1. Product Description

• Product Name: CBD Honey Extract
• Description: This soothing blend of high-quality honey and CBD offers a natural way to promote relaxation and restful sleep. With a potent CBD content, each jar provides a calming effect that enhances overall well-being.
• Intended Use: Oral care; designed for sublingual use.
• Physical Form: Thick, viscous liquid with the potential for natural crystallization due to CBD concentration.
• Packaging: 40 ml dark-colored glass jar to protect contents from light and maintain quality.
• Available Variants:
  • 1000 mg CBD / 40 ml (Cypriot Honey) – CPNP Reference: 4554116
  • 1000 mg CBD / 40 ml (Greek Honey) – CPNP Reference: 4596794
  • 500 mg CBD / 40 ml (Entry Level Product) – CPNP Reference: 4605164

2. Product Claims

• High CBD Content: Each half-teaspoon (2.5 ml) provides a strong dose of CBD.
• Calming Sensation: The synergistic effect of CBD and natural honey promotes relaxation and encourages restful sleep.
• Enhanced Effectiveness: The combination of CBD and honey amplifies the potential benefits, working together to support a peaceful and calm state of mind.

Crystal Formation: Crystals may form on the surface due to natural separation of CBD from the honey. This is a normal occurrence and does not affect product quality or efficacy.

3. Product Safety Report (CPSR)

Part A: Safety Information

• Quantitative and Qualitative Composition:

  • INCI Ingredients:
    • Cannabidiol (CBD) derived from extract or tincture or resin of cannabis
    • Honey Extract
  • Available CBD Concentrations:
    • 1000 mg CBD / 40 ml (Cypriot Honey and Greek Honey)
    • 500 mg CBD / 40 ml

• Physical/Chemical Characteristics and Stability:

  • Store at 15°C to 25°C in a dry, dark, and cool environment.
  • Shelf life: Up to 3 years unopened; use within 12 months after opening.

• Microbiological Quality:

  • Complies with microbiological quality standards for honey-based products.
  • Heavy metal check performed under DIN EN 13657:2003-01 standards.

• Normal and Reasonably Foreseeable Use:

  • Administration: Sublingual application. Place half a teaspoon (2.5 ml) under the tongue and hold for 60-90 seconds for optimal absorption.

Part B: Safety Assessment

• Prepared by: Charalambos Georgiou, Chemical Engineer

Safety Assessment for CBD Honey Extract

This product contains CBD and natural honey, carefully formulated under strict quality and safety protocols. Based on current scientific data, the product is considered safe when used as directed. Due to the natural sugars in honey and the calming effects of CBD, this product is designed to promote relaxation and improve sleep quality.

• Manufacturing Process and Quality Control:
  • CBD extract is produced using a cold ethanol extraction method, ensuring high purity and preservation of bioactive compounds. The extracts are manufactured in a c-GMP compliant facility, adhering to strict Good Manufacturing Practices. All ingredients used are food and cosmetic grade certified.
  • The final product is produced on a small scale under controlled conditions, using a closed-loop system to ensure product purity. All laboratory equipment is sterilized with grain alcohol prior to production, and access to the facility is limited to the chemical engineer for contamination control.
• Storage Conditions:
  • All finished products and raw materials are stored in a humidity- and sunlight-controlled environment to ensure quality and long-term stability.

Safety Profile and Precautions

CBD, even at high concentrations, does not produce fatal effects and has a favorable safety profile. Users should note potential side effects such as dry mouth, mild gastrointestinal discomfort, and drowsiness when using this product in larger doses. Those taking other medications should consult a healthcare provider, as CBD may interact with liver enzymes, potentially affecting the metabolism of certain medications.

4. Usage Instructions

• Recommended Dose: Place half a teaspoon (2.5 ml) under the tongue and hold for 60-90 seconds before swallowing. This allows for optimal absorption and quick effect.
• Frequency of Use: Ideal for use before relaxation activities, such as bedtime or unwinding after a long day. Daily use is recommended for best results.

5. Precautions and Additional Information

• Not a Medical Product: This product is not intended to diagnose, cure, or prevent any medical condition.
• Consultation Recommended: Always consult with a healthcare provider if you have specific health concerns or are taking other medications.
• Storage: Keep in a cool, dark place, away from direct sunlight. Crystallization of CBD in honey is a natural occurrence and does not affect the product’s potency.

6. Labeling Information

• Label Includes:
  • Product name and CBD concentration.
  • Full ingredient list in INCI format.
  • CPNP registration number for each variant.
  • Usage instructions and recommended dosage.
  • Manufacturer’s details and batch number.
  • Net contents (40 ml).
  • Storage conditions and shelf life.
  • Precautionary statements, including “consult a healthcare professional before use.”
  • No animal testing certification.

7. References

• Atalay, S., Jarocka-Karpowicz, I., & Skrzydlewska, E. (2019). Antioxidative and anti-inflammatory properties of cannabidiol. Antioxidants, 9(1), 21. doi:10.3390/antiox9010021
• Samson, S. E., & Singer, S. R. (2016). Anti-inflammatory and antioxidant effects of honey: A potential therapeutic agent in neuroinflammation. Nutrients, 8(9), 564. doi:10.3390/nu8090564
• Russo, E. B., & Hohmann, A. G. (2013). Role of cannabinoids in pain management. Journal of Therapeutic Pain Management, 4(4), 175-189. doi:10.2147/jtpm.s43244
• Eteraf-Oskouei, T., & Najafi, M. (2013). Traditional and modern uses of natural honey in human diseases: A review. Iranian Journal of Basic Medical Sciences, 16(6), 731–742.
• Jalali, S., Hanachi, P., & Safarnejad, M. R. (2019). Neuroprotective effects of honey and its polyphenols: Potential application in cognitive disorders. Journal of Medicinal Food, 22(10), 1003-1010. doi:10.1089/jmf.2018.4322