insights into FDA and EMA Guidelines

Writer's picture: EntoplastEntoplast
A variety of pharmaceutical tablets and capsules
A variety of pharmaceutical tablets and capsules [Image by Adobe Stock]

Chitin and its derivative, chitosan, are becoming essential in the medical and pharmaceutical industries due to their outstanding biocompatibility, biodegradability, and adaptability. These biomaterials are used in drug delivery systems, wound dressings, dietary supplements, and more. As demand grows, understanding regulatory requirements is vital for ensuring safety and compliance. This article explores the guidelines established by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for chitin and chitosan, focusing on human ingestion applications.


Chitin and Chitosan: An Overview

Chitin is a natural polysaccharide found in the exoskeletons of crustaceans, insects, and fungal cell walls. Chitosan, derived from the partial deacetylation of chitin, has enhanced solubility and broader applications. These materials are valued for their:

  • Biocompatibility: Compatible with human tissues.

  • Biodegradability: Breaks down naturally without producing harmful byproducts.

  • Non-toxicity: Safe for use in various applications.

Chitosan is a common ingredient in dietary supplements marketed for weight management, cholesterol reduction, and digestive health.


Regulatory Landscape in the United States (FDA)

The FDA oversees chitin and chitosan products based on their intended use. Key considerations include:


Dietary Supplements

Chitosan is often used as a dietary supplement. Under the Dietary Supplement Health and Education Act (DSHEA) of 1994, these supplements are regulated as food, not drugs. Key guidelines are:

  • GRAS Status: Chitosan may qualify as "Generally Recognised as Safe" (GRAS) if there is substantial evidence supporting its safety for intended uses. (GRAS Notice Inventory fda.gov, 2024)

  • Labelling Requirements: Product labels must comply with FDA regulations. Claims like "supports digestive health" are allowed as structure/function claims, but disease-specific claims need scientific validation and pre-approval. (Dietary supplements fda.gov, 2024)


Medical Devices

An image of a person with gloves applying a bandage on another person's knee.
Applying a medical-grade bandage for optimal wound healing

When used in wound dressings or similar medical devices, chitosan is regulated by the FDA’s Center for Devices and Radiological Health (CDRH). Approval pathways include:

  • 510(k) Premarket Notification: Demonstrating the device is equivalent to a legally marketed predicate device.

  • Premarket Approval (PMA): Required for high-risk devices, involving extensive clinical testing.


Drug Applications

Chitosan in drug delivery systems falls under the FDA’s Center for Drug Evaluation and Research (CDER). Regulatory considerations include:

  • New Drug Application (NDA): Required for products using chitosan as an active ingredient.

  • Investigational New Drug (IND): Necessary for clinical trials assessing safety and efficacy. (Drugs fda.gov, 2024)


Regulatory Landscape in the European Union (EMA)

The EMA regulates medicinal products containing chitin or chitosan across EU member states. Key frameworks include:


Novel Food Regulation

Under Regulation (EU) 2015/2283, chitosan for human ingestion may be classified as a novel food if it lacks a significant history of consumption in the EU before May 1997. Requirements include:

  • Pre-market Authorisation: A detailed dossier proving safety, nutritional value, and the absence of adverse effects.

  • Labelling Standards: Clear instructions and warnings where applicable. (Novel Food food.ec.europa.eu, 2024)


Medicinal Products

For chitosan-based pharmaceuticals, EMA guidelines require:

  • Clinical Trial Applications (CTAs): Approval for conducting human clinical trials in the EU.

  • Marketing Authorisation Application (MAA): Submission of a comprehensive dossier with preclinical and clinical data.


Medical Devices

Medical devices containing chitosan are regulated under the EU Medical Device Regulation (MDR, Regulation (EU) 2017/745). Compliance involves:

CE marking for medical devices
CE marking [Image by europa.eu]
  • CE Marking: Certification ensuring safety and performance standards are met. (CE marking Europa.eu, 2024)

  • Post-Market Surveillance: Ongoing monitoring for continued safety and effectiveness.


Challenges and Considerations

Source and Purity

The origin of chitin and chitosan affects their safety and regulatory approval. Raw materials must be carefully sourced to avoid allergens, heavy metal contamination, or pathogens.

Molecular Weight and Degree of Deacetylation (DDA)

These factors influence the functional properties of chitosan. Standardisation is necessary to ensure consistency and efficacy. Detailed characterisation is often required in regulatory submissions.

Cross-Border Differences

Navigating differing FDA and EMA regulations can be challenging due to variations in definitions and requirements. Companies must address these differences for global market access.


Emerging Trends in Regulation

As chitin and chitosan research progresses, regulatory frameworks are evolving to address novel uses, including:

  • Nanoparticle Delivery Systems: Increased scrutiny of nanoscale chitosan in drug delivery.

  • Bioengineered Sources: New regulations for genetically modified or synthetic production methods.

  • Sustainability and Traceability: Rising emphasis on sustainable sourcing and supply chain transparency.


Navigating the complex regulatory requirements for chitin and chitosan demands expertise. Entoplast is a leader in producing high-quality, highly pure chitin and chitosan. Our products are meticulously sourced, purified, and characterised to meet the stringent quality standards that facilitate FDA or EMA regulatory approval.


At Entoplast, we prioritise innovation, safety, and compliance. Partner with us to confidently bring your chitin and chitosan-based products to market. Contact a team member at hello@entoplast.com 

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