With the continuous growth of the global dietary supplement market, demand for Quercetin (CAS number: 117-39-5) as a functional food ingredient is steadily increasing. However, the varying quality of Quercetin products in the market presents challenges for both buyers and consumers. Understanding international regulatory requirements and product quality standards is essential for ensuring product safety and effectiveness.

1. U.S. FDA Regulation

In the United States, Quercetin as a dietary supplement ingredient is regulated by the FDA. According to the Dietary Supplement Health and Education Act (DSHEA), dietary supplement manufacturers must comply with the following requirements:

• GRAS Certification: The U.S. FDA has designated Quercetin as “Generally Recognized As Safe” (GRAS) for use in food and beverage industries
• Manufacturing Standards: Compliance with cGMP (Current Good Manufacturing Practice) standards is a fundamental requirement for FDA-regulated dietary supplement manufacturers
• Label Accuracy: Product ingredient lists must accurately reflect actual contents

2. EU EFSA Regulation

In the European market, Quercetin as a dietary supplement ingredient is regulated by EFSA (European Food Safety Authority):

• Health Claims Regulation: EU Regulation (EC) No 1924/2006 imposes strict restrictions on functional claims for dietary supplements
• Scientific Evidence Requirements: Any health claims regarding Quercetin must be based on sufficient scientific evidence
• Novel Food Regulations: Some high-purity quercetin may require approval under Novel Food regulations

3. Other Major Markets

• Australia TGA: Regulated as a complementary medicine ingredient
• Canada: Regulated as a Natural Health Product (NHP)
• Japan: Regulated as a functional food ingredient

1. Purity Testing

• HPLC Purity: ≥98%
• Single impurity: ≤0.5%
• Total impurities: ≤2.0%

2. Heavy Metal Testing

Heavy Metal	Limit Standard
Lead (Pb)	≤10 ppm
Arsenic (As)	≤3 ppm
Cadmium (Cd)	≤1 ppm
Mercury (Hg)	≤0.5 ppm

3. Microbial Limit Testing

• Total plate count: ≤1000 CFU/g
• Mold and yeast: ≤100 CFU/g
• E. coli: Not detected

4. Physical Indicator Testing

• Moisture content: ≤5.0%
• Ash: ≤5.0%
• Particle size: According to product specifications

1. Source: Natural Extraction vs. Chemical Synthesis

Quercetin production primarily uses natural extraction methods. Natural Extraction: Extracted from plants such as sophora flowers and onion skins. Chemical Synthesis: Total synthesis route with good batch consistency.

2. Purification Process

• Multiple crystallization
• Chromatographic separation
• Activated carbon adsorption treatment

3. Packaging and Storage Conditions

• Packaging Materials: Light-resistant packaging required (such as aluminum foil composite bags)
• Storage Temperature: Recommended 0-10°C refrigerated
• Humidity Control: Relative humidity ≤60%

1. Verify Product Specifications

Request suppliers to provide detailed Certificates of Analysis (COA), confirming the following key parameters: CAS Number: 117-39-5, Purity: ≥98%, Molecular Formula: C15H10O7.

2. Review Supplier Qualifications

Select suppliers with relevant certifications: ISO 9001 (Quality Management System), ISO 22000 (Food Safety Management System), cGMP certification, and Kosher/Halal certification for specific markets.

3. Request Testing Reports

Batch testing reports should include HPLC purity testing, heavy metal content testing, microbial limit testing, and stability research data.

4. Sample Testing

Conduct small batch sample testing, comparison with market reference standards, and solubility and absorbability testing.

Selecting suppliers with comprehensive quality management systems and the ability to provide complete technical documentation helps ensure consistent product quality and stability. In an increasingly competitive market, compliant operations and quality assurance are key factors for sustainable business development.

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